Conditions: Myeloid Malignancies
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 54
Healthy volunteers: no

Brief summary:
The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab (Mag), in combination with anti-leukemia therapies in participants with acute myeloid leukemia (AML).

Detailed description:
The anti-leukemia therapies are defined as follows:

* Venetoclax (Ven)
* Azacitidine (Aza)
* Mitoxantrone, etoposide, and cytarabine (MEC)

This study consists of 3 safety run-in cohorts;

* Safety Run-in Cohort 1 (1L Unfit AML Mag + Ven + Aza)
* Safety Run-in Cohort 2 (R/R AML Mag + MEC)
* Safety Run-in Cohort 3 (Post-chemo Maintenance Mag + CC-486)

Participants will receive treatment at the assigned dose level for at least 4 cycles in the Safety Run-in cohorts, after which they may continue at the assigned dose level or switch to the RP2D upon agreement between the investigator and the sponsor. After completion of each safety run-in cohort and identification of the RP2D for that cohort, participants may be enrolled into the corresponding Phase 2 cohorts;

* Phase 2 Cohort 1 (1L Unfit AML Mag + Ven + Aza)
* Phase 2 Cohort 2 (R/R AML Mag + MEC)
* Phase 2 Cohort 3 (Post-chemo Maintenance Mag + CC-486)

Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts.

Note: All cohorts are closed to screening and enrollment.

Arms:
arm 1: Participants with newly diagnosed untreated acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy will receive magrolimab 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose in every 28-day cycle along with azacitidine and venetoclax first in the Safety Run-in Cohort. Once the safety of recommended dose of magrolimab is confirmed, the participants in Phase 2 Cohort will be enrolled to receive the treatment. arm 2: Participants with relapsed/refractory (RR) AML after intensive induction chemotherapy will receive magrolimab 1 mg/ on Days 1, 4; 15 mg/kg, on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose along with mitoxantrone + etoposide + cytarabine (MEC) first in the Safety Run-in Cohort. Once the safety of recommended dose of magrolimab is confirmed, the participants in Phase 2 Cohort will be enrolled to receive the treatment. arm 3: Participants with AML who achieved CR or CRi with MRD positivity following intensive induction chemotherapy will receive magrolimab 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose along with CC-486 as maintenance therapy first in the Safety Run-in Cohort. Once the safety of recommended dose of magrolimab is confirmed, the participants in Phase 2 Cohort will be enrolled to receive the treatment.

Interventions: intervention 1: Magrolimab intervention 2: Azacitidine intervention 3: Venetoclax intervention 4: Mitoxantrone intervention 5: Etoposide intervention 6: Cytarabine intervention 7: CC-486
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered either subcutaneously or IV, 75 mg/milligram per square (m\^2) on Days 1 to 7 or Days 1 to 5, 8 and 9 during every cycle intervention 3: Administered orally at a dose of 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle intervention 4: Administered intravenously, 8 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3 intervention 5: Administered intravenously, 100 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3 intervention 6: Administered intravenously, 1000 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3 intervention 7: Administered orally, 300 mg on Days 1-14 during each cycle

Protocol document:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL
Study Title:
A Phase 2 Multi-Arm Study of Magrolimab Combinations in 
Patients with Myeloid Malignancies
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
147229
Not Applicable
NCT04778410
Indication:
Myeloid Malignancies
Protocol ID:
GS-US-546-5920
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List.
Protocol Version/Date:
Original:
10 December 2020
Amendment 1: 15 June 2021
Amendment 2: 20 September 2021
Amendment 3: 27 January 2022
Amendment 4: 09 May 2022
Amendment 5: 11 November 2022
Amendment 6: 02 November 2023
This study will be conducted under United States Food and Drug Administration investigational 
new drug (IND) regulations (21 Code of Federal Regulations Part 312); however, sites located in 
the European Economic Area, United Kingdom, and Switzerland are not included under the IND 
and are considered non-IND sites.
This study will be conducted in compliance with this protocol and in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, and that are consistent with 
International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and applicable 
regulatory requirements.
GILEAU 


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CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable 
institutional review board or independent ethics committee. The information is only to be used 
by you in connection with authorized clinical studies of the investigational drug described in 
the protocol. You will not disclose any of the information to others without written 
authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed 
consent from those persons to whom the drug may be administered.


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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................3
LIST OF IN-TEXT TABLES .........................................................................................................................................7
LIST OF IN-TEXT FIGURES........................................................................................................................................7
PROTOCOL SYNOPSIS................................................................................................................................................8
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .................................................................................24
1.
INTRODUCTION................................................................................................................................................28
1.1.
Background..............................................................................................................................................28
1.1.1.
Acute Myeloid Leukemia......................................................................................................28
1.1.2.
Current Treatment Landscape for Acute Myeloid Leukemia................................................28
1.2.
Magrolimab .............................................................................................................................................29
1.2.1.
General Information ..............................................................................................................29
1.2.2.
Preclinical Pharmacology and Toxicology............................................................................31
1.2.3.
Clinical Studies of Magrolimab.............................................................................................31
1.3.
Information About Venetoclax and Azacitidine......................................................................................35
1.3.1.
Description of Venetoclax.....................................................................................................35
1.3.2.
Description of Azacitidine.....................................................................................................35
1.3.3.
Clinical Data for Venetoclax + Azacitidine ..........................................................................36
1.4.
Information About Mitoxantrone, Etoposide, and Cytarabine................................................................37
1.4.1.
Description of Mitoxantrone .................................................................................................37
1.4.2.
Description of Etoposide .......................................................................................................37
1.4.3.
Description of Cytarabine......................................................................................................37
1.4.4.
Clinical Data for Mitoxantrone, Etoposide, and Cytarabine .................................................37
1.5.
Information About CC-486 .....................................................................................................................37
1.5.1.
Description of CC-486 ..........................................................................................................37
1.5.2.
Clinical Data for CC-486.......................................................................................................38
1.6.
Rationale for This Study..........................................................................................................................38
1.6.1.
Cohort 1 (1L Unfit AML Mag+Ven+Aza): Magrolimab in Combination 
with Azacitidine and Venetoclax in Patients with Newly Diagnosed, 
Previously Untreated AML Who Are Ineligible for Intensive 
Chemotherapy .......................................................................................................................38
1.6.2.
Cohort 2 (R/R AML Mag+MEC): Magrolimab in Combination with 
MEC in Patients with AML Who Are Refractory to or Have Relapsed 
After Initial Induction Chemotherapy...................................................................................40
1.6.3.
Cohort 3 (Post-Chemo Maint Mag+CC-486): Magrolimab in 
Combination with CC-486 in Patients with AML who Achieve CR or 
CRi with MRD Positivity after Intensive Induction Chemotherapy.....................................40
1.7.
Rationale for Dose Selection of Magrolimab..........................................................................................41
1.8.
Risk/Benefit Assessment for the Study ...................................................................................................42
1.9.
Compliance..............................................................................................................................................43
2.
OBJECTIVES AND ENDPOINTS......................................................................................................................44
2.1.
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML Mag+Ven+Aza)...................................44
2.2.
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML Mag+MEC) .................................................45
2.3.
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-Chemo Maint Mag+CC-486) ...............................47
3.
STUDY DESIGN.................................................................................................................................................48
3.1.
Study Design ...........................................................................................................................................48
3.1.1.
Safety Run-in Cohorts ...........................................................................................................49
3.1.2.
Phase 2 Cohorts .....................................................................................................................52


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3.1.3.
Closure of Cohorts 1 and 3....................................................................................................52
3.2.
Study Treatments.....................................................................................................................................52
3.3.
Duration of Treatment .............................................................................................................................56
3.4.
Discontinuation Criteria ..........................................................................................................................56
3.5.
End of Study............................................................................................................................................58
3.6.
Poststudy Care.........................................................................................................................................58
3.7.
Source Data .............................................................................................................................................58
3.8.
Pharmacokinetics/Biomarker Testing .....................................................................................................58
3.8.1.
Biomarker and Genomic Samples to Address the Study Objectives ....................................58
3.8.2.
..................................59
4.
PATIENT POPULATION ...................................................................................................................................60
4.1.
Number of Patients and Patient Selection ...............................................................................................60
4.1.1.
Patient Replacement ..............................................................................................................60
4.2.
Inclusion Criteria.....................................................................................................................................60
4.3.
Exclusion Criteria....................................................................................................................................64
5.
INVESTIGATIONAL MEDICINAL PRODUCTS.............................................................................................66
5.1.
All Cohorts (Magrolimab).......................................................................................................................66
5.1.1.
Description and Handling of Magrolimab.............................................................................66
5.1.2.
Dosage and Administration of Magrolimab..........................................................................67
5.1.3.
Dose Modification and Delays for Magrolimab....................................................................68
5.1.4.
Premedication and Prophylaxis for Magrolimab...................................................................70
5.1.5.
Prior and Concomitant Medications: Permitted Concomitant Medications 
for All Cohorts.......................................................................................................................70
5.2.
Cohort 1 (1L Unfit AML Mag+Ven+Aza)..............................................................................................71
5.2.1.
Description and Handling of Venetoclax ..............................................................................72
5.2.2.
Description and Handling of Azacitidine..............................................................................72
5.2.3.
Dosage and Administration of Azacitidine and Venetoclax .................................................72
5.2.4.
Premedication and Prophylaxis for Azacitidine and Venetoclax..........................................73
5.2.5.
Dose Modification and Delays for Azacitidine and Venetoclax...........................................74
5.2.6.
Prior and Concomitant Medications: Prohibited Concomitant Medications 
for Cohort 1 ...........................................................................................................................77
5.3.
Cohort 2 (R/R AML Mag+MEC)............................................................................................................78
5.3.1.
Description and Handling of Mitoxantrone...........................................................................78
5.3.2.
Description and Handling of Etoposide ................................................................................79
5.3.3.
Description and Handling of Cytarabine...............................................................................79
5.3.4.
Dosage and Administration of Mitoxantrone, Etoposide, and Cytarabine............................80
5.3.5.
Premedication and Prophylaxis for Mitoxantrone, Etoposide, and 
Cytarabine .............................................................................................................................80
5.3.6.
Dose Modification and Delays for Mitoxantrone, Etoposide, and 
Cytarabine .............................................................................................................................80
5.3.7.
Prior and Concomitant Medications: Prohibited Concomitant Medications 
for Cohort 2 ...........................................................................................................................81
5.4.
Cohort 3 (Post-Chemo Maint Mag+CC-486)..........................................................................................81
5.4.1.
Description and Handling of CC-486....................................................................................82
5.4.2.
Dosing and Administration of CC-486..................................................................................82
5.4.3.
Premedication and Prophylaxis for CC-486..........................................................................82
5.4.4.
Dose Modification and Delays for CC-486...........................................................................82
5.4.5.
Prior and Concomitant Medications: Prohibited Concomitant Medications 
for Cohort 3 ...........................................................................................................................84
5.5.
Accountability for Investigational Medicinal Product ............................................................................84
5.5.1.
Investigational Medicinal Product Return or Disposal .........................................................85
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6.
STUDY PROCEDURES......................................................................................................................................86
6.1.
Patient Enrollment and Treatment Assignment.......................................................................................86
6.2.
Pretreatment Assessments .......................................................................................................................86
6.2.1.
Screening Visit ......................................................................................................................86
6.2.2.
Baseline/Day 1 Assessments .................................................................................................87
6.3.
On-Study Treatment Assessments...........................................................................................................88
6.4.
Efficacy Assessments ..............................................................................................................................88
6.5.
Safety Assessments .................................................................................................................................89
6.5.1.
Pregnancy Test ......................................................................................................................89
6.5.2.
Complete Blood Counts ........................................................................................................89
6.5.3.
Type and Screen and Direct Antiglobulin Test .....................................................................90
6.5.4.
Vital Signs .............................................................................................................................90
6.5.5.
Physical Examination ............................................................................................................90
6.5.6.
Electrocardiograms................................................................................................................90
6.5.7.
Adverse Events......................................................................................................................90
6.5.8.
Laboratory Assessments........................................................................................................90
6.5.9.
Concomitant Medications......................................................................................................92
6.6.
Pharmacokinetic Assessments.................................................................................................................93
6.7.
Immunogenicity Assessments .................................................................................................................93
6.8.
Pharmacodynamics and Biomarker Assessments ...................................................................................93
6.8.1.
Minimal Residual Disease.....................................................................................................93
6.8.2.
Leukemia Stem Cell Frequency ............................................................................................94
6.8.3.
Leukemia Mutation Profiles and Burden ..............................................................................94
6.8.4.
Changes in Immune Effector Cell Composition ...................................................................94
6.8.5.
Changes in Immune Effector Cell Signaling Molecules .......................................................94
6.8.6.
Expression of Prophagocytic and Antiphagocytic Signals by Leukemia 
Cells.......................................................................................................................................95
6.9.
Posttreatment Assessments......................................................................................................................95
6.10.
Assessments for Early Discontinuation from Study................................................................................95
6.11.
End of Study............................................................................................................................................95
6.12.
Poststudy Care.........................................................................................................................................95
6.13.
Sample Storage........................................................................................................................................95
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT................................................................................96
7.1.
Definitions of Adverse Events and Serious Adverse Events...................................................................96
7.1.1.
Adverse Events......................................................................................................................96
7.1.2.
Serious Adverse Events.........................................................................................................96
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports .........................98
7.2.
Assessment of Adverse Events and Serious Adverse Events..................................................................98
7.2.1.
Assessment of Causality for Study Drugs and Procedures ...................................................99
7.2.2.
Assessment of Severity..........................................................................................................99
7.3.
Investigator Reporting Requirements and Instructions ...........................................................................99
7.3.1.
Requirements for Collection Prior to Study Drug Initiation .................................................99
7.3.2.
Adverse Events......................................................................................................................99
7.3.3.
Serious Adverse Events.......................................................................................................100
7.3.4.
Study Drug Special Situations Reports ...............................................................................100
7.3.5.
Concomitant Therapy Reports.............................................................................................100
7.4.
Reporting Process for Serious Adverse Events and Special Situation Reports.....................................101
7.4.1.
Serious Adverse Event Reporting Process ..........................................................................101
7.4.2.
Special Situations Reporting Process ..................................................................................101
7.5.
Gilead Reporting Requirements ............................................................................................................103
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events.........................................................................................................................103


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7.7.
Abnormal Liver Function Tests.............................................................................................................104
7.8.
Toxicity Management............................................................................................................................104
7.8.1.
Magrolimab .........................................................................................................................104
7.8.2.
Venetoclax...........................................................................................................................109
7.8.3.
Azacitidine...........................................................................................................................110
7.8.4.
Mitoxantrone .......................................................................................................................110
7.8.5.
Etoposide .............................................................................................................................110
7.8.6.
Cytarabine............................................................................................................................111
7.8.7.
CC-486 ................................................................................................................................112
8.
STATISTICAL CONSIDERATIONS...............................................................................................................113
8.1.
Analysis Objectives and Endpoints.......................................................................................................113
8.1.1.
Analysis Objectives.............................................................................................................113
8.1.2.
Primary Endpoints...............................................................................................................113
8.1.3.
Secondary Endpoints...........................................................................................................113
8.1.4.
8.2.
Planned Analyses...................................................................................................................................118
8.2.1.
Interim Analysis ..................................................................................................................118
8.2.2.
Primary Analysis .................................................................................................................118
8.2.3.
Final Analysis......................................................................................................................118
8.3.
Analysis Conventions............................................................................................................................118
8.3.1.
Analysis Sets .......................................................................................................................118
8.3.2.
Data Handling Conventions ................................................................................................119
8.4.
Demographic and Baseline Characteristics Analysis............................................................................120
8.5.
Efficacy Analysis...................................................................................................................................120
8.5.1.
Primary Analysis .................................................................................................................120
8.5.2.
Secondary Analyses.............................................................................................................120
8.6.
Safety Analysis......................................................................................................................................120
8.6.1.
Extent of Exposure ..............................................................................................................121
8.6.2.
Adverse Events....................................................................................................................121
8.6.3.
Laboratory Evaluations .......................................................................................................121
8.6.4.
Other Safety Evaluations.....................................................................................................121
8.7.
Pharmacokinetic Analysis .....................................................................................................................121
8.8.
Immunogenicity Analysis......................................................................................................................122
8.9.
Biomarker Analysis...............................................................................................................................122
8.10.
Sample Size ...........................................................................................................................................122
9.
RESPONSIBILITIES.........................................................................................................................................123
9.1.
Investigator Responsibilities .................................................................................................................123
9.1.1.
Good Clinical Practice.........................................................................................................123
9.1.2.
Financial Disclosure ............................................................................................................123
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval..............................................................................................................................123
9.1.4.
Informed Consent ................................................................................................................123
9.1.5.
Confidentiality.....................................................................................................................124
9.1.6.
Study Files and Retention of Records .................................................................................124
9.1.7.
Case Report Forms ..............................................................................................................125
9.1.8.
Investigator Inspections.......................................................................................................126
9.1.9.
Protocol Compliance ...........................................................................................................126
9.2.
Sponsor Responsibilities .......................................................................................................................126
9.2.1.
Protocol Modifications ........................................................................................................126
9.2.2.
Study Reports and Publications...........................................................................................126
9.3.
Joint Investigator/Sponsor Responsibilities ..........................................................................................127
9.3.1.
Payment Reporting ..............................................................................................................127
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9.3.2.
Access to Information for Monitoring.................................................................................127
9.3.3.
Access to Information for Auditing or Inspections .............................................................127
9.3.4.
Study Discontinuation .........................................................................................................127
10.
REFERENCES...................................................................................................................................................128
11.
APPENDICES....................................................................................................................................................132
Appendix 1.
Investigator Signature Page...................................................................................................133
Appendix 2.
Schedules of Assessment and Treatment Administration .....................................................134
Appendix 3
Pandemic Risk Assessment and Mitigation Plan ..................................................................147
Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities ........................................................................................................................152
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements..................................................................................................153
Appendix 6.
Eastern Cooperative Oncology Group Performance Status...................................................157
Appendix 7.
Disease Response Criteria Based on European Leukemia Net (ELN) and 
International Working Group (IWG) Criteria........................................................................158
Appendix 8.
Cockcroft-Gault Method for Estimating Creatinine Clearance .............................................161
Appendix 9.
World Health Organization (WHO) Classification of AML.................................................162
Appendix 10.
Amendment History ..............................................................................................................163
LIST OF IN-TEXT TABLES
Table 1.
Dose Level and Schedule for Safety Run-in Cohort 1 (1L Unfit AML 
Mag+Ven+Aza).......................................................................................................................53
Table 2.
Dose Level and Schedule for Safety Run-in Cohort 2 (R/R AML Mag+MEC) .....................53
Table 3.
Dose Level and Schedule for Safety Run-in Cohort 3 (Post-Chemo Maint 
Mag+CC-486)..........................................................................................................................54
Table 4.
Dose De-escalation for Safety Run-in Cohort 1 (1L Unfit AML Mag+Ven+Aza).................54
Table 5.
Dose De-escalation for Safety Run-in Cohort 2 (R/R AML Mag+MEC)...............................55
Table 6.
Dose De-escalation for Safety Run-in Cohort 3 (Post-Chemo Maint Mag+CC-486).............56
Table 7.
Repriming Guidelines for Magrolimab ...................................................................................69
Table 8.
Magrolimab Dosing Guidance for Planned Surgical Procedures During the Study ...............69
Table 9.
Venetoclax and Azacitidine Dose Modifications and Delays Due to Hematological 
Toxicity....................................................................................................................................75
Table 10.
Azacitidine Dose Modification for Nonhematologic Toxicities .............................................77
Table 11.
Management of Potential Venetoclax Interactions with CYP3A and P-gp Inhibitors............78
Table 12.
CC-486 Dose Modifications for Adverse Reactions ...............................................................83
Table 13.
Laboratory Analyte Listing (to Be Performed at Screening)...................................................91
Table 14.
Laboratory Analyte Listing (to Be Performed During the Study)...........................................92
Table 15.
Management of Infusion-related Reactions...........................................................................107
Table 16.
Pneumonitis Management Algorithm....................................................................................109
LIST OF IN-TEXT FIGURES
Figure 1.
Effect of Magrolimab on Anemia, and Mitigation with a Priming/Maintenance 
Dosing Regimen ......................................................................................................................33
Figure 2.
Treatment-Emergent Adverse Events with ≥ 15% Incidence in Study 5F9005......................34
Figure 3.
In Vitro Phagocytosis of AML Cells with Magrolimab, Azacitidine and/or 
Venetoclax...............................................................................................................................39
Figure 4.
Study Schema ..........................................................................................................................48


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title: 
A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients 
with Myeloid Malignancies
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
147229
Not Applicable
NCT04778410
Study Centers 
Planned:
Approximately 35 centers globally
Primary and 
Secondary 
Objectives and 
Endpoints:
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML 
Mag+Ven+Aza)
Primary and secondary objectives and endpoints for patients with newly 
diagnosed, previously untreated acute myeloid leukemia (AML) who 
are ineligible for intensive chemotherapy are as follows:
Primary Objectives
Primary Endpoints
•
To evaluate the efficacy of 
magrolimab in combination with 
the anti-leukemia therapy 
venetoclax + azacitidine as 
determined by the complete 
remission (CR) rate (Phase 2 
Cohort 1)
•
To evaluate the safety and 
tolerability, and to determine the 
recommended Phase 2 dose (RP2D) 
of magrolimab in combination with 
the anti-leukemia therapy 
venetoclax + azacitidine (Safety 
Run-in Cohort 1)
•
CR rate, defined as the proportion 
of patients who achieve CR as 
determined by the investigator 
based on prespecified criteria 
(Phase 2 Cohort 1)
•
Incidence of dose-limiting toxicities 
(DLTs), treatment-emergent 
adverse events (AEs), and 
laboratory abnormalities according 
to the National Cancer Institute 
(NCI) Common Terminology 
Criteria for Adverse Events 
(CTCAE) Version 5.0 (Safety 
Run-in Cohort 1)
Secondary Objectives
Secondary Endpoints
•
To evaluate additional measures of 
efficacy of magrolimab in 
combination with the anti-leukemia 
therapy venetoclax + azacitidine
•
To evaluate the safety and 
tolerability of magrolimab in 
combination with the anti-leukemia 
•
Overall response rate (ORR), 
including CR, complete remission 
with incomplete hematologic 
recovery (CRi), complete remission 
with partial hematologic recovery 
(CRh), partial remission (PR), and 
morphologic leukemia-free state 
(MLFS) 


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therapy venetoclax + azacitidine 
(Phase 2 Cohort 1)
•
To evaluate the pharmacokinetics 
(PK) of magrolimab in combination 
with the anti-leukemia therapy 
venetoclax + azacitidine 
•
To evaluate the immunogenicity of 
magrolimab in combination 
with the anti-leukemia therapy 
venetoclax + azacitidine 
•
CR/CRi rate
•
Complete remission without 
minimal residual disease (CRMRD−) 
rate
•
Complete remission or complete 
remission with partial hematologic 
recovery (CR/CRh) rate
•
Cytogenetic complete remission 
(cCR)
•
Duration of responses (DOR)
•
Duration of CR
•
Duration of CR/CRi
•
Duration of CR/CRh
•
Event-free survival
•
Overall survival (OS) 
•
Red blood cell (RBC) transfusion 
independence rate
•
Platelet transfusion independence 
rate 
•
Incidence of treatment-emergent 
AEs and laboratory abnormalities 
according to the NCI CTCAE 
Version 5.0 (Phase 2 Cohort 1)
•
Magrolimab concentrations over 
time
•
Rate and magnitude of 
anti-magrolimab antibodies
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML Mag+MEC)
Primary and secondary objectives and endpoints for patients with 
relapsed or refractory (R/R) AML are as follows:
Primary Objectives
Primary Endpoints
•
To evaluate the efficacy of 
magrolimab in combination with 
the anti-leukemia 
therapy mitoxantrone, etoposide, 
and cytarabine (MEC) as 
determined by the CR rate 
(Phase 2 Cohort 2)
•
To evaluate the safety and 
tolerability, and to determine the 
RP2D of magrolimab in 
combination with the 
anti-leukemia therapy MEC 
(Safety Run-in Cohort 2)
•
CR rate, defined as the proportion of 
patients who achieve CR as 
determined by the investigator based 
on prespecified criteria (Phase 2 
Cohort 2)
•
Incidence of DLTs, 
treatment-emergent AEs, and 
laboratory abnormalities according 
to the NCI CTCAE Version 5.0 
(Safety Run-in Cohort 2)


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Secondary Objectives
Secondary Endpoints
•
To evaluate additional measures of 
efficacy of magrolimab in 
combination with the anti-
leukemia therapy MEC
•
To evaluate the safety and 
tolerability of magrolimab in 
combination with the anti-
leukemia therapy MEC (Phase 2 
Cohort 2)
•
To evaluate the PK of magrolimab 
in combination with the 
anti-leukemia therapy MEC 
•
To evaluate the immunogenicity of 
magrolimab in combination with 
the anti-leukemia therapy MEC
•
ORR, including CR, CRi, CRh, PR, 
and MLFS 
•
CR/CRi rate
•
CRMRD− rate
•
CR/CRh rate
•
cCR
•
DOR
•
Duration of CR 
•
Duration of CR/CRi
•
Duration of CR/CRh
•
EFS
•
OS 
•
RBC transfusion independence rate
•
Platelet transfusion independence 
rate 
•
Incidence of treatment-emergent 
AEs and laboratory abnormalities 
according to the NCI CTCAE 
Version 5.0 (Phase 2 Cohort 2)
•
Magrolimab concentrations over 
time
•
Rate and magnitude of 
anti-magrolimab antibodies
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-Chemo Maint 
Mag+CC-486)
Primary and secondary objectives and endpoints for patients with newly 
diagnosed AML who are in CR or CRi with minimal residual disease 
(MRD) positivity following intensive chemotherapy are as follows:
Primary Objectives
Primary Endpoints
•
To evaluate the efficacy of 
magrolimab in combination with 
anti-leukemia therapy CC-486 as 
determined by the MRD negative CR 
rate (Phase 2 Cohort 3)
•
To evaluate the safety and 
tolerability, and to determine the 
RP2D of magrolimab in combination 
with the anti-leukemia therapy 
CC-486 (Safety Run-in Cohort 3)
•
MRD negative CR rate, defined as the 
proportion of patients who maintain 
CR as determined by the investigator 
based on prespecified criteria and reach 
MRD negative disease status as 
determined using multiparameter flow 
cytometry with a sensitivity of < 0.1% 
(Phase 2 Cohort 3)
•
Incidence of DLTs, treatment-
emergent AEs, and laboratory 
abnormalities according to the NCI 
CTCAE Version 5.0 (Safety Run-in 
Cohort 3)


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Secondary Objectives
Secondary Endpoints
•
To evaluate additional measures of 
efficacy of magrolimab in 
combination with the anti-leukemia 
therapy CC-486
•
To evaluate the safety and 
tolerability of magrolimab in 
combination with the anti-leukemia 
therapy CC-486 (Phase 2 Cohort 3)
•
To evaluate the PK of magrolimab in 
combination with the anti-leukemia 
therapy CC-486 
•
To evaluate the immunogenicity of 
magrolimab in combination with the 
anti-leukemia therapy CC-486 
•
MRD negative CR/CRi rate
•
Relapse-free survival (RFS)
•
OS
•
Duration of MRD negative CR
•
Duration of MRD negative CR/CRi
•
RBC transfusion independence rate
•
Platelet transfusion independence 
rate
•
Incidence of treatment-emergent AEs 
and laboratory abnormalities 
according to the NCI CTCAE 
Version 5.0 (Phase 2 Cohort 3)
•
Magrolimab concentrations over 
time
•
Rate and magnitude of 
anti-magrolimab antibodies
Study Design:
This is a Phase 2, open-label, multicenter, multi-arm study to evaluate 
magrolimab in combination with anti-leukemia therapies in patients 
with AML. The study schematic is as follows:
AML = acute myeloid leukemia; MEC = mitoxantrone, etoposide, and cytarabine; 
MRD = minimal residual disease; RP2D = recommended Phase 2 dose
This study will include the following 3 safety run-in cohorts: 
•
Safety Run-in Cohort 1 (1L Unfit AML Mag+Ven+Aza), closed 
to enrollment globally as of Protocol Amendment 5: magrolimab + 
Cohort 1 *: 
1L Unfit AML Ma!!+Ven+Aza: 
Safety run-in (N=6) 
Safety 
Phase 2 
Previously untreated AM L 
evaluation and I Magrolimab + venetoclax 
I 
patients age 
75 years or 
Magrolima b + 
RP2D 
+ azacitidine 
ineligible for intensive 
venetoclax + azacitidine 
-------+ 
induction chemotherapy 
N=40 
Cohort 2: 
R/R AML Mag+MEC: 
Safety run-in (N=6) 
Safety 
Phase 2 
AML patients who are 
evaluation and 
I 
I 
refractory, in fi rst, or in 
RP2D 
Magrolimab + MEC 
second relapse after 
Magrolimab + MEC 
-------+ 
N=30 
intensive induction 
chemotherapy 
Cohort 3* : 
Post-chemo Maint Mag+CC-486: 
Safety run-in (N=6) 
Safety 
Phase 2 
AML patients in CR or CRi 
evaluation and 
I 
I 
RP2D 
Magrolimab + CC-486 
with intensive induction 
Magrolimab + CC-486 
-------+ 
chemotherapy who are 
N=40 
MRD+ 
• Cohorts 1 and 3 closed to enrollment globally as of Protocol Amendment 5. 


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venetoclax + azacitidine in patients with newly diagnosed, 
previously untreated AML who are ineligible for intensive 
chemotherapy
•
Safety Run-in Cohort 2 (R/R AML Mag+MEC): magrolimab + 
MEC in patients with R/R AML
•
Safety Run-in Cohort 3 (Post-chemo Maint Mag+CC-486), 
closed to enrollment globally as of Protocol Amendment 5: 
magrolimab + CC-486 as maintenance therapy in patients with 
newly diagnosed AML who are in CR or CRi with MRD positivity 
following intensive chemotherapy
•
Safety Run-in Cohorts: Initially, 6 patients will be enrolled into 
Safety Run-in Cohorts 1, 2, and 3. Initial dose levels are presented in 
the main protocol. A DLT assessment period of 1 cycle (28 days) 
will occur. 
Dose de-escalation decisions will be made as follows: 
• If no more than 2 patients in a safety run-in cohort experience a DLT 
in Cycle 1, enrollment into the corresponding Phase 2 cohort will 
begin at this dose level. 
• If 3 or more (> 33%) patients in a safety run-in cohort experience a 
DLT up to the end of Cycle 1, another 6 patients will be enrolled in 
that cohort at a lower dose and evaluated in the same manner to 
define the RP2D. 
Dose de-escalation levels are presented in the main protocol. Any dose 
de-escalation for Cohorts 1 and 3 will occur with the combination 
regimen, as there is a lack of dose-dependent toxicities observed with 
magrolimab in over 500 patients treated to date with magrolimab as 
monotherapy or in combination, and agents being evaluated in 
combination with magrolimab have identified or potential dose-related 
toxicities as cytotoxic agents (ie, venetoclax and CC-486). For Cohort 2, 
any dose de-escalation will occur with magrolimab, as the combination 
with chemotherapy (ie, MEC) has not been extensively studied. The 
selected RP2D for any cohort cannot exceed the identified maximum 
tolerated dose (MTD) for that cohort.
DLT Assessment Period: The DLT assessment period is the first cycle 
(28 days). For patients who are being evaluated for prolonged 
myelosuppression, the 28 day DLT assessment period will extend to 
42 days for Safety Run-in Cohorts 1 and 2. Patients are considered 
evaluable for assessment of a DLT if either of the following criteria is 
met in the DLT assessment period: 
•
The patient experienced a DLT at any time after initiation of the first 
dose of study treatment.


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•
The patient did not experience a DLT and completed at least 
4 infusions of magrolimab and at least 14 doses of venetoclax and 
5 doses of azacitidine (Safety Run-in Cohort 1), at least 3 days of 
dosing with MEC (Safety Run-in Cohort 2), or at least 10 doses of 
CC-486 (Safety Run-in Cohort 3).
If a patient experiences a DLT during the DLT assessment period, the 
investigator should contact the medical monitor to discuss whether the 
patient can remain on study drug. Patients who are not evaluable for 
DLT will be replaced in the safety run-in cohorts. 
The DLT definition is provided in the main protocol.
After completion of each safety run-in cohort and identification of the 
RP2D for that cohort, the corresponding Phase 2 cohort may be enrolled 
as follows: 
•
Phase 2 Cohort 1 (1L Unfit AML Mag+Ven+Aza), closed to 
enrollment globally as of Protocol Amendment 5: 40 patients with 
newly diagnosed, previously untreated AML who are ineligible for 
intensive chemotherapy will be enrolled to receive magrolimab + 
venetoclax + azacitidine.
•
Phase 2 Cohort 2 (R/R AML Mag+MEC): 30 patients with R/R 
AML will be enrolled to receive magrolimab + MEC.
•
Phase 2 Cohort 3 (Post-chemo Maint Mag+CC-486), closed to 
enrollment globally as of Protocol Amendment 5: 40 patients with 
newly diagnosed AML who are in CR or CRi with MRD positivity 
following intensive chemotherapy may be enrolled to receive 
magrolimab + CC-486. 
Up to 5 to 10 additional patients may be enrolled in each of the Phase 2 
cohorts to collect additional safety, efficacy, and/or PK/PD data.
Cohort 1 closed to enrollment globally as of Protocol Amendment 5 and 
no new patients enrolled in Cohort 1 thereafter. Cohort 1 patients 
enrolled prior to sponsor’s notification and implementation of Protocol 
Amendment 5 will continue on study until end of study or early 
discontinuation criteria are met as outlined in the main protocol.
Number of 
Patients Planned:
Up to approximately 164 patients will be enrolled in the study, with up 
to 54 patients in the safety run-in cohorts and up to 110 patients in the 
Phase 2 cohorts.
A total of 18 patients were enrolled into Cohort 1 (7 patients in safety 
run-in and 11 patients in Phase 2).
No patients were enrolled into Cohort 3 safety run-in and Phase 2.


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Target 
Population:
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML 
Mag+Ven+Aza), closed to enrollment globally as Protocol 
Amendment 5: patients with newly diagnosed, previously untreated 
AML confirmed based on World Health Organization (WHO) criteria 
who are age 75 years or older, or who are age 18 years to 74 years and 
have comorbidities that preclude the use of intensive chemotherapy
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML 
Mag+MEC): patients with confirmation of AML by WHO criteria who 
are refractory to or have relapsed after the initial intensive 
chemotherapy 
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-chemo Maint 
Mag+CC-486), closed to enrollment globally as of Protocol 
Amendment 5: patients with confirmation of AML by WHO criteria 
who achieved CR or CRi with presence of MRD (MRD positive) after 
intensive induction chemotherapy with or without consolidation therapy 
prior to starting maintenance therapy 
Duration of 
Treatment:
Cohorts 1 and 3: treatment until discontinuation criteria is met. 
Cohort 2: treatment for up to 12 months.
Patients in each safety run-in cohort will receive 1 cycle (28 days) of 
study treatment before being evaluated for DLTs. Patients in the safety 
run-in cohorts will continue study treatment at the assigned dose level 
for at least 4 cycles, after which they may continue at the assigned dose 
level or switch to the RP2D upon agreement between the investigator 
and the sponsor. Safety run-in cohort patients will continue dosing until 
Phase 2 cohort end-of-treatment criteria are met. 
Patients in Phase 2 Cohorts 1 and 3 will receive study treatment until 
disease progression, unacceptable toxicity, and/or loss of clinical 
benefit. 
Patients in Phase 2 Cohort 2 will receive MEC for 2 to 3 cycles. Patients 
who do not achieve an objective response (OR) (ie, CR, CRi, CRh, PR, 
or MLFS) after 2 cycles will be discontinued from therapy. For patients 
achieving a response after 1 to 2 cycles, an additional single MEC cycle 
will be administered. Magrolimab will be administered in Phase 2 
Cohort 2 until disease progression, unacceptable toxicity, and/or loss of 
clinical benefit for up to 12 months.
Diagnosis and 
Main Eligibility 
Criteria:
Inclusion Criteria
All Patients
1) White blood cell (WBC) count ≤ 20 × 103/µL prior to first dose 
of study treatment. If the patient’s WBC count is > 20  103/µL 
prior to first dose of study treatment, the patient can be enrolled, 


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assuming all other eligibility criteria are met. However, ensure 
that the WBC count is ≤ 20 × 103/µL prior to the first dose of 
study treatment and prior to each magrolimab dose for the first 
4 weeks. 
NOTE: Patients can be treated with hydroxyurea and/or 
leukapheresis throughout the study or prior to first dose of study 
treatment to reduce the WBC count to ≤ 20 ×  103/µL to enable 
eligibility for magrolimab dosing.
2) Hemoglobin (Hb) must be ≥ 9 g/dL prior to initial dose of study 
treatment. 
NOTE: Transfusions are allowed to meet Hb eligibility.
3) Adequate liver function as demonstrated by the following:
a.
aspartate aminotransferase ≤ 3.0  upper limit of 
normal (ULN)
b. alanine aminotransferase ≤ 3.0  ULN
c.
bilirubin ≤ 1.5  ULN, or ≤ 3.0  ULN and primarily 
unconjugated if patient has a documented history of 
Gilbert syndrome or genetic equivalent.
4) Patients must have adequate renal function as demonstrated by a 
creatinine clearance (CLcr) ≥ 30 mL/min calculated by the 
Cockcroft-Gault formula.
5) Patient has provided informed consent.
6) Patient is willing and able to comply with clinic visits and 
procedures outlined in the study protocol.
7) Male or female, age ≥ 18 years.
8) Pretreatment blood cross-match completed. 
9) Male patients and female patients of childbearing potential who 
engage in heterosexual intercourse must agree to use 
protocol-specified method(s) of contraception.
10) Patients must be willing to consent to mandatory pretreatment 
and on-treatment bone marrow biopsies (trephines), unless not 
feasible as determined by the investigator and discussed with the 
sponsor.
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML 
Mag+Ven+Aza), closed to enrollment globally as of Protocol 
Amendment 5 
11) Newly diagnosed, previously untreated patients with 
confirmation of AML by WHO criteria who are ineligible for 
treatment with a standard cytarabine and anthracycline induction 


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regimen due to age, comorbidity, or other factors. Patients must 
be considered ineligible for induction therapy defined by the 
following:
a.
≥ 75 years of age
b. ≥ 18 to 74 years of age with at least 1 of the following 
comorbidities:
i. ECOG performance status of 2 or 3
ii. Diffusing capacity of the lung of carbon 
monoxide ≤ 65% or forced expiratory volume in 
1 second ≤ 65%
iii. LVEF ≤ 50%
iv. CLcr < 45 mL/min calculated by the 
Cockcroft-Gault formula 
v. Any other comorbidity that the investigator 
judges to be incompatible with intensive 
chemotherapy that must be approved by the 
sponsor medical monitor before study enrollment. 
12) ECOG performance status:
•
Of 0 to 2 for subjects ≥ 75 years of age
OR
•
Of 0 to 3 for subjects ≥ 18 to 74 years of age
13) Patients who have not received prior anti-leukemia therapy for 
AML (excluding hydroxyurea), hypomethylating agent (HMA), 
low-dose cytarabine, and/or venetoclax. 
NOTE: Patients with prior myelodysplastic syndrome (MDS) who 
have not received prior HMA, venetoclax, or a chemotherapeutic 
agent are eligible. Other prior MDS therapies, including but not 
limited to lenalidomide, erythroid-stimulating agents, or similar 
RBC-, WBC-, or platelet direct therapies or growth factors, are 
allowed.
14) Patients who have not received strong and/or moderate 
cytochrome P450 enzyme 3A inducers (eg, St John’s Wort) 
within 7 days prior to the initiation of study treatment. 
15) Patients who have not consumed grapefruit, grapefruit products, 
Seville oranges (including marmalade containing Seville 
oranges) or starfruit within 3 days prior to the initiation of study 
treatment or are willing to discontinue consumption of these 
while receiving study drug. 


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16) Patients without malabsorption syndrome or other conditions 
that preclude enteral route of administration.
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML Mag+MEC)
17) Patients with confirmation of AML by WHO criteria who are 
refractory to or have experienced first relapse after initial 
intensive chemotherapy, which includes 1 or 2 cycles of a 
7 + 3-based induction regimen or a purine analogue-based 
induction therapy, such as fludarabine or cladribine paired with 
anthracyclines and cytarabine (eg, fludarabine, high-dose 
cytarabine [ara-C], granulocyte colony-stimulating factor 
[G-CSF], and idarubicin [FLAG-Ida] or cladribine, ara-C, 
G-CSF, and mitoxantrone [CLAG-M]) or failed therapy after 
remission (eg, consolidation) during any number of cycles 
(maximum of 4) of high- or intermediate-dose cytarabine. For 
other intensive regimens, please discuss with the medical 
monitor.
NOTE: Patients who are relapsed after or are refractory to more than 
1 line of anti-AML treatment are not eligible.
Patients who relapsed after undergoing stem cell transplant may be 
eligible.
18) At least 2 weeks must have elapsed since any prior anti-leukemia 
agents. 
NOTE: Localized non-central nervous system (CNS) radiotherapy, 
hydroxyurea, and erythroid and/or myeloid growth factors are not 
criteria for exclusion.
19) ECOG performance status of 0 to 2.
20) Patients with LVEF ≥ 50%, lack of symptomatic congestive 
heart failure, or clinically significant cardiac arrhythmias.
21) Patients who have not been treated with trastuzumab within 
7 months prior to the initiation of study treatment
22) Patients who have not previously received maximum cumulative 
doses of anthracyclines and anthracenediones
23) Patients without degenerative or toxic encephalopathies
24) Patients who did not undergo hematopoietic stem cell 
transplantation (SCT) in the past 100 days, are not on 
immunosuppressive therapy post SCT in the 2 weeks prior to the 
first dose of study treatment, or have no active clinically 
significant graft-versus-host disease. 
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-chemo Maint 
Mag+CC-486), closed to enrollment globally as of Protocol 
Amendment 5


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25) Patients with confirmation of AML by WHO criteria who 
achieved a CR or CRi with presence of MRD (MRD positive by 
local flow cytometry assay, defined as ≥ 0.1% detectable MRD) 
after intensive induction chemotherapy with or without 
consolidation therapy, prior to starting maintenance therapy for 
newly diagnosed AML.
26) ECOG performance status of 0 to 2.
27) Patients without malabsorption syndrome or other conditions 
that preclude enteral route of administration.
Exclusion Criteria
All Patients
1) Positive serum pregnancy test.
2) Breastfeeding female.
3) Known hypersensitivity to any of the study drugs, the 
metabolites, or formulation excipient
4) Patients who received any live vaccine within 4 weeks prior to 
initiation of study treatments.
5) Prior treatment with cluster of differentiation 47 (CD47) or 
signal regulatory protein alpha (SIRPα)-targeting agents.
6) Current participation in another interventional clinical trial.
7) Known inherited or acquired bleeding disorders.
8) Clinical suspicion of or documented active CNS involvement 
with AML.
9) Patients who have acute promyelocytic leukemia.
10) Significant disease or medical conditions, as assessed by the 
investigator and sponsor, that would substantially increase the 
risk:benefit ratio of participating in the study. This includes, but 
is not limited to, acute myocardial infarction within the last 
6 months, unstable angina, uncontrolled diabetes mellitus, 
significant active infections, and congestive heart failure New 
York Heart Association Class III-IV.
11) Second malignancy, except MDS, treated basal cell or localized 
squamous skin carcinomas, localized prostate cancer, or other 
malignancies for which patients are not on active anticancer 
therapies and have had no evidence of active malignancy for 
over 1 year. Previous hormonal therapy with luteinizing 
hormone-releasing hormone agonists for prostate cancer; and 
treatment with bisphosphonates and receptor activator of nuclear 
factor kappa-B ligand (RANKL) inhibitors are not criteria for 
exclusion.


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NOTE: Patients on maintenance therapy alone who have no 
evidence of active malignancy for at least ≥ 1 year are eligible.
12) Known medical history of active or chronic hepatitis B or C 
infection or medical history of human immunodeficiency virus 
(HIV) infection.
Study Procedures/
Frequency:
Screening assessments include written informed consent; review of 
medical history; complete physical examination (including vital signs, 
body weight, and height); serum pregnancy test (females of childbearing 
potential); complete blood count (CBC) with differential, platelets, 
reticulocytes; serum or plasma chemistry; prothrombin time, 
international normalized ratio, and activated partial thromboplastin time 
or partial thromboplastin time; extended red blood cell phenotyping or 
genotyping, ABO/Rh type, and screen (any of the 4 blood groups A, B, 
AB, and O composing the ABO system [ABO]/Rh), direct antiglobulin 
test; urinalysis; bone marrow biopsy and aspirate for blast evaluation, 
MRD assessment, cytogenetics, receptor occupancy (RO; to be collected 
at selected study sites), and correlative studies; peripheral blood smear 
for blasts; ECOG performance status; 12-lead electrocardiogram; 
echocardiogram or multigated acquisition (scan) for patients of Cohort 2 
only; and recording of all serious AEs and any AEs related to 
protocol-mandated procedures occurring after signing of the informed 
consent form and prior and concomitant medications.
Eligible patients will return to the study site within 30 days after 
screening for the following baseline/Day 1 assessments: serum or urine 
pregnancy test (females of childbearing potential); predose CBC with 
differential, platelets, reticulocytes and postdose Hb; haptoglobin and 
lactate dehydrogenase; serum or plasma chemistry; peripheral blood 
smear for general morphology; peripheral blood sample for RO (to be 
collected at selected study sites) and correlative studies; buccal swab 
(may be collected at any visit during the study); PK and antidrug 
antibody (ADA) sample collection; vital signs, weight, and symptom-
directed physical examination; and recording of all AEs and 
concomitant medications.
On-treatment assessments include clinical laboratory evaluations; PK 
and ADA evaluations; bone marrow aspirate/biopsy for response 
assessment, MRD assessment, cytogenetics, RO (to be collected at 
selected study sites), and correlative studies; peripheral blood sample for 
RO (to be collected at selected study sites) and correlative studies; vital 
signs and symptom-directed physical examinations; and monitoring for 
AEs and concomitant medications.


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Test Product, Dose, 
and Mode of 
Administration:
Study treatment regimens are presented in the main protocol and 
comprise the following:
Safety Run-in Cohort 1 and Phase 2 Cohort 1, closed to enrollment 
globally as of Protocol Amendment 5
•
Magrolimab 1 mg/kg intravenous (IV)
•
Magrolimab 15 mg/kg IV
•
Magrolimab 30 mg/kg IV
•
Azacitidine 75 mg/m2 subcutaneous or IV
•
Venetoclax 10 mg oral tablets
•
Venetoclax 50 mg oral tablets
•
Venetoclax 100 mg oral tablets 
Safety Run-in Cohort 2 and Phase 2 Cohort 2
•
Magrolimab 1 mg/kg IV
•
Magrolimab 15 mg/kg IV
•
Magrolimab 20 mg/kg IV
•
Magrolimab 30 mg/kg IV
•
Mitoxantrone 8 mg/m2 IV
•
Etoposide 100 mg/m2 IV
•
Cytarabine 1000 mg/m2 IV
Safety Run-in Cohort 3 and Phase 2 Cohort 3, closed to enrollment 
globally as of Protocol Amendment 5
•
Magrolimab 1 mg/kg IV
•
Magrolimab 15 mg/kg IV
•
Magrolimab 30 mg/kg IV
•
CC-486 200 mg oral tablets
•
CC-486 300 mg oral tablets
Reference Therapy, 
Dose, and Mode of 
Administration:
None 


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Criteria for 
Evaluation:
Safety:
Safety will be evaluated by incidence of AEs, assessment of clinical 
laboratory test findings, physical examination, 12-lead 
electrocardiogram, and vital signs measurements. Adverse events will 
be graded using NCI CTCAE Version 5.0.
Efficacy:
Assessment of leukemia response in patients with AML will be 
conducted by investigators and determined based on prespecified 
criteria. 
Pharmacokinetics/ 
Immunogenicity:
Magrolimab concentrations will be evaluated in combination with the 
following: 
•
Venetoclax and azacitidine
•
Mitoxantrone, etoposide, and cytarabine
•
CC-486
Samples will also be collected for the detection of ADAs against 
magrolimab. 
Statistical Methods:
Analysis Data Sets
The All Enrolled Analysis Set is the primary analysis set for analyses of 
patient demographics and baseline characteristics, enrollment, and 
disposition, and includes all patients who receive a study patient 
identification number.
The Full Analysis Set (FAS) is the primary analysis set for efficacy 
analyses and includes all enrolled patients who receive at least 1 dose of 
any study treatment. Treatment assignment in the FAS will be made 
according to the assigned treatment.
The Safety Analysis Set is the primary analysis set for safety analyses 
and includes all patients who receive at least 1 dose of study treatment. 
Treatment assignment in the Safety Analysis Set will be made according 
to the actual treatment received. 
The DLT Evaluable Analysis Set includes all safety run-in cohort 
patients in the Safety Analysis Set who have safety assessments through 
the protocol-specified DLT assessment window and fulfill the 
protocol-specified criteria for evaluation for DLT. 
The PK Analysis Set includes all enrolled patients who receive at least 
1 dose of magrolimab and have at least 1 measurable posttreatment 
serum concentration of magrolimab.
The Immunogenicity Analysis Set includes all enrolled patients who 
receive at least 1 dose of magrolimab and have at least 1 evaluable 
anti-magrolimab antibody test result.


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The Biomarker Analysis Set includes all enrolled patients who receive 
at least 1 dose of magrolimab and have evaluable baseline and 
postbaseline measurements to provide interpretable results for the 
specific parameter of interest.
Efficacy Analysis
The point estimates of the CR rate, CR/CRi rate, CR/CRh rate, CRMRD− 
rate, cCR rate, and ORR and the corresponding 2-sided exact 95% CIs 
based on the Clopper-Pearson method will be provided for Cohorts 1 
and 2. The MRD negative CR rate will be summarized similarly for 
Cohort 3. The analyses of RBC and platelet transfusion independence 
rates (conversion rate and maintenance rate) will be similar to those of 
ORR. The CR and MRD negative CR data will also be tested against the 
historical control rates using 1-group Chi-square test for each cohort 
separately. 
Medians, first quartile, and third quartile of the EFS distribution, and the 
proportion of patients who are event free at Weeks 12, 24, and 48 from 
the first dosing date will be estimated by cohort using the Kaplan-Meier 
(KM) method and the corresponding 95% CIs will be reported. 
Kaplan-Meier plots will be provided. Analyses of OS will be similar to 
those of EFS. 
For the time-to-event endpoints of duration of CR, duration of CR/CRi, 
duration of CR/CRh, DOR, RFS, duration of MRD negative CR, and 
MRD negative CR/CRi, analyses will be conducted on the subsets for 
which the outcome measures are defined. Specifically, the duration of 
CR, duration of CR/CRi, duration of CR/CRh, and DOR will be based 
on patients in Cohorts 1 and 2 who achieve CR, CR/CRi, CR/CRh, and 
OR, respectively. The RFS will be analyzed for Cohort 3, duration of 
MRD negative CR will be based on patients in Cohort 3 who achieve 
MRD negative status and maintain CR, and the duration of MRD 
negative CR/CRi will be based on patients in Cohort 3 who achieve 
MRD negative status and maintain CR/CRi. The KM method will be 
used to estimate median durations and 95% CIs, and KM plots will be 
provided.
Safety Analysis
Extent of exposure to study drugs, AEs, clinical laboratory evaluations, 
graded laboratory abnormalities, vital signs measurements, and physical 
examination findings will be summarized by cohort for the Safety 
Analysis Set using number and percentage of patients for categorical 
data and number of patients, mean, standard deviation, minimum, 
quartiles, median, and maximum for continuous data. Study drug 
administration, study drug compliance, and other safety variables will 
also be summarized.


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Summa1y statistics will be presented for magrolimab senun 
concentrations at each scheduled time point for the PK Analysis Set. 
Plots of individual semm concentration versus time profiles and mean 
concentration versus time profiles will be generated. 
Immunogenicity Analysis 
The rate and magnitude of anti-magrolimab antibody incidence, 
prevalence, persistence, and transience will be summarized for the 
Immunogenicity Analysis Set. Titer summaries may also be generated, 
if relevant. 
Biomai·ker Analysis 
The baseline level, absolute level, and change from baseline level over 
time will be summai·ized using descriptive statistics for each biomarker 
at the applicable sainple collection time point by treatment cohort, as 
appropriate. 
Sainple Size 
Sainple size calculation is as follows: 
• 
For Coho1i 2, a sainple size of 36 (30 patients in Phase 2 Coho1i 2 
together with 6 patients in Safety Run-in Coho1i 2) provides an 
83 .1 % power for a I-group Chi-square test at I-sided alpha of 
0.1 level to detect a CR rate of~ 35% for the combination compai·ed 
with a historical control CR rate of 19%. 
The original protocol for the study included a Cohort 1, for which 
46 patients were planned to be emolled (6 patients in Safety Run-in and 
40 patients in Phase 2); however, Coho1i 1 was closed to emollment 
following emollment of 18 patients (7 patients in safety nm-in and 
11 patients in Phase 2), up to implementation of Protocol Amendment 5. 
The original protocol also included a Coho1i 3, for which 46 patients 
were planned to be enrolled ( 6 patients in Safety Run-in and 40 patients 
in Phase 2); however, Coho1i 3 was closed to enrollment and no patients 
were enrolled. 
This study will be conducted in accordance with the guidelines of Good Clinical Practice, 
including archiving of essential documents. 
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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
5F9
magrolimab
ABO
any of the 4 blood groups A, B, AB, and O composing the ABO system
ADA
antidrug antibody
AE
adverse event
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AML
acute myeloid leukemia
ANC
absolute neutrophil count
aPTT
activated partial thromboplastin time
AST
aspartate aminotransferase
CBC
complete blood count
cCR
cytogenetic complete remission
CD47
cluster of differentiation 47
CI
confidence interval
CLcr
creatinine clearance
CLL
chronic lymphocytic leukemia
Cmax
maximum observed concentration of drug
CMV
cytomegalovirus
CNS
central nervous system
CR
complete remission 
CR/CRh
complete remission or complete remission with partial hematologic recovery
CR/CRi
complete remission or complete remission with incomplete hematologic recovery
CRF
case report form
CRh
complete remission with partial hematologic recovery
CRi
complete remission with incomplete hematologic recovery
CRMRD−
complete remission without minimal residual disease
CRMRD+/unk
complete remission with positive or unknown minimal residual disease
CSR
clinical study report
CYP
cytochrome P450 enzyme
CTCAE
Common Terminology Criteria for Adverse Events
DAT
direct antiglobulin test
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acid
DOR
duration of response


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EC
ethics committee
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDC
electronic data capture
EFS
event-free survival
ELISA
enzyme-linked immunosorbent assay
ELN
European Leukemia Net
EOT
end of treatment
EU
European Union
FAS
Full Analysis Set
Fc
crystallizable fragment
FDA
Food and Drug Administration
GCP
Good Clinical Practice
G-CSF
granulocyte colony-stimulating factor
Gilead
Gilead Sciences
Hb
hemoglobin
HMA
hypomethylating agent
HR
hazard ratio
IB
investigator’s brochure
ICF
informed consent form
ICH
International Council for Harmonisation (of Technical Requirements for 
Pharmaceuticals for Human Use)
IEC
independent ethics committee
IgG4
immunoglobulin G 4
IND
investigational new drug
INR
international normalized ratio
IRB
institutional review board
IRR
infusion-related reaction
IUD
intrauterine device
IV
intravenous
Ki
inhibitory constant
KM
Kaplan-Meier
LHRH
luteinizing hormone-releasing hormone
LSC
leukemia stem cell
LVEF
left ventricular ejection fraction


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mAb
monoclonal antibody
mag
magrolimab
MDACC
MD Anderson Cancer Center
MDS
myelodysplastic syndrome
MEC
mitoxantrone, etoposide, and cytarabine
MedDRA
Medical Dictionary for Regulatory Activities
MLFS
morphologic leukemia-free state
MOA
mechanism of action
MRD 
minimal residual disease
MTD
maximum tolerated dose
MUGA
multigated acquisition (scan)
NCI
National Cancer Institute
NHL
non-Hodgkin lymphoma
OR
objective response
ORR
overall response rate
OS
overall survival
PD
pharmacodynamic(s)
P-gp
P-glycoprotein
PK
pharmacokinetic(s)
PR
partial remission
PS
Patient Safety
PT
prothrombin time
PTT
partial thromboplastin time
Q1
first quartile
Q3
third quartile
QW
once weekly
R/R
relapsed/refractory
RANKL
receptor activator of nuclear factor kappa-B ligand
RBC
red blood cell
RFS
relapse-free survival
RNA
ribonucleic acid
RO
receptor occupancy
RP2D
recommended Phase 2 dose
SAE
serious adverse event
SC
subcutaneous


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SCT
stem cell transplantation
SIRPα
signal regulatory protein alpha
SOC
standard of care
SOP
standard operating procedure
SRT
safety review team
SSR
special situation report
SUSAR
suspected unexpected serious adverse reaction
TLS
tumor lysis syndrome
ULN
upper limit of normal
US
United States
USPI
United States prescribing information
w/v
weight to volume ratio
WBC
white blood cell
WES
whole exome sequencing
WHO
World Health Organization


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1.
INTRODUCTION
1.1.
Background
1.1.1.
Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is an aggressive clonal hematopoietic malignancy of myeloid 
cells in the blood and bone marrow leading to cytopenias and ultimately mortality via sequelae 
of bone marrow failure. The incidence of AML rises from 3 cases per 100,000 people in young 
adults to greater than 20 cases per 100,000 people in older adults. Initial treatment for AML is 
dependent on age and comorbidities. For patients < 60 years of age, 5-year overall survival (OS) 
is approximately 40% to 50% but is only 5% for patients > 60 years of age. For younger patients 
who are fit for intensive chemotherapy, induction chemotherapy with cytarabine and an 
anthracycline chemotherapy is the standard of care (SOC). In patients who are older and/or have 
comorbidities that preclude the use of induction chemotherapy, lower-intensity therapy is given 
with hypomethylating agents (HMAs) and low-dose cytarabine, with or without venetoclax, a 
Bcl-2 inhibitor. In all settings of AML, disease relapse is common despite an initial therapeutic 
response and is the most common reason for death.
1.1.2.
Current Treatment Landscape for Acute Myeloid Leukemia
1.1.2.1.
Patients Newly Diagnosed with AML Who are Ineligible for Intensive 
Chemotherapy
Patients who are older (approximately 75 years of age and older) or who have comorbidities 
precluding the use of intensive induction chemotherapy are treated with HMAs (ie, azacitidine or 
decitabine), low-dose cytarabine, and these agents in combination with venetoclax, a Bcl-2 
inhibitor. In 2018, venetoclax in combination with HMAs or low-dose cytarabine was granted 
accelerated approval in the United States (US) for this population. This approval was based on 
results from multiple single-arm studies in which venetoclax demonstrated a complete remission 
(CR) rate of 37% in combination with azacitidine, 54% in combination with decitabine, and 
21% in combination with low-dose cytarabine {VENCLEXTA 2020}. The median duration of 
CR was approximately 4.8 to 6.0 months. Final results from a subsequent randomized 
Phase 3 trial that evaluated venetoclax + azacitidine versus azacitidine monotherapy in the same 
patient population demonstrated a significant benefit in median OS compared with the control 
arm (14.7 vs 9.6 months, hazard ratio [HR] 0.66) {DiNardo 2020}. In addition, the CR/complete 
remission with incomplete hematologic recovery (CRi) rate was higher in the venetoclax 
+ azacitidine arm than the azacitidine control arm (66.4% vs. 28.3%). These data have supported 
the use of venetoclax in combination with HMAs as the SOC for newly diagnosed patients with 
AML who are ineligible for intensive chemotherapy.


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1.1.2.2.
Patients with Relapsed or Refractory AML after Induction Chemotherapy
Standard of care treatment for newly diagnosed AML patients who are eligible for induction 
chemotherapy consists of a combination of cytarabine and an anthracycline. Despite initial CR 
rates above 50% with induction chemotherapy, a substantial portion will be refractory to initial 
chemotherapy and a majority of patients will ultimately relapse, particularly those with poor-risk 
features. Treatment options in the relapsed/refractory (R/R) setting consist of salvage 
chemotherapy with a goal of undergoing allogeneic stem cell transplantation (SCT) for long-term 
remission. Various salvage chemotherapies are used in the treatment of R/R AML, including 
mitoxantrone, etoposide, and cytarabine (MEC); fludarabine, cytarabine, idarubicin, and 
granulocyte colony-stimulating factor (G-CSF); and G-CSF, clofarabine, and cytarabine. With 
all of these agents, the CR rates range from 15% to 25%, with a median OS of approximately 
3 to 5 months {Feldman 2005, Greenberg 2004}.
1.1.2.3.
Maintenance Therapy for Patients with AML Remission
Given the high relapse rates with available therapies for newly diagnosed AML, maintenance 
therapy for patients who are in remission has been explored and is an area of intense clinical 
interest. Given that induction chemotherapy and consolidation represent a finite treatment 
course, a high rate of relapse can occur after completion of definitive therapy. Novel therapeutic 
agents that are well tolerated and that can extend both relapse-free survival (RFS) and OS are 
needed. Recently, CC-486 (Onureg®, Celgene Corp., Summit, NJ, USA), an oral nucleoside 
metabolic inhibitor in oral tablet formulation, received US Food and Drug Administration (FDA) 
approval for use in AML patients who achieved first CR or CRi following intensive induction 
chemotherapy who are not able to complete intensive curative therapy. This approval was based 
on the randomized Phase 3 study, QUAZAR, which compared CC-486 versus placebo in patients 
55 years and older who were in first CR or CRi following intensive chemotherapy and/or 
consolidation and were ineligible for hematopoietic SCT. The median OS was significantly 
longer for patients who received CC-486 compared with those who received placebo (24.7 vs. 
14.8 months, HR 0.69) {ONUREG 2020}. Relapse-free survival was also significantly longer in 
those who received CC-486 compared with those who received placebo (10.2 vs. 4.8 months). 
The minimal residual disease (MRD) negativity rate for the CC-486 group was 56%, although a 
high degree of MRD negativity (47%) was also observed in the placebo group {Wei 2019}. In 
summary, CC-486 has emerged as a SOC option for maintenance therapy in AML patients in 
first remission who are not candidates for SCT.
1.2.
Magrolimab
1.2.1.
General Information
Cluster of differentiation 47 (CD47) is a key molecule mediating cancer cell evasion of innate 
immune surveillance. CD47 expression is a well-characterized mechanism by which cancer cells, 
including cancer stem cells, overcome phagocytosis due to intrinsic expression of prophagocytic 
“eat me” signals {Jaiswal 2009, Majeti 2009}. The progression from normal cell to cancer cell 
involves changes in genes and gene expression that trigger programmed cell death and 
programmed cell removal {Chao 2012}. Many of the steps in cancer progression subvert the 


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multiple mechanisms of programmed cell death, and the expression of the dominant 
antiphagocytic signal, CD47, may represent an important checkpoint {Chao 2012}. Increased 
CD47 expression was identified first on leukemic stem cells in human AML {Majeti 2009}, and 
since then it has been found that CD47 expression is increased on the surface of cancer cells in a 
diverse set of human tumor types.
In mouse xenograft models, CD47-blocking monoclonal antibodies (mAbs) inhibit human 
xenograft tumor growth and metastasis by enabling the phagocytosis and elimination of cancer 
cells from various hematologic malignancies and solid tumors {Chao 2011a, Chao 2010a, Chao 
2011b, Edris 2012, Kim 2012, Majeti 2009, Willingham 2012}. Binding of CD47 expressed by 
cancer cells to its ligand, signal regulatory protein alpha (SIRPα), expressed on phagocytes leads 
to inhibition of tumor cell phagocytosis. Thus, blockade of the CD47 SIRPα-signaling pathway 
by an anti-CD47 antibody leads to phagocytosis and elimination of tumor cells. Selective 
targeting of tumor cells by an anti-CD47 antibody is due to the presence of prophagocytic signals 
expressed mainly on tumor cells and not on normal cell counterparts {Chao 2010b}. In addition, 
the anti-CD47 antibody can induce an anti-AML T-cell response through cross-presentation of 
tumor antigens by macrophage and antigen-presenting cells after tumor cell phagocytosis {Liu 
2015b, Tseng 2013}.
Magrolimab is a humanized anti-CD47 mAb that blocks the interaction of CD47 with its receptor 
and enables phagocytosis of human cancer cells {Liu 2015a}. The activity of magrolimab is 
primarily dependent on blocking CD47 binding to SIRPα and not on the recruitment of 
crystallizable fragment (Fc)-dependent effector functions, although the presence of the 
immunoglobulin G4 (IgG4) Fc domain is required for its full activity. For this reason, 
magrolimab was engineered with a human IgG4 isotype that is relatively inefficient at recruiting 
Fc-dependent effector functions that might enhance toxic effects on normal CD47-expressing 
cells {Liu 2015a}. Nonclinical studies using xenograft cancer models provide compelling 
evidence that magrolimab triggers phagocytosis and elimination of cancer cells from human 
solid tumors and hematologic malignancies. Based on this mechanism of action (MOA) and its 
potent nonclinical activity, magrolimab is being developed as a novel therapeutic candidate for 
solid tumors and hematologic malignancies.
The magrolimab program represents a novel strategy for the treatment of cancer and is the first 
therapeutic agent to target the CD47-SIRPα axis. Extensive nonclinical studies have 
demonstrated activity against both human solid tumors (breast, ovarian, pancreas, colon, 
leiomyosarcoma, bladder, prostate, and others) and hematologic malignancies (AML, acute 
lymphoblastic leukemia, non-Hodgkin lymphoma [NHL], myeloma, myelodysplastic syndrome 
[MDS], and others).
As described in the 2020 investigator’s brochure (IB), magrolimab is being investigated as an 
anti-AML therapeutic in 6 ongoing clinical studies in the US and United Kingdom, as 
monotherapy or in combination with other therapeutics, for the treatment of NHL, AML, and 
MDS. A total of 568 patients have been treated as of the data cut-off dates in the 2020 IB.


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While magrolimab has single-agent preclinical and clinical activity, efficacy is best enhanced in 
combination with other anti-AML agents. Preclinical and clinical studies have shown that 
magrolimab combinations with cytotoxic agents can enhance prophagocytic signals on tumor 
cells, which can lead to synergistic phagocytosis of cancer cells by macrophages. As such, 
magrolimab is being evaluated clinically in several combinations with cytotoxic agents including 
chemotherapy.
For further information on magrolimab, refer to the current IB.
1.2.2.
Preclinical Pharmacology and Toxicology
The combination of magrolimab + azacitidine was evaluated in leukemic nonclinical models. 
Nonclinical synergy was observed based on the upregulation of prophagocytic signals (including 
calreticulin) on leukemic cells of a TP53 mutated cell line by azacitidine combined with 
blockade of the antiphagocytic signal CD47 with magrolimab {Feng 2018}. 
Magrolimab + azacitidine led to synergistic phagocytosis of leukemic cells in vitro and near 
100% long-term durable remissions in an aggressive nonclinical leukemia mouse model, 
compared with modest effects with either monotherapy. These data support the mechanistic and 
nonclinical rationale for combining magrolimab with azacitidine in AML. Further nonclinical 
data including efficacy, toxicology, and pharmacology are provided in the current IB.
1.2.3.
Clinical Studies of Magrolimab
1.2.3.1.
Summary of Clinical Pharmacology
Clinical pharmacokinetic (PK) data have been collected in all ongoing and completed studies of 
magrolimab conducted to date. Pharmacokinetic data have been analyzed in a Phase 1 study 
(SCI-CD47-001) in patients with solid tumor. In this study, patients were treated with weekly 
magrolimab doses ranging from 0.1 to 45 mg/kg, with increasing plasma concentrations 
associated with increasing dose. Nonlinear PK consistent with target-mediated clearance was 
observed over this dose range. However, at maintenance doses of 10 mg/kg and above, 
target-mediated clearance was saturated within the dosing regimen, and trough levels associated 
with magrolimab efficacy in nonclinical studies were achieved. Nine of 88 (10%) evaluable 
patients tested positive for antidrug antibody (ADA) against magrolimab at any time point 
including baseline; ADA positivity had no impact on PK or clinical safety in these patients.
In a Phase 1 AML study (SCI-CD47-002), similarly to the solid tumor Phase 1 study, nonlinear 
PK consistent with target-mediated clearance was observed. Three of 20 (15%) evaluable 
patients tested positive for ADA against magrolimab at any time point including baseline; ADA 
positivity had no impact on PK. Antidrug antibody positivity in either study was not associated 
with increased adverse events (AEs).
Preliminary PK data of magrolimab from other ongoing and completed studies (5F9003, 5F9004, 
5F9005, and 5F9006) of magrolimab indicate similar PK properties across all tumor populations 
and in the presence of co-administered drugs. Across all studies, 34 of 507 (6.7%) patients tested 
positive for ADA against magrolimab at any time point including baseline. Antidrug antibody 
positivity was not associated with changes in PK or AE profile.


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A preliminary population PK analysis of combined magrolimab PK data indicated that results for 
magrolimab population PK were typical of other nonlinear antibodies. No clinically significant 
covariates of PK variability were identified.
1.2.3.2.
Summary of Clinical Safety
Magrolimab is administered as an intravenous (IV) infusion and it is currently being studied in 
6 clinical studies. Two completed single-agent Phase 1 studies include Study SCI-CD47-001 in 
patients with advanced solid tumors and lymphomas, and Study SCI-CD47-002 in patients with 
R/R AML, along with 2 Phase 1b partnered studies in AML, as well as urothelial carcinoma. 
Four combination studies include the following: Study 5F9003, a Phase 1b/2 study of 
magrolimab with rituximab in patients with R/R NHL; Study 5F9004, a Phase 1b/2 study of 
magrolimab with cetuximab in patients with solid tumors and colorectal cancer; Study 5F9005, a 
Phase 1b study of magrolimab with azacitidine in patients with AML and MDS; and Study 
5F9006, a Phase 1b study of magrolimab with avelumab in patients with solid tumors and 
ovarian cancer. As of July 2020, over 500 patients have been treated with magrolimab. Overall, 
the safety profile has been acceptable with magrolimab as monotherapy or in combination, with 
no maximum tolerated dose (MTD) reached in any study with dosing up to 45 mg/kg. Two 
anticipated adverse reactions included on-target anemia and infusion-related reactions (IRRs), 
which are expected with mAbs. Importantly, on-target anemia due to CD47 blockade-mediated 
red blood cell (RBC) clearance was mitigated with a priming/maintenance dose strategy. The 
average hemoglobin (Hb) decline with the first (priming) dose was 0.4 g/dL to 1.5 g/dL across 
indications, with many patients improving their Hb on therapy back to baseline, with a decrease 
in RBC transfusion requirements for those patients who were transfusion-dependent at baseline.
Magrolimab has been evaluated as a monotherapy or in combination in multiple solid tumor 
types. In the Phase 1 study SCI-CD47-001 of magrolimab monotherapy, 88 patients with 
advanced solid tumors were treated with magrolimab doses up to 45 mg/kg. No MTD was 
reached. As described in the 2020 IB, across 548 patients treated with magrolimab, including 
patients with both solid tumors and hematologic malignancies, fatigue, anemia, and headache 
were the 3 most frequently reported AEs (43.0%, 40.8%, and 36.4% of patients, respectively). 
Patients experienced mostly Grade 1 and 2 fatigue (2.8% of patients reported severe fatigue).
Anemia is the most common treatment-related AE, reported in 35.4% of patients. Approximately 
13% of all patients experienced anemia Grade 1 or 2, and 22% experienced severe anemia. 
Notably, many events of severe anemia occurred in patients with AML and MDS who had severe 
anemia at baseline. Anemia was typically manifested as a decline in Hb observed within the first 
2 weeks of treatment. The initial decrease in Hb after the first dose averages 0.5 to 2 g/dL. In 
patients with solid tumors, the decrease in Hb was followed by a compensatory reticulocytosis, 
with many patients experiencing a gradual return to baseline despite continued dosing. The 
changes in Hb and reticulocytes described with magrolimab treatment are fairly consistent across 
tumor types and are shown in Figure 1. Hyperbilirubinemia (predominately unconjugated) 
indicates extravascular hemolysis consistent with phagocytic removal of RBCs arising from the 
blockade of CD47 signaling. Administration of a low priming dose of magrolimab mitigated 
on-target anemia, an effect that is mostly observed after the first dose.


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Figure 1.
Effect of Magrolimab on Anemia, and Mitigation with a 
Priming/Maintenance Dosing Regimen
5F9 = magrolimab
The RBC profile of a solid tumor patient treated with magrolimab monotherapy is shown {Sikic 2019}.
Infusion-related reactions are also a commonly reported AE with magrolimab. Of 548 patients 
across 5 studies, 29% had at least 1 IRR. Most common signs and symptoms of IRR related to 
magrolimab included chills, pyrexia, back pain, headache, nausea, vomiting, dyspnea, anemia, 
and blood bilirubin increase. These IRRs were generally observed during the initial 2 doses of 
magrolimab. Current recommendations for premedication and IRR management are described in 
Sections 5.1.4 and 7.8.1.2. Lastly, hemagglutination (RBC agglutination) as observed on the 
peripheral smear is a common treatment effect and was reported as a treatment-related AE in 
11.8% of all patients.
Transient hemagglutination is observed after the initial priming or first maintenance dose of 
drug; however, it is less common thereafter, and has not been consistently correlated with any 
clinical sequelae.
As of January 2020, 68 patients (39 untreated higher risk MDS patients and 29 untreated 
induction chemotherapy-ineligible AML patients) have been enrolled in Study 5F9005 with the 
combination of magrolimab + azacitidine {Sallman 2020b}. The safety profile of magrolimab in 
combination with azacitidine was acceptable and consistent with azacitidine monotherapy, with 
no apparent increased toxicities in combination. No MTD was reached with magrolimab dosing 
of 30 mg/kg weekly. The most common treatment-related AEs with magrolimab were anemia, 
neutropenia/neutrophil count decreased, and thrombocytopenia/platelet count decreased 
(Figure 2). Treatment discontinuation due to any AE occurred in 1 of 68 patients (1.47%).
16 
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Figure 2. 
Treatment-Emergent Adverse Events with 2::. 15% Incidence 
in Study 5F9005 
Dyspnea 
Infusion related reaction 
Dizzines 
WBC count decrease 
Pyrexi 
Constipatio 
Infections 
Febrile neutropeni 
Fatigu 
Thrombocytopenia" 
Neutropenia 
Anemia 
Treatment-
related AEs 
Treatment-
emergent AEs 
• 
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• 
Grade2 
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• 
Grade4 
-100 -80 
-60 
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-20 
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20 
40 
60 
80 
100 
Frequency(%) 
AE = adverse event; WBC = white blood cell 
* Includes prefen-ed tenns of neutropenia and neutrophil count decreased 
** Includes prefen-ed tenns of thrombocytopenia and platelet count decreased 
1.2.3.3. 
Summaiy of Clinical Efficacy 
As of July 2020, 52 treatment-naive AML patients who were ineligible for induction 
chemotherapy have been treated with magrolimab + azacitidine in the Phase 1 b study, 5F9005 
{Sallman 2020a}. Among 34 patients who were evaluable for efficacy, 65% achieved an 
objective response (OR), 44% achieved CR, 12% achieved CRi, 3% achieved a paiiial response, 
62% achieved morphologic leukemia-free state (MLFS), 32% achieved stable disease, and 
3% had progressive disease as their best response. Time to response was more rapid (median 
2.04 months) than that expected for azacitidine alone. For patients with abnonnal cytogenetics at 
baseline, 7 of 15 patients (47%) achieved a cytogenetic CR, and 7 of 19 patients (37%) with CR 
or CRi achieved MRD negativity as detected by flow cytometiy. In 21 patients with mutated 
TP53, 71 % achieved an OR, 48% achieved a CR, and 19% achieved CRi. The median OS for 
patients with TP53 mutation (N = 34) was 12.9 months and the median OS for patients with 
wild-type TP53 (N = 16) was 18.9 months. The efficacy of magrolimab + azacitidine appears 
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improved compared to azacitidine monotherapy based on data from historical trials, in which CR 
rates are between 10% and 20%. High rates of MRD negativity and prolonged OS are 
encouraging. Additional patients continue to be enrolled on the Phase 1b study. In addition, a 
randomized Phase 3 study will evaluate magrolimab in combination with azacitidine versus 
physician’s choice of venetoclax plus azacitidine or intensive chemotherapy in previously 
untreated patients with AML with the TP53 mutation. 
For further clinical efficacy and safety information of magrolimab in other indications, refer to 
the current magrolimab IB.
1.3.
Information About Venetoclax and Azacitidine 
1.3.1.
Description of Venetoclax
Venetoclax is a selective, orally bioavailable, small-molecule Bcl-2 family inhibitor that binds 
with high affinity (inhibitory constant [Ki] < 0.010 nM) {Souers 2013}.
Anti-apoptotic Bcl-2 family members are associated with tumor initiation, disease progression, 
and chemotherapy resistance {Fesik 2005}. Overexpression of Bcl-2 has been demonstrated in 
AML and chronic lymphocytic leukemia (CLL) cells, where it mediates cell survival and 
resistance to chemotherapeutic agents. Venetoclax restores apoptosis by binding to Bcl-2 protein, 
thereby displacing pro-apoptotic proteins such as bcl-2–interacting mediator of cell death, 
triggering mitochondrial outer membrane permeabilization and the activation of caspases. 
Venetoclax has demonstrated cell-killing activity against patient-derived CLL cells and AML 
cells and a variety of lymphoma and leukemia cell lines.
In the US, venetoclax is approved for the treatment of adult patients with CLL or small 
lymphocytic leukemia {VENCLEXTA 2020}. Venetoclax in combination with azacitidine, 
decitabine, or low-dose cytarabine, is approved for the treatment of newly diagnosed AML in 
adults who are ≥ 75 years of age, or who have comorbidities that preclude use of intensive 
induction chemotherapy.
In the European Union, venetoclax is approved as monotherapy for the treatment of adult 
patients with CLL and in combination with hypomethylating agents for treatment of adult 
patients with newly diagnosed AML who are ineligible for intensive chemotherapy.
1.3.2.
Description of Azacitidine
Azacitidine is a nucleoside analog, specifically a chemical analog of cytidine. Azacitidine has 
2 known primary antineoplastic MOAs: 1) inhibition of DNA methyltransferase leading to 
hypomethylation of DNA and 2) direct cytotoxicity of malignant hematopoietic cells through cell 
death via its incorporation into DNA and RNA.


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Azacitidine is SOC and approved in the US for treatment of subtypes of MDS including, but not 
limited to, MDS with refractory anemia with excess blasts, a subtype that is mostly composed of 
patients with intermediate to very high risk MDS by Revised International Prognostic Scoring 
System criteria {VIDAZA 2018}. Azacitidine is also an SOC therapy for previously untreated 
patients with AML who are ineligible for induction chemotherapy or SCT based on age, 
comorbidities, or other factors. In Europe, azacitidine is approved for patients with 
intermediate-2 and high-risk MDS according to International Prognostic Scoring System criteria 
and for patients with AML who are ineligible for SCT.
1.3.3.
Clinical Data for Venetoclax + Azacitidine
Venetoclax in combination with azacitidine or decitabine was studied in M14-358, a 
non-randomized, open-label clinical study involving patients with newly diagnosed AML 
{VENCLEXTA 2020}. Sixty-seven of the 84 patients who received venetoclax with azacitidine 
were ≥ 75 years of age or had comorbidities that precluded the use of intensive induction 
chemotherapy. Patients received venetoclax after a 5-week ramp-up to a final 400-mg once-daily 
oral dose and azacitidine at the standard dosing. The median follow-up was 15.9 months (range: 
0.4 to 40.3 months). Forty-three percent (29 of 67 patients) achieved a CR (95% CI: 31%, 56%) 
and 18% (12 of 67 patients) achieved a CR with partial hematologic recovery (CRh) (95% CI: 
9.6%, 29%). Median time to first CR or CRh was 1.0 month (range: 0.7 to 8.9 months). The 
median duration of CR was 23.8 months (95% CI: 15.4, –) and the median duration of CR or 
CRh was 26.5 months (95% CI: 17.4, –). Of patients treated with venetoclax in combination with 
azacitidine, 12% (8 of 67) subsequently received SCT. Seventeen of the 84 patients who received 
venetoclax with azacitidine were 65 to 74 years of age and did not have known comorbidities 
that precluded the use of intensive induction chemotherapy. For the 17 patients treated with 
venetoclax in combination with azacitidine, the CR rate was 35% (95% CI: 14%, 62%) and the 
CRh rate was 41% (95% CI: 18%, 67%). Nine patients (53%) subsequently received SCT. The 
most common AEs of any grade observed with patients treated with venetoclax and azacitidine 
or venetoclax and decitabine were febrile neutropenia (69%), fatigue (62%), constipation (62%), 
musculoskeletal pain (54%), dizziness (54%), nausea (54%), abdominal pain (46%), diarrhea 
(46%), pneumonia (46%), sepsis (excluding fungal; 46%), cough (38%), pyrexia (31%), 
hypotension (31%), oropharyngeal pain (31%), edema (31%), and vomiting (31%).
The Phase 3 randomized, double-blind, placebo-controlled study VIALE-A, investigating 
venetoclax in combination with azacitidine versus azacitidine in combination with placebo in 
treatment-naive AML patients who are ineligible for intensive chemotherapy, confirms the 
efficacy of venetoclax + azacitidine with a statistically significant improvement in OS. Median 
OS with venetoclax + azacitidine was 14.7 months, while the median OS with 
azacitidine + placebo was 9.6 months (HR 0.66 [95% CI: 0.52, 0.85]; p < .001) {DiNardo 2020}. 
Safety of the combination in VIALE-A was similar to what had been previously reported and can 
be managed with standard supportive care.


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1.4.
Information About Mitoxantrone, Etoposide, and Cytarabine
1.4.1.
Description of Mitoxantrone
Mitoxantrone is a cytotoxic chemotherapy and is classified as an anthracenedione antineoplastic 
agent. It is administered intravenously and is indicated in combination with other 
chemotherapeutic agents for the treatment of AML.
1.4.2.
Description of Etoposide
Etoposide is a cytotoxic chemotherapy and is classified as a topoisomerase II enzyme inhibitor. 
It is administered intravenously and is indicated in combination with other chemotherapeutic 
agents for the treatment of AML.
1.4.3.
Description of Cytarabine
Cytarabine is a cytotoxic chemotherapy and an antimetabolic agent. It is administered 
intravenously and is indicated as a single agent or in combination with other chemotherapeutic 
agents for the treatment of AML.
1.4.4.
Clinical Data for Mitoxantrone, Etoposide, and Cytarabine
MEC is considered a long-standing SOC option for AML patients who are relapsed after or 
refractory to initial induction chemotherapy. Multiple clinical studies have evaluated MEC in the 
R/R setting and have demonstrated clinical activity, with a CR rate of approximately 20% and a 
median OS of approximately 3 to 5 months {Greenberg 2004, Roboz 2014}. MEC has a similar 
safety profile to other salvage chemotherapy regimens used in AML, most notably 
myelosuppression.
1.5.
Information About CC-486
1.5.1.
Description of CC-486
CC-486 (Onureg) is an oral HMA indicated for continued treatment of adult patients with AML 
who achieved first CR or CRi following intensive chemotherapy and who are not able to 
complete curative therapy {ONUREG 2020}. CC-486 is given orally on a daily dosing regimen.


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1.5.2.
Clinical Data for CC-486
CC-486 was approved by the US FDA in 2020 for the treatment of AML patients in CR or CRi 
following intensive chemotherapy. This approval was supported by data from the randomized 
Phase 3 QUAZAR study comparing CC-486 versus placebo in patients 55 years and older who 
were in first CR or CRi following intensive chemotherapy and/or consolidation and were 
ineligible for hematopoietic SCT. The median OS was significantly longer for patients who 
received CC-486 than for those who received placebo (24.7 vs. 14.8 months, HR 0.69). 
Relapse-free survival was also significantly longer for patients who received CC-486 than those 
who received placebo (10.2 vs. 4.8 months) {Abrisqueta 2019}. The MRD negative response 
rate for CC-486 (CR/CRi MRD positive to CR/CRi MRD negative) was 37%, although a high 
degree of MRD negativity conversion was also observed in the placebo arm (19%) {Roboz 
2020}. In summary, CC-486 has emerged as a SOC option for maintenance therapy in AML 
patients in first remission who are not candidates for SCT.
1.6.
Rationale for This Study
Patients with either newly diagnosed AML who are unfit for intensive chemotherapy or have 
R/R AML or MRD positive disease require improvements in clinical outcomes. Outside of an 
allogeneic SCT, there are limited curative therapies available for these patients. Thus, novel 
treatments that have a strong scientific and clinical rationale are needed to improve clinical 
outcomes. Magrolimab is being evaluated in each of these patient populations based on the 
strong scientific rationale for the proposed magrolimab combinations and clinical data 
supporting these evaluations.
Cohort 1 was closed to enrollment given that sufficient safety and efficacy data have been 
attained from Study 2020-0027 at MD Anderson Cancer Center (MDACC) to support further 
testing of the Mag+Ven+Aza combination in the currently active Phase 3 Study 
GS-US-590-6154 (ENHANCE-3).
Cohort 3 was closed to enrollment due to lack of enrollment.
1.6.1.
Cohort 1 (1L Unfit AML Mag+Ven+Aza): Magrolimab in Combination with 
Azacitidine and Venetoclax in Patients with Newly Diagnosed, Previously 
Untreated AML Who Are Ineligible for Intensive Chemotherapy
Magrolimab is under clinical evaluation in combination with azacitidine in the ongoing Phase 1b 
study, 5F9005, in patients with AML who are previously untreated and ineligible for intensive 
induction chemotherapy. Among 34 evaluable patients, 65% achieved an OR and 44% achieved 
a CR. Time to response was rapid (median 2.04 months) {Sallman 2020a}. Clinical activity has 
also been observed in patients with the TP53 mutation, a poor-risk subgroup with an overall 
response rate (ORR) of 71%. Median OS was 12.9 months in patients with the TP53 mutation 
and 18.9 months in patients with wild-type TP53. Given the encouraging efficacy data observed 
with the magrolimab plus azacitidine and venetoclax plus azacitidine double combinations, the 
triple combination of magrolimab plus azacitidine plus venetoclax is anticipated to show superior 
activity over either double combination. Furthermore, nonclinical data demonstrate that 
venetoclax can enhance magrolimab-mediated phagocytosis, which can be further enhanced by 
azacitidine (Figure 3).


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Figure 3. 
In Vitro Phagocytosis of AML Cells with Magrolimab, Azacitidine 
and/or Venetoclax 
AML = acute myeloid leukemia 
3 
g> 2 
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II) 
Q) 
Cl 
1 
0. 
0 t; 1 
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::!!!: 
• 
p<0.0001 
p=0.003 I 
p,i-ooos I 
• 
• 
Human macrophages were incubated with AML HL60 cells in the presence of the indicated therapeutic agents with macrophage 
phagocytosis of AML cells measured. 
Based on the nonclinical and clinical data described here, an investigator-initiated study 
sponsored by the MDACC commenced in the second half of2020 to evaluate the safety, 
tolerability, recommended dose, and preliminaiy efficacy of magrolimab plus azacitidine and 
venetoclax in R/R AML patients and frontline AML patients who are ineligible for intensive 
chemotherapy. Emerging data from that study have info1med design elements for this study. 
Venetoclax and azacitidine have overlapping toxicities, particulai·ly myelosuppression and 
infections. Aneinia, neutropenia, thrombocytopenia, and infections have been reported in patients 
treated with magrolimab. 
In sunnna1y, the nonclinical rationale and clinical data suppo1i the evaluation of magrolimab in 
combination with azacitidine and venetoclax in frontline AML patients who are ineligible for 
intensive chemotherapy. 
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1.6.2.
Cohort 2 (R/R AML Mag+MEC): Magrolimab in Combination with MEC in 
Patients with AML Who Are Refractory to or Have Relapsed After Initial 
Induction Chemotherapy
Patients with primary refractory AML or in relapse from AML after induction chemotherapy 
have a poor prognosis and a median OS of less than 6 months despite receiving SOC therapy 
with salvage chemotherapy. MEC is a commonly used salvage chemotherapy option in this 
setting but yields CR rate of approximately 20% and a median OS of approximately 5 months 
{Greenberg 2004, Roboz 2014}. Thus, combination therapies that can enhance the efficacy of 
MEC are needed to improve clinical outcomes. Cytotoxic chemotherapies can synergize with 
magrolimab, which increases prophagocytic signals on tumor cells by blocking the 
antiphagocytic CD47 signal, thus enhancing phagocytosis. Nonclinical data have demonstrated 
both in vitro and in vivo that the antitumor activity of magrolimab is enhanced when combined 
with chemotherapy ({Sikic 2016} and data on file). The combination of mitoxantrone and 
etoposide (components of MEC chemotherapy) induces high rates of prophagocytic signal 
expression (specifically calreticulin) and macrophage phagocytosis compared with other 
chemotherapeutic agents {Obeid 2007}. Given these nonclinical proof-of-concept data and the 
common usage of MEC as a salvage chemotherapy in R/R AML, the combination of magrolimab 
with MEC is under evaluation in this study.
1.6.3.
Cohort 3 (Post-Chemo Maint Mag+CC-486): Magrolimab in Combination 
with CC-486 in Patients with AML who Achieve CR or CRi with MRD 
Positivity after Intensive Induction Chemotherapy
As described above, AML patients who achieve a CR or CRi after induction chemotherapy or 
consolidation therapy, particularly those who are MRD positive, have a significant risk of relapse 
prior to starting maintenance therapy. CC-486 is a SOC option for older patients after induction 
chemotherapy who are ineligible for SCT. Despite the clinical benefit observed, OS and RFS 
were approximately 14.6 months and 7.1 months for patients who were MRD positive and 
treated with CC-486 {Roboz 2020}. Thus, novel agents that can be safely combined with 
CC-486 to extend RFS are needed. Strong nonclinical and clinical rationale exists for treatment 
of this population with the combination of magrolimab and CC-486. CC-486 is an oral therapy 
with similarities to azacitidine. Magrolimab, which acts by blocking anti-phagocytic CD47, has 
been shown in vitro and in vivo to synergize with azacitidine, which upregulates prophagocytic 
signals on leukemic cells, thus leading to enhanced phagocytosis {Feng 2018}. Clinically, 
magrolimab enhances azacitidine activity in patients with untreated AML who are unfit to 
receive intensive chemotherapy. Magrolimab + azacitidine led to a 65% ORR with a 44% CR 
rate in an ongoing Phase 1b study in this population {Sallman 2020a}. These results compare 
favorably with historical azacitidine CR rates, which are approximately 10% to 20%. Notably, 
37% of patients with CR/CRi achieved MRD negativity, an important outcome measure in this 
maintenance AML cohort. In addition, the safety profile of magrolimab + azacitidine was well 
tolerated, with no MTD reached and only 3.8% of patients discontinuing therapy due to a 
treatment-related AE. Based on these clinical data, the combination of magrolimab with CC-486 
is anticipated to be well tolerated and efficacious and lead to higher rates of MRD negativity and 
RFS, key outcomes for this population.


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1.7.
Rationale for Dose Selection of Magrolimab
The rationale for the magrolimab dose proposed in this study originates from safety, efficacy, 
and PK/pharmacodynamics (PD) data, and modelling and simulation analyses based on data 
obtained from all ongoing and completed clinical studies with magrolimab in patients with solid 
tumors, NHL, and AML/MDS.
In the first-in-human study of magrolimab (SCI-CD47-001) in patients with solid tumors and 
lymphomas, after an initial priming dose of 1 mg/kg on the first day, magrolimab was tested as a 
monotherapy at weekly doses of up to 45 mg/kg. The use of an initial 1 mg/kg priming dose was 
integrated into the dosing regimen to mitigate the on-target anemia induced by CD47 blockade. 
An initial priming dose leads to elimination of aged RBCs that are sensitive to CD47 blockade 
and triggers reticulocytosis of young RBCs that are not affected by CD47 blockade {Chen 
2018}. Utilizing a priming dose leads to an initial, transient, and mild anemia that generally 
normalizes back to baseline over several weeks, even in the presence of repeated therapeutic 
doses of magrolimab {Advani 2018, Liu 2015a, Sikic 2019}. The maximum weekly dose of 
45 mg/kg has an acceptable safety profile, and no MTD was identified in this study.
In Studies SCI-CD47-002 and 5F9005 in patients with AML/MDS, magrolimab was 
administered as a monotherapy at doses of up to 30 mg/kg twice weekly and in combination with 
azacitidine at doses of up to 30 mg/kg once weekly. In these studies, no significant dose-limiting 
toxicity (DLT) was observed, and magrolimab had an acceptable safety profile over the tested 
dose range up to a maximum of 30 mg/kg twice weekly. In transfusion-dependent lower-risk 
MDS patients (Study 5F9005), a magrolimab dosing regimen of 60 mg/kg is being evaluated. 
This dose was shown to be safe and well tolerated in the initial DLT evaluation period, with no 
DLTs observed as of October 2020. Furthermore, in these 2 studies, an intrapatient dose 
escalation approach was followed; after the priming dose, the patients received doses of 
15 mg/kg on Day 8 during Week 2, after which the dose was escalated to 30 mg/kg on Day 11 
and then weekly thereafter. This schedule was based on nonclinical data indicating enhanced 
safety of intrapatient dose escalation. In studies 5F9003 and 5F9004, magrolimab, in 
combination with rituximab and cetuximab, respectively, was found to have an acceptable safety 
profile at doses up to 45 mg/kg every week followed by every other week.
The proposed dosing regimen of magrolimab in this study is expected to have an acceptable 
safety profile based on the entirety of safety data in multiple oncology populations including the 
proposed study population, both as a monotherapy and in combination with other tumor-targeted 
antibodies and chemotherapeutics.


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In Study SCI-CD47-002 and Study 5F9005, CD47 RO by magrolimab was tested at baseline and 
at multiple time points on treatment, on both peripheral blood and bone maiTow cells, including 
leukemic blasts. A PK/PD model linking dose exposure and blood and bone maiTow RO was 
developed and described these data well. Simulations with the model predicted that > 90% RO 
would be achieved in the bone maiTow cells at the magrolimab dosing regimens proposed in this 
study. This level of RO is typically associated with maximal efficacy for all immune-oncology 
antibodies. Therefore, the ro osed dose re imens ai·e ex ected to maximize efficac in the 
AML atient o ulations. 
Based on results from the Phase 1 b study of magrolimab in MDS and AML (Study 5F9005), the 
cmTent study is designed to employ the same intrnpatient dose escalation regimen for 
magrolimab to mitigate on-target toxicities such as anemia and other toxicities observed in 
nonclinical AML models. Treatment should be continued until disease progression, relapse, loss 
of clinical benefit, or unacceptable toxicity occur. 
In smnmaiy, the proposed dose regimens have been shown to have acceptable safety profiles in 
oncology patient populations. Based on PK/PD modeling, the proposed doses ai·e predicted to 
result in optimal efficacy in myeloid malignancy populations and maximize patient and caregiver 
convemence. 
1.8. 
Risk/Benefit Assessment for the Study 
For each of the study cohorts, strong scientific, nonclinical, and clinical data exist that suppo1i 
the rationale to evaluate magrolimab combinations in the selected patient populations. 
For the IL Unfit AML Mag+Ven+Aza coho1i (Coho1i 1), nonclinical data demonstrate enhanced 
efficacy when magrolimab is combined with venetoclax and azacitidine. Fmihe1more, 
encouraging clinical activity is observed with both the magrolimab plus azacitidine and 
venetoclax plus azacitidine double combinations, suppo1iing the concept that a triple 
combination may lead to improved efficacy. Venetoclax and azacitidine have overlapping 
toxicities, paiiiculai·ly myelosuppression. Anemia, neutropenia, thrombocytopenia, and 
infections have also been repo1ied in patients treated with magrolimab, and management 
guidelines for these risks provided in Section 7.8.1. The combination ofMag+Ven+Aza is 
anticipated to be well tolerated. Specific mitigation measures, including an inclusion criterion 
requiring Hb 
9 g/dL at the initiation of study treatment, magrolimab priming/maintenance 
dosing regimen, and frequent blood count monitoring, are in place to closely monitor for anemia. 
For the R/R AML Mag+MEC coho1i (Coho1i 2), strong scientific and nonclinical data exist 
supporting the enhancement of efficacy when magrolimab is added to cytotoxic chemotherapy, 
including MEC. Fmthennore, magrolimab is not anticipated to have overlapping hepatotoxicity. 
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For the Post-chemo Maint Mag+CC-486 cohort (Cohort 3), strong nonclinical and clinical data 
exist to support the rationale for combining magrolimab with CC-486. Given that CC-486 shares 
similar properties with azacitidine, it is anticipated that the combination of magrolimab with 
CC-486 will be as similarly well tolerated and effective as the combination of magrolimab with 
azacitidine. Magrolimab plus azacitidine has been well tolerated in AML patients to date, with 
no MTD reached and a 3.8% AE discontinuation rate in an ongoing study. A CR rate of 44% was 
observed with the combination, which is substantially higher than azacitidine monotherapy CR 
rates in historical studies. While CC-486 is not identical to the parenteral form of azacitidine, 
these agents have the same active substance and share many similarities. Therefore, CC-486 is 
anticipated to be well tolerated and effective when combined with magrolimab.
For all cohorts, specific safety assessments to monitor for expected toxicities to each of these 
agents will be implemented, including monitoring for anemia, myelosuppression, tumor lysis 
syndrome (TLS), hepatotoxicity, IRRs, and other expected toxicities.
During a pandemic, additional potential risks to patients have been identified and may include 
adequate study drug availability, interruptions to the study visit schedule, and adherence to 
protocol-specified safety monitoring or laboratory assessments. Refer to Appendix 3 for further 
details on the risks and risk mitigation strategy. Given the risk mitigation measures that are being 
implemented, the expected benefit-risk assessment to patients remains unchanged.
In summary, based on strong scientific rationale, nonclinical and emerging clinical efficacy data, 
and manageable safety profile with the proposed magrolimab combination regimens, this study 
has an acceptable risk:benefit ratio for patients who participate.
1.9.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.


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2.
OBJECTIVES AND ENDPOINTS
Objectives and endpoints for Study GS-US-546-5920 are presented by cohort in Sections 2.1, 
2.2, and 2.3. Analysis of the study endpoints is described in Sections 8.1.2, 8.1.3, and 8.1.4.
2.1.
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML 
Mag+Ven+Aza)
Primary, secondary, 
 objectives and endpoints for patients with newly diagnosed, 
previously untreated AML who are ineligible for intensive chemotherapy are as follows:
Primary Objectives
Primary Endpoints
•
To evaluate the efficacy of magrolimab in 
combination with the anti-leukemia therapy 
venetoclax + azacitidine as determined by the CR 
rate (Phase 2 Cohort 1)
•
To evaluate the safety and tolerability, and to 
determine the recommended Phase 2 dose (RP2D) 
of magrolimab in combination with the anti-
leukemia therapy venetoclax + azacitidine (Safety 
Run-in Cohort 1)
•
CR rate, defined as the proportion of patients who 
achieve CR as determined by the investigator 
based on prespecified criteria (Phase 2 Cohort 1)
•
Incidence of DLTs, treatment-emergent AEs, and 
laboratory abnormalities according to the National 
Cancer Institute (NCI) Common Terminology 
Criteria for Adverse Events (CTCAE) Version 5.0 
(Safety Run-in Cohort 1)
Secondary Objectives
Secondary Endpoints
•
To evaluate additional measures of efficacy of 
magrolimab in combination with the anti-leukemia 
therapy venetoclax + azacitidine
•
To evaluate the safety and tolerability of 
magrolimab in combination with the anti-leukemia 
therapy venetoclax + azacitidine (Phase 2 
Cohort 1)
•
To evaluate the PK of magrolimab in combination 
with the anti-leukemia therapy 
venetoclax + azacitidine 
•
To evaluate the immunogenicity of magrolimab in 
combination with the anti-leukemia therapy 
venetoclax + azacitidine
•
ORR, including CR, CRi, CRh, partial remission 
(PR), and MLFS 
•
CR/CRi rate
•
Complete remission without minimal residual 
disease (CRMRD−) rate
•
Complete remission or complete remission with 
partial hematologic recovery (CR/CRh) rate
•
Cytogenetic complete remission (cCR)
•
Duration of responses (DOR)
•
Duration of CR
•
Duration of CR/CRi
•
Duration of CR/CRh
•
Event-free survival (EFS)
•
OS 
•
RBC transfusion independence rate
•
Platelet transfusion independence rate 
•
Incidence of treatment-emergent AEs and 
laboratory abnormalities according to the NCI 
CTCAE Version 5.0 (Phase 2 Cohort 1)
•
Magrolimab concentrations over time
•
Rate and magnitude of anti-magrolimab antibodies
CCI


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2.2.
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML Mag+MEC)
Primary, secondary,
 objectives and endpoints for patients with R/R AML are as 
follows:
Primary Objectives
Primary Endpoints
•
To evaluate the efficacy of magrolimab in 
combination with the anti-leukemia therapy MEC 
as determined by the CR rate (Phase 2 Cohort 2)
•
To evaluate the safety and tolerability, and to 
determine the RP2D of magrolimab in 
combination with the anti-leukemia therapy MEC 
(Safety Run-in Cohort 2)
•
CR rate, defined as the proportion of patients who 
achieve CR as determined by the investigator based 
on prespecified criteria (Phase 2 Cohort 2)
•
Incidence of DLTs, treatment-emergent AEs, and 
laboratory abnormalities according to the NCI 
CTCAE Version 5.0 (Safety Run-in Cohort 2)
Secondary Objectives
Secondary Endpoints
•
To evaluate additional measures of efficacy of 
magrolimab in combination with the 
anti-leukemia therapy MEC
•
ORR, including CR, CRi, CRh, PR, and MLFS 
•
CR/CRi rate
•
CRMRD− rate
•
CR/CRh rate
CCI
CCI


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•
To evaluate the safety and tolerability of 
magrolimab in combination with the anti-
leukemia therapy MEC (Phase 2 Cohort 2)
•
To evaluate the PK of magrolimab in 
combination with the anti-leukemia therapy MEC 
•
To evaluate the immunogenicity of magrolimab 
in combination with the anti-leukemia therapy 
MEC
•
cCR
•
DOR
•
Duration of CR
•
Duration of CR/CRi
•
Duration of CR/CRh
•
EFS
•
OS 
•
RBC transfusion independence rate
•
Platelet transfusion independence rate 
•
Incidence of treatment-emergent AEs and 
laboratory abnormalities according to the NCI 
CTCAE Version 5.0 (Phase 2 Cohort 2)
•
Magrolimab concentrations over time
•
Rate and magnitude of anti-magrolimab antibodies
CCI


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2.3.
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-Chemo Maint 
Mag+CC-486)
Primary, secondary, 
 objectives and endpoints for patients with newly diagnosed 
AML who are in CR or CRi with MRD positivity following intensive chemotherapy are as follows:
Primary Objectives
Primary Endpoints
•
To evaluate the efficacy of magrolimab in 
combination with anti-leukemia therapy CC-486 as 
determined by the MRD negative CR rate (Phase 2 
Cohort 3)
•
To evaluate the safety and tolerability, and to 
determine the RP2D of magrolimab in combination 
with the anti-leukemia therapy CC-486 (Safety Run-
in Cohort 3)
•
MRD negative CR rate, defined as the proportion of 
patients who maintain CR as determined by the 
investigator based on prespecified criteria and reach 
MRD negative disease status as determined using 
multiparameter flow cytometry with a sensitivity of 
< 0.1% (Phase 2 Cohort 3)
•
Incidence of DLTs, treatment-emergent AEs, and 
laboratory abnormalities according to the NCI 
CTCAE Version 5.0 (Safety Run-in Cohort 3)
Secondary Objectives
Secondary Endpoints
•
To evaluate additional measures of efficacy of 
magrolimab in combination with the anti-leukemia 
therapy CC-486
•
To evaluate the safety and tolerability of magrolimab 
in combination with the anti-leukemia therapy CC-
486 (Phase 2 Cohort 3)
•
To evaluate the PK of magrolimab in combination 
with the anti-leukemia therapy CC-486 
•
To evaluate the immunogenicity of magrolimab in 
combination with the anti-leukemia therapy CC-486
•
MRD negative CR/CRi rate
•
RFS
•
OS
•
Duration of MRD negative CR
•
Duration of MRD negative CR/CRi
•
RBC transfusion independence rate
•
Platelet transfusion independence rate
•
Incidence of treatment-emergent AEs and laboratory 
abnormalities according to the NCI CTCAE Version 
5.0 (Phase 2 Cohort 3)
•
Magrolimab concentrations over time
•
Rate and magnitude of anti-magrolimab antibodies
CCI
CCI


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3.
STUDY DESIGN
3.1.
Study Design
This is a Phase 2, open-label, multicenter, multi-arm study to evaluate magrolimab in 
combination with anti-leukemia therapies in patients with AML. This trial includes safety run-in 
cohorts (Section 3.1.1) and Phase 2 cohorts (Section 3.1.2). 
The study schematic is presented in Figure 4.
Figure 4.
Study Schema
AML = acute myeloid leukemia; MEC = mitoxantrone, etoposide, and cytarabine; MRD = minimal residual disease; 
RP2D = recommended Phase 2 dose
Cohort 1 *: 
1L Unfit AML Ma +Ven+Aza: 
Previously untreated AML 
patients age;;:-: 75 years or 
ineligible for intensive 
induction chemotherapy 
Cohort 2: 
R/R AML MaP+MEC: 
AML patients who are 
refractory, in first, or in 
second relapse after 
intensive induction 
chemotherapy 
Cohort 3*: 
Post-chemo Maint Mag+CC-486: 
AM L patients in CR or CRi 
with intensive induction 
chemotherapy who are 
MRD+ 
Safety run-in (N=G) 
Safety 
~--------~ evaluation and 
Magrolimab + 
venet oclax + azacitidine 
Safety run-in (N=6) 
Magrolimab + MEC 
Safety run-in (N=6) 
Magrolimab + CC-486 
RP2D 
Safety 
evaluation and 
RP2D 
Safety 
evaluation and 
RP20 
Cohorts 1 and 3 dosed to enrollment globally os of Protocol Amendment 5. 
Phase 2 
Magrolimab + venetoclax 
+ azacit idine 
N=40 
Phase 2 
Magrolimab + MEC 
N=30 
Phase 2 
Magrolimab + CC-486 
N=40 


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3.1.1.
Safety Run-in Cohorts
This study will include the following 3 safety run-in cohorts: 
•
Safety Run-in Cohort 1 (1L Unfit AML Mag+Ven+Aza), closed to enrollment globally as 
of Protocol Amendment 5: magrolimab + venetoclax + azacitidine in patients with newly 
diagnosed, previously untreated AML who are ineligible for intensive chemotherapy
•
Safety Run-in Cohort 2 (R/R AML Mag+MEC): magrolimab + MEC in patients with R/R 
AML
•
Safety Run-in Cohort 3 (Post-chemo Maint Mag+CC-486), closed to enrollment globally 
as of Protocol Amendment 5: magrolimab + CC-486 as maintenance therapy in patients with 
newly diagnosed AML who are in CR or CRi with MRD positivity following intensive 
chemotherapy 
Initially, 6 patients will be enrolled into Safety Run-in Cohorts 1, 2, and 3 to receive study 
treatment according to the dose levels presented in Table 1, Table 2, or Table 3, respectively. 
A DLT assessment period of 1 cycle (28 days) will occur. The DLT assessment period and 
definition are provided in Sections 3.1.1.1 and 3.1.1.2.
Dose de-escalation decisions will be made as follows: 
•
If no more than 2 patients in a safety run-in cohort experience a DLT in Cycle 1, enrollment 
into the corresponding Phase 2 cohort will begin at this dose level. 
•
If 3 or more (> 33%) patients in a safety run-in cohort experience a DLT up to the end of 
Cycle 1, another 6 patients will be enrolled in that cohort at a lower dose and evaluated in the 
same manner to define the RP2D. 
De-escalation dose levels for each safety run-in cohort are presented in Table 4, Table 5, and 
Table 6. Any dose de-escalation for Cohorts 1 and 3 will occur with the combination regimen, as 
there is a lack of dose-dependent toxicities observed with magrolimab in over 500 patients 
treated to date with magrolimab as monotherapy or in combination, and agents being evaluated 
in combination with magrolimab have identified or potential dose-related toxicities as cytotoxic 
agents (ie, venetoclax and CC-486). For Cohort 2, any dose de-escalation will occur with 
magrolimab, as the combination with chemotherapy (ie, MEC) has not been extensively studied. 
The selected RP2D for any cohort cannot exceed the identified MTD for that cohort.


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3.1.1.1.
DLT Assessment Period
The DLT assessment period is the first cycle (28 days). For patients who are being evaluated for 
prolonged myelosuppression (Section 3.1.1.2), the 28-day DLT assessment period will extend to 
42 days for Safety Run-in Cohorts 1 and 2. Patients are considered evaluable for assessment of a 
DLT if either of the following criteria is met in the DLT assessment period:
•
The patient experienced a DLT at any time after initiation of the first dose of study treatment.
•
The patient did not experience a DLT and completed at least 4 infusions of magrolimab and 
at least 14 doses of venetoclax and 5 doses of azacitidine (Safety Run-in Cohort 1), at least 
3 days of dosing with MEC (Safety Run-in Cohort 2), or at least 10 doses of CC-486 (Safety 
Run-in Cohort 3).
If a patient experiences a DLT during the DLT assessment period, the investigator should contact 
the medical monitor to discuss whether the patient can remain on study drug.
Patients who are not evaluable for DLT will be replaced in the safety run-in cohorts.
3.1.1.2.
DLT Definition
All toxicities will be graded according to the NCI CTCAE Version 5.0. A DLT is defined as any 
Grade 4 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity (that has 
worsened in severity from pretreatment baseline) during the 4-week DLT assessment period and 
is related to magrolimab or magrolimab combination.
The following are exceptions to the DLT definition and are NOT considered DLTs:
•
Myelosuppression (Grade 4 neutropenia and thrombocytopenia) lasting no longer than 
42 days from the start of study treatment for Cohorts 1 and 2, and no longer than 21 days 
from the start of study treatment for Cohort 3. Complications within the first 4 weeks that are 
associated with myelosuppression, such as fevers, infections, bleeding, and related 
hospitalizations, will also not be considered DLTs. However, Grade 4 neutropenia or 
thrombocytopenia lasting longer than 42 days from the start of study treatment for Cohorts 
1 and 2, or 21 days from the start of study treatment for Cohort 3, without evidence of 
leukemia, will be considered DLTs. Absence of residual disease must be verified by 
peripheral blood count and bone marrow aspirate and biopsy at Day 43 (+ 10 days) for 
Cohorts 1 and 2.
•
Grade 3 indirect/unconjugated hyperbilirubinemia that resolves to ≤ Grade 2 or pretreatment 
baseline with supportive care within 7 days and is not associated with other clinically 
significant consequences.
•
Grade 3 isolated electrolyte laboratory abnormalities that resolve to ≤ Grade 2 or 
pretreatment baseline with supportive care within 7 days and are not associated with other 
clinically significant consequences.


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•
Grade 3 elevation in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or 
alkaline phosphatase (ALP) that resolves to ≤ Grade 2 or pretreatment baseline with 
supportive care within 7 days and is not associated with other clinically significant 
consequences.
•
Grade 3 nausea, vomiting, or diarrhea that resolves to ≤ Grade 2 or pretreatment baseline 
with supportive care within 7 days.
•
Grade 3 fatigue that resolves to ≤ Grade 2 or pretreatment baseline within 2 weeks.
•
Grade 3 magrolimab IRRs in the absence of an optimal pretreatment regimen, which is 
defined as acetaminophen or a comparable non-steroidal anti-inflammatory agent, plus an 
antihistamine and corticosteroids.
•
Other single laboratory values out of normal range that have no clinical correlate and resolve 
to Grade ≤ 2 or to pretreatment baseline within 7 days with adequate medical management.
•
Transient Grade 3 nausea, vomiting, diarrhea, local reactions, influenza-like symptoms, 
myalgia, fever, headache, acute pain, or skin toxicity that resolves to ≤ Grade 2 within 
≤ 72 hours after medical management (eg, supportive care, including immunosuppressant 
treatment) has been initiated.
•
Grade 3 or 4 TLS or related electrolyte disturbances (hyperkalemia, hypophosphatemia, 
hyperuricemia) that resolve to ≤ Grade 2 within 14 days.
The recommended dose for the Phase 2 cohorts will be determined by the sponsor based on all 
relevant clinical and PK data from all patients treated in the safety run-in cohorts.
3.1.1.3.
Safety Review Team
A safety review team (SRT) will be established to assess safety of patients across the cohorts.
The SRT will consist of at least 1 investigator, a Gilead safety physician, and the Gilead medical 
monitor. Others may be invited to participate as members of the SRT if additional expertise is 
desired. The medical monitor serves as the chair of the SRT. An SRT charter (or similar 
document) will be agreed on by all SRT members prior to the first SRT meeting. The data 
reviewed at the SRT meeting to make decisions will be defined in the SRT charter (or similar 
document). The quality control checks performed on the data reviewed and used for making 
decisions will be described in the SRT charter (or similar document).


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3.1.2.
Phase 2 Cohorts
After completion of each safety run-in cohort and identification of the RP2D for that cohort, the 
corresponding Phase 2 cohort may be enrolled as follows:
•
Phase 2 Cohort 1 (1L Unfit AML Mag+Ven+Aza), closed to enrollment globally as of 
Protocol Amendment 5: 40 patients with newly diagnosed, previously untreated AML who 
are ineligible for intensive chemotherapy will be enrolled to receive magrolimab + 
venetoclax + azacitidine.
•
Phase 2 Cohort 2 (R/R AML Mag+MEC): 30 patients with R/R AML will be enrolled to 
receive magrolimab + MEC.
•
Phase 2 Cohort 3 (Post-chemo Maint Mag+CC-486), closed to enrollment globally as of 
Protocol Amendment 5: 40 patients with newly diagnosed AML who are in CR or CRi with 
MRD positivity following intensive chemotherapy may be enrolled to receive magrolimab + 
CC-486. 
Up to 5 to 10 additional patients may be enrolled in each of the Phase 2 cohorts to collect 
additional safety, efficacy, and/or PK/PD data.
3.1.3.
Closure of Cohorts 1 and 3
Cohort 1 closed to enrollment globally as of Protocol Amendment 5 and no new patients enrolled 
in Cohort 1 thereafter. A total of 18 patients were enrolled into Cohort 1 (7 patients in safety 
run-in and 11 patients in Phase 2).
Cohort 1 patients enrolled prior to sponsor’s notification and implementation of Protocol 
Amendment 5 will continue on study, receive study treatment (Sections 3.3, 5.1, and 5.2), and 
undergo all study assessments (Section 6), until end of study or discontinuation criteria are met 
(Sections 3.4 and 3.5).
Cohort 3 closed to enrollment globally as of Protocol Amendment 5 and no patients were 
enrolled. 
3.2.
Study Treatments
Study treatments for each safety run-in cohort are presented in Table 1, Table 2, and Table 3, 
respectively. Dose de-escalation plans for each safety run-in cohort are presented in Table 4, 
Table 5, and Table 6, respectively. Schedules of treatment administration are provided in 
Appendix Table 6, Appendix Table 7, and Appendix Table 8.
Refer to Section 3.1.3 for information on Cohort 1 patients enrolled prior to implementation of 
Protocol Amendment 5.


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Table 1.
Dose Level and Schedule for Safety Run-in Cohort 1 (1L Unfit AML 
Mag+Ven+Aza)
Dose Schedule (Day per 28-Day Cycle)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Azacitidine 
75 mg/m2 SC or IV
Days 1-7
or
Days 1-5, 8, 9a
Days 1-7
or
Days 1-5, 8, 9a
Days 1-7
or
Days 1-5, 8, 9a
Venetoclax 
PO
100 mg on Day 1 
200 mg on Day 2 
400 mg on Days 3-28
400 mg on Days 1-28 
Magrolimab Administration
Magrolimab 
1 mg/kg IV (over 3 hours)
Days 1, 4
Magrolimab 
15 mg/kg IV (over 3 hours)
Day 8
Magrolimab 
30 mg/kg IV (over 2 hours)
Days 11 and 15, and then QW × 5 doses 
Magrolimab 
30 mg/kg IV (over 2 hours)
Q2W beginning 1 week after the 5th weekly 30 mg/kg dose
IV = intravenous; PO = orally; Q2W = every 2 weeks; QW = once weekly; SC = subcutaneous
a Or any other alternative schedule, as long as 7 doses of azacitidine of the cycle are administered within 9 consecutive days.
Table 2.
Dose Level and Schedule for Safety Run-in Cohort 2 (R/R AML 
Mag+MEC)
Dose Schedule (Day per 28-Day Cycle)
Drug/Dose/Route
Cycle 1 
Cycle 2 to 3a
Mitoxantrone
8 mg/m2 IV (over 15-30 min)
Days 1-5
Days 1-5
Etoposide 
100 mg/m2 IV (over 30-60 min)
Days 1-5
Days 1-5
Cytarabine 
1000 mg/m2 IV (over 1 hour)
Days 1-5
Days 1-5
Magrolimab Administration
Magrolimab
1 mg/kg IV (over 3 hours)
Days 1, 4
Magrolimab 
15 mg/kg IV (over 3 hours)
Day 8
Magrolimab 
30 mg/kg IV (over 2 hours)
Days 11 and 15, and then QW × 5 doses 
Magrolimab 
30 mg/kg IV (over 2 hours)
Q2W beginning 1 week after the 5th weekly 30 mg/kg dose, up 
to 12 months of total magrolimab treatment
IV = intravenous; MEC = mitoxantrone, etoposide, cytarabine; Q2W= every 2 weeks; QW = once weekly
a
If patient achieved blast clearance after Cycle 1, one additional cycle of MEC will be given (total 2 cycles). If patient 
achieved blast clearance only after Cycle 2, a third cycle of MEC will be given. If no blast clearance at the end of Cycle 2, 
patient should be discontinued from the study.


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Table 3.
Dose Level and Schedule for Safety Run-in Cohort 3 (Post-Chemo 
Maint Mag+CC-486)
Dose Schedule (Day per 28-Day Cycle)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
CC-486 
300 mg PO
Days 1-14
Days 1-14
Days 1-14
Magrolimab Administration
Magrolimab 
1 mg/kg IV (over 3 hours)
Days 1, 4
Magrolimab 
15 mg/kg IV (over 3 hours)
Day 8
Magrolimab 
30 mg/kg IV (over 2 hours)
Days 11 and 15, and then QW × 5 doses 
Magrolimab 
30 mg/kg IV (over 2 hours)
Q2W beginning 1 week after the 5th weekly 30 mg/kg dose
IV = intravenous; PO = orally; Q2W= every 2 weeks; QW = once weekly
Table 4.
Dose De-escalation for Safety Run-in Cohort 1 (1L Unfit AML 
Mag+Ven+Aza)
Dose Level
Dosing (28-Day Cycle)
Venetoclax starting dose
Cycle 1: 100 mg PO Day 1, 200 mg Day 2, 400 mg Days 3-28, 
Cycle 2 and later: 400 mg Days 1-28
Level Minus 1
Cycle 1: 100 mg PO Day 1, 200 mg Day 2, 400 mg Days 3-21, 
Cycle 2 and later: 400 mg Days 1-21
Level Minus 2
Cycle 1: 100 mg PO Day 1, 200 mg Day 2, 400 mg Days 3-14, 
Cycle 2 and later: 400 mg Days 1-14
Magrolimab and 
azacitidine (all dose levels)
Will be administered at the starting dose and not dose-reduced for any of the dose 
minus levels
PO = orally


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Table 5.
Dose De-escalation for Safety Run-in Cohort 2 (R/R AML Mag+MEC)
Dosing (28-Day Cycle)
MEC
Magrolimab
Dose Level
Cycles 1 and 2 to 3a
Up to 12 Months
Starting dose
Mitoxantrone 8 mg/m2 IV 
(over 15-30 min) Days 1-5
Etoposide 100 mg/m2 IV 
(over 30-60 min) Days 1-5
Cytarabine 1000 mg/m2 IV 
(over 1 hour) Days 1-5 
Magrolimab:
1 mg/kg IV (over 3 hours) Days 1, 4; 
15 mg/kg IV (over 3 hours) Day 8;
30 mg/kg IV (over 2 hours) Days 11 and 15, and then QW × 5 doses 
30 mg/kg IV (over 2 hours) Q2W beginning 1 week after the 5th weekly 30 mg/kg dose
Level Minus 1
Mitoxantrone 8 mg/m2 IV 
(over 15-30 min) Days 1-5
Etoposide 100 mg/m2 IV 
(over 30-60 min) Days 1-5
Cytarabine 1000 mg/m2 IV 
(over 1 hour) Days 1-5 
Magrolimab:
1 mg/kg IV (over 3 hours) Days 1, 4; 
15 mg/kg IV (over 3 hours) Day 8;
20 mg/kg IV (over 2 hours) Days 11 and 15, and then QW × 5 doses
20 mg/kg IV (over 2 hours) Q2W beginning 1 week after the 5th weekly 20 mg/kg dose
Level Minus 2
Mitoxantrone 8 mg/m2 IV 
(over 15-30 min) Days 1-5
Etoposide 100 mg/m2 IV 
(over 30-60 min) Days 1-5
Cytarabine 1000 mg/m2 IV 
(over 1 hour) Days 1-5 
Magrolimab:
1 mg/kg IV (over 3 hours) Days 1, 4; 
15 mg/kg IV (over 3 hours) Day 8;
15 mg/kg IV (over 2 hours) Days 11 and 15, and then QW × 5 doses
15 mg/kg IV (over 2 hours) Q2W beginning 1 week after the 5th weekly 15 mg/kg dose
IV = intravenous; MEC = mitoxantrone, etoposide, cytarabine; QW = once weekly; Q2W= every 2 weeks
a
If patient achieved blast clearance after Cycle 1, one additional cycle of MEC will be given (total 2 cycles). If patient achieved blast clearance only after Cycle 2, a third cycle 
of MEC will be given. If no blast clearance at the end of Cycle 2, patient should be discontinued from the study.


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Table 6.
Dose De-escalation for Safety Run-in Cohort 3 (Post-Chemo Maint 
Mag+CC-486)
Dose Level
Dosing (28-Day Cycle) (Cycles 1, 2, and 3+)
CC-486 Starting dose
300 mg PO Days 1-14 
Level Minus 1
200 mg PO Days 1-14
Level Minus 2
200 mg PO Days 1-7
Magrolimab (all dose levels)
Magrolimab will be administered at the starting dose and will not be 
dose-reduced for any of the dose minus levels
PO = per oral route
3.3.
Duration of Treatment
Cohorts 1 and 3: treatment until discontinuation criteria is met. 
Cohort 2: treatment for up to 12 months.
Patients in each safety run-in cohort will receive 1 cycle (28 days) of study treatment before 
being evaluated for DLTs. Patients in the safety run-in cohorts will continue study treatment at 
the assigned dose level for at least 4 cycles, after which they may continue at the assigned dose 
level or switch to the RP2D upon agreement between the investigator and the sponsor. Safety 
run-in cohort patients will continue dosing until Phase 2 cohort end-of-treatment criteria are met.
Patients in Phase 2 Cohorts 1 and 3 will receive study treatment until disease progression, 
unacceptable toxicity, and/or loss of clinical benefit.
Patients in Phase 2 Cohort 2 will receive MEC for 2 to 3 cycles. Patients who do not achieve an 
OR (ie, CR, CRi, CRh, PR, or MLFS) after 2 cycles will be discontinued from therapy. For 
patients achieving a response after 1 to 2 cycles, an additional single MEC cycle will be 
administered. Magrolimab will be administered in Phase 2 Cohort 2 until disease progression, 
unacceptable toxicity, and/or loss of clinical benefit for up to 12 months.
3.4.
Discontinuation Criteria
Reasons for discontinuation of study treatment must include, but are not limited to, the 
following: 
•
Disease progression (including treatment failure and relapse)
•
Unacceptable toxicity
•
Loss of clinical benefit
•
Death
•
Pregnancy during the study


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•
Patient request, with or without a stated reason
•
Patient noncompliance
•
Initiation of anti-AML therapy
•
SCT
•
Investigator or treating physician decision 
•
Protocol violation
•
Lost to follow-up
•
Discontinuation of the study at the request of Gilead, a regulatory agency, or an institutional 
review board (IRB)/independent ethics committee (IEC)
Although disease progression is considered a sufficient reason for discontinuing a patient from 
study treatment, given the delayed treatment benefit commonly seen in immune therapies, the 
investigator is advised to continue to treat the patient until the investigator considers the study 
treatment to be no longer clinically beneficial to the patient, or the change of disease state 
renders the patient unacceptable for further treatment in the judgment of the investigator. 
All patients must be followed through completion of all study treatments.
If patients remain on study drugs beyond disease progression, a second bone marrow assessment, 
along with required laboratory tests for response assessment, should be done within 4 weeks. If 
disease progression is confirmed at the second bone marrow assessment, the patient should be 
discontinued from the study treatment.
Patients who discontinue study treatment are to return for an end-of-treatment (EOT) visit for 
evaluation of safety within 7 days (± 7 days) of their last dose or the decision to end study 
treatment, whichever is later. In addition, patients are to have a safety follow-up telephone call 
30 days and 70 days (± 7 days) after their last dose of study treatment. When a serious adverse 
event (SAE) or treatment-related AE is reported during the telephone call, the patient should 
come to the clinic for physical examination and blood tests, if clinically needed. Follow-up for 
ongoing SAEs or treatment-related AEs after the safety follow-up visit/call will stop if a patient 
begins another anti-AML therapy.
When considering SCT, note that no significant magrolimab-related transplant complications 
have been observed in patients who have achieved a response and undergone SCT in an ongoing 
magrolimab study in AML and MDS (Study 5F9005); however, a 4-week wash-out period for 
magrolimab is recommended prior to SCT.
If a patient discontinues study dosing (for example, as a result of an AE), every attempt should 
be made to keep the patient in the study and continue to perform the required study-related 
follow-up and procedures. If this is not possible or acceptable to the patient or investigator, the 
patient may be withdrawn from the study.


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The assessments to be performed at each of the posttreatment visits are listed in 
Appendix Table 9.
Refer to Section 3.1.3 for information on Cohort 1 patients enrolled prior to implementation of 
Protocol Amendment 5.
3.5.
End of Study
All Patients: The end of the entire study for all patients is defined as the date on which the last 
patient remaining on study completes the last study visit/call or when the sponsor decides to end 
the study. The sponsor reserves the right to terminate the study at any time for any reason 
(including safety).
Individual Patients: Patients are considered to have completed study participation altogether 
when they are no longer followed for safety.
3.6.
Poststudy Care 
Upon withdrawal from study treatment, patients will receive the care upon which they and their 
physicians agree. Patients will be followed for AEs as specified in Appendix Table 9.
3.7.
Source Data
The source data for this study will be obtained from original records (eg, clinic notes, hospital 
records, patient charts), local and/or specialty (PK, ADA, and/or PD) laboratory testing, and/or 
additional biomarker testing. 
3.8.
Pharmacokinetics/Biomarker Testing 
3.8.1.
Biomarker and Genomic Samples to Address the Study Objectives 
Peripheral blood, bone marrow aspirate and trephine biopsy, and buccal swab samples will be 
collected from all patients who have provided consent to participate in this study at the time 
points listed in the schedules of assessments (Appendix Table 1, Appendix Table 2, 
Appendix Table 3, Appendix Table 4, Appendix Table 5, and Appendix Table 9). The samples 
may be used to evaluate the association of systemic and/or tissue-based biomarkers with study 
treatment response, including efficacy and/or AEs, and dosage selection, and to better understand 
the biological pathways involved in AML pathogenesis and the immune response to AML, as 
well as the efficacy and MOA for magrolimab combinations. Because biomarker science is a 
rapidly evolving area of investigation, and AEs in particular are difficult to predict, it may not be 
possible to specify prospectively all tests that may be done on the specimens provided. The 
specific analyses will include, but may not be limited to, the biomarkers and assays described 
below. The testing outlined below is based upon the current state of scientific knowledge. It may 
be modified during or after the end of the study to remove tests no longer indicated and/or to add 
new tests based upon new state of the art knowledge. 


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The blood, bone maiTow, and buccal swab samples collected will be used to measure 
biomai·kers, which may include but will not be limited to the frequency of leukemia stem cells or 
MRD, presence of or changes to immune cell populations, secreted protein factors, the 
expression of cell surface mai·kers on either tumor cells or cells of the tumor microenvironment, 
and genetic mutations in tumor cells or subclones of tumor cells. 
The samples will also be used for genomic research to identify or validate genetic mai·kers that 
may increase our knowledge and understanding of the biology of the study disease and related 
diseases, and to study the association of genetic mai·kers with disease pathogenesis, progression, 
and/or ti·eatment outcomes, including efficacy, AEs, and the processes of dmg absmption and 
disposition. These specimens may also be used to develop biomai·ker or diagnostic assays and 
establish the perfo1mance chai·acteristics of these assays. Genomics reseai·ch may include 
sequencing of genetic material derived from both cancer cells and nonnal cells. Sequencing of 
genetic material derived from cancer cells will be used to better understand the MOA of 
magrolimab combinations in this patient population, and potentially to identify subsets of 
patients who are likely to benefit. Sequencing of genetic material derived from n01mal cells will 
be used to define differences in sequences that are cancer specific. 
Samples collected for biomai·ker assessments will be desh'oyed no later than 15 yeai·s after the 
end of study or in accordance with country requirements. 
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4.
PATIENT POPULATION
4.1.
Number of Patients and Patient Selection
Up to approximately 164 patients will be enrolled in the study, with up to 54 patients in the 
safety run-in cohorts and up to 110 patients in the Phase 2 cohorts.
Refer to Section 3.1.3 for information on Cohort 1 patients enrolled prior to implementation of 
Protocol Amendment 5.
The following patient populations will be enrolled into the study:
•
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML Mag+Ven+Aza), closed to 
enrollment globally as of Protocol Amendment 5: patients with newly diagnosed, previously 
untreated AML confirmed based on World Health Organization (WHO) criteria who are age 
75 years or older, or who are age 18 years to 74 years and have comorbidities that preclude 
the use of intensive chemotherapy
•
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML Mag+MEC): patients with 
confirmation of AML by WHO criteria who are refractory to or have relapsed after the initial 
intensive chemotherapy
•
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-chemo Maint Mag+CC-486), closed 
to enrollment globally as of Protocol Amendment 5: patients with confirmation of AML by 
WHO criteria who achieved CR or CRi with presence of MRD (MRD positive) after 
intensive induction chemotherapy with or without consolidation therapy prior to starting 
maintenance therapy 
4.1.1.
Patient Replacement
For the safety run-in cohorts, patients who do not meet the DLT assessment criteria will be 
replaced. In the Phase 2 cohorts, there will be no patient replacement.
4.2.
Inclusion Criteria
All Patients
All patients must meet the following inclusion criteria to be eligible for participation in this 
study:
1) White blood cell (WBC) count ≤ 20 × 103/µL prior to first dose of study treatment. If the 
patient’s WBC count is > 20  103/µL prior to first dose of study treatment, the patient can be 
enrolled, assuming all other eligibility criteria are met. However, ensure that the WBC count 
is ≤ 20 × 103/µL prior to the first dose of study treatment and prior to each magrolimab dose 
for the first 4 weeks. 


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NOTE: Patients can be treated with hydroxyurea and/or leukapheresis throughout the study 
or prior to first dose of study treatment to reduce the WBC count to ≤ 20 ×  103/µL to enable 
eligibility for magrolimab dosing. 
2) Hb must be ≥9 g/dL prior to initial dose of study treatment 
NOTE: Transfusions are allowed to meet Hb eligibility (see Section 7.8.1.1). 
3) Adequate liver function as demonstrated by the following:
a) AST ≤ 3.0  upper limit of normal (ULN)
b) ALT ≤ 3.0  ULN
c) bilirubin ≤ 1.5  ULN, or ≤ 3.0  ULN and primarily unconjugated if patient has a 
documented history of Gilbert syndrome or genetic equivalent. 
4) Patients must have adequate renal function as demonstrated by a creatinine clearance (CLcr) 
≥ 30 mL/min calculated by the Cockcroft-Gault formula.
5) Patient has provided informed consent.
6) Patient is willing and able to comply with clinic visits and procedures outlined in the study 
protocol.
7) Male or female, age ≥ 18 years.
8) Pretreatment blood cross-match completed (as detailed in Section 6.5.3).
9) Male patients and female patients of childbearing potential who engage in heterosexual 
intercourse must agree to use protocol-specified method(s) of contraception as described in 
Appendix 5.
10) Patients must be willing to consent to mandatory pretreatment and on-treatment bone marrow 
biopsies (trephines), unless not feasible as determined by the investigator and discussed with 
the sponsor.
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML Mag+Ven+Aza), closed to 
enrollment globally as of Protocol Amendment 5
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety 
Run-in Cohort 1 and Phase 2 Cohort 1 must fulfill the following cohort-specific inclusion 
criteria:


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11) Newly diagnosed, previously untreated patients with confirmation of AML by WHO criteria 
who are ineligible for treatment with a standard cytarabine and anthracycline induction 
regimen due to age, comorbidity, or other factors. Patients must be considered ineligible for 
induction therapy defined by the following:
a) ≥ 75 years of age 
b) ≥ 18 to 74 years of age with at least 1 of the following comorbidities:
i.
ECOG performance status of 2 or 3
ii.
Diffusing capacity of the lung of carbon monoxide ≤ 65% or forced expiratory 
volume in 1 second ≤ 65%
iii.
LVEF ≤ 50%
iv.
CLcr < 45 mL/min calculated by the Cockcroft-Gault formula 
v.
Any other comorbidity that the investigator judges to be incompatible with intensive 
chemotherapy that must be approved by the sponsor medical monitor before study 
enrollment. 
12) ECOG performance status:
•
Of 0 to 2 for subjects ≥ 75 years of age
OR
•
Of 0 to 3 for subjects ≥ 18 to 74 years of age
13) Patients who have not received prior anti-leukemia therapy for AML (excluding 
hydroxyurea), HMA, low-dose cytarabine, and/or venetoclax. 
NOTE: Patients with prior MDS who have not received prior HMA, venetoclax, or a 
chemotherapeutic agent are eligible. Other prior MDS therapies, including but not limited to 
lenalidomide, erythroid stimulating agents, or similar RBC-, WBC-, or platelet direct 
therapies or growth factors, are allowed.
14) Patients who have not received strong and/or moderate cytochrome P450 enzyme (CYP) 3A 
inducers (eg, St. John’s Wort) within 7 days prior to the initiation of study treatment.
15) Patients who have not consumed grapefruit, grapefruit products, Seville oranges (including 
marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of 
study treatment or are willing to discontinue consumption of these while receiving study 
drug.


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16) Patients without malabsorption syndrome or other conditions that preclude enteral route of 
administration.
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML Mag+MEC)
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety 
Run-in Cohort 2 and Phase 2 Cohort 2 must fulfill the following cohort-specific inclusion 
criteria:
17) Patients with confirmation of AML by WHO criteria who are refractory to or have 
experienced first relapse after initial intensive chemotherapy, which includes 1 or 2 cycles of 
a 7 + 3 based induction regimen or a purine analogue based induction therapy, such as 
fludarabine or cladribine paired with anthracyclines and cytarabine (eg, fludarabine, 
high-dose cytarabine [ara-C], G-CSF, and idarubicin [FLAG-Ida] or cladribine, ara-C, 
G-CSF, and mitoxantrone [CLAG-M]) or failed therapy after remission (eg, consolidation) 
during any number of cycles (maximum of 4) of high- or intermediate-dose cytarabine. For 
other intensive regimens, please discuss with the medical monitor.
NOTE: Patients who are relapsed after or are refractory to more than 1 line of anti-AML 
treatment are not eligible.
Patients who relapsed after undergoing stem cell transplant may be eligible.
18) At least 2 weeks must have elapsed since any prior anti-leukemia agents. 
NOTE: Localized non-central nervous system (CNS) radiotherapy, hydroxyurea, and 
erythroid and/or myeloid growth factors are not criteria for exclusion.
19) ECOG performance status of 0 to 2.
20) Patients with LVEF ≥ 50%, lack of symptomatic congestive heart failure, or clinically 
significant cardiac arrhythmias.
21) Patients who have not been treated with trastuzumab within 7 months prior to the initiation of 
study treatment
22) Patients who have not previously received maximum cumulative doses of anthracyclines and 
anthracenediones
23) Patients without degenerative or toxic encephalopathies
24) Patients who did not undergo hematopoietic SCT in the past 100 days, are not on 
immunosuppressive therapy post SCT in the 2 weeks prior to the first dose of study 
treatment, or have no active clinically significant graft-versus-host disease.


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Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-chemo Maint Mag+CC-486), closed to 
enrollment globally as of Protocol Amendment 5
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety 
Run-in Cohort 3 and Phase 2 Cohort 3 must fulfill the following cohort-specific inclusion 
criteria:
25) Patients with confirmation of AML by WHO criteria who achieved a CR or CRi with 
presence of MRD (MRD positive by local flow cytometry assay, defined as ≥ 0.1% 
detectable MRD) after intensive induction chemotherapy with or without consolidation 
therapy, prior to starting maintenance therapy for newly diagnosed AML. 
26) ECOG performance status of 0 to 2.
27) Patients without malabsorption syndrome or other conditions that preclude enteral route of 
administration.
4.3.
Exclusion Criteria 
Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
1) Positive serum pregnancy test (Appendix 5). 
2) Breastfeeding female.
3) Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
4) Patients who received any live virus vaccine within 4 weeks prior to initiation of study 
treatments.
5) Prior treatment with CD47 or SIRPα-targeting agents.
6) Current participation in another interventional clinical trial.
7) Known inherited or acquired bleeding disorders.
8) Clinical suspicion of or documented active CNS involvement with AML.
9) Patients who have acute promyelocytic leukemia.
10) Significant disease or medical conditions, as assessed by the investigator and sponsor, that 
would substantially increase the risk:benefit ratio of participating in the study. This includes, 
but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, 
uncontrolled diabetes mellitus, significant active infections, and congestive heart failure 
New York Heart Association Class III-IV.


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11) Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, 
localized prostate cancer, or other malignancies for which patients are not on active 
anticancer therapies and have had no evidence of active malignancy for over 1 year. Previous 
hormonal therapy with luteinizing hormone-releasing hormone (LHRH) agonists for prostate 
cancer and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B 
ligand (RANKL) inhibitors are not criteria for exclusion.
NOTE: Patients on maintenance therapy alone who have no evidence of active malignancy 
for at least ≥ 1 year are eligible.
12) Known medical history of active or chronic hepatitis B or C infection or medical history of 
human immunodeficiency virus (HIV) infection.


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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
All study drugs should be prepared as outlined in the Pharmacy Manual for the study. 
The first dose of study drugs should be administered within 72 hours after enrollment. Patients 
should be premedicated in accordance with Sections 5.1.4, 5.2.4, 5.3.5, and 5.4.3. 
The dosing regimen for each cohort is presented in Section 3.2.
Refer to Section 3.1.3 for information on Cohort 1 patients enrolled prior to implementation of 
Protocol Amendment 5.
5.1.
All Cohorts (Magrolimab)
5.1.1.
Description and Handling of Magrolimab 
5.1.1.1.
Formulation
Magrolimab is formulated as a sterile, clear to slightly opalescent, colorless to slightly yellow, 
preservative-free liquid intended for IV administration containing 10 mM sodium acetate, 
5% (weight to volume ratio [w/v]) sorbitol, 0.01% (w/v) polysorbate 20 at pH of 5.0. Each vial is 
manufactured to ensure a deliverable volume of 10 mL containing 200 mg of magrolimab at a 
concentration of 20 mg/mL. 
5.1.1.2.
Packaging and Labeling
Magrolimab is supplied in single-use, 10 mL glass vials with coated elastomeric stoppers and 
aluminum crimp overseals with a flip-off cap.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, European Union (EU) Guidelines to 
Good Manufacturing Practice, Annex 13 (Investigational Medicinal Products), and/or other local 
regulations. 
5.1.1.3.
Storage and Handling
Magrolimab should be stored at 2°C to 8°C (36°F to 46°F). Magrolimab should not be frozen. 
Protect from light during storage. Do not shake. Storage conditions are specified on the label. 
Until dispensed to the patients, study drugs should be stored in a securely locked area, accessible 
only to authorized site personnel. 
To ensure the stability and proper identification, study drug(s) should not be stored in a container 
other than the container in which they were supplied. 


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Consideration should be given to handling, preparation, and disposal through measures that 
minimize drug contact with the body. Appropriate precautions should be followed to avoid direct 
eye contact or exposure when handling.
5.1.2.
Dosage and Administration of Magrolimab
The magrolimab dosing regimen for each safety run-in cohort is presented in Table 1, Table 2, 
and Table 3. The dose de-escalation regimens for magrolimab in Safety Run-in Cohort 2 are 
presented in Table 5. Treatment schedules are provided in Appendix 2.
Magrolimab will be administered by IV infusion. The duration of infusion will be 3 hours 
(± 30 minutes) for the first 3 doses of magrolimab, and then 2 hours (± 30 minutes) for infusions 
beyond the first 3 doses. The reduced infusion time to 2 hours is utilized based on prior data 
demonstrating majority CD47 RO on peripheral blood cells, thus mitigating anticipated RBC 
toxicities from magrolimab. 
During the first 28 days of treatment, WBC count must be ≤ 20  103/µL prior to each 
magrolimab dose. Patients with WBC > 20  103/µL can be treated with hydroxyurea (up to 
4 g/day) and/or leukapheresis throughout the study to reduce the WBC to ≤ 20  103/µL. 
Within 24 hours prior to each of the 2 first doses of magrolimab infusion during initial treatment, 
all patients must have a documented Hb ≥ 9 g/dL. Patients who do not meet these criteria must 
be transfused and have their Hb rechecked to meet 9 g/dL prior to each of the first 2 doses of 
magrolimab.
Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and second doses 
of magrolimab during initial treatment. The patient should be transfused as clinically appropriate. 
Investigators should consider additional Hb monitoring during the first week of treatment in 
patients with symptoms of anemia or at increased risk for complications of anemia.
All patients should be monitored hourly during infusion and for 1 hour after infusion for priming, 
repriming/re-escalation, and maintenance doses during the first 28 days of treatment. Patients 
should be monitored (including measurement of vital signs, as clinically appropriate) for signs 
and symptoms of infusion-related reaction, which have been observed in previous magrolimab 
studies. Postinfusion monitoring should begin after the infusion is complete. Postinfusion 
monitoring is not required for doses after Day 22. Patients who experience any 
treatment-emergent AEs during the observation period should be further monitored, as clinically 
appropriate.
The dose of magrolimab will be calculated based on actual weight at enrollment (using weight 
obtained either at screening or on Cycle 1 Day 1) and remains constant throughout the study 
unless there is a > 10% change in body weight from baseline. Modifications to the study 
treatment doses administered should be made for a > 10% change in body weight from baseline 
and according to local and regional prescribing standards. Dose modifications for changes in 
body weight ≤ 10% may be made according to local institutional guidelines.


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Patients may continue study treatment until they show evidence of disease progression, relapse, 
loss of clinical benefit, or unacceptable toxicity (further details about treatment discontinuation 
are provided in Sections 3.3 and 3.4). 
Treatment Delay and Repriming/Re-escalation for Magrolimab 
Given the large CD47 antigen sink on normal cells, patients who have a long dose delay of 
magrolimab are required to be reprimed with magrolimab dosing to resaturate the CD47 antigen 
sink. Guidelines for repriming/re-escalation for magrolimab after a dose delay are provided in 
Section 5.1.3.
5.1.3.
Dose Modification and Delays for Magrolimab
The dose of magrolimab should not be reduced except in Safety Run-in Cohort 2 in the case of 
dose de-escalation based on DLTs. 
Clinical safety and PK data from dose finding studies in both solid tumor and hematologic 
malignancies have not demonstrated any dose-dependent toxicities associated with magrolimab. 
Dose reduction/modification of magrolimab may be allowed in certain circumstances (eg, with 
certain AEs), with approval by the sponsor. If a dose reduction is considered, initial 33% dose 
reduction from the RP2D should be done (from 30 to 20 mg/kg, and from 20 to 15 mg/kg).
When the combination drugs (venetoclax + azacitidine or MEC or CC-486) are delayed due to 
toxicities, magrolimab should continue independently as per magrolimab administration schedule 
(Appendix Table 4). Continuous dosing of magrolimab is needed to maintain efficacious 
exposures as delays of greater than 1 week when magrolimab is dosed every 2 weeks have been 
seen to result in lower clinical efficacy. Magrolimab may be withheld if treatment-emergent 
and/or related AEs occur, and will require approval by the sponsor if the delay is longer than 
3 days.
The repriming guidelines presented in Table 7 should be followed for patients with magrolimab 
dose delays. In case of repriming, assessments should follow magrolimab repriming table 
(Appendix Table 5). 
In case of repriming, before the administration of the 2 first doses of magrolimab, Hb should be 
≥ 9 g/dL. Transfusions are allowed to meet this Hb level.


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Table 7.
Repriming Guidelines for Magrolimab
Dose
Dosing Frequency
Minimum Duration of Treatment 
Gap That Will Lead to 
Repriming
1 mg/kg
NA – used at initial priming
2 weeks
Weekly or more frequent (during first 
4 to 8 weeks)
2 weeks
15 mg/kg
Every 2 weeks (after 8 weeks of 
treatment)
4 weeks
Weekly or more frequent (during first 
4 to 8 weeks)
2 weeks
20 mg/kg
Every 2 weeks (after 8 weeks of 
treatment)
4 weeks
30 mg/kg
Every 2 weeks (after 8 weeks of 
treatment), weekly or more frequent
4 weeks
NA = not applicable
If planned surgical procedures are needed for patients on study treatment, magrolimab will be 
delayed and restarted in accordance with Table 8.
Table 8.
Magrolimab Dosing Guidance for Planned Surgical Procedures 
During the Study
Planned Surgical Procedure
Magrolimab Dose Guidance
Minimally invasive procedure
(Examples: biopsies [excluding lung/liver], 
skin/subcutaneous lesion removal, 
cataract/glaucoma/eye surgery/cystoscopy)
Hold magrolimab dose 3 days prior to procedure and 
restart after 3 days
Moderately invasive procedure
(Examples: lung/liver biopsy, hysterectomy, 
cholecystectomy, hip/knee replacement, minor 
laparoscopic procedures, stent/angiopathy)
Hold magrolimab dose 5 days prior to procedure and 
restart after 5 days
Highly invasive procedure
(Examples: CNS/spine surgery, major vascular 
surgery, cardiothoracic surgery, major laparoscopic 
surgery)
Hold magrolimab dose 7 days prior to procedure and 
restart after 7 days
CNS = central nervous system


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5.1.4.
Premedication and Prophylaxis for Magrolimab
Premedication is required prior to the administration of the first 4 doses of magrolimab and in 
case of reintroduction with repriming. Premedication should include oral acetaminophen 650 to 
1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg, or 
comparable regimen. If less than 4 hours has elapsed since a prior dose of acetaminophen has 
been given, the dose of acetaminophen premedication may be omitted. For patients who do not 
experience an IRR with the first 4 doses of magrolimab, corticosteroid pretreatment can be 
discontinued at the investigators’ discretion. Patients who experience IRRs with the first 4 doses 
of magrolimab should continue premedication with corticosteroids prior to subsequent doses at 
the investigator’s discretion. Premedication decisions for subsequent infusions should be based 
on the treating physician’s clinical judgment and the presence/severity of prior IRRs. Guidance is 
provided in Table 15. 
5.1.5.
Prior and Concomitant Medications: Permitted Concomitant Medications 
for All Cohorts
For the anti-leukemia regimens administered with magrolimab in this study, the current local or 
regional prescribing information should be consulted regarding permitted and prohibited 
concomitant medications.
Live vaccines are prohibited during the study, and for 3 months after the last dose of study 
treatment {Rubin 2014}.
Premedication, as well as prophylaxis for AEs as described in Sections 5.1.4, 5.2.4, 5.3.5, and 
5.4.3, is permitted while on study treatment. Localized non-CNS radiotherapy, erythroid and/or 
myeloid growth factors, hormonal therapy with LHRH agonists for prostate cancer, hormonal 
maintenance therapy for breast cancers, and treatment with bisphosphonates RANKL inhibitors 
are permitted. Red blood cell and platelet transfusions are permitted during screening and prior 
to enrollment to ensure adequate Hb level, and as per investigator clinical judgment. Blood 
transfusions are also permitted during the study as clinically indicated for management of 
cytopenias and should be recorded in the electronic case report form (eCRF) dedicated to 
transfusions during the study. Hydroxyurea and/or leukapheresis can be used throughout the 
study to reduce the WBC to ≤ 20  103/µL. In nonclinical studies, co-administration of 
magrolimab and hydroxyurea in human leukemia engrafted immunodeficient mice did not cause 
phagocytosis of normal bone marrow cells, suggesting limited on-mechanism toxicity in patients. 
No gross safety abnormalities were observed in these nonclinical studies. While no formal 
analyses have been performed, in clinical studies, no significant safety concerns have been 
observed in patients who have received concomitant magrolimab and hydroxyurea or 
magrolimab, azacitidine, and hydroxyurea.
All concomitant medications, including all prescription, over-the-counter, herbal supplements, 
and IV medications and fluids received within 30 days before the first dose of study treatment 
through the 70-days (± 7 days) safety follow-up visit should be recorded in the eCRF.


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5.1.5.1.
COVID-19 Vaccine
There is no contraindication to the COVID-19 vaccine with magrolimab. Given that 
immunocompromised individuals on myelosuppressive treatment may have attenuated responses 
to vaccines, investigators should, after consultation with local guidelines, consider delay of 
COVID-19 vaccination for patients in Cohort 1 (receiving magrolimab + venetoclax + 
azacitidine therapy) or Cohort 2 (who are receiving ongoing MEC chemotherapy) until recovery 
of a neutropenic individual’s absolute neutrophil count (ANC) and determine the ideal timing of 
the subsequent dose of vaccine based on count recovery. For Cohort 2 patients who have 
completed MEC induction chemotherapy cycles or for Cohort 3 patients, there is no specific 
recommendation on the timing of a COVID-19 vaccine; individuals may receive the vaccine 
when available. However, if these patients are neutropenic, investigators may use clinical 
judgement in determining the timing of the COVID-19 vaccine. Investigators should document 
vaccinations. Investigators should notify patients of the risks of delaying the COVID-19 
vaccination and document this along with any mitigation strategies for preventing COVID-19 
infection.
5.2.
Cohort 1 (1L Unfit AML Mag+Ven+Aza)
Information for magrolimab is provided in Section 5.1.
The start of the cycle is the first day of azacitidine + venetoclax. 
In the event 1 or more components of the study treatment (magrolimab, azacitidine, and/or 
venetoclax) are discontinued, the following combinations are permitted:
•
Magrolimab + azacitidine
•
Azacitidine (single agent)
•
Venetoclax + azacitidine
The following combinations are not permitted:
•
Magrolimab (single agent)
•
Venetoclax (single agent)
•
Magrolimab + venetoclax
If azacitidine is permanently discontinued, the patient must discontinue the remaining study 
treatment. 
Patients who discontinue study treatment but continue in a response or are achieving clinical 
benefit will continue to be followed on study for response assessments to ascertain relapse.


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When both magrolimab and azacitidine are given on the same visit day, magrolimab will be 
administered at least 1 hour after the completion of azacitidine administration.
5.2.1.
Description and Handling of Venetoclax
5.2.1.1.
Formulation
Information regarding the formulation of venetoclax can be found in the local prescribing 
information {VENCLEXTA 2020}.
5.2.1.2.
Packaging and Labeling
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guidelines to Good Manufacturing 
Practice, Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.2.1.3.
Storage and Handling
Further information regarding storage and handling of venetoclax is available in the local 
prescribing information. 
5.2.2.
Description and Handling of Azacitidine
5.2.2.1.
Formulation
Information regarding the formulation of azacitidine can be found in the local prescribing 
information.
5.2.2.2.
Packaging and Labeling
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guidelines to Good Manufacturing 
Practice, Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.2.2.3.
Storage and Handling
Further information regarding storage and handling of azacitidine is available in the local 
prescribing information. 
5.2.3.
Dosage and Administration of Azacitidine and Venetoclax
The azacitidine and venetoclax dosing regimen for Safety Run-in Cohort 1 is presented in 
Table 1. The dose de-escalation regimens for venetoclax in Safety Run-in Cohort 1 are presented 
in Table 4. The treatment schedule is provided in Appendix Table 6.
Azacitidine administration should be completed at least 1 hour before magrolimab administration 
on days when both drugs are administered.


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Azacitidine will be administered according to region-specific drug labeling, either 
subcutaneously (SC) or IV, at the standard dose of 75 mg/m2 on Days 1 to 7 of each 28-day 
cycle. Azacitidine may be administered on an alternative schedule such as Days 1 to 5, Day 8, 
and Day 9 of a 28-day cycle for flexibility and convenience as long as the 7 doses of azacitidine 
of the cycle are administered within 9 consecutive days. When administered IV, the total dose of 
azacitidine (diluted in a 50 to 100 mL infusion bag of either 0.9% sodium chloride injection or 
lactated Ringer’s injection solution) is infused over a period of 10 to 40 minutes (refer to the 
azacitidine local prescribing information for detailed instructions for preparation and 
administration).
The dose of azacitidine will be calculated based on actual height and weight at enrollment (using 
weight obtained either at screening or on Cycle 1 Day 1) and remains constant throughout the 
study unless there is a > 10% change in body weight from baseline. Modifications to the study 
treatment doses administered should be made for a > 10% change in body weight from baseline 
and according to local and regional prescribing standards. Dose modifications for changes in 
body weight ≤ 10% may be made according to local institutional guidelines.
Prior to initiation of venetoclax, WBC count must be ≤ 20  103/µL. Patients with WBC 
> 20  103/µL can be treated with hydroxyurea and/or leukapheresis throughout the study to 
reduce the WBC to ≤ 20  103/µL.
Venetoclax should be administered orally once daily with a meal and water, at approximately the 
same time each day. Patients should be advised to swallow the tablet whole, and not chew, crush, 
or break the tablets. If a dose is missed and it has been less than 8 hours, patients should be 
advised to take their dose as soon as possible. If a dose is missed and more than 8 hours has 
passed, the missed dose should be skipped, and the next dose should be taken at the usual time. If 
a patient vomits after taking venetoclax, an extra dose should not be taken but rather the next 
dose should be taken at the usual time.
Patients treated with venetoclax may develop TLS. Assess blood chemistry (potassium, uric acid, 
phosphorous, calcium, and creatinine). Correct pre-existing abnormalities prior to initiation of 
treatment with venetoclax. Blood chemistry must be monitored for TLS at predose, 6 to 8 hours 
after each new dose during ramp-up (Days 1, 2, and 3), and 24 hours after reaching the 
maintenance dose.
For patients taking concomitant CYP3A and P-glycoprotein (P-gp) inhibitors, refer to Table 11 
for venetoclax dosing and administration.
5.2.4.
Premedication and Prophylaxis for Azacitidine and Venetoclax
Prior to first dose of venetoclax, patients must be provided with prophylactic measures including 
adequate hydration and antihyperuricemic agents and continue during the ramp-up phase 
(Days 1, 2, and 3).
Prophylactic antibiotics for the prevention of neutropenic fever are not required on study but may 
be administered per local institutional guidelines or investigator discretion.


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5.2.5.
Dose Modification and Delays for Azacitidine and Venetoclax
Dose modification and treatment delay of azacitidine may not occur for patients in the initial 
28-day period (Cycle 1).
If  2 doses of azacitidine are missed during the 7-day dosing period, dosing should continue so 
that the patient receives the full 7 days of treatment, as long as these additional doses are given 
within 1 week of the previous dose. If ≥ 3 doses of azacitidine are missed during the 7-day 
dosing period, the investigator should contact the sponsor, and a dosing decision should be made 
on an individual case basis.
5.2.5.1.
Venetoclax and Azacitidine Dose Modifications and Delays Due to Hematologic 
Toxicity 
Dose modifications and delays for venetoclax due to AEs should follow Table 9 or the 
venetoclax local prescribing information. If bone marrow assessment done in Cycle 1 shows 
blast clearance (< 5%), venetoclax dose for the remainder of the cycle can be omitted to allow 
for count recovery.


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Table 9.
Venetoclax and Azacitidine Dose Modifications and Delays Due to 
Hematological Toxicity
Event
Occurrence
Action Takena
Occurrence prior to 
achieving remissionb
In most instances, venetoclax and azacitidine cycles 
should not be interrupted due to cytopenia prior to 
achieving remission. 
First occurrence after 
achieving remission 
and lasting at least 
7 daysc,d
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and decrease the duration to 21 days. 
Resume azacitidine at the same dose.
Second occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and same duration (21 days). Resume 
azacitidine at the same dose.
Third occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and decrease the duration to 14 days. 
Resume azacitidine at the same dose.
Fourth occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and duration (14 days) and reduce the 
azacitidine dose to 50 mg/m2.
Fifth occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose, decrease the duration to 7 days, and 
continue the azacitidine dose at 50 mg/m2.
Sixth occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and duration (7 days) and decrease the 
azacitidine dose to 37.5 mg/m2.
Grade 4 neutropenia with 
or without fever or 
infection; or Grade 4 
thrombocytopenia
Seventh occurrence 
and beyond in cycles 
after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and duration (7 days), and decrease the 
azacitidine dose to 25 mg/m2.
a Transfuse blood products and administer prophylactic and treatment anti-infectives as clinically indicated. 
b Remission denotes a bone marrow blast count < 5%. 
c Administer granulocyte colony-stimulating factor if clinically indicated for Grade 4 neutropenia after remission is achieved.
d Also applies to patients with Grade 4 neutropenia that lasts longer than 7 days from the day blast is noted to be < 5% in the 
first remission bone marrow.


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If per dosing modification Table 9, the patient is eligible to start the cycle, but the cycle is 
delayed, investigator should contact the medical monitor. 
The start of the subsequent cycle should not be delayed beyond 2 weeks if the patient’s clinical 
condition allows safe resumption of the cycle. If the start of the subsequent cycle is delayed 
beyond 2 weeks, the investigator should contact the medical monitor. 
If after the venetoclax and azacitidine dosing schedule modifications, patients do not experience 
Grade 4 neutropenia or Grade 4 thrombocytopenia for at least 2 cycles, physicians can consider 
escalating the venetoclax and azacitidine doses to their immediate previous higher dosing 
regimens.
5.2.5.2.
Venetoclax and Azacitidine Dose Modifications and Delays Due to 
Nonhematologic Toxicity 
Renal abnormalities ranging from elevated serum creatinine to renal failure have been reported 
with rare frequency in patients treated with azacitidine. In addition, renal tubular acidosis, 
defined as a decrease in serum bicarbonate to < 20 mmol/L in association with an alkaline urine 
and hypokalemia (serum potassium < 3 mmol/L), has been rarely observed. If unexplained 
reductions in serum bicarbonate (< 20 mmol/L) occur, the azacitidine dose should be reduced 
by 50% on the next cycle. Similarly, if unexplained elevations in serum creatinine or blood urea 
nitrogen to ≥ 2-fold above baseline values and above the ULN occur, the next cycle should be 
delayed until values return to normal or baseline, and the azacitidine dose should be reduced 
by 50%. The reduced dose should be maintained during subsequent cycles unless toxicity 
develops.
For venetoclax-related or venetoclax/azacitidine-related nonhematologic toxicities that 
are ≥ Grade 3 that do not resolve to  Grade 1 or baseline levels with adequate supportive care, 
venetoclax dosing should be held until resolution to  Grade 1 or baseline levels. While 
venetoclax is held, magrolimab and azacitidine treatment can be continued as scheduled.
For other azacitidine only-related nonhematologic toxicities or nonhematological toxicities that 
do not resolve after holding venetoclax that are ≥ Grade 3 that do not resolve to  Grade 2 or 
baseline levels, azacitidine dosing should be delayed up to 14 days until resolution to  Grade 
2 or baseline levels. If ≥ Grade 3 toxicities continue despite this dose delay, dose modification of 
azacitidine should be performed in accordance with Table 10.


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Table 10.
Azacitidine Dose Modification for Nonhematologic Toxicities
Azacitidine Dosing Instructions if Recoverya is Not Achieved Within 14 Days
Toxicity
First Occurrenceb
Second Occurrenceb
Third Occurrenceb
Grade 3 or higher 
nonhematologic 
adverse events that 
are clinically 
relevant
Reduce azacitidine dose 
to 50 mg/m2 
administered Days 1–7 
per cycle
AND
Reassess toxicity on 
subsequent cycle; if still 
persistent despite dose 
delay, proceed to 
second occurrence.
Reduce azacitidine dose 
to 37.5 mg/m2 
administered Days 1–7 
per cycle
AND
Reassess toxicity on 
subsequent cycle; if still 
persistent despite dose 
delay, proceed to third 
occurrence.
Reduce azacitidine dose to 
25 mg/m2 administered Days 1–7 
per cycle.
AND
Reassess toxicity on subsequent 
cycle; if still persistent despite dose 
delay, then administer azacitidine at 
25 mg/m2 on Days 1–5 per cycle. 
Reassess toxicity on subsequent 
cycle. 
Fourth occurrence and beyond: If 
toxicity still persists, then contact 
the medical monitor for azacitidine 
dosing instructions.
a
Recovery is defined as improvement of nonhematologic toxicity to ≤ Grade 2 or baseline value within 14 days of dose 
delay.
b
Azacitidine may be dose-escalated back to the original dose or next higher dose level if there is resolution of the toxicity to 
≤ Grade 2 or to baseline grade.
For Grade 3 or higher nonhematologic AEs that are clinically relevant and related to venetoclax, 
hold venetoclax until toxicity is resolved to Grade 2 or lower, or to baseline grade.
5.2.6.
Prior and Concomitant Medications: Prohibited Concomitant Medications 
for Cohort 1
For the anti-leukemia regimens administered with magrolimab in this study, the current local or 
regional prescribing information should be consulted regarding permitted and prohibited 
concomitant medications.
Anti-leukemia therapies including chemotherapy (with the exception of hydroxyurea), targeted 
therapies, and immunotherapy are not permitted while patients are on study treatment.
Any investigational drugs other than magrolimab are prohibited during study treatment.
Concomitant use of venetoclax with strong CYP3A inducers or moderate CYP3A inducers 
should be avoided, as use with a strong CYP3A inducer decreases venetoclax Cmax, which may 
decrease venetoclax efficacy. 
Concomitant use of preparations containing St. John’s wort is contraindicated during the study.


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Conversely, concomitant use of strong and moderate CYP3A inhibitors with venetoclax 
increases exposure of venetoclax and therefore may increase the risk of venetoclax-related 
toxicity including TLS. Venetoclax dose modification based on concomitant use of a strong or 
moderate CYP3A inhibitor or P-gp inhibitor at initiation, during, or after the ramp-up phase, is 
described in Table 11. Resume the venetoclax dosage that was used prior to concomitant use of a 
strong or moderate CYP3A inhibitor or P-gp inhibitor 2 to 3 days after discontinuation of the 
inhibitor. Avoid grapefruit products, Seville oranges, and starfruit during treatment with 
venetoclax, as they contain inhibitors of CYP3A.
For additional information about drug interactions with venetoclax, refer to the local prescribing 
information. 
Table 11.
Management of Potential Venetoclax Interactions with CYP3A and 
P-gp Inhibitors
Co-administered Drug
Initiation and Ramp-up 
Phase
Steady Daily Dose (After Ramp-up Phase)
Posaconazole
Day 1 – 10 mg venetoclax
Day 2 – 20 mg venetoclax
Day 3 – 50 mg venetoclax
Day 4 – 70 mg venetoclax
Reduce venetoclax dose to 70 mg
Other strong CYP3A inhibitor 
Day 1 – 10 mg venetoclax
Day 2 – 20 mg venetoclax
Day 3 – 50 mg venetoclax
Day 4 – 100 mg venetoclax
Reduce venetoclax dose to 100 mg
Moderate CYP3A inhibitor 
P-gp inhibitor
Reduce the venetoclax dose by at least 50%
CYP3A = cytochrome P450 enzyme 3A; P-gp = P-glycoprotein 
5.3.
Cohort 2 (R/R AML Mag+MEC)
The start of the cycle is the first day of MEC.
Information for magrolimab is provided in Section 5.1. Magrolimab infusion should be 
completed at least 1 hour before starting MEC chemotherapy if given on the same day. 
5.3.1.
Description and Handling of Mitoxantrone
5.3.1.1.
Formulation
Information regarding the formulation of mitoxantrone can be found in the local prescribing 
information.


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5.3.1.2.
Packaging and Labeling
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guidelines to Good Manufacturing 
Practice, Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.3.1.3.
Storage and Handling
Further information regarding storage and handling of mitoxantrone is available in the local 
prescribing information.
5.3.2.
Description and Handling of Etoposide
5.3.2.1.
Formulation
Information regarding the formulation of etoposide can be found in the local prescribing 
information.
5.3.2.2.
Packaging and Labeling
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guidelines to Good Manufacturing 
Practice, Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.3.2.3.
Storage and Handling
Further information regarding storage and handling of etoposide is available in the local 
prescribing information.
5.3.3.
Description and Handling of Cytarabine
5.3.3.1.
Formulation
Information regarding the formulation of cytarabine can be found in the local prescribing 
information.
5.3.3.2.
Packaging and Labeling
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guidelines to Good Manufacturing 
Practice, Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.3.3.3.
Storage and Handling
Further information regarding storage and handling of cytarabine is available in the local 
prescribing information.


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5.3.4.
Dosage and Administration of Mitoxantrone, Etoposide, and Cytarabine
The MEC dosing regimen for Safety Run-in Cohort 2 is presented in Table 2. The treatment 
schedule is provided in Appendix Table 7. 
Magrolimab infusion should be completed at least 1 hour before starting MEC chemotherapy if 
given on the same day.
5.3.5.
Premedication and Prophylaxis for Mitoxantrone, Etoposide, and 
Cytarabine
Premedications for mitoxantrone, etoposide, and cytarabine can be administered per local 
institutional guidelines. 
5.3.6.
Dose Modification and Delays for Mitoxantrone, Etoposide, and Cytarabine
MEC is a cytotoxic therapy and causes myelosuppression. Given that patients with AML will 
also be cytopenic as a result of their leukemia, dose modifications or delays of MEC should only 
occur if there is no evidence of leukemia, as defined by a bone marrow blast count of < 5% and 
absence of circulating peripheral blasts. 
In the setting of absence of leukemic disease, treatment with MEC should be delayed in instances 
of ANC < 500/mm3 or platelets < 50,000/mm3 until recovery to an ANC ≥ 1000/mm3 or platelets 
> 75,000/mm3 or ANC and platelet values equal to or above the patient’s baseline values.
The individual components of the MEC regimen have distinct dose modification considerations 
and are detailed below.
Mitoxantrone
Mitoxantrone clearance is reduced by hepatic impairment. Patients with total bilirubin 
> 3.5 mg/dL should reduce the dose of mitoxantrone by 50%. Mitoxantrone can be dosed at the 
full dose once total bilirubin is ≤ 3.5 mg/dL. 
Etoposide
Etoposide is renally metabolized and dose modifications should be made for impaired CLcr. If 
CLcr is 15 to 50 mL/min, administer 75% of the etoposide dose. If CLcr is < 15 mL/min, 
consider further dose reductions per institutional guidelines (ie, a 50% dose reduction). 
Liver dysfunction may reduce the metabolism and increase the toxicity of etoposide; however, 
dose adjustment instructions are not provided in the US prescribing information (USPI). For 
patients with total bilirubin (predominantly direct) > 3 mg/dL or AST > 5  ULN, administer 
50% of the etoposide dose. Etoposide can be dosed at standard levels once total bilirubin is 
< 3 mg/dL or AST is < 5  ULN. 


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Cytarabine
No dose adjustments are required for renal or hepatic impairment.
5.3.7.
Prior and Concomitant Medications: Prohibited Concomitant Medications 
for Cohort 2
For the anti-leukemia regimens administered with magrolimab in this study, the current local or 
regional prescribing information should be consulted regarding permitted and prohibited 
concomitant medications.
Anti-leukemic therapies, including chemotherapy (with the exception of hydroxyurea), targeted 
therapies, and immunotherapy, are not permitted while patients are on study treatment.
Any investigational drugs other than magrolimab are prohibited during study treatment.
Drugs with cardiotoxic potential are prohibited during the study because of the potential 
cardiotoxicity with the use of mitoxantrone.
In patients receiving oral anticoagulant therapy, partial thromboplastin time (PTT) or 
international normalized ratio (INR) should be closely monitored and adjusted as needed with 
the addition and withdrawal of treatment with mitoxantrone and etoposide.
In patients treated with oral digoxin, monitor plasma digoxin levels during cytarabine treatment.
Gentamycin used against Klebsiella pneumoniae and 5-Fluorocytosine are contraindicated 
during cytarabine treatment.
Co-administration of antiepileptic drugs and etoposide injection can lead to decreased seizure 
control due to pharmacokinetic interactions between the drugs. 
Concomitant phenytoin or phenobarbital therapy is associated with increased etoposide clearance 
and reduced efficacy, and other enzyme-inducing antiepileptic therapy may be associated with 
increased etoposide clearance and reduced efficacy.
5.4.
Cohort 3 (Post-Chemo Maint Mag+CC-486)
The start of the cycle is the first day of CC-486.
Information for magrolimab is provided in Section 5.1. CC-486 is to be administered before 
magrolimab in Cycle 1.


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5.4.1.
Description and Handling of CC-486
5.4.1.1.
Formulation
Information regarding the formulation of CC-486 can be found in the current prescribing 
information {ONUREG 2020}.
5.4.1.2.
Packaging and Labeling
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guidelines to Good Manufacturing 
Practice, Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.4.1.3.
Storage and Handling
Further information regarding storage and handling of CC-486 is available in the local 
prescribing information {ONUREG 2020}.
5.4.2.
Dosing and Administration of CC-486
The CC-486 dosing regimen for Safety Run-in Cohort 3 is presented in Table 3. The dose 
de-escalation regimens for CC-486 in Safety Run-in Cohort 3 are presented in Table 6. The 
treatment schedule is provided in Appendix Table 8.
If a patient discontinues CC-486, magrolimab should also be discontinued.
CC-486 (Onureg) will be administered at a dose of 300 mg orally once daily on Days 1 through 
14 of each 28-day cycle in accordance with USPI. CC-486 should be taken at the same time each 
day. If a dose of CC-486 is missed, or not taken at the usual time, the dose should be taken as 
soon as possible on the same day, and the normal dosing schedule resumed the following day. 
Two doses should not be taken on the same day. CC-486 should not be substituted with IV or SC 
azacitidine products. CC-486 treatment will be administered until disease progression, 
unacceptable toxicity, and/or loss of clinical benefit. 
5.4.3.
Premedication and Prophylaxis for CC-486
An anti-emetic should be administered 30 minutes prior to each dose of CC-486 for the first 
2 cycles. Anti-emetic prophylaxis may be omitted after 2 cycles if there has been no nausea or 
vomiting. Anti-emetic regimens can be administered by USPI or local institutional guidelines. 
5.4.4.
Dose Modification and Delays for CC-486
CC-486 can cause myelosuppression, gastrointestinal toxicity, and other toxicities. Dose 
modifications/reductions of CC-486 will be made in accordance with the US package insert. 
Dose modifications for these toxicities are described in Table 12.


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Table 12.
CC-486 Dose Modifications for Adverse Reactions
Adverse Reaction
Severity
Dose Modificationa
Neutrophils less than 0.5 Gi/L 
on Day 1 of the cycle
Interrupt treatment. Resume at the same dose once 
neutrophils return to 0.5 Gi/L or higher.
Neutrophils less than 1 Gi/L 
with fever at any time
First occurrence:
Interrupt treatment. Resume at the same dose once 
neutrophils return to 1 Gi/L or higher.
Occurrence in 2 consecutive cycles:
Interrupt treatment. After neutrophils return to 
1 Gi/L or higher, resume at reduce dose of 200 mg.
If a patient continues to experience febrile 
neutropenia after dose reduction, reduce the 
treatment duration by 7 days.
If febrile neutropenia reoccurs after dose and 
schedule reduction, discontinue CC-486.
Myelosuppression
Platelets less than 50 Gi/L 
with bleeding
First occurrence:
Interrupt treatment. Resume at the same dose once 
platelets return to 50 Gi/L or higher.
Occurrence in 2 consecutive cycles:
Interrupt treatment. After platelets return to 50 Gi/L 
or higher, resume at reduced dose of 200 mg.
If a patient continues to experience 
thrombocytopenia with bleeding after dose 
reduction, reduce the treatment duration by 7 days. 
If thrombocytopenia with bleeding reoccurs after 
dose and schedule reduction, discontinue CC-486.
Grade 3 or 4 nausea or 
vomiting
Interrupt dosing, resume at the same dose once 
toxicity has resolved to Grade 1 or lower (or 
baseline).
If toxicity recurs, interrupt dosing until resolved to 
Grade 1 or lower (or baseline). Resume at reduced 
dose of 200 mg.
If a patient continues to experience the toxicity after 
dose reduction, reduce the treatment duration by 
7 days.
If the toxicity continues or recurs after dose and 
schedule reduction, discontinue CC-486. 
Gastrointestinal toxicity
Grade 3 or 4 diarrhea
Interrupt dosing, resume at the same dose once 
toxicity has resolved to Grade 1 or lower (or 
baseline).
If toxicity recurs, interrupt dosing until resolved to 
Grade 1 or lower (or baseline). Resume at reduced 
dose of 200 mg.
If a patient continues to experience the toxicity after 
dose reduction, reduce the treatment duration by 
7 days.
If the toxicity continues or recurs after dose and 
schedule reduction, discontinue CC-486.


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Adverse Reaction
Severity
Dose Modificationa
Other Adverse 
Reactions
Grade 3 or 4
Interrupt dosing, resume at the same dose once 
toxicity has resolved to Grade 1 or lower (or 
baseline).
If toxicity recurs, interrupt dosing until resolved to 
Grade 1 or lower (or baseline). Resume at reduced 
dose of 200 mg.
If a patient continues to experience the toxicity after 
dose reduction, reduce the treatment duration by 
7 days.
If the toxicity continues or recurs after dose and 
schedule reduction, discontinue CC-486.
Gi = giga per liter; PO = per oral route; RP2D = recommended Phase 2 dose
a If a 200 mg PO dose of CC-486 is selected as the RP2D, then omit further dose reduction and go directly to language “reduce 
the treatment duration by 7 days”. 
5.4.5.
Prior and Concomitant Medications: Prohibited Concomitant Medications 
for Cohort 3
For the anti-leukemia regimens administered with magrolimab in this study, the current local or 
regional prescribing information should be consulted regarding permitted and prohibited 
concomitant medications.
Anti-leukemic therapies, including chemotherapy (with the exception of hydroxyurea), targeted 
therapies, and immunotherapy, are not permitted while patients are on study treatment.
Any investigational drugs other than those used in the study are prohibited during study 
treatment.
5.5.
Accountability for Investigational Medicinal Product
The investigator is responsible for ensuring adequate accountability of all used and unused study 
drug (kits, vials, etc.) This includes acknowledgment of receipt of each shipment of study drug 
(quantity and condition). All used and unused study drug dispensed to patients must be returned 
to the site.
Each study site must keep accountability records that capture the following:
•
The date received and quantity of study drug (kits, vials, etc.).
•
The date, patient number, and the study lot number dispensed.
•
The date, quantity of used, and unused study drug returned, along with the initials of the 
person recording the information.


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5.5.1.
Investigational Medicinal Product Return or Disposal
Gilead recommends that used and unused study drug supplies be destroyed at the site. If the site 
has an appropriate standard operating procedure (SOP) for drug destruction as determined by 
Gilead, the site may destroy used (empty or partially empty) and unused study drug supplies in 
accordance with that site’s approved SOP. A copy of the site’s approved SOP will be obtained 
for the electronic trial master file. If study drug is destroyed at the site, the investigator must 
maintain accurate records for all study drugs destroyed. Records must show the identification 
and quantity of each unit destroyed, the method of destruction, and the person who disposed of 
the study drug. Upon study completion, copies of the study drug accountability records must be 
filed at the site. Another copy will be returned to Gilead. 
If the site does not have an appropriate SOP for drug destruction, used and unused study drug 
supplies are to be sent to the designated disposal facility for destruction. The study monitor will 
provide instructions for return.
The study monitor will review study drug supplies and associated records at periodic intervals.


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6.
STUDY PROCEDURES
The study procedures to be conducted for each patient enrolled in the study are presented in 
tabular form in Appendix 2 (Appendix Table 1, Appendix Table 2, Appendix Table 3, 
Appendix Table 4, Appendix Table 5, and Appendix Table 9) and described in the text that 
follows. 
The investigator must document any deviation from the protocol procedures and notify Gilead or 
the contract research organization.
Refer to Section 3.1.3 for information on Cohort 1 patients enrolled prior to implementation of 
Protocol Amendment 5.
6.1.
Patient Enrollment and Treatment Assignment
Entry into screening does not guarantee enrollment into the study. In order to manage the total 
study enrollment, Gilead, at its sole discretion, may suspend screening and/or enrollment at any 
site or study wide at any time.
Patients who meet eligibility criteria will be enrolled using an integrated web response system. 
The first dose of study drugs should be administered within 72 hours after enrollment.
Patients who are determined to be not eligible after screening may be rescreened once at the 
discretion of the investigator. Rescreening must be discussed with and approved by the study 
medical monitor on a case-by-case basis. Patients who are determined to be eligible for 
rescreening must be reconsented with a new screening number assigned.
6.2.
Pretreatment Assessments
6.2.1.
Screening Visit
Screening assessments are outlined in Appendix Table 1.
Patients will be screened within 30 days before enrollment to determine eligibility for 
participation in the study. The following will be performed and documented at screening:
•
Obtain written informed consent
•
Obtain demographics and medical history, including cancer history, date of recent RBC 
and/or platelet transfusions, AML molecular marker results at diagnosis, and 
echocardiogram/multigated acquisition (scan) (MUGA) or pulmonary function tests if done 
within the 3 months prior to signing the informed consent form (ICF)
•
Complete physical examination, including vital signs, body weight, and height
•
Serum pregnancy test (females of childbearing potential)


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•
Complete blood count (CBC) with differential, platelets, reticulocytes
•
Serum or plasma chemistry
•
Prothrombin time, INR, and activated partial thromboplastin time or partial thromboplastin 
time
•
Extended red blood cell phenotyping or genotyping, ABO system (ABO)/Rhesus factor (Rh) 
type, and screen (any of the 4 blood groups A, B, AB, and O composing the ABO/Rh), direct 
antiglobulin test (DAT)
•
Urinalysis
•
Bone marrow biopsy and aspirate for blast evaluation, MRD assessment, cytogenetics, and 
correlative studies
•
Bone marrow aspirate for RO (to be collected at selected study sites)
•
Peripheral blood smear (for blasts)
•
ECOG performance status (Appendix 6)
•
Perform 12-lead electrocardiogram (ECG) (single)
•
Echocardiogram or MUGA, if not done within the past 30 days prior to consent, for Cohort 2 
patients only
•
Record all SAEs and any AEs related to protocol-mandated procedures occurring after 
signing of the ICF
•
Record prior and concomitant medications
•
Entry criteria
From the time of obtaining informed consent through the first administration of study drug, 
record all SAEs, as well as any AEs related to protocol-mandated procedures on the AEs eCRF. 
All other untoward medical occurrences observed during the screening period, including 
exacerbation or changes in medical history, are to be considered medical history. Additional 
details are provided in Section 7, Adverse Events and Toxicity Management.
6.2.2.
Baseline/Day 1 Assessments
Baseline/Day 1 assessments are outlined in Appendix Table 2, Appendix Table 3, 
Appendix Table 4, and Appendix Table 5. 


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Patients must return to the study site within 30 days of screening for baseline/Day 1 assessments. 
The following will be performed and documented at baseline/Day 1:
•
Serum or urine pregnancy test (females of childbearing potential)
•
Predose CBC with differential, platelets, reticulocytes and postdose Hb
•
Haptoglobin and lactate dehydrogenase 
•
Serum or plasma chemistry
•
Vital signs, weight, and symptom-directed physical examination
•
Recording of all AEs and concomitant medications
•
Peripheral blood smear for general morphology
•
Peripheral blood sample for correlative studies
•
Peripheral blood sample for RO (to be collected at selected study sites)
•
Buccal swab (may be collected on Day 1 or at any time during the study)
•
PK and ADA sample collection
6.3.
On-Study Treatment Assessments
On-study treatment assessments include evaluations of efficacy (Section 6.4), safety 
(Section 6.5), PK (Section 6.6), immunogenicity (Section 6.7), and PD and biomarkers 
(Section 6.8). The schedule for on-treatment assessments is provided in Appendix Table 2, 
Appendix Table 3, Appendix Table 4, and Appendix Table 5.
6.4.
Efficacy Assessments
Clinical response will be assessed by the investigator using prespecified criteria (Appendix 7).
Response assessments will be done in conjunction with bone marrow assessments, according to 
the schedule of assessments (Appendix Table 2 and Appendix Table 3). Bone marrow 
assessments (including aspirate and core/trephine biopsy) are required for response assessments 
and may be used for blast evaluation, MRD assessment, cytogenetics, RO (to be collected at 
selected study sites), and correlative studies. Peripheral blood smears for blasts should be done on 
the day of the bone marrow assessments. Details for preparation and distribution of aspirate and 
biopsy/trephine specimens to the testing laboratories will be provided in the laboratory manual 
for this study.


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If the patient is cytopenic at the time of the bone marrow assessment, CBC is to be monitored at 
least once per week until optimal count recovery is reached. The best accompanying laboratory 
CBC result within the ± 2-week window is to be used to support an efficacy response 
assessment, with the date of response assigned as the date of bone marrow assessment. If a 
patient achieves a CR, subsequent bone marrow biopsies are still required to be performed in 
accordance with the schedule of assessments.
Bone marrow aspirate and biopsy slides or blocks for efficacy assessments will be prepared for 
potential evaluation of response assessments by independent central review.
Response assessment will be obtained at the EOT visit unless a prior response assessment has 
been performed within the last 30 days or progressive disease has been documented.
6.5.
Safety Assessments
Safety will be evaluated by incidence of AEs, assessment of clinical laboratory test findings 
(chemistry, hematology), physical examination, 12-lead ECG, and vital signs measurements.
6.5.1.
Pregnancy Test
Pregnancy tests are required only for female patients of childbearing potential. Note that a 
woman is considered to be of childbearing potential following the initiation of puberty (Tanner 
Stage 2) until becoming postmenopausal, unless permanently sterile or with medically 
documented ovarian failure. Permanent sterilization includes hysterectomy, bilateral 
oophorectomy, or bilateral salpingectomy in a female patient of any age. Women are considered 
to be in a postmenopausal state when they are > 54 years of age with cessation of previously 
occurring menses for > 12 months without an alternative cause. In addition, women of < 54 years 
of age with amenorrhea of > 12 months may also be considered postmenopausal if their 
follicle-stimulating hormone level is in the postmenopausal range and they are not using 
hormonal contraception or hormonal replacement therapy. A negative serum pregnancy test is 
required at screening. A negative serum or urine pregnancy test is required at Cycle 1 Day 1 and 
every 4 weeks thereafter. The Cycle 1 Day 1 pregnancy test does not need to be repeated if the 
screening pregnancy test was performed within the 72 hours before study treatment 
administration. For further details, refer to Appendix 5.
6.5.2.
Complete Blood Counts
Samples for CBCs should be collected per the schedules of assessments in Appendix 2. White 
blood cell count must be ≤ 20 x 103/µL prior to first dose of study drug and prior to each 
magrolimab dose for the first 28 days (see Section 5.1.2). Hemoglobin must be checked again 
3 to 6 hours after the initiation of the first and second doses of magrolimab during initial 
treatment. The patient should be transfused as clinically appropriate. Investigators should 
consider additional Hb monitoring during the first week of treatment in patients with symptoms 
of anemia or at increased risk for complications of anemia. Additional samples for CBC may be 
collected outside of the protocol-specified time points to ensure WBC level ≤ 20 x 103/µL for the 
first 4 weeks and repriming/re-escalation first 4 weeks.


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6.5.3.
Type and Screen and Direct Antiglobulin Test
Magrolimab may interfere with RBC phenotyping due to expected coating of the RBC 
membrane. Due to the risk of developing anemia, and because magrolimab may make 
phenotyping difficult, ABO/Rh type, antibody screen, RBC phenotyping or genotyping, and 
DAT need to be performed at screening prior to exposure to magrolimab, as described in 
Section 7.8.1.1.
Red blood cell phenotyping/genotyping, ABO type, and DAT do not need to be repeated if 
results dated before screening are available. Antibody screen does not need to be repeated if 
results dated before screening are available, unless the patient was transfused since that time.
6.5.4.
Vital Signs
Vital signs will include heart rate, respiratory rate, oxygen saturation, blood pressure, 
temperature, and weight. Height should be recorded during screening only. Weight should be 
recorded during screening and on Day 1 of each cycle. Vital signs are to be recorded prior to 
dosing of study treatment at the visits specified in the schedules of assessments in Appendix 2.
6.5.5.
Physical Examination
Complete physical examination will be performed at screening. Thereafter, symptom-directed 
physical examinations are acceptable and may also include routine examination of the skin 
(including fingers, toes, and ears) and neurologic system.
6.5.6.
Electrocardiograms
A single 12-lead ECG will be performed at screening. 
6.5.7.
Adverse Events
At each visit, all AEs observed by the investigator or reported by the patient that occur after the 
first dose of study treatment through 70 days (± 7 days) after the last dose of study treatment are 
to be reported using the applicable eCRF (Section 7.1.1). Full details on the definitions, 
assessment, and reporting instructions for AEs are provided in Section 7.
6.5.8.
Laboratory Assessments
Laboratory assessments to be performed at screening are presented in Table 13. Laboratory 
assessments to be performed during the study are presented in Table 14.


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Table 13.
Laboratory Analyte Listing (to Be Performed at Screening)
Safety Laboratory Measurements 
Chemistry
(Serum or Plasma)
Hematology
Urinalysis
Other Laboratory Measurements
Sodium
Potassium
Chloride
Bicarbonate
Total protein
Albumin
Calcium
Magnesium
Phosphorus
Glucose
BUN or urea
Creatinine
Uric acid
Total bilirubin
Direct bilirubin
Indirect bilirubin
Haptoglobin
LDH
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
Hemoglobin
Hematocrit
Platelets
WBC differential
ANC
Eosinophils
Basophils
Lymphocytes
Monocytes
Reticulocytes
PT
INR
aPTT or PTT
RBC
Protein
Serum pregnancy test
Extended RBC phenotyping or 
genotyping
Type and screen (ABO/Rh), DAT
Blast evaluation (on CBC)
Bone marrow aspirate and biopsy:
MRD assessment
Cytogenetics
Receptor occupancy (to be collected 
at selected study sites)
Correlative studies
Peripheral blood smear: 
Blasts (with bone marrow 
assessments)
ABO = any of the 4 blood groups A, B, AB, and O composing the ABO system; ALT = alanine aminotransferase; ANC = absolute 
neutrophil count; aPTT = activated partial thromboplastin time; AST = aspartate aminotransferase; BUN = blood urea nitrogen; 
CBC = complete blood count; DAT = direct antiglobulin test; INR = international normalized ratio; LDH = lactate dehydrogenase; 
MRD = minimal residual disease; PT = prothrombin time; PTT = partial thromboplastin time; RBC = red blood cell; Rh = Rhesus 
factor; SGOT = serum glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic transaminase; WBC = white blood cell
Refer to Appendix Table 1 for collection time points.


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Table 14.
Laboratory Analyte Listing (to Be Performed During the Study)
Safety Laboratory Measurements
Chemistry
(Serum or Plasma)
Hematologya
Other Laboratory Measurements
Sodium
Potassium
Calcium
Chloride
Bicarbonate
Albumin
Glucose
BUN or urea
Creatinine
Uric acid (Cohorts 1 and 2)
Phosphorus (Cohorts 1 and 2)
Total bilirubin
Direct bilirubin
Indirect bilirubin
Haptoglobin
LDH
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
Hemoglobin
Hematocrit
Platelets
WBC differential
ANC
Lymphocytes
Reticulocytes
Serum or urine pregnancy test
Pharmacokinetics
Antidrug antibodies
Blast evaluation (on CBC)
Bone marrow aspirate and biopsy:
MRD assessment
Cytogenetics
Receptor occupancy (to be collected at 
selected study sites)
Correlative studies
Peripheral blood smear: 
Blasts (with bone marrow assessments)
General cell morphology
ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; BUN = blood urea 
nitrogen; CBC = complete blood count; LDH = lactate dehydrogenase; MRD = minimal residual disease; SGOT = serum 
glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic transaminase; WBC = white blood cell
a If the patient is cytopenic at the time of bone marrow assessments, CBC to be monitored at least once per week subsequently 
until optimal count recovery is reached. The best CBC result within the ± 2-weeks window is to be used for the response 
assessment, with the date of the response being the date of the bone marrow assessment.
Refer to Appendix Table 2, Appendix Table 3, Appendix Table 4, and Appendix Table 5 for collection time points.
6.5.9.
Concomitant Medications
All concomitant medications taken by the patient while on study are to be documented. Changes 
in baseline concomitant medication information are to be collected after informed consent 
through the study treatment period, and up until 70 days (± 7 days) after treatment 
discontinuation. Concomitant medication associated with procedure-related AEs will be captured 
from the time of informed consent and onward. Information to be collected includes therapy 
name, indication, dose, unit, frequency, route, start date, and stop date and must be reported 
using the applicable eCRF. Note that any anti-AML therapies after the study treatment period 
should also be collected per the schedule of assessments (Appendix Table 9).


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Pharmacokinetic Assessments 
Final 
Amendment6 
Samples for PK assessment of magrolimab will be collected from all patients in accordance with 
the schedule of assessments (Appendix Table 4 and Appendix Table 5). Sernm magrolimab 
concentrations will be measured by a validated immunoassay. 
6.7. 
Immunogenicity Assessments 
Samples for assessment of anti-magrolimab antibodies will be collected in all patients in 
accordance with the schedule of assessments (Appendix Table 4 and Appendix Table 5). 
Antidrng antibody assessment will be perfo1med using a validated assay following a 3-tiered 
approach: screening, confnmato1y, and titer testing. 
6.8. 
Pharmacodynamics and Biomarker Assessments 
Peripheral blood samples will be collected for assessment of PD and biomarkers according to the 
schedule of assessments (Appendix Table 2, Appendix Table 3, Appendix Table 4, and 
Appendix Table 5). Phannacodynamic and biomarker assessments provide impo1i ant 
info1mation regarding the efficacy and MOA of a diug. They also may identify paii icular patient 
subsets likely to respond to a therapy. Leukemia patients in this trial will be assessed by methods 
including, but not limited to, the studies described below. 
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6.9.
Posttreatment Assessments
Posttreatment assessments are presented in Appendix Table 9. 
6.10.
Assessments for Early Discontinuation from Study
Reasons for discontinuation of study treatment are provided in Section 3.4.
6.11.
End of Study
End of the entire study for all patients and for individual patients is defined in Section 3.5.
6.12.
Poststudy Care
Upon withdrawal from study treatment, patients will receive the care upon which they and their 
physicians agree. Patients will be followed for AEs as specified in Appendix Table 9.
6.13.
Sample Storage
The stored biological samples may be used by Gilead or its research partner for future testing to 
provide additional data to answer questions that relate to the main study. At the end of this study, 
these samples may be retained in storage by Gilead for a period up to 15 years. If patients 
provide additional specific consent, residual PK samples may be destroyed no later than 15 years 
after the end of study or per country requirements.
CCI


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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events and Serious Adverse Events
7.1.1.
Adverse Events
An AE is any untoward medical occurrence in a clinical study patient administered a study drug 
that does not necessarily have a causal relationship with the treatment. An AE can therefore be 
any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use 
of a study drug, whether or not the AE is considered related to the study drug. Adverse events 
may also include pretreatment or posttreatment complications that occur as a result of 
protocol-specified procedures or special situations (Section 7.1.3). 
An AE does not include the following:
•
Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion. 
The condition that led to the procedure may be an AE and must be reported.
•
Pre-existing diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen
•
Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions)
•
Overdose without clinical sequelae (Section 7.1.3)
•
Any medical condition or clinically significant laboratory abnormality with an onset date 
before the ICF is signed and not related to a protocol-associated procedure is not an AE but 
rather considered to be pre-existing and should be documented as medical history.
•
Pre-existing events that increase in severity or change in nature after study drug initiation or 
during or as a consequence of participation in the clinical study will also be considered AEs.
7.1.2.
Serious Adverse Events
An SAE is defined as an event that, at any dose, results in the following:
•
Death
•
A life-threatening situation (Note: The term “life-threatening” in the definition of “serious” 
refers to an event in which the patient was at risk of death at the time of the event; it does not 
refer to an event that hypothetically might have caused death if it were more severe.)
•
In-patient hospitalization or prolongation of existing hospitalization


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•
Persistent or significant disability/incapacity
•
A congenital anomaly/birth defect
•
A medically important event or reaction. Such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is reportable under 
expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. 
7.1.2.1.
Protocol-Specific Adverse Event/Serious Adverse Event Definitions
Given the primary and secondary endpoints of the study, in order to maintain study integrity, the 
following events that are assessed as unrelated to study drug will not be considered AEs/SAEs:
•
Progression of AML
•
Deaths related to progression of AML
Events that are considered to represent progression of the underlying AML should not be 
recorded as AEs/SAEs. These data will be captured as efficacy assessment data only. If there is 
any uncertainty as to whether an event is due to disease progression, it should be reported as an 
AE/SAE.
Death that is attributed by the investigator as solely due to progression of AML and that occurs 
during the protocol-specified AE reporting period should be recorded only on the death eCRF 
(ie, not collected as an SAE on the AE eCRF). 
7.1.2.1.1.
Deaths not related to AML progression
All other deaths (ie, deaths that are not due to AML progression) occurring during the 
protocol-specified AE reporting period, regardless of attribution, will be recorded on the AE 
eCRF and reported within 24 hours of awareness and no later than the next business day.
When recording a death on the eCRF, the event or condition that is considered the primary cause 
of death should be the AE term, and the outcome should be fatal. A patient can only have 1 AE 
(SAE) with a fatal outcome and severity of CTCAE Grade 5.


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7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports
Special situation reports (SSRs) include all reports of medication error, abuse, misuse, overdose, 
occupational exposure, drug interactions, exposure via breastfeeding, unexpected benefit, 
transmission of infectious agents via the product, counterfeit or falsified medicine, and 
pregnancy regardless of an associated AE. 
Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration, or administration of a study drug while the medication is in the control of a 
health care professional, patient, or consumer. Medication errors may be classified as a 
medication error without an AE, which includes situations of missed dose, medication error with 
an AE, intercepted medication error, or potential medication error.
Abuse is defined as persistent or sporadic intentional excessive use of a study drug by a patient.
Misuse is defined as any intentional and inappropriate use of a study drug that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a study 
drug given per administration or cumulatively that is above the maximum recommended dose 
allowed by the protocol or the product labeling (as it applies to the daily dose of the patient in 
question). In cases of a discrepancy in drug accountability, overdose will be established only 
when it is clear that the patient has taken the excess dose(s). Overdose cannot be established 
when the patient cannot account for the discrepancy, except in cases in which the investigator 
has reason to suspect that the patient has taken the additional dose(s).
Occupational exposure is defined as exposure to a study drug as a result of one’s professional or 
nonprofessional occupation.
Drug interaction is defined as any drug/drug, drug/food, or drug/device interaction.
Unexpected benefit is defined as an unintended therapeutic effect the results of which are judged 
to be desirable and beneficial. 
Transmission of infectious agents is defined as any suspected transmission of an infected agent 
through a Gilead study drug.
Counterfeit or falsified medicine is defined as any study drug with a false representation of (a) its 
identity, (b) its source, or (c) its history.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event information 
and assessments.


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7.2.1.
Assessment of Causality for Study Drugs and Procedures
The investigator or qualified subinvestigator is responsible for assessing the relationship to study 
drug using clinical judgment and the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study drug. For SAEs, an 
alternative causality must be provided (eg, pre-existing condition, underlying disease, 
intercurrent illness, concomitant medication).
•
Yes: There is reasonable possibility that the AE may have been caused by the study drug.
It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of AE reporting. 
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study procedure.
•
Yes: The AE occurred as a result of protocol procedures (eg, venipuncture).
7.2.2.
Assessment of Severity 
The severity of AEs will be graded using the NCI CTCAE Version 5.0. For each episode, the 
highest grade attained should be reported as defined in the Toxicity Grading Scale (Appendix 4). 
7.3.
Investigator Reporting Requirements and Instructions 
7.3.1.
Requirements for Collection Prior to Study Drug Initiation
After informed consent, but prior to initiation of study medication, the following types of events 
must be reported on the applicable eCRFs: all SAEs and any AEs related to protocol-mandated 
procedures.
7.3.2.
Adverse Events
Following initiation of study medication, all AEs, regardless of cause or relationship, will be 
collected until 70 days (± 7 days) after last administration of study drug and reported on the 
eCRFs as instructed.
All AEs should be followed up until resolution or until the AE is stable, if possible. Gilead may 
request that certain AEs be followed beyond the protocol-defined follow-up period.


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7.3.3.
Serious Adverse Events
All SAEs, regardless of cause or relationship, that occur after the patient first consents to 
participate in the study (ie, signing the ICF) and throughout the duration of the study, including 
the posttreatment follow-up visit, must be reported on the applicable eCRFs and Patient Safety 
(PS) as instructed below in this section. This also includes any SAEs resulting from protocol-
associated procedures performed after the ICF is signed.
Any SAEs and deaths that occur after the posttreatment follow-up visit but within 70 days 
(± 7 days) of the last dose of study drug, regardless of causality, should also be reported. 
Investigators are not obligated to actively seek SAEs after the protocol-defined follow-up period; 
however, if the investigator learns of any SAEs that occur after the protocol-defined follow-up 
period has concluded and the event is deemed relevant to the use of study drug, the investigator 
should promptly document and report the event to Gilead PS.
Instructions for reporting SAEs are described in Section 7.4.1.
7.3.4.
Study Drug Special Situations Reports
All study drug SSRs that occur from study drug initiation and throughout the duration of the 
study, including the posttreatment follow-up visit, must be reported to Gilead PS (Section 7.4.2). 
Adverse events and SAEs resulting from SSRs must be reported in accordance with the AE and 
SAE reporting guidance (Section 7.4).
7.3.5.
Concomitant Therapy Reports
7.3.5.1.
Gilead Concomitant Therapy Special Situations Report
Special situations involving a Gilead concomitant therapy (not considered a study drug) that 
occur after the patient first consents to participate in the study (ie, signing the informed consent) 
and throughout the duration of the study, including the posttreatment follow-up visit, must be 
reported to Gilead PS utilizing the paper SSR (Section 7.4.2.1).
7.3.5.2.
Non-Gilead Concomitant Therapy Report
Special situations involving non-Gilead concomitant medications do not need to be reported on 
the SSR form; however, for special situations that result in AEs due to a non-Gilead concomitant 
medication, the AE should be reported on the AE form. 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
All clinical sequelae in relation to these SSRs will be reported as AEs or SAEs at the same time 
using the AE eCRF and/or the SAE report form. Details of the symptoms and signs, clinical 
management, and outcome will be reported, when available.


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7.4.
Reporting Process for Serious Adverse Events and Special Situation Reports
7.4.1.
Serious Adverse Event Reporting Process
For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be transmitted by email or fax when requested and applicable. 
Transmission of such documents should occur without personal patient identification, 
maintaining the traceability of a document to the patient identifiers.
Additional information may be requested to ensure the timely completion of accurate safety 
reports.
Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the patient’s eCRF and the SAE narrative section of the Safety Report 
Form eCRF.
7.4.1.1.
Electronic Serious Adverse Event Reporting Process
Site personnel will record all SAE data on the applicable eCRFs and from there transmit the SAE 
information to Gilead PS within 24 hours of the investigator’s knowledge of the event from ICF 
signature throughout the duration of the study, including the protocol-required posttreatment 
follow-up period. 
If it is not possible to record and transmit the SAE information electronically, record the SAE on 
the paper SAE reporting form and transmit within 24 hours:
Gilead:
Gilead PS
Email: Safety_fc@gilead.com 
or
Fax: 1-650-522-5477
If an SAE has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary. If the database is not locked, any SAE reported via paper must be 
transcribed as soon as possible on the applicable eCRFs and transmitted to Gilead PS.
7.4.2.
Special Situations Reporting Process 
7.4.2.1.
Paper Special Situations Reporting Process for Study Drug
All special situations will be recorded on the SSR form and transmitted by emailing or faxing the 
report form within 24 hours of the investigator’s knowledge of the event to the attention of 
Gilead PS from study drug initiation throughout the duration of the study, including the 
protocol-required posttreatment follow-up period.


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Gilead PS
Email: Safety_fc@gilead.com 
or
Fax: 1-650-522-5477
7.4.2.2.
Reporting Process for Gilead Concomitant Medications
Special situations that involve concomitant medications manufactured by Gilead that are not 
considered study drug must be reported within 24 hours of the investigator’s knowledge of the 
event to Gilead PS utilizing the paper SSR form to:
Gilead PS
Email: Safety_fc@gilead.com 
or
Fax: 1-650-522-5477
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
Special situations involving non-Gilead concomitant medications do not need to be reported on 
the SSR form; however, special situations that result in AEs due to a non-Gilead concomitant 
medication must be reported as an AE.
7.4.2.3.
Pregnancy Reporting Process
The investigator should report pregnancies in female study patients that are identified after 
initiation of study drug and throughout the study, including the protocol-required posttreatment 
follow-up period, to Gilead PS using the pregnancy report form within 24 hours of becoming 
aware of the pregnancy. Contact details for transmitting the pregnancy report form are as 
follows:
Gilead PS
Email: Safety_FC@gilead.com 
or
Fax: 1-650-522-5477
The pregnancy itself is not considered an AE, nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
All other premature terminations of pregnancy (eg, a spontaneous abortion, an induced 
therapeutic abortion due to complications or other medical reasons) must be reported within 
24 hours as an SAE, as described in Section 7.4.1. The underlying medical reason for this 
procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Section 7.4.1. Furthermore, any SAE occurring as an adverse pregnancy outcome after the study 
must be reported to the Gilead PS.


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The patient should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome of the pregnancy should be reported to Gilead PS using the pregnancy 
outcome report form. If the end of the pregnancy occurs after the study has been completed, the 
outcome should be reported directly to Gilead PS. Gilead PS contact information is as follows: 
email: Safety_FC@gilead.com and fax: +1 (650) 522-5477. 
Refer to Appendix 5 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.
7.5.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Clinical Trials Directive (2001/20/EC), and relevant updates, and 
other country-specific legislation or regulations, Gilead may be required to expedite to 
worldwide regulatory agencies reports of SAEs, which may be in the form of line-listings, 
serious adverse drug reactions, or suspected unexpected serious adverse reactions (SUSARs). In 
accordance with the EU Clinical Trials Directive (2001/20/EC), Gilead or a specified designee 
will notify worldwide regulatory agencies and the relevant IEC in concerned Member States of 
applicable SUSARs as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the IB or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study drug. The investigator should notify the IRB or IEC of SUSAR reports as soon as 
is practical, where this is required by local regulatory agencies, and in accordance with the local 
institutional policy. 
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not to be recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, urinalysis) that require 
medical or surgical intervention or lead to study drug interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, ECG, x-rays, vital signs) that are associated with 
signs and/or symptoms must be recorded as an AE or SAE if they meet the definition of an AE 
or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory abnormality is part of a 
syndrome, record the syndrome or diagnosis (eg, anemia), not the laboratory result (eg, 
decreased Hb).
Severity should be recorded and graded according to the NCI CTCAE Version 5.0. For AEs 
associated with laboratory abnormalities, the event should be graded on the basis of the clinical 
severity in the context of the underlying conditions; this may or may not be in agreement with 
the grading of the laboratory abnormality.


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7.7.
Abnormal Liver Function Tests
Liver toxicity will be evaluated for all patients.
In the absence of an explanation for increased liver function tests, such as viral hepatitis, 
pre-existing or acute liver disease, or exposure to other agents associated with liver injury, the 
patient may be discontinued from the study treatment if the investigator determines that it is not 
in the patient’s best interest to continue. Discontinuation of treatment should be considered if 
there is an indication of severe liver injury according to Hy’s Law, defined by US FDA 
Guidance for Industry, Drug-Induced Liver Injury: Premarketing Clinical Evaluation {U.S. 
Department of Health & Human Services (DHHS) 2009}, as:
• Treatment-emergent ALT or AST elevation (≥ 3  ULN), AND 
• Treatment-emergent total bilirubin elevation (> 2  ULN), and absence of cholestasis (defined 
as ALP < 2  ULN), AND 
• No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, 
alcohol ingestion, congestive heart failure, worsening liver metastases).
7.8.
Toxicity Management 
7.8.1.
Magrolimab
7.8.1.1.
Anemia, Blood Crossmatching, and Packed Red Blood Cell Transfusion 
Procedures
Magrolimab binds to RBCs and leads to erythrophagocytosis. CD47 is a member of the Rh 
complex in the RBCs membrane. Therefore, when magrolimab binds to CD47, it is likely to 
interfere with routine blood bank tests needed in case of transfusion. Notify blood transfusion 
centers/blood banks of this interference with blood bank testing and inform them that a patient 
will receive magrolimab.
In clinical studies, anemia is the most common treatment-related AE and is typically manifested 
as a decline in Hb of about 0.5 g/dL to 1.5 g/dL observed in the first 1 to 2 weeks of treatment. 
This decrease in Hb level is acceptable in patients with no other significant diseases or medical 
conditions. However, for patients with significant diseases or medical conditions, such as 
unstable angina, ischemic heart disease, or uncontrolled diabetes mellitus, treatment-related 
anemia could be life-threatening or fatal. Significant drops (up to 3 g/dL) have been observed in 
early doses.
Within 24 hours prior to each of the first 2 doses of magrolimab infusion during initial treatment, 
all patients must have a documented hemoglobin ≥ 9 g/dL. Patients who do not meet these 
criteria must be transfused and have their hemoglobin rechecked to meet 9 g/dL prior to each of 
the first 2 doses of magrolimab.


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Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and second doses 
of magrolimab during initial treatment. The patient should be transfused as clinically appropriate. 
Investigators should consider additional Hb monitoring during the first week of treatment in 
patients with symptoms of anemia or at increased risk for complications of anemia.
Patients with low baseline Hb level, especially those with cardiac history or risk factors, must be 
monitored closely after initial administrations of magrolimab as preexisting anemia could be 
exacerbated. Red blood cell transfusions are permitted prior to study treatment to ensure 
adequate Hb level as per the investigator’s clinical judgment. The need for RBC transfusions and 
anemia from other causes in patients with cancer, means that care has to be taken with RBC 
cross-matching and packed RBC transfusions.
Prior to initiation of magrolimab, ABO/Rh type, antibody screen, DAT, and extended RBC 
phenotyping (including minor antigens such as CcDEe, Cw, MNSs, Kk, FyaFyb, and JkaJkb) 
will be performed for each patient. Red blood cell genotyping instead of extended RBC 
phenotyping is acceptable for any patient. Red blood cell genotyping (instead of an extended 
RBC phenotyping) must be performed if a patient received any RBC or whole blood transfusion 
within the previous 3 months (unless laboratory has availability for special techniques for 
performing phenotyping for patients with recent transfusion). Results must be available before 
the first dose of magrolimab.
For patients after exposure to magrolimab
For all elective RBC and platelet transfusions, use leukocyte-reduced and gamma-irradiated units 
per institutional guidelines. For RBC phenotype/genotype matched units are preferred. However, 
CMV-seronegative units for CMV-seronegative patients will not be required for this study.
In case ABO/Rh type cannot be resolved, use pretreatment (historical) phenotype/genotype 
matched units for minor RBC antigens (CcDEe and Kk, to the feasible extent). Regarding the 
ABO type, institution can use historical blood group or O type as per the institutional guidelines.
For emergency transfusions, the transfusion centers may consider using emergency Group O red 
cells if phenotype/genotype matched units are not available.
Whenever possible, blood plasma therapy should be blood type specific. Platelets should be 
blood type compatible whenever possible and, if not, should have been tested and found not to 
have high titer anti-A or anti-B. Otherwise, plasma and platelet products can be provided as per 
the institutional policy.
A recent report has suggested that cross-match interference by RBCs due to treatment with 
magrolimab may be resolved by use of gamma-clone anti-IgG and multiple alloadsorptions with 
papain-treated RBC samples, pooled single donor apheresis platelets or commercial human 
platelet concentrate product if required {Troughton 2018, Velliquette 2019}.


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7.8.1.2.
Management of Infusion-Related Reactions
An IRR is defined by the NCI CTCAE Version 5.0 (under the category “General disorders and 
administration site conditions”) as “a disorder characterized by adverse reaction to the infusion 
of pharmacological or biological substances” (Appendix 4). For the purposes of this study, the 
time frame for IRR assessment is the 24-hour period beginning from the start of the infusion. 
Premedication use described in Section 5.1.4 will be used to manage IRRs preemptively.
Recommendations for the management of infusion-related reactions are in Table 15:


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Table 15.
Management of Infusion-related Reactions
CTCAE Grade
Management
Grade 1
Mild transient reaction.
Remain at bedside and monitor patient until recovery from symptoms.
Patients who experience IRRs with the first 4 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
Grade 2
Requiring symptomatic 
treatment and prophylactic 
medications for ≤ 24 hours.
Stop the magrolimab infusion, begin an IV infusion of normal saline, and 
consider treating the patient with diphenhydramine 50 mg IV (or equivalent) 
and/or 500 to 750 mg of oral acetaminophen.
Remain at bedside and monitor patient until resolution of symptoms.
Corticosteroid therapy may also be given at the discretion of the investigator.
If the infusion is interrupted, wait until symptoms resolve, then restart the 
infusion at 50% of the original infusion rate.
If no further complications occur after 1 hour (± 10 minutes), the rate may be 
increased to 100% of the original infusion rate. Monitor the patient closely.
If symptoms recur, stop infusion and disconnect patient from the infusion 
apparatus. No further magrolimab will be administered at that visit.
Patients who experience IRRs with the first 4 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
The amount of magrolimab infused must be recorded on the eCRF.
Patients who experience a Grade 2 IRR during the postinfusion observation 
period that does not resolve to ≤ Grade 1 during that time should be observed 
until the AE resolves or stabilizes, with vital sign measurements as medically 
indicated for the management of the AE.
Grade 3-4
Grade 3: Prolonged reactions or 
recurrence of symptoms 
following initial improvement, 
or where hospitalization is 
indicated for other clinical 
sequelae.
Grade 4: Life-threatening 
consequences, where urgent 
intervention is indicated.
Immediately discontinue infusion of magrolimab.
Begin an IV infusion of normal saline and consider treating the patient as 
follows: Administer bronchodilators, epinephrine 0.2 to 1 mg of a 
1:1000 solution for SC administration or 0.1 to 0.25 mg of a 1:10,000 solution 
injected slowly for IV administration and/or diphenhydramine 50 mg IV with 
methylprednisolone 100 mg IV (or equivalent), as needed.
The patient should be monitored until the investigator is comfortable that the 
symptoms will not recur.
Patients who experience Grade 3 IRRs must be given premedication prior to 
subsequent doses. In this setting, premedication with oral acetaminophen (650 
to 1000 mg), oral or IV diphenhydramine (25 to 50 mg), and IV 
dexamethasone (4 to 20 mg), or a comparable regimen, is recommended for 
the subsequent 2 doses. Continued premedication with corticosteroids beyond 
these 2 doses may be administered at the discretion of the treating physician.
Patients who receive premedication and still experience a recurrent Grade 3 
IRR or patients who experience a Grade 4 IRR at any time should be 
permanently discontinued from the study treatment.
For anaphylaxis, investigators should follow their institutional guidelines for 
treatment.
All patients with a Grade 3 or higher IRR will be observed until the AE 
resolves or stabilizes, with vital sign measurements and additional evaluations 
as medically indicated for the management of the AE.
AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; eCRF = electronic case report form; 
IRR = infusion-related reaction; IV = intravenous: SC = subcutaneous


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7.8.1.3.
Severe Neutropenia
Severe neutropenia and febrile neutropenia have been reported in patients treated with 
magrolimab. Close monitoring of hematologic parameters (Appendix Table 1, Appendix Table 2, 
Appendix Table 3, Appendix Table 4, Appendix Table 5, and Appendix Table 9) including 
neutrophils is required for all patients treated with magrolimab. Prophylactic antibiotics and/or 
antimycotics should be considered. Administer G-CSF if clinically indicated. 
Recommendations for magrolimab dose delay in case of severe neutropenia: 
•
Before achieving remission, for Grade 4 neutropenia (ANC < 500/μL) with or without fever 
or infection, the delay of magrolimab dosing is not recommended. In cases of Grade 4 
neutropenia with serious infection, see Section 7.8.1.4 for recommendations on dose delay. 
•
After achieving remission, for Grade 4 neutropenia (ANC <500/μL) with fever or infection, 
and lasting at least 7 days, magrolimab dosing delay should be considered. Upon resolution 
to Grade ≤ 2, resume magrolimab at the same dose should be considered.
7.8.1.4.
Serious Infections
Patients (with or without neutropenia) should be regularly monitored for signs and symptoms of 
infection. For patients with prolonged neutropenia or patients at risk, consider infection 
prophylaxis including antibiotics (eg, fluoroquinolone) or antifungal agents (eg, oral triazoles or 
parenteral echinocandin) in accordance with current guidelines.
For serious infections, hold magrolimab until the infection has resolved clinically. For serious 
infections that remain active for ≥ 14 days, consider discontinuation of magrolimab.
7.8.1.5.
Thromboembolic Events
Thromboembolic events, including deep vein thromboses and pulmonary embolisms, have been 
reported in some patients receiving magrolimab, sometimes early in therapy. Available data for 
magrolimab do not support a clear or consistent relationship between clinical thromboembolic 
events and magrolimab use. Patients should be closely monitored for the symptoms of 
thromboembolic events and treated accordingly.
7.8.1.6.
Management of Pneumonitis
Pneumonitis has been infrequently observed in patients receiving magrolimab. Generally, 
immune-related AEs have not been observed in clinical use with magrolimab. In contrast to 
T-cell checkpoint inhibitors, magrolimab primarily exerts its antitumor efficacy through 
macrophage-mediated phagocytosis of tumor cells. Nonspecific T-cell or other host immune 
responses that are seen with T-cell checkpoint inhibitors have not been observed with 
magrolimab in nonclinical studies. Additionally, no events of macrophage activation syndrome 
or hemophagocytic lymphohistiocytosis have been reported in clinical studies.


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In instances of suspected pneumonitis, first rule out non-inflammatory causes (eg, infections). If 
a non-inflammatory cause is identified, treat accordingly and continue therapy per protocol. 
Evaluate with imaging (eg, chest x-ray or computed tomography) and pulmonary consultation.
Management of potential pneumonitis is detailed in Table 16 and follows the American Society 
of Clinical Oncology (ASCO) guidelines for immune-related AEs{Brahmer 2018}. Patients who 
experience Grade 3 to 4 pneumonitis will be permanently discontinued from study treatment.
Table 16.
Pneumonitis Management Algorithm
Pneumonitis
CTCAE Grade of 
Pneumonitis
Management
Follow-Up
Grade 1
Radiographic changes 
(CXR or CT) only.
Monitor for signs and symptoms 
weekly and consider monitoring with 
CXR.
Consider pulmonary and infectious 
disease consults.
Consider re-imaging with CT in 3 to 
4 weeks as clinically indicated.
May resume magrolimab with 
radiographic evidence of improvement or 
resolution.
If no clinical improvement or worsening, 
treat as Grade 2. 
Grade 2
Mild to moderate new 
symptoms.
Interrupt magrolimab therapy per 
protocol.
Pulmonary and infectious disease 
consults.
Consider empirical antibiotics.
Monitor signs and symptoms every 2 
to 3 days; consider hospitalization.
1 mg/kg/day oral prednisone or IV 
equivalent.
Consider bronchoscopy, lung biopsy.
Re-image every 1 to 3 days.
If improving to baseline, taper 
corticosteroids over 4 to 6 weeks and 
resume magrolimab therapy per protocol.
If no clinical improvement after 48 to 
72 hours or worsening, treat as Grade 3 
to 4.
Grade 3-4
Severe new symptoms; 
new/worsening hypoxia; 
life-threatening.
Discontinue magrolimab therapy.
Hospitalize.
Pulmonary and infectious disease 
consults.
1 to 2 mg/kg/day methylprednisolone 
IV or IV equivalent.
Add empirical antibiotics and consider 
prophylactic antibiotics for 
opportunistic infections.
Consider bronchoscopy, lung biopsy.
If improving to baseline, taper 
corticosteroids over 4 to 6 weeks.
If no clinical improvement after 48 hours 
or worsening, consider additional 
immunosuppression (eg, infliximab, 
cyclophosphamide, IV immunoglobulin, 
mycophenolate mofetil).
CT = computed tomography; CTCAE = Common Terminology Criteria for Adverse Events; CXR = chest x-ray; IV = intravenous.
7.8.2.
Venetoclax
Safety management guidelines for venetoclax are described in Section 5.2.5. Additional safety 
guidelines are provided in the venetoclax local prescribing information {VENCLEXTA 2020}.


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7.8.3.
Azacitidine
Safety management guidelines for azacitidine are described in Section 5.2.5. Additional safety 
guidelines are provided in the azacitidine prescribing information {VIDAZA 2018}.
7.8.4.
Mitoxantrone
Safety management guidelines for mitoxantrone are in accordance with the prescribing 
information {MitoXANTRONE 2018}. Key considerations are described here. 
Myelosuppression
Mitoxantrone can cause severe myelosuppression when used for AML treatment. Close 
monitoring of laboratory counts, infectious prophylaxis, and supportive blood products and 
growth factors is needed. Mitoxantrone should only be administered by physicians experienced 
with treating AML. 
Cardiac Risk
Mitoxantrone can cause congestive heart failure during or after therapy. Cardiotoxicity risk 
increases with cumulative mitoxantrone use. History of cardiovascular disease, prior therapy 
with anthracyclines or anthracenediones or use of other cardiotoxic drugs can increase this risk. 
All patients should be assessed for cardiac signs and symptoms by history, physical examination, 
and ECG prior to the start of therapy. In addition, all patients should have an echocardiogram to 
evaluate LVEF prior to starting therapy. 
Secondary AML
Secondary AML has been reported in patients treated with mitoxantrone. In 1774 patients with 
breast cancer who received mitoxantrone concomitantly with other cytotoxic agents and 
radiotherapy, the cumulative risk of developing treatment-related AML was estimated at 1.1% at 
5 years after receiving the therapy. 
Hypersensitivity Reactions
Hypersensitivity reactions to mitoxantrone, including anaphylaxis, can occur. If hypersensitivity 
reactions occur, immediately interrupt treatment with mitoxantrone and institute supportive 
management per local guidelines. Permanently discontinue mitoxantrone treatment in any patient 
who experiences a severe hypersensitivity reaction. 
7.8.5.
Etoposide
Safety management guidelines for etoposide are in accordance with the prescribing information 
{ETOPOPHOS 2019}. Key considerations are described here. 


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Myelosuppression
Etoposide when given as an anti-leukemic regimen can cause severe myelosuppression. Close 
monitoring of laboratory counts, infectious prophylaxis, and supportive blood products and 
growth factors is needed. Etoposide should only be administered by physicians experienced with 
treating AML. 
Hypersensitivity Reactions
Hypersensitivity reactions to etoposide, including anaphylaxis, can occur. If hypersensitivity 
reactions occur, immediately interrupt treatment with etoposide and institute supportive 
management per local guidelines. Permanently discontinue etoposide treatment in any patient 
who experiences a severe hypersensitivity reaction. 
Secondary Leukemias
Secondary leukemias have been observed with etoposide. Further details are provided in the 
prescribing information {ETOPOPHOS 2019}.
7.8.6.
Cytarabine
Safety management guidelines for cytarabine are in accordance with the prescribing information 
{CYTARABINE 2020}. Key considerations are described here. 
Myelosuppression
Cytarabine can cause severe myelosuppression. Close monitoring of laboratory counts, infectious 
prophylaxis, and supportive blood products and growth factors is needed. Cytarabine should only 
be administered by physicians experienced with treating AML.
Neurotoxicity
Neurotoxicity has been observed with high-dose cytarabine use. Neurologic symptoms vary but 
range from somnolence and ataxia to more severe complications such as seizures and even death. 
Close monitoring for neurologic toxicities, including monitoring for signs and symptoms, 
neurologic examinations, and imaging (if pertinent) should be conducted. Supportive care 
measures per institutional guidelines should be instituted for observed neurotoxicities. For severe 
neurotoxicities, cytarabine should be discontinued. 
Hypersensitivity Reactions
Hypersensitivity reactions to cytarabine, including anaphylaxis, can occur. If hypersensitivity 
reactions occur, immediately interrupt treatment with cytarabine and institute supportive 
management per local guidelines. Permanently discontinue cytarabine treatment in any patient 
who experiences a severe hypersensitivity reaction. 


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7.8.7.
CC-486
Safety management guidelines for CC-486 are in accordance with the prescribing information 
{ONUREG 2020}. Key considerations are described here. 
Myelosuppression
CC-486 can cause myelosuppression. Complete blood counts should be performed at least every 
other week for the first 2 cycles and at least prior to each cycle thereafter. 
Hypersensitivity Reactions
CC-486 can cause hypersensitivity reactions. Treatment with CC-486 should be discontinued in 
any patient who experiences a severe hypersensitivity reaction.
Risk of Substitution with Other Azacitidine Products
CC-486 should not be substituted for IV or SC azacitidine. The indications and dosing of 
CC-486 differ from those of azacitidine.


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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
Objectives are presented in Section 2.
8.1.2.
Primary Endpoints
The primary endpoints for the Phase 2 cohorts are as follows:
•
Rate of Complete Remission (Phase 2 Cohorts 1 and 2): The CR rate is defined as the 
proportion of patients who achieve CR (CRMRD− or complete remission with positive or 
unknown MRD [CRMRD+/unk]) as determined by the investigator based on prespecified criteria 
(Appendix 7) while on study prior to initiation of any new anti-AML therapy. 
•
Minimal Residual Disease Negative Complete Remission Rate (Phase 2 Cohort 3): The MRD 
negative CR rate is defined as the proportion of patients who maintain CR as determined by 
the investigator based on prespecified criteria (Appendix 7) and reach MRD negative disease 
status on 2 consecutive bone marrow assessments as determined using multiparameter flow 
cytometry with a sensitivity of < 0.1% while on study prior to initiation of any new 
anti-AML therapy. For this cohort, patients will need to have 2 consecutive MRD negative 
values to be considered MRD negative for analysis. 
The primary endpoint for the safety run-in cohorts is as follows:
•
Incidence of DLTs, as defined in Section 3.1.1.2, and incidence of treatment-emergent AEs 
and laboratory abnormalities according to the NCI CTCAE Version 5.0
8.1.3.
Secondary Endpoints
The secondary efficacy endpoints are as follows:
•
Overall Response Rate (Cohorts 1 and 2): The ORR is the proportion of patients who achieve 
CR (CRMRD− or CRMRD+/unk), CRi, CRh, PR, or MLFS as determined by the investigator 
based on prespecified criteria (Appendix 7) while on study prior to initiation of any new 
anti-AML therapy.
•
Complete Remission Rate/Complete Remission with Incomplete Hematologic Recovery 
(Cohorts 1 and 2): The CR/CRi rate is the proportion of patients who achieve CR (CRMRD− or 
CRMRD+/unk) or CRi as determined by the investigator based on prespecified criteria 
(Appendix 7) while on study prior to initiation of any new anti-AML therapy.


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•
Minimal Residual Disease Negative Complete Remission Rate (Cohorts 1 and 2): The 
CRMRD− rate is the proportion of patients who achieve a CRMRD− as determined by the 
investigator based on prespecified criteria (Appendix 7) while on study prior to initiation of 
any new anti-AML therapy. 
•
Complete Remission or Complete Remission with Partial Hematologic Recovery Rate 
(Cohorts 1 and 2): The CR/CRh rate is the proportion of patients who achieve CR (CRMRD− 
or CRMRD+/unk) or CRh as determined by the investigator based on prespecified criteria 
(Appendix 7) while on study prior to initiation of any new anti-AML therapy. 
•
Cytogenetic Complete Remission (Cohorts 1 and 2): The cCR rate is the proportion of 
patients who achieve cCR determined by investigator based on the prespecified criteria 
(Appendix 7) while on study prior to initiation of any new anti-AML therapy.
•
Duration of Response (Cohorts 1 and 2): The DOR is measured from the time assessment 
criteria are met for CR (CRMRD− or CRMRD+/unk), CRi, CRh, PR, or MLFS, whichever is first 
recorded, until the first date of AML relapse, progressive disease, or death (including 
assessments post SCT). Those who are not observed to have a relapse, progressive disease, or 
death will be censored at the date of their last response assessment. If patients start taking 
new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse, 
duration of response will be censored at the last response assessment before the initiation of 
the new anti-AML therapies.
•
Duration of Complete Remission (Cohorts 1 and 2): The duration of CR is measured from 
the time the assessment criteria are first met for CR (CRMRD− or CRMRD+/unk) until the first 
date of AML relapse or death (including assessments post SCT). Those who are not observed 
to have relapsed disease or death will be censored at the date of their last response 
assessment. If patients start taking new anti-AML therapies (except SCT and post SCT 
maintenance treatment) before relapse, duration of CR will be censored at the last response 
assessment before the initiation of the new anti-AML therapies.
•
Duration of Complete Remission or Complete Remission with Incomplete Hematologic 
Recovery (Cohorts 1 and 2): The duration of CR/CRi is measured from the time the 
assessment criteria are first met for CR (CRMRD− or CRMRD+/unk) or CRi until the first date of 
AML relapse or death (including assessments post SCT). Those who are not observed to 
have relapsed disease or death will be censored at the date of their last response assessment. 
If patients start taking new anti-AML therapies (except SCT and post SCT maintenance 
treatment) before relapse, duration of CR + CRi will be censored at the last response 
assessment before the initiation of the new anti-AML therapies.
•
Duration of Complete Remission or Complete Remission with Partial Hematologic Recovery 
(Cohorts 1 and 2): The duration of CR/CRh is measured from the time the assessment criteria 
are first met for CR (CRMRD− or CRMRD+/unk) or CRh until the first date of AML relapse or 
death (including assessments post SCT). Those who are not observed to have relapsed 
disease or death will be censored at the date of their last response assessment. If patients start 
taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before 
relapse, duration of CR + CRh will be censored at the last response assessment before the 
initiation of the new anti-AML therapies. 


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•
Event-Free Survival (Cohorts 1 and 2): EFS is defined as the time from the date of the first 
dose of study treatment to the earliest date of documented relapse from CR, treatment failure 
(defined as failure to achieve CR before the fifth cycle of 
magrolimab+venetoclax+azacitidine in Phase 2 Cohort 1 and before the third cycle of 
magrolimab + MEC in Phase 2 Cohort 2), or death from any cause. Response assessments 
post SCT will be included in the analysis. Deaths post SCT or new anti-AML therapies 
(except SCT and post SCT maintenance) will be included. Those who are not observed to 
have one of these events during the study will be censored at the date of their last response 
assessment during the study. Day 1 of treatment will be assigned as the event date for 
patients with treatment failure.
•
Minimal Residual Disease Negative Complete Remission or Complete Remission with 
Incomplete Hematologic Recovery Rate (Cohort 3): The MRD negative CR/CRi rate is 
defined as the proportion of patients who maintain CR/CRi as determined by the investigator 
based on prespecified criteria (Appendix 7) and reach MRD negative disease status on 
2 consecutive bone marrow assessments as determined using multiparameter flow cytometry 
with a sensitivity of < 0.1% while on study prior to initiation of any new anti-AML therapy.
•
Relapse-Free Survival (Cohort 3): RFS is measured from the time of the first dose of study 
treatment until the first date of AML relapse or death from any cause, whichever comes first. 
Those who are not observed to have relapsed disease or death will be censored at the date of 
their last response assessment during the study. 
•
Duration of Minimal Residual Disease Negative Complete Remission (Cohort 3): The 
duration of MRD negative CR is measured from the time the patient achieves MRD negative 
status (first of the 2 consecutive MRD negative bone marrow assessments) and maintains CR 
until the first date of AML relapse, loss of MRD negative status, or death (including 
assessments post SCT). Those who are not observed to have relapsed disease, loss of MRD 
negative status, or death will be censored at the date of their last response assessment. If 
patients start taking new anti-AML therapies (except SCT and post SCT maintenance 
treatment) before relapse, duration of MRD negative CR will be censored at the last response 
assessment before the initiation of the new anti-AML therapies.
•
Duration of Minimal Residual Disease Negative Complete Remission or Complete 
Remission with Incomplete Hematologic Recovery (Cohort 3): The duration of MRD 
negative CR/CRi is measured from the time the patient achieves MRD negative status (first 
of the 2 consecutive MRD negative bone marrow assessments) and maintains CR/CRi until 
the first date of AML relapse, loss of MRD negative status, or death (including assessments 
post SCT). Those who are not observed to have relapsed disease, loss of MRD negative 
status, or death will be censored at the date of their last response assessment. If patients start 
taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before 
relapse, duration of MRD negative CR + CRi will be censored at the last response 
assessment before the initiation of the new anti-AML therapies.


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• 
Overall Survival: The OS is measured from the date of the first dose of study treatment to the 
date of death from any cause. Those who are not observed to die during the study will be 
censored at last date they are known to be alive. 
• 
Red Blood Cell Transfusion Independence Rate: The RBC trnnsfusion independence rate is 
the proportion of patients who have a 56-day or longer period with no RBC or whole blood 
transfusion at any time between the date of the first dose and discontinuation of study 
treatment among all patients who are RBC trnnsfusion-dependent at baseline, defined as 
having received an RBC or whole blood transfusion within the 28 days prior to the first dose 
of study treatment (conversion rate), and among all patients who are RBC 
transfusion-independent at baseline (maintenance rate). 
• 
Platelet Transfusion Independence Rate: The platelet ti·ansfusion independence rate is the 
propo1iion of patients who have a 56-day or longer period with no platelet transfusions at any 
time between the date of the first dose and discontinuation of study treatment among all 
patients who are platelet ti·ansfusion-dependent at baseline, defined as having received a 
platelet transfusion within the 28 days prior to the first dose of study ti·eatment ( conversion 
rate), and among all patients who are platelet transfusion independent at baseline 
(maintenance rate). 
The secondaiy safety endpoint is as follows (Phase 2 coho1is): 
• 
Incidence ofti·eatment-emergent AEs and laborato1y abnonnalities according to the NCI 
CTCAE Version 5.0 
The secondaiy PK endpoint is as follows: 
• 
PK concentrations of magrolimab in combination with venetoclax and azacitidine; 
mitoxantrone, etoposide, and cytai·abine; or CC-486 
The secondaiy immunogenicity endpoint is as follows: 
• 
Rate and magnitude of anti-magrolimab antibody incidence and prevalence 
I 
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8.2.
Planned Analyses
8.2.1.
Interim Analysis
Prior to the final analysis, interim analyses may be conducted, and the analyses may be 
submitted to regulatory agencies to seek guidance for the overall clinical development program.
8.2.2.
Primary Analysis 
The primary analysis will be conducted after all patients have discontinued the study or have 
been on study for at least 24 weeks and completed the Week 24 response assessments, 
outstanding data queries have been resolved or adjudicated as unresolvable, and the data have 
been cleaned and finalized for the analysis.
8.2.3.
Final Analysis
The final analysis will be performed after all patients have discontinued the study, outstanding 
data queries have been resolved or adjudicated as unresolvable, and the data have been cleaned 
and finalized. 
8.3.
Analysis Conventions
8.3.1.
Analysis Sets
8.3.1.1.
Efficacy
The primary analysis set for efficacy analysis is the Full Analysis Set (FAS). The FAS includes 
all enrolled patients who receive at least 1 dose of any study treatment, with treatment group 
designated according to the assigned treatment.
8.3.1.2.
Safety
The primary analysis set for safety analyses is the Safety Analysis Set. It includes all patients 
who receive at least 1 dose of study treatment, with treatment assignments designated according 
to the actual treatment received. This analysis set will be used in the analyses of safety endpoints, 
as well as study treatment administration. All data collected during treatment up to 70 days 
(± 7 days) after treatment discontinuation will be included in the safety summaries.
The DLT Evaluable Analysis Set includes all patients in the Safety Analysis Set who are 
enrolled in the safety run-in cohorts, have safety assessments through the protocol-specified DLT 
assessment window (first 4 weeks of study dosing, inclusive), and fulfill the criteria for 
evaluation for DLT specified in Section 3.1.1.
Safety assessments relevant to the DLT Evaluable Analysis Set definition include laboratory 
serum chemistry tests and hematology tests as specified in Section 3.1.1. The RP2D will be 
based on the DLT Evaluable Analysis Set.


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8.3.1.3.
Pharmacokinetics 
The PK Analysis Set includes all enrolled patients who receive at least 1 dose of magrolimab and 
have at least 1 measurable posttreatment serum concentration of magrolimab.
8.3.1.4.
Immunogenicity
The Immunogenicity Analysis Set includes all enrolled patients who receive at least 1 dose of 
magrolimab and have at least 1 evaluable anti-magrolimab antibody test result. 
8.3.1.5.
Biomarker
The Biomarker Analysis Set includes all enrolled patients who receive at least 1 dose of 
magrolimab and have evaluable baseline and postbaseline measurements to provide interpretable 
results for the specific parameter of interest. 
8.3.1.6.
Demographic and Baseline Characteristics 
The All Enrolled Analysis Set includes all patients who receive a study patient identification 
number in the study after screening. This will be the primary analysis set for analyses of patient 
demographic and baseline characteristics, enrollment, and disposition.
8.3.2.
Data Handling Conventions
By-patient listings will be created for important variables from each eCRF module. Summary 
tables for continuous variables will contain the following statistics: N (number in analysis set), 
n (number with data), mean, standard deviation, 95% CIs for the mean, median, minimum, and 
maximum. Summary tables for categorical variables will include: N, n, percentage, and 95% CIs 
for the percentage. Unless otherwise indicated, 95% CIs for binary variables will be calculated 
using the binomial distribution (exact method) and will be 2-sided. Data will be described and 
summarized by treatment cohort. 
The baseline value used in each analysis will be the last (most recent) pretreatment value before 
or on the first dosing date of study treatment. As appropriate, changes from baseline to each 
subsequent time point will be described and summarized. Similarly, as appropriate, the greatest 
change from baseline during the study will also be described and summarized. Graphical 
techniques (ie, waterfall plots, Kaplan-Meier [KM] curves, line plots) may be used when such 
methods are appropriate and informative. Analyses will be based on observed data unless 
methods for handling missing data are specified. If there is a significant degree of non-normality, 
analyses may be performed on log-transformed data or nonparametric tests may be applied, as 
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8.4.
Demographic and Baseline Characteristics Analysis
Demographic and baseline measurements will be summarized using standard descriptive 
methods. Demographic summaries will include sex, race/ethnicity, and age. Baseline data will 
include a summary of body weight, height, body mass index, WHO AML classification, and 
ECOG performance status.
8.5.
Efficacy Analysis
8.5.1.
Primary Analysis
The point estimates of the CR rate and the corresponding 2-sided exact 95% CIs based on the 
Clopper-Pearson method will be provided for Cohorts 1 and 2. The MRD negative CR rate will 
be summarized similarly for Cohort 3. The CR and MRD negative CR data will also be tested 
against the historical control rates listed in Section 8.10 using 1-group Chi-square test for each 
cohort separately. 
8.5.2.
Secondary Analyses
The point estimates of the ORR, CR rate, CR/CRi rate, CRMRD− rate, cCR rate, and CR/CRh rate 
and the corresponding 2-sided exact 95% CIs based on the Clopper-Pearson method will be 
provided for Cohorts 1 and 2. The analyses of RBC and platelet transfusion independence rates 
(conversion rate and maintenance rate) will be similar to those of ORR. 
Medians, first quartile (Q1), and third quartile (Q3) of EFS distribution, and the proportion of 
patients who are event free at Weeks 12, 24, and 48 from the first dosing date will be estimated 
by cohort using the KM method and the corresponding 95% CIs will be reported. Kaplan-Meier 
plots will be provided. Analyses of OS will be similar to those of EFS. 
For the time-to-event endpoints of duration of CR, duration of CR/CRi, duration of CR/CRh, 
DOR, RFS, duration of MRD negative CR, and MRD negative CR/CRi, analyses will be 
conducted on the subsets for which the outcome measures are defined. Specifically, the duration 
of CR, duration of CR/CRi, duration of CR/CRh, and DOR will be based on patients in 
Cohorts 1 and 2 who achieve CR, CR/CRi, CR/CRh, and OR, respectively. The RFS will be 
analyzed for Cohort 3, duration of MRD negative CR will be based on patients in Cohort 3 who 
achieve MRD negative status and maintain CR, and the duration of MRD negative CR/CRi will 
be based on patients in Cohort 3 who achieve MRD negative status and maintain CR/CRi. The 
KM method will be used to estimate median durations and 95% CIs, and KM plots will be 
provided.
8.6.
Safety Analysis
All safety data collected on or after the date that any drug in a study treatment regimen was first 
dosed up to the date of the last dose of any drug in a study treatment regimen plus 70 days 
(± 7 days) will be summarized by treatment group (according to the study drug received). Data 
for the pretreatment and treatment-free safety follow-up periods will be included in data listings. 
For categorical safety data, including incidence of AEs and categorizations of laboratory data, 
the number and percentage of patients will be summarized. For continuous safety data, including 
laboratory data, the number of patients, mean, standard deviation, minimum, quartiles, median, 
and maximum will be summarized. 


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8.6.1.
Extent of Exposure
A patient’s extent of exposure to study drug data will be generated from the study drug 
administration data. Exposure data will be summarized for each drug separately by treatment 
cohort. 
8.6.2.
Adverse Events
Clinical and laboratory AEs will be coded using the Medical Dictionary for Regulatory 
Activities (MedDRA). System organ class, high-level group term, high-level term, preferred 
term, and lower-level term will be attached to the clinical database.
Events will be summarized on the basis of the date of onset for the event. A treatment-emergent 
AE will be defined as any AE that begins on or after the date of first dose of study drug up to the 
date of last dose of study drug plus 70 days (± 7 days).
Summaries (number and percentage of patients) of treatment-emergent AEs (by system organ 
class and preferred term) will be provided by treatment group. 
Adverse events that occurred before exposure to study treatment will be reported in data listings 
and appropriately identified as non-treatment-emergent AEs.
8.6.3.
Laboratory Evaluations
Selected laboratory data (using conventional units) will be summarized using only observed data. 
Data and change from baseline at all scheduled time points will be summarized.
Graded laboratory abnormalities will be defined using the grading scheme in Appendix 4. 
Incidence of treatment-emergent laboratory abnormalities, defined as values that increase at 
least 1 toxicity grade from baseline at any time point postbaseline, will be summarized by 
treatment group. If baseline data are missing, then any graded abnormality (ie, at least Grade 1) 
will be considered treatment emergent.
Laboratory abnormalities that occur before the first dose of study drug or after the patient has 
been discontinued from treatment for at least 70 days (± 7 days) will be included in a data listing.
8.6.4.
Other Safety Evaluations
Vital signs and physical examination findings will be summarized at select time points. Study 
drug administration, study drug compliance, and other safety variables will also be summarized. 
Details will be provided in the statistical analysis plan.
8.7.
Pharmacokinetic Analysis 
The PK Analysis Set will be used for summaries of PK concentration of magrolimab versus time. 
Due to the sparse nature of PK collection, PK parameters will not be calculated. 


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Summaiy statistics will be presented for magrolimab sernm concentrntions at each scheduled 
time point. Descriptive graphical plots of individual sernm concentration versus time profiles and 
mean concentration versus time profiles will be generated. 
Missing concentrntion values will be reported as is in data listings. Concentration values below 
lower limit of quantitation will be handled as zero in surnmaiy statistics and repo1ied as is in data 
listings. 
All data from this study may be combined with PK data from other Gilead clinical studies and 
analyzed using a population PK model. Such an analysis would be repo1ied separately. 
8.8. 
Immunogenicity Analysis 
Immunogenicity will be assessed using a 3-tier-screen, confnmato1y, and titer-approach on 
study samples using a validated immunoassay. The rate and magnitude of anti-magrolimab 
antibody incidence, prevalence, persistence, and transience will be sUilllnai·ized for the 
Immune enici Anal sis Set. Titer smnmai·ies ma also be enerated if relevant. 
8.9. 
Biomarker Analysis 
The baseline level, absolute level, and change from baseline level over time will be smnmarized 
using descriptive statistics for each biomai·ker at the a licable sam le collection time oint by 
treatment coho1i as a ro riate. 
8.10. 
Sample Size 
Sample size calculation is as follows: 
1) For Coho1i 2, a sample size of 36 (30 patients in Phase 2 Coho1i 2 together with 6 patients in 
Safety Run-in Coho1i 2) provides an 83.1 % power for a I-group Chi-square test at I-sided 
alpha of 0.1 level to detect a CR rate of~ 35% for the combination compai·ed with a 
historical control CR rate of 19% { Greenberg 2004} . 
The original protocol for the study included a Coho1i 1, for which 46 patients were planned to be 
enrolled (6 patients in Safety Run-in and 40 patients in Phase 2); however, Coho1i 1 was closed 
to enrollment following enrollment of 18 patients (7 patients in Safety Run-in and 11 patients in 
Phase 2). 
The original protocol also included a Coho1i 3, for which 46 patients were planned to be enrolled 
(6 patients in Safety Run-in and 40 patients in Phase 2); however, Coho1i 3 was closed to 
enrollment and no patients were enrolled. 
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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with the International 
Council for Harmonisation (ICH) E6(R2) addendum to its guideline for GCP and applicable laws 
and regulations.
9.1.2.
Financial Disclosure
The investigator and subinvestigators will provide prompt and accurate documentation of their 
financial interest or arrangements with Gilead, or proprietary interests in the study drug during 
the course of a clinical study. This documentation must be provided prior to the investigator’s 
(and any subinvestigator’s) participation in the study. The investigator and subinvestigator agree 
to notify Gilead of any change in reportable interests during the study and for 1 year following 
completion of the study. Study completion is defined as the date when the last patient completes 
the protocol-defined activities.
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval
The investigator (or Gilead as appropriate according to local regulations) will submit this 
protocol, ICF, and any accompanying material to be provided to the patient (such as 
advertisements, patient information sheets, or descriptions of the study used to obtain informed 
consent) to an IRB/IEC. The investigator will not begin any study patient activities until 
approval from the IRB/IEC has been documented and provided as a letter to the investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC any modifications made to the protocol or any accompanying material to be 
provided to the patient after initial IRB/IEC approval, with the exception of those necessary to 
reduce immediate risk to study patients.
9.1.4.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study before undertaking any study-related procedures. The investigator 
must use the most current IRB- or IEC-approved ICF for documenting written informed consent. 
Each ICF (or assent as applicable) will be appropriately signed and dated by the patient or the 
patient’s legally authorized representative, the person conducting the consent discussion, and an 
impartial witness (if required by IRB or IEC or local requirements). 


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• 
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the tests perfo1med on the samples will not be given to the patient or the investigator. 
9.1.5. 
Confidentiality 
The investigator must ensure that patients' anonymity will be strictly maintained and that their 
identities are protected from unauthorized pa1iies. Only an identification code and any other 
unique identifier(s) as allowed by local law (such as year of bi1i h) will be recorded on any fo1m 
or biological sample submitted to Gilead, IRB/IEC, or the laborato1y. Laborato1y specimens 
must be labeled in such a way as to protect patient identity while allowing the results to be 
recorded to the proper patient. Refer to specific laborato1y instructions. NOTE: The investigator 
must keep a screening log with details for all patients screened and enrolled in the study, in 
accordance with the site procedures and regulations. Patient data will be processed in accordance 
with all applicable regulations. 
The investigator agrees that all info1mation received from Gilead, including but not limited to the 
IB, this protocol, case repo1i fonns (CRFs)/eCRFs, study drng info1mation, and any other study 
info1mation, remains the sole and exclusive property of Gilead during the conduct of the study 
and thereafter. This info1mation is not to be disclosed to any third pa1iy (except employees or 
agents directly involved in the conduct of the study or as required by law) without prior written 
consent from Gilead. The investigator fmiher agrees to take all reasonable precautions to prevent 
the disclosure by any employee or agent of the study site to any third paiiy or othe1wise into the 
public domain. 
9.1.6. 
Study Files and Retention of Records 
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following 2 categories: (1) investigator's study file, and (2) patient 
clinical source documents. 
The investigator's study file will contain the protocol/amendments, CRFs/eCRFs, IRB/IEC and 
governmental approval with conespondence, the ICF, diug records, staff cmTicula vitae and 
authorization fo1ms, and other appropriate documents and conespondence. 
The required source data should include sequential notes containing at least the following 
info1mation for each patient: 
• 
Patient identification 
• 
Documentation that patient meets eligibility criteria, ie, medical histo1y, physical 
examination, and confomation of diagnosis (to suppo1i inclusion and exclusion criteria) 
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•
Documentation of the reason(s) a consented patient is not enrolled
•
Participation in study (including study number)
•
Study discussed and date of informed consent
•
Dates of all visits
•
Documentation that protocol-specific procedures were performed
•
Results of efficacy parameters, as required by the protocol
•
Start and end date (including dose regimen) of study drug, including dates of dispensing and 
return
•
Record of all AEs and other safety parameters (start and end date, and including causality 
and severity) and documentation that adequate medical care has been provided for any AE
•
Concomitant medication (start and end date; dose if relevant; dose changes)
•
Date of study completion and reason for early discontinuation, if it occurs
All clinical study documents must be retained by the investigator for at least 2 years or according 
to local laws, whichever is longer, after the last approval of a marketing application in an ICH 
region (ie, US, Europe, or Japan) and until there are no pending or planned marketing 
applications in an ICH region; or, if no application is filed or if the application is not approved 
for such indication, for 2 years after the investigation is discontinued and regulatory authorities 
have been notified. Investigators may be required to retain documents longer if specified by 
regulatory requirements, by local regulations, or by an agreement with Gilead. The investigator 
must notify Gilead before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Gilead to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
patient, appropriate copies should be made for storage away from the site.
9.1.7.
Case Report Forms
For each patient consented, an eCRF casebook will be completed by an authorized study staff 
member whose training for this function is completed in the electronic data capture (EDC) 
system. The eCRF casebook will only capture the data required per the protocol schedules of 
assessments. The Inclusion/Exclusion Criteria and Enrollment eCRFs should be completed only 


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after all data related to eligibility have been received. Data entry should be performed in 
accordance with the CRF Completion Guidelines provided by the sponsor. Subsequent to data 
entry, a study monitor will perform source data verification within the EDC system. 
System-generated or manual queries will be issued in the EDC system as data discrepancies are 
identified by the monitor or Gilead staff who routinely review the data for completeness, 
correctness, and consistency. The site investigator, site coordinator, or other designee is 
responsible for responding to the queries in a timely manner, within the system, either by 
confirming the data as correct or updating the original entry, and providing the reason for the 
update (eg, data entry error). Original entries as well as any changes to data fields will be stored 
in the audit trail of the system. At a minimum, prior to any interim time points or database lock 
(as instructed by Gilead), the investigator will use his/her log-in credentials to confirm that the 
forms have been reviewed, and that the entries accurately reflect the information in the source 
documents. At the conclusion of the study, Gilead will provide the site investigator with a 
read-only archive copy of the data entered by that site. This archive must be stored in accordance 
with the records retention requirements outlined in Section 9.1.6.
9.1.8.
Investigator Inspections
The investigator will make available all source documents and other records for this study to 
Gilead’s appointed study monitors, to IRBs/IECs, or to regulatory authority or health authority 
inspectors.
9.1.9.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications may be made only by the sponsor. 
9.2.2.
Study Reports and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agencies when 
applicable and in accordance with local regulatory requirements. Gilead will ensure that the 
report meets the standards set out in the ICH Guideline for Structure and Content of Clinical 
Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain cases. For 
studies with sites in countries following the EU Regulation No. 536/2014, a CSR will be 
submitted within 1 year (6 months for pediatric studies, in accordance with Regulation [EC] 
No. 1901/2006) after the global end of study (as defined in Section 3.5).
Investigators in this study may communicate, orally present, or publish study data in scientific 
journals or other scholarly media in accordance with the Gilead clinical trial agreement.


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9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol (eg, attendance at investigator meetings). If required under the applicable statutory and 
regulatory requirements, Gilead will capture and disclose to federal and state agencies any 
expenses paid or reimbursed for such services, including any clinical study payments, meal, 
travel expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
The monitor is responsible for routine review of the CRF/eCRF at regular intervals throughout 
the study to verify adherence to the protocol and the completeness, consistency, and accuracy of 
the data being entered on them. The monitor should have access to any patient records needed to 
verify the entries in the CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, on-site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority, the 
investigator agrees to notify the Gilead medical monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both Gilead and the investigator reserve the right to terminate the study at any time. Should this 
be necessary, both parties will arrange discontinuation procedures and notify the patients, 
appropriate regulatory authority, IRBs, and IECs. In terminating the study, Gilead and the 
investigator will ensure that adequate consideration is given to the protection of the patients’ 
interests.


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10.
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Feldman EJ, Brandwein J, Stone R, Kalaycio M, Moore J, O'Connor J, et al. Phase III 
randomized multicenter study of a humanized anti-CD33 monoclonal antibody, 
lintuzumab, in combination with chemotherapy, versus chemotherapy alone in 
patients with refractory or first-relapsed acute myeloid leukemia. J Clin Oncol 
2005;23 (18):4110-6.
Feng D, Gip P, McKenna KM, Zhao F, Mata O, Choi TS, et al. Combination Treatment with 5F9 
and Azacitidine Enhances Phagocytic Elimination of Acute Myeloid Leukemia 
[Abstract 2729]. American Society of Hematology Annual Meeting & Exposition; 
2018 December 2; San Diego, CA. 
Fesik SW. Promoting apoptosis as a strategy for cancer drug discovery. Nature reviews. Cancer 
2005;5 (11):876-85.
Greenberg PL, Lee SJ, Advani R, Tallman MS, Sikic BI, Letendre L, et al. Mitoxantrone, 
etoposide, and cytarabine with or without valspodar in patients with relapsed or 
refractory acute myeloid leukemia and high-risk myelodysplastic syndrome: a 
phase III trial (E2995) (Author Manuscript). J Clin Oncol 2004;22 (6):1078-86.
Jaiswal S, Jamieson CH, Pang WW, Park CY, Chao MP, Majeti R, et al. CD47 Is Up-Regulated 
on Circulating Hematopoietic Stem Cells and Leukemia Cells to Avoid 
Phagocytosis. Cell 2009;138 (2):271-85.
Kim D, Wang J, Willingham SB, Martin R, Wernig G, Weissman IL. Anti-CD47 antibodies 
promote phagocytosis and inhibit the growth of human myeloma cells. Leukemia 
2012;26 (12):2538-45.


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Liu J, Wang L, Zhao F, Tseng S, Narayanan C, Shura L, et al. Pre-Clinical Development of a 
Humanized Anti-CD47 Antibody with Anti-Cancer Therapeutic Potential. PLoS 
One. 2015a;10 (9):e0137345.
Liu X, Pu Y, Cron K, Deng L, Kline J, Frazier WA, et al. CD47 blockade triggers T cell-
mediated destruction of immunogenic tumors. Nat Med 2015b;21 (10):1209-15.
Majeti R, Chao MP, Alizadeh AA, Pang WW, Jaiswal S, Gibbs KD, Jr., et al. CD47 Is an 
Adverse Prognostic Factor and Therapeutic Antibody Target on Human Acute 
Myeloid Leukemia Stem Cells. Cell 2009;138 (2):286-99.
MitoXANTRONE, Hospira Inc. MitoXANTRONE Injection, (concentrate). U.S. Prescribing 
Information. Lake Forest, IL. Revised June. 2018:
Obeid M, Tesniere A, Ghiringhelli F, Fimia GM, Apetoh L, Perfettini JL, et al. Calreticulin 
exposure dictates the immunogenicity of cancer cell death. Nat Med 2007;13 
(1):54-61.
ONUREG, Celgene Corporation. ONUREG (azacitidine) tablets, for oral use. U.S. Prescribing 
Information. Summit, NJ. Revised September. 2020:
Roboz GJ, Ravandi F, Wei AH, Dombret H, Dohner H, Thol F, et al. CC-486 Prolongs Survival 
for Patients with Acute Myeloid Leukemia (AML) in Remission after Intensive 
Chemotherapy (IC) Independent of the Presence of Measurable Residual Disease 
(MRD) at Study Entry: Results from the QUAZAR AML-001 Maintenance Trial. 
Blood 2020;136 (Supplement 1):32-3.
Roboz GJ, Rosenblat T, Arellano M, Gobbi M, Altman JK, Montesinos P, et al. International 
randomized phase III study of elacytarabine versus investigator choice in patients 
with relapsed/refractory acute myeloid leukemia. J Clin Oncol 2014;32 (18):1919-
26.
Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical 
practice guideline for vaccination of the immunocompromised host. Clin Infect 
Dis 2014;58 (3):e44-100.
Sallman D, Asch AS, Kambhampati S, Al Malki M, Zeidner JF, Donnellan W, et al. The First-
in-Class Anti-CD47 Antibody Magrolimab in Combination With Azacitidine is 
Effective in AML Patients: Phase 1b Results [Accepted Abstract]. 62nd American 
Society of Hematology (ASH) Annual Meeting Virtual; 2020a 05-08 December. 
Sallman DA, Asch A, Al-Malki M, Lee D, Garcia-Manero G, Donnellan W, et al. Tolerability 
and Efficacy of the First-in-Class Anti-CD47 Antibody Magrolimab Combined 
With Azacitidine in MDS and AML Patients: Phase 1b Results [Presentation]. 
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Sikic BI, Lakhani N, Patnaik A, Shah SA, Chandana SR, Rasco D, et al. First-in-Human, First-
in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With 
Advanced Cancers. J Clin Oncol 2019;37 (12):946-53.
Sikic BI, Padda SK, Shah SA, Colevas AD, Narayanan S, Fisher GA, et al. A first-in-human, 
first-in-class phase I trial of the anti-CD47 antibody Hu5F9-G4 in patients with 
advanced cancers. 2016:
Souers AJ, Leverson JD, Boghaert ER, Ackler SL, Catron ND, Chen J, et al. ABT-199, a potent 
and selective BCL-2 inhibitor, achieves antitumor activity while sparing platelets. 
Nat Med 2013;19 (2):202-8.
Troughton MC, Simmons LW, Langley C, Youssef M, Marques MB. A Novel Use of Human 
Platelet Concentrate to Resolve Interference of Anti-CD47 in Serologic Testing 
[IGT46]. Transfusion 2018;58 (S2):179A-80A.
Tseng D, Volkmer JP, Willingham SB, Contreras-Trujillo H, Fathman JW, Fernhoff NB, et al. 
Anti-CD47 antibody-mediated phagocytosis of cancer by macrophages primes an 
effective antitumor T-cell response. Proc Natl Acad Sci U S A 2013;110 
(27):11103-8.
U.S. Department of Health & Human Services (DHHS), Food & Drug Administration (FDA), 
Center for Drug Evaluation and Research (CDER), Center for Biologics 
Evaluation and Research (CBER). Guidance for Industry: Drug-Induced Liver 
Injury: Premarketing Clinical Evaluation. July, 2009.
Velliquette RW, Aeschlimann J, Kirkegaard J, Shakarian G, Lomas-Francis C, Westhoff CM. 
Monoclonal anti-CD47 interference in red cell and platelet testing. Transfusion 
2019;59 (2):730-7.
VENCLEXTA, AbbVie Inc. VENCLEXTA® (venetoclax tablets), for oral use. U.S Prescribing 
Information. North Chicago, IL. Revised October. 2020:
VIDAZA, Celgene Corporation. VIDAZA® (azacitidine for injection), for subcutaneous or 
intravenous use. US Prescribing Information. Summit, NJ. Revised: September. 
2018:
Wei AH, Dohner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, et al. The QUAZAR 
AML-001 Maintenance Trial: Results of a Phase III International, Randomized, 
Double-Blind, Placebo-Controlled Study of CC-486 (Oral Formulation of 
Azacitidine) in Patients with Acute Myeloid Leukemia (AML) in First Remission 
[Abstract]. Blood 2019;134 (Suppl 2):LBA-3.
Willingham SB, Volkmer JP, Gentles AJ, Sahoo D, Dalerba P, Mitra SS, et al. The CD47-signal 
regulatory protein alpha (SIRPa) interaction is a therapeutic target for human 
solid tumors. Proc Natl Acad Sci U S A 2012;109 (17):6662-7.


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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Schedules of Assessment and Treatment Administration
Appendix 3
Pandemic Risk Assessment and Mitigation Plan
Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 6.
Eastern Cooperative Oncology Group Performance Status
Appendix 7.
Disease Response Criteria Based on European Leukemia Net (ELN) and 
International Working Group (IWG) Criteria
Appendix 8.
Cockcroft-Gault Method for Estimating Creatinine Clearance
Appendix 9.
World Health Organization (WHO) Classification of AML
Appendix 10.
Amendment History


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Appendix 1.
Investigator Signature Page
GILEAD SCIENCES, INC.
333 LAKESIDE DRIVE
FOSTER CITY, CA 94404
STUDY ACKNOWLEDGMENT
A PHASE 2 MULTI-ARM STUDY OF MAGROLIMAB COMBINATIONS IN 
PATIENTS WITH MYELOID MALIGNANCIES
GS-US-546-5920 Protocol Amendment 6, 02 November 2023
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval.
[See appended electronic signature]
Name (Printed)
Medical Monitor
Signature
[See appended electronic signature]
Date
INVESTIGATOR STATEMENT
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated.
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study.
Principal Investigator Name (Printed)
Signature
Date
Site Number
PPD


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Appendix 2.
Schedules of Assessment and Treatment Administration
Appendix Table 1.
Schedule of Assessments – Screening
Assessment
Study Day -30 to -1
Informed consent
Xa
Demographics
X
Medical and cancer history, including date of recent RBC and/or platelet transfusions, 
AML molecular marker results at diagnosis (if available), and echocardiogram/MUGA or 
pulmonary function tests if done within the 3 months prior 
X
Complete physical examination
X
Vital signs, height, and weight
X
Serum pregnancy testb
X
CBC with differential, platelets, reticulocytes
X
Serum or plasma chemistry
X
PT, INR, and aPTT (or PTT)
X
Extended RBC phenotyping or genotyping, type, and screen (ABO/Rh), DAT
X
Urinalysis
X
Bone marrow biopsy and aspirate for blast evaluation, MRD assessment, cytogenetics, 
and correlative studiesc
X
Peripheral blood smear (for blasts)d
X
Bone marrow aspirate for receptor occupancy (to be collected at selected study sites)c
X
ECOG performance status
X
12-Lead ECG (single)
X
Echocardiogram or MUGA for Cohort 2 only (if not done in the past 30 days)
X
All SAEs and any AEs related to protocol-mandated procedures
X
Prior and concomitant medications
X
Entry criteria
X
ABO = any of the 4 blood groups A, B, AB, and O composing the ABO system; AE = adverse event; AML = acute myeloid 
leukemia; aPTT = activated partial thromboplastin time; CBC = complete blood count; DAT = direct antiglobulin test; 
ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; INR = international normalized ratio; 
MRD = minimal residual disease; MUGA = multigated acquisition (scan); PT = prothrombin time; PTT = partial thromboplastin 
time; RBC = red blood cell; Rh = Rhesus factor; RO = receptor occupancy; SAE = serious adverse event
a Screening must be completed prior to enrollment. Enrollment must occur within 30 days of signing informed consent. The first 
dose of study treatment must be given within 72 hours after enrollment.
b Screening pregnancy test may be used as the Cycle 1 Day 1 test if performed within 72 hours of first dose of study treatment 
and can be performed locally without a requirement to visit the study site; additional guidance is provided in Section 6.5.1. A 
follicle-stimulating hormone test is required for female patients who are < 54 years old who are not on hormonal contraception 
and who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure.
c A trephine (biopsy) is to be collected for baseline. This procedure must be performed prior to the first dose of study treatment 
at the latest. An aspirate sample will be collected for blast evaluation, MRD assessment, RO (to be collected at selected study 
sites), and correlative studies. Bone marrow aspirate samples are to be obtained at the time of bone marrow (trephine) biopsy. 
Conventional cytogenetics to be tested per institutional standards. 
d Peripheral blood smears for blasts are to be collected along with bone marrow aspirate/biopsy.


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Appendix Table 2.
Schedule of Assessments – Treatment Period (Cohorts 1 and 3)
Cycle (28-day Cycles)
Visit Window 
(Days)a
1
2
3+
None
± 3
± 3
± 3
Cycle Day
1
2
4
8
11
15
22
28
Weekly for 
2 weeksb
1
8
15
22
28
Weekly for 
2 weeksb
1
15
28
Weekly for 
2 weeksb
Safety
Pregnancy testc 
X
Every 4 weeks following Cycle 1 Day 1
CBC with 
differential, 
platelets, 
reticulocytesd,e
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Haptoglobin 
and LDHd
X
X
X
X
X
Peripheral 
blood smear 
for general 
morphologyd,p
X
X
X
Serum or 
plasma 
chemistryd
X
X
X
X
X
X
X
X
X
X
Vital signsf
X
X
X
X
X
X
X
X
X
X
X
Weight
X
X
X
Symptom-
directed 
physical 
examinationd
X
X
X
X
X
Adverse 
eventsg
Concomitant 
medicationsg


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Cycle (28-day Cycles)
Visit Window 
(Days)a
1
2
3+
None
± 3
± 3
± 3
Cycle Day
1
2
4
8
11
15
22
28
Weekly for 
2 weeksb
1
8
15
22
28
Weekly for 
2 weeksb
1
15
28
Weekly for 
2 weeksb
Efficacy/ 
Biomarkers
Peripheral 
blood smear 
for blastso
X
X
Q2C, 
Q3Cn
Peripheral 
blood sample 
for correlative 
studiesh
X
X
X
X
X
Cycle 6 
only
Bone marrow 
aspirate/biopsy 
for correlative 
studiesi and 
receptor 
occupancyj
X
X
Xk
Bone marrow 
aspirate/biopsy 
for response 
assessment, 
cytogenetics, 
and MRD 
assessmentl
X
X
Q2C, 
Q3Cm
Bone marrow 
slides or blocks 
for central 
review
X
X
Q2C, 
Q3Cm
Buccal swabn
X
CBC = complete blood count; EOT= end of treatment; LDH = lactate dehydrogenase; MRD = minimal residual disease; RO = receptor occupancy; Q2C = every 2 cycles; 
Q3C = every 3 cycles; WBC = white blood cell
a Any other visit window specifications for individual assessments should be applied.


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b In the absence of count recovery at Day 28, CBC should be collected weekly for 2 weeks or until start of the next cycle, whichever is earlier. The best CBC result within the 
± 2-week window is to be used for the response assessment, with the date of response being the date of the bone marrow assessment. Complete blood count does not need to be 
repeated if the prior CBC (including prior Day 28 CBC) is within 3 days of Day 1.
c The serum pregnancy test collected at screening may be used as the Cycle 1 Day 1 test if performed within 72 hours of first dose of study treatment. Urine or serum pregnancy 
tests will be conducted every 4 weeks following Cycle 1 Day 1 and can be performed locally without a requirement to visit the study site; additional guidance is provided in 
Section 6.5.1.
d Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of any study treatment except for Hb, which must be 
performed within 24 hours prior to magrolimab dosing. Thereafter, pretreatment assessments are to be collected within 24 hours prior to any intravenous/subcutaneous study 
drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
e Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 × 103/µL prior to each magrolimab dose during Cycle 1.
f Vital signs will be assessed prior to administration of any study treatment. Details are provided in Section 6.5.4.
g Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are 
not scheduled.
h Samples will be collected predose within 12 hours prior to study treatment administration. Peripheral blood for correlative studies does not need to be repeated at Cycle 2 Day 1 
if done at Cycle 1 Day 28 within 3 days of Cycle 2 Day 1.
i At each bone marrow time point, both trephine (biopsy) and aspirate samples are to be collected for correlative studies.
j Samples for RO will be collected at selected study sites. 
k Samples will be collected on Day 28 of Cycles 4, 6, 9, 12, and 15.
l A trephine (biopsy) is to be collected for response assessment. An aspirate sample will be collected for response assessment and MRD assessment. Response assessments may 
be adjusted by ± 1 week for Day 28 of Cycles 1 and 2. After Cycle 2 Day 28, the window is ± 14 days. Conventional cytogenetics to be tested per institutional standards.
m Samples will be collected on Day 28 of Cycles 4 and 6, and then every 3 cycles thereafter during study treatment. 
n Single sample will be collected on Day 1 or at any time during the study.
o Peripheral blood smears for blasts are to be collected along with bone marrow aspirate/biopsy and assessed locally.
p Peripheral blood smears for general morphology will be collected predose and assessed locally.


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Appendix Table 3.
MEC Administration and Associated Assessment Schedule – Treatment Period (Cohort 2) 
Cycle (28-day Cycles)
MEC Cycle 1
MEC Cycle 2 (and 3 if applicable)a
Starting at the end of MEC Cycle 
Visit Window (Days)b
None
± 3
± 3
± 3
Cycle Day
1
2
4
8
11
15
22
28
Weekly 
for 
2 weeksl
1
8
15
22
28
Weekly 
for 
2 weeksl
Every 4 weeks
thereafter
(up to 12 months of 
total treatment)
Every 8 weeks x 2 
and every 12 weeks 
thereafter
(up to 12 months of 
total treatment)
Safety
Pregnancy testc 
X
Every 4 weeks following Cycle 1 Day 1
X
CBC with differential, 
platelets, reticulocytesd
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Haptoglobin and LDHd
X
X
X
X
X
Peripheral blood smear 
for general 
morphologyd,n
X
X
X
Serum or plasma 
chemistryd
X
X
X
X
X
X
X
X
X
Vital signse
X
X
X
X
X
X
X
X
X
X
Weight
X
X
X
Symptom-directed 
physical examinationd
X
X
X
X
X
Adverse eventsf
Concomitant 
medicationsf
Efficacy/ Biomarkers
Peripheral blood smear 
for blastsm
X
X 
(Cycle 2 
only)
X
Peripheral blood 
sample for correlative 
studiesg
X
X
X
X
X
(Cycle 2 
only)
16 weeks after end 
of MEC cycle
-


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Cycle (28-day Cycles)
MEC Cycle 1
MEC Cycle 2 (and 3 if applicable)a
Starting at the end of MEC Cycle 
Visit Window (Days)b
None
± 3
± 3
± 3
Cycle Day
1
2
4
8
11
15
22
28
Weekly 
for 
2 weeksl
1
8
15
22
28
Weekly 
for 
2 weeksl
Every 4 weeks
thereafter
(up to 12 months of 
total treatment)
Every 8 weeks x 2 
and every 12 weeks 
thereafter
(up to 12 months of 
total treatment)
Bone marrow 
aspirate/biopsy for 
correlative studiesi and 
receptor occupancyh
X
X 
(Cycle 2 
only)
X
Bone marrow 
aspirate/biopsy for 
response assessment, 
cytogenetics, and 
MRD assessmentj
X
X 
(Cycle 2 
only)
X
Bone marrow slides or 
blocks for central 
review
X
X 
(Cycle 2 
only)
X
Buccal swabk
X
CBC = complete blood count; LDH = lactate dehydrogenase; MEC = mitoxantrone, etoposide, cytarabine; MRD = minimal residual disease
a If patient achieved blast clearance after Cycle 1, one additional cycle of MEC will be given (total 2 cycles). If patient achieved blast clearance only after Cycle 2, a third cycle of 
MEC will be given. If no blast clearance at the end of Cycle 2, patient should be discontinued from the study.
b Any other visit window specifications for individual assessments should be applied.
c The serum pregnancy test collected at screening may be used as the Cycle 1 Day 1 test if performed within 72 hours of first dose of study treatment. Urine or serum pregnancy 
tests will be conducted every 4 weeks following Cycle 1 Day 1 and can be performed locally without a requirement to visit the study site; additional guidance is provided in 
Section 6.5.1.
d Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of any study treatment except for Hb, which must be 
performed within 24 hours prior to magrolimab dosing. Thereafter, pretreatment assessments are to be collected within 24 hours prior to any intravenous/subcutaneous study 
drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
e Vital signs will be assessed prior to administration of any study treatment. Details are provided in Section 6.5.4.
f Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are 
not scheduled.
g Samples will be collected predose within 12 hours prior to study treatment administration.
h Samples for receptor occupancy will be collected at selected study sites. 
i At each bone marrow time point, both trephine (biopsy) and aspirate samples are to be collected for correlative studies. 
j A trephine (biopsy) is to be collected for response assessment. An aspirate sample will be collected for response assessment and MRD assessment. Response assessments may 
be adjusted by ± 1 week for Day 28 of Cycles 1 and 2. After Cycle 2 Day 28, the window is ± 14 days. Conventional cytogenetics to be tested per institutional standards.


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k Single sample will be collected on Day 1 or at any time during the study. 
l In the absence of count recovery at Day 28, CBC should be collected weekly for 2 weeks or until start of the next cycle, whichever is earlier. The best CBC result within the 
± 2-week window is to be used for the response assessment, with the date of response being the date of the bone marrow assessment. Complete blood count does not need to be 
repeated if the prior CBC (including prior Day 28 CBC) is within 3 days of Day 1.
m Peripheral blood smears for blasts are to be collected along with bone marrow aspirate/biopsy and assessed locally.
n Peripheral blood smears for general morphology will be collected predose and assessed locally.


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Appendix Table 4.
Magrolimab Administration and Associated Assessment Schedule – Treatment Period for All Cohorts
Visit Window (Days)
Nonea
± 3a
Day
1 
2
4 
8
11
15
Weekly x 5 
± 3 days
Every 2 weeks 
± 3 days
Vital signsb
X
X
X
X
X
X
X
Hemoglobinc
Pre- and 
postdose
Pre- and 
postdose
Peripheral blood 
sample for receptor 
occupancyd,e
X
Pharmacokinetic
Within 12 hours 
prior to 
magrolimab 
dosing
Antidrug antibodiesf
Within 72 hours 
prior to 
magrolimab 
dosing
Within 12 hours 
prior to magrolimab 
dosing for 2nd 
weekly dose
Within 12 hours 
prior to magrolimab 
dosing before 1st, 
5th, 9th, 15th and 
21st biweekly 
maintenance doses 
of 30 mg/kg 
Magrolimab 
Administration
Premedicationg
X
X
X
X
Magrolimabh
X
X
X
X
X
X
X
CBC = complete blood count; PK = pharmacokinetic(s)
a In cases of magrolimab repriming/re-escalation following a treatment delay (Section 5.1.3), follow magrolimab schedule of assessment and administration for repriming 
(Appendix Table 5). 
b Vital signs will be assessed prior to administration of magrolimab. Details are provided in Section 6.5.4.
c Hemoglobin must be performed within 24 hours prior to magrolimab dosing on Days 1 and 4 to ensure hemoglobin is ≥ 9 g/dL. Within 24 hours prior to each of the first 2 doses 
of magrolimab infusion during initial treatment, all patients must have a documented hemoglobin ≥ 9 g/dL. Patients who do not meet these criteria must be transfused and have 
their hemoglobin rechecked to meet 9 g/dL prior to each of the first 2 doses of magrolimab. An additional hemoglobin check must be performed 3 to 6 hours after the initiation 
of the first 2 doses of magrolimab (see Section 5.1.2).
d Samples will be collected predose within 12 hours prior to administration of magrolimab.
e Samples for receptor occupancy will be collected at selected study sites. 
f When collected on the day of study treatment dosing, the blood sample for antidrug antibodies must be collected at the same time as the predose PK sample.
g Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment and in case of reintroduction with repriming. Premedication should 
include oral acetaminophen 650 to 1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg, or comparable regimen. If less than 4 hours has 
elapsed since a prior dose of acetaminophen has been given, the dose of acetaminophen premedication may be omitted. For patients who do not experience an IRR with the first 
4 doses of magrolimab, corticosteroid pretreatment can be discontinued at the investigators’ discretion. Patients who experience IRRs with the first 4 doses of magrolimab 
should continue premedication with corticosteroids prior to subsequent doses at the investigator’s discretion. Premedication decisions for subsequent infusions should be based 
on the treating physician’s clinical judgment and the presence/severity of prior infusion related reactions (Section 5.1.4).
h Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses of magrolimab, and then 2 hours 
(± 30 minutes) for infusions beyond the first 3 doses. Monitor patients for 1 hour post infusion for priming, repriming/re-escalation, and maintenance doses during the first 
4 weeks of treatment. For magrolimab dosing, please refer to Table 1.


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Appendix Table 5.
Magrolimab Repriming Administration and Associated Assessment Schedule – Treatment Period for All 
Cohorts
Visit Window (Days)a
None
± 3
Day
1
2
4
8
11
15
22b
29, then every 
2 weeks OR 57, 
then every 
2 weeks
Safety
CBC with 
differential, 
platelets, 
reticulocytesc,d
X
X
X
X
X
X
X
Haptoglobin and 
LDHc
X
X
X
X
Chemistryc
X
X
X
X
X
Peripheral blood 
smear for general 
morphologyc,e
X
X
X
Vital signsf
X
X
X
X
X
X
X
Weight
X
X
Symptom-directed 
physical 
examinationc
X
X
X
Adverse eventsg
Concomitant 
medicationsg
Efficacy/ Biomarkers
Peripheral blood 
sample for receptor 
occupancyh,i
X
X
X
Xj
Xj
PK/ Immunogenicity
PKj
X
X
Xj
Xj
Antidrug 
antibodiesk
X
Xk
Xk


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Visit Window (Days)a
None
± 3
Day
1
2
4
8
11
15
22b
29, then every 
2 weeks OR 57, 
then every 
2 weeks
Magrolimab 
Administration
Premedicationl
X
X
X
X
Magrolimabm
X
X
X
X
X
X
X
ADA = antidrug antibody; CBC = complete blood count; EOT = end of treatment; LDH = lactate dehydrogenase; PK = pharmacokinetic(s); RO = receptor occupancy; 
Q4W = every 4 weeks; WBC = white blood cell
a Any other visit window specifications for individual assessments should be applied.
b In case the repriming occurs during the first 4 weeks of magrolimab treatment, patient should receive magrolimab 30 mg/kg weekly × 5 after receiving Day 15 dose. All Day 22 
safety assessments should be completed weekly × 5. One week after the 5th weekly dose, dosing will be 30 mg/kg Q2W.
c Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of magrolimab except for Hb, which must be performed 
within 24 hours prior to magrolimab dosing. Thereafter, pretreatment assessments are to be collected within 24 hours prior to magrolimab dosing during the first 2 weeks and 
within 72 hours prior to magrolimab thereafter. 
d Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 × 103/µL prior to each magrolimab dose during first 4 weeks 
of repriming.
e Peripheral blood smears for general morphology will be collected predose and assessed locally.
f Vital signs will be assessed prior to administration of magrolimab. Details are provided in Section 6.5.4.
g Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are 
not scheduled.
h Samples will be collected predose within 12 hours prior to study treatment administration.
i Samples for RO will be collected at selected study sites.
j Samples will be collected within 72 hours before the first dose of magrolimab and within 12 hours before subsequent doses of magrolimab. In addition to Day 1, Day 2 (for RO 
only), and Day 8 , predose samples will also be collected before the Day 29 dose (only applicable if the repriming schedule has 4 additional weekly doses post Day 22), as well 
as before the 1st, 5th, 9th, 15th and 21st biweekly maintenance doses of 30 mg/kg, respectively. 
k When collected on the day of magrolimab dosing, the blood sample for ADA must be collected at the same time as the predose PK sample. ADA samples will be collected at 
predose on Day 1 and Day 29 (only applicable if the repriming schedule has 4 additional weekly doses post Day 22), as well as before the 1st, 5th, 9th, 15th and 21st biweekly 
maintenance doses of 30 mg/kg, respectively. 
l Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment in case of reintroduction with repriming. Premedication should 
include oral acetaminophen 650 to 1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg, or comparable regimen. If less than 4 hours has 
elapsed since a prior dose of acetaminophen has been given, the dose of acetaminophen premedication may be omitted. For patients who do not experience an IRR with the first 
4 doses of magrolimab, corticosteroid pretreatment can be discontinued at the investigators’ discretion. Patients who experience IRRs with the first 4 doses of magrolimab 
should continue premedication with corticosteroids prior to subsequent doses at the investigator’s discretion. Premedication decisions for subsequent infusions should be based 
on the treating physician’s clinical judgment and the presence/severity of prior infusion related reactions (Section 5.1.4).
m Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses of magrolimab, and then 2 hours 
(± 30 minutes) for infusions beyond the first 3 doses. Monitor patients for 1 hour post infusion, during first 4 weeks for repriming. For magrolimab dosing, please refer to 
Table 1.


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Appendix Table 6.
Schedule of Treatment Administration for Venetoclax and Azacitidine – Cohort 1 (1L Unfit AML 
Mag+Ven+Aza)
Cycle (28-day Cycles)
1
2
3+
Cycle Daya
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
Visit Window (days)
0
± 3
± 3
± 3
Azacitidineb
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Venetoclaxc
Daily Days 1-28
Daily Days 1-28
Daily Days 1-28
AML = acute myeloid leukemia
a Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are 
not scheduled.
b Azacitidine administration should be completed at least 1 hour before magrolimab administration on days when both drugs are administered. Azacitidine may be administered 
on an alternative schedule such as Days 1 to 5, Day 8, and Day 9 of a 28-day cycle for flexibility and convenience as long as the 7 doses of azacitidine of the cycle are 
administered within 9 consecutive days. Please refer to Table 1.
c Venetoclax is administered daily. Please refer to Table 1. In cases of dose de-escalation, refer to Table 4 for the venetoclax dosing schedule.


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Appendix Table 7.
Schedule of Treatment Administration for MEC – Cohort 2 (R/R AML Mag+MEC)
1
2 to 3b
Cycle Daya
1
2
3
4
5
8
11
15
22
1
2
3
4
5
8
15
22
Visit Window (days)
0
± 3
± 3
Mitoxantrone
X
X
X
X
X
X
X
X
X
X
Etoposide
X
X
X
X
X
X
X
X
X
X
Cytarabine
X
X
X
X
X
X
X
X
X
X
AML = acute myeloid leukemia; MEC = mitoxantrone, etoposide, cytarabine; R/R = relapsed/refractory
a Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are 
not scheduled.
b If patient achieved blast clearance after Cycle 1, one additional cycle of MEC will be given (total 2 cycles). If patient achieved blast clearance only after Cycle 2, a third cycle of 
MEC will be given. If no blast clearance at the end of Cycle 2, patient should be discontinued from the study.
Appendix Table 8.
Schedule of Treatment Administration for CC-486 – Cohort 3 (Post-Chemo Maint Mag+CC-486)
Cycle (28-day Cycles)
1
2
3+
Cycle Daya
1
4
8
11
15
22
1
8
15
22
1
Visit Window (days)
0
± 3
± 3
± 3
CC-486
Daily Days 1-14
Daily Days 1-14
Daily Days 1-14
CC-486 = Onureg
a Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are 
not scheduled.
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 


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Appendix Table 9.
Schedule of Assessments – Post Treatment
End-of-treatment Visit
Safety Follow-up Visit/ 
Telephone Calla
Safety Follow-up Visit/ 
Telephone Calla
Within 7 Days after Last 
Dose or EOT Decision
30 Days
after Last Dose
70 Days
after Last Dose
Visit Window (Days)
± 7 
± 7 
± 7
Serum or urine pregnancy testb
Q4W
CBC with differential, platelets, reticulocytes
X
Serum or plasma chemistry
X
Peripheral blood for correlative studies
X
Pharmacokinetics
X
Antidrug antibodies 
X
Bone marrow aspirate/biopsy for response assessmentc, cytogeneticsd, and MRD 
assessment 
X
Bone marrow aspirate/biopsy for correlative studies 
X
Peripheral blood smear (for blasts)e
X
ECOG performance status
X
Vital signs 
X
Symptom-directed physical examination
X
Adverse eventsf
X
X
X
Concomitant medications
X
X
X
New anti-AML therapy reportingg
X
X
X
AE = adverse event; AML = acute myeloid leukemia; CBC = complete blood count; ECOG = Eastern Cooperative Oncology Group; EOT = end of treatment; MRD = minimal 
residual disease; Q4W = every 4 weeks; SAE = serious adverse event
a If the patient experiences a treatment-related AE or an SAE (regardless of attribution), the patient must be asked to come to the site.
b Pregnancy testing will be continued monthly up to 6 months after the end of treatment per the duration of contraception requirement as discussed in Appendix 5. Testing after 
70 days of safety follow-up may be done at home and the result self-reported by the patient.
c Response assessment at EOT visit not required if performed within the last 30 days or progressive disease has been documented.
d Conventional cytogenetics to be tested per institutional standards.
e Peripheral blood smears for blasts are to be collected along with bone marrow aspirate/biopsy.
f Report all AEs through the Safety Follow-up Visit/Call, and any treatment-related SAEs thereafter through the 70-day safety follow-up visit/call.
g Collect data for the first new anti-AML therapy following the last dose of study treatment.


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Appendix 3
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, potential risks associated with patients being unable to 
attend study visits have been identified for this study.
These potential risks and mitigation plans can be summarized as follows:
1) Schedule of assessments:
a) Physical examination:
i)
For all assessments where a physical examination is indicated, this portion of the visit 
can be conducted virtually; however, when samples need to be collected or dosing 
performed, these activities must occur in the clinic.
ii) If a virtual visit is conducted for the physical examination assessment portion, in 
order to limit a patient’s time in the clinic, vital signs may be omitted.
b) Dosing:
i)
For Cycle 2 and repriming cycles, magrolimab can be administered on Day 7 with 
azacitidine, with collection of Day 8 assessments (ie, laboratory assessments, PK) on 
Day 7 in order to minimize an extra patient visit.
ii) Dosing delays with magrolimab:
(1) For patients who may have travel restrictions, the 4-week period of magrolimab 
dose delay for repriming can be extended to 6 weeks in order to minimize the 
need for repriming for patients in this scenario. Medical monitor approval is 
needed for this specific situation. Magrolimab every-2-week dosing should be 
encouraged as dosing intervals longer than this will lead to suboptimal efficacy.
iii) Dosing with azacitidine:
(1) If needed under specific circumstances, sites can allow for administration of 
azacitidine locally nearer to patient’s residence, with proper documentation (eg, 
name of site, name of physician overseeing transfusion, name of laboratory used, 
including accreditation certificate). Administration of azacitidine outside the 
center should be reserved only in cases where patients will not be able to get 
azacitidine dosing otherwise.
(2) If treatment administration is given locally, then the patient should be evaluated 
by a local hematologist on Day 1 of that treatment cycle and have all laboratory 
assessments required on the Day 1 treatment cycle performed as per the protocol. 
The site should procure the clinical notes and laboratory reports for the principal 
investigator (PI) review and signature. The site is to ensure that all of these 
documents are filed in the patient’s source records.


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(3) The treating physician at the study site should speak to the local hematologist and 
review protocol guidelines/dosing of azacitidine/reporting of reactions and 
document this information in the medical records.
c) Sample collection:
i)
While it is preferred to collect all protocol-specified laboratory samples, if resources 
are limited, PK/ADA samples may be collected and stored (frozen) and not shipped in 
real-time if staff are not available to do so.
ii) MRD testing should be collected and shipped in real-time. 
iii) For correlative peripheral blood or bone marrow aspirate samples, if they cannot be 
shipped according to their corresponding standard procedures same day, or 
refrigerated overnight for shipment the next day, please isolate the mononuclear cells 
(eg, by Ficoll gradient) and cryopreserve according to local best practices. If it is not 
possible to either ship samples or preserve and store according to the guidance above, 
then collection of these samples may be omitted until normal operations can resume.
d) General patient selection guidance:
i)
To minimize patients receiving RBC transfusions given the current transfusion 
product shortage, we recommend selecting patients with higher hemoglobin 
thresholds at baseline and use IV iron and/or erythropoietin where clinically 
indicated.
2) Study drug supplies to patients and sites:
a) Patients may be unable to return to the site for a number of visits to get the study drug, or 
the site may be unable to accept any patient visits. Without study drugs, the patient would 
not be able to stay on the study drug as planned per protocol.
Mitigation plan: If permitted by local EC/IRB/Regulatory authority as applicable and 
with sponsor’s approval, study drug supplies may be provided to the patient from the site 
without a clinic visit. It must be confirmed that the patient may safely continue on study 
drug as determined by the PI. A virtual study visit, via phone or video conferencing, must 
be performed prior to remote study drug resupply. At the earliest opportunity, the site will 
schedule in-person patient visits and return to the protocol’s regular schedule of 
assessments. A qualified courier may be utilized to ship the study drug from sites to study 
patients, and a qualified vendor may be utilized to perform infusions in the patients’ local 
vicinity.
b) Shipments of study drug from the sponsor to the investigational site could be delayed 
because of transportation issues. Without study drug, the patient would not be able to stay 
on the study drug as planned per protocol.


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Mitigation plan: The sites’ study drug inventory should be closely monitored. Site staff 
should notify the sponsor or delegate if they foresee shortage in study drug inventory or if 
there is any interruption in local shipping service. The sponsor will continue to monitor 
inventory at the study drug depot and study sites. Manual shipments will be triggered as 
necessary.
3) Patient safety monitoring and follow-up:
a) Patients may be unable or unwilling to come to the study site for their scheduled study 
visits as required per protocol.
Mitigation plan: For patients who may be unable or unwilling to visit the study site for 
their scheduled study visits as required per protocol, the PI or qualified delegate will 
conduct a virtual study visit, via phone or video conferencing, to assess the patient within 
target visit window date whenever possible. During the virtual study visit, the following 
information at minimum will be reviewed:
i)
Confirm if patient has experienced any AEs/serious adverse events (SAEs)/special 
situations (including pregnancy) and follow-up on any unresolved AE/SAEs
ii) Review current list of concomitant medications and document any new concomitant 
medications
iii) If applicable, confirm patient’s study drug supply is sufficient to last until the next 
planned visit date. If study drug resupply is needed it will be provided as described 
above in (2)
iv) If applicable, confirm that electronic diary questionnaires and patient-reported 
outcomes have been completed and transmitted
v) If applicable, remind patient to maintain current dosing and to keep all dispensed 
study drug kits for return at the next on-site visit
b) Patients may be unable or unwilling to travel to the site for planned assessments (eg, 
safety blood draws); hence, samples may not be sent for central laboratory analyses.
Mitigation plan: Accredited local laboratory may be utilized as appropriate to monitor 
patient safety until the patient can return to the site for their regular follow-up per 
protocol. Any laboratory assessments conducted at a local laboratory due to the pandemic 
will be documented accordingly. Pregnancy testing may be performed using a home urine 
pregnancy test if local laboratory pregnancy testing is not feasible. Alternative sample 
handling and storage may be possible for samples routinely sent to the central laboratory; 
sites should refer to the study laboratory manual and discuss with the sponsor for further 
guidance.
c) Patients may be unable or unwilling to attend the study visit to sign an updated ICF 
version if there is an update.


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Mitigation plan: The site staff will follow their approved consent process and remain in 
compliance with local EC/IRB and national laws and regulations. Remote consent will be 
allowed if it has been approved by the local EC/IRB. The consent process will be 
documented and confirmed by normal consent procedure at the earliest opportunity.
d) The safety of trial patients is important and testing of COVID-19 infection will be based 
on local clinical guidelines for testing based on signs/symptoms and or suspected 
exposure to COVID-19.
Mitigation plan: If patient has a diagnosis of COVID-19 while on this clinical study, 
study drugs may be held until clinical improvement or resolution in accordance with the 
treating physician’s judgment and general magrolimab/azacitidine dose delay guidance in 
the protocol. Additional supportive care and treatment measures for COVID-19 infection 
on the study will be performed in accordance with local institutional guidelines. Patients 
with a COVID-19 infection while participating in a clinical trial will have this event 
documented as an adverse event in the clinical database.
4) Protocol and monitoring compliance:
a) Protocol deviations may occur if scheduled visits cannot occur as planned per protocol.
Mitigation plan: If it is not possible to complete a required procedure, an unscheduled 
visit should be conducted as soon as possible when conditions allow. The situation should 
be recorded and explained as a protocol deviation. Any missed patient visits or deviation 
to the protocol due to the pandemic must be reported in the eCRF and described in the 
clinical study report (CSR). Any virtual study visits that are conducted in lieu of clinic 
visits due to the pandemic will be documented as a protocol deviation related to the 
pandemic.
b) Monitors may be unable to carry out source data review or source data verification 
(SDV), or study drug accountability or assess protocol and GCP compliance. This may 
lead to delays in SDV, an increase in protocol deviations, or under reporting of AEs.
Mitigation plan: The study monitor is to remain in close communication with the site to 
ensure data entry and query resolution. The study monitor is to reference the Study 
Monitoring Plan for guidance on how to conduct a remote monitoring visit. The study 
staff is to save and document all relevant communication in the study files. The status of 
sites that cannot accept monitoring visits and/or patients on site, must be tracked centrally 
and updated on a regular basis.
5) Missing data and data integrity:
a) There may be an increased amount of missing data due to patients missing 
visits/assessments. This could have an impact on the analysis and the interpretation of 
clinical study data.


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Mitigation plan: Implications of a pandemic on methodological aspects for the study will 
be thoroughly assessed and documented, and relevant actions will be taken as appropriate 
(ie, modification of the statistical analysis plan) and in compliance with regulatory 
authorities’ guidance. Overall, the CSR will describe the impact of the pandemic on the 
interpretability of study data.
Risks will be assessed continuously, and temporary measures will be implemented to mitigate 
these risks as part of a mitigation plan, as described above. These measures will be 
communicated to the relevant stakeholders as appropriate and are intended to provide alternate 
methods that will ensure the evaluation and assessment of the safety of patients who are enrolled 
in this study.
Since these potential risks are considered mitigated with the implementation of these measures, 
the expected benefit-risk assessment of the study drugs in study patients remains unchanged. In 
the event that these potential risks cannot be mitigated due to the escalation of a pandemic, 
randomization of new patients will be placed on hold until the pandemic outbreak is under 
control by following local regulatory guidelines.


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Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and 
Laboratory Abnormalities
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_R
eference_8.5x11.pdf


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Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1)
Definitions
a) Definition of Childbearing Potential
For the purposes of this study, a female born patient is considered of childbearing potential 
following the initiation of puberty (Tanner stage 2) until becoming post-menopausal, unless the 
patient is permanently sterile or has medically documented ovarian failure. 
Women are considered to be in a postmenopausal state when they are > 54 years of age with 
cessation of previously occurring menses for > 12 months without an alternative cause. In 
addition, women of < 54 years of age with amenorrhea of > 12 months may also be considered 
postmenopausal if their follicle-stimulating hormone level is in the postmenopausal range and 
they are not using hormonal contraception or hormonal replacement therapy.
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female patient of any age.
b) Definition of Male Fertility
For the purposes of this study, a male-born patient is considered to be fertile after the initiation of 
puberty unless the patient is permanently sterile by bilateral orchidectomy or medical 
documentation.
2)
Contraception Requirements for Female Patients
a) Study Drug Effects on Pregnancy and Hormonal Contraception
Magrolimab is contraindicated in pregnancy as a higher incidence of total pregnancy loss has 
been observed in and embryo-fetal development toxicity study in cynomolgus monkeys and there 
is a strong suspicion of human fetotoxicity in early pregnancy based on the nonclinical data. For 
magrolimab, there is no anticipated PK interaction with progestin or other steroids based on the 
distinct clearance pathways. 
Based on the mechanism of action (MOA) and findings in animals, azacitidine may cause fetal 
harm when administered to a pregnant woman. Advise females with reproductive potential to 
avoid pregnancy during treatment with azacitidine. Studies in vitro have demonstrated that CYP 
enzyme induction or inhibition by azacitidine at clinically achievable plasma concentrations is 
unlikely.
Based on its MOA and findings in animals, venetoclax may cause embryo-fetal harm when 
administered to a pregnant woman. Advise females with reproductive potential to avoid 
pregnancy during treatment with venetoclax. It is currently unknown whether venetoclax may 
reduce the effectiveness of hormonal contraceptives. 


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Based on its MOA and findings in animals, mitoxantrone may cause fetal harm when 
administered to a pregnant woman. Women of childbearing potential should be advised to avoid 
becoming pregnant. Women treated with mitoxantrone have an increased risk of transitory or 
persistent amenorrhea. To date, post-marketing experience has not revealed any significant drug 
interactions in patients who have received mitoxantrone for treatment of cancer.
Based on animal studies and its MOA, etoposide can cause fetal harm when administered to a 
pregnant woman. Women of childbearing potential should be advised to avoid becoming 
pregnant. 
Cytarabine can cause fetal harm when administered to a pregnant woman. Women of 
childbearing potential should be advised to avoid becoming pregnant. 
Based on the MOA and findings in animals, CC-486 (Onureg) can cause fetal harm when 
administered to a pregnant woman. Based on animal data, CC-486 (Onureg) may impair female 
fertility. Studies in vitro have demonstrated that CYP enzyme induction or inhibition by 
azacitidine at clinically achievable plasma concentrations is unlikely.
Refer to the latest version of the magrolimab IB for additional information. Refer to the regional 
prescribing information for information on the potential risks of treatment with azacitidine 
{VIDAZA 2018}, venetoclax {VENCLEXTA 2020}, mitoxantrone {MitoXANTRONE 2018}, 
etoposide {ETOPOPHOS 2019}, cytarabine {CYTARABINE 2020}, and CC-486 {ONUREG 
2020}.
b) Contraception Requirements for Female Patients of Childbearing Potential
The inclusion of female patients of childbearing potential requires the use of highly effective 
contraceptive measures with a failure rate of < 1% per year. They must have a negative serum 
pregnancy test at screening and a negative pregnancy test is required prior to study treatment 
administration on Cycle 1 Day 1. Pregnancy tests will be performed every 4 weeks thereafter 
(described in the protocol) until the end of contraception requirement.
Duration of required contraception for female patients in this clinical trial should start from 
screening visit until 6 months after the last dose of the latest administered study drug.
Female patients must agree to one of the following contraceptive methods: 
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the patient’s preferred and usual lifestyle. 
Or
Consistent and correct use of 1 of the following methods of birth control listed below: 
•
Non-hormonal intrauterine device (IUD) 
•
Hormonal IUD (must be used in conjunction with a barrier method)


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•
Bilateral tubal occlusion (upon medical assessment of surgical success)
•
Vasectomy in the male partner (upon medical assessment of surgical success)
Or 
Female patients who wish to use a hormonally based method must use it in conjunction with a 
barrier method, preferably a male condom. Hormonal methods are restricted to those associated 
with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted 
for use in this protocol are as follows, where local standard of care practices allow:
•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
Oral contraceptives (either combined or progesterone only)
Injectable progesterone
Transdermal contraceptive patch
Contraceptive vaginal ring
Subdermal contraceptive implant
•
Barrier methods (each method must be used with a hormonal method)
Male condom (with or without spermicide)
Female condom (with or without spermicide)
Diaphragm with spermicide
Cervical cap with spermicide
Sponge with spermicide
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved. 
Female patients must also refrain from egg donation, cryopreservation of cells, and in vitro 
fertilization during treatment and until the end of contraception requirement. If needed, female 
patients should be advised to seek advice about egg donation and cryopreservation prior to 
treatment.


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3)
Contraception Requirements for Male Patients
Male patients with female partners of childbearing potential must use condoms during treatment 
and until 6 months after the last dose of the latest administered companion drug. If the female 
partner of childbearing potential is not pregnant, use of any locally approved contraceptive 
method should also be considered. Based on companion drugs, male patients must also refrain 
from sperm donation and cryopreservation of cells during treatment and until the end of 
contraception requirement for the companion drug. If needed, male patients should be advised to 
seek advice about sperm donation and cryopreservation prior to treatment.
4)
Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.
5)
Procedures to Be Followed in the Event of Pregnancy
Female patients will be instructed to notify the investigator if they become pregnant or suspect 
they are pregnant at any time from start of the study to 6 months post last study drug dose. Study 
drug must be discontinued immediately.
Male patients whose partner has become pregnant or suspects she is pregnant from start of study 
to 6 months post last study drug dose must also report the information to the investigator. 
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.4.2.3.


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Appendix 6.
Eastern Cooperative Oncology Group Performance Status 
Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative 
Oncology Group. Am J Clin Oncol. 1982;5:649-655. Available online:
http://ecog-acrin.org/resources/ecog-performance-status. Accessed 18 February 2020.


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Appendix 7. 
Disease Response Criteria Based on European Leukemia Net (ELN) 
and International Working Group (IWG) Criteria 
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Appendix Table 10. Response Criteria in Acute Myeloid Leukemia (Based on ELN 2017 
Recommendations with Modifications)
Definitions
Response 
Criteria
Neutrophils
Platelets
Bone Marrow 
Blasts
Other
Complete 
remission without 
minimal residual 
disease (CRMRD−) 
> 1.0  109/L
> 100  109/L
< 5%
MRD negative (determined using 
multiparameter flow cytometry with 
a sensitivity of < 0.1%). Absence of 
circulating blasts and blasts with 
Auer rods; absence of 
extramedullary disease. 
Complete 
remission with 
positive or 
unknown minimal 
residual disease 
(CRMRD+/unk)
> 1.0  109/L
> 100  109/L
< 5%
MRD positive (determined using 
multiparameter flow cytometry with 
a sensitivity of < 0.1%) or 
unknown. Absence of circulating 
blasts and blasts with Auer rods; 
absence of extramedullary disease. 
Complete 
remission with 
incomplete 
hematologic 
recovery (CRi)
Neutrophils > 1.0  109/L
OR
Platelets > 100  10
9/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease. (All CR 
criteria except residual neutropenia 
[< 1.0  109/L] or thrombocytopenia 
[< 100  109/L]).
Complete 
remission with 
partial 
hematologic 
recovery (CRh)
> 0.5  109/L
> 50  109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease.
Morphologic 
leukemia-free 
state (MLFS)a 
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; no 
hematologic recovery required; 
marrow should not merely be 
“aplastic”; at least 200 cells should 
be enumerated or cellularity should 
be at least 10% 
Partial remission 
(PR) 
> 1.0  109/L 
> 100  109/L 
Decrease of bone 
marrow blast 
percentage to 5% 
to 25%; and 
decrease of 
pretreatment bone 
marrow blast 
percentage by at 
least 50% 
Blasts < 5% with Auer rods may 
also be considered a PR 
Stable disease
Absence of CRMRD-, CRMRD+/unk, CRi, CRh, PR, MLFS; and criteria for progressive disease 
not met 


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Definitions
Response 
Criteria
Neutrophils
Platelets
Bone Marrow 
Blasts
Other
Progressive 
disease 
Evidence for an increase in bone marrow blast percentage and/or increase of absolute blast 
counts in the blood: 
•
≥ 50% increase in marrow blasts over baseline (a minimum 15% point increase is 
required in cases with < 30% blasts at baseline; or persistent marrow blast percentage of 
> 70% over at least 3 months; without at least a 100% improvement in ANC to an 
absolute level > 0.5  109/L [500/μL], and/or platelet count to > 50  109/L 
[50,000/μL] non-transfused); or 
•
≥ 50% increase in peripheral blasts (WBC  % blasts) to> 25  109/L (> 25,000/μL) (in 
the absence of differentiation syndrome); or 
•
New extramedullary disease. 
Hematologic 
relapse (after 
CRMRD−, 
CRMRD+/unk, CRi, 
CRh)
Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of 
extramedullary disease
ANC = absolute neutrophil count; CRh = complete remission with partial hematologic recovery; CRi = complete remission with 
incomplete hematologic recovery; CRMRD− = complete remission without minimal residual disease; CRMRD+/unk = complete 
remission with positive or unknown minimal residual disease; MLFS = morphologic leukemia-free state; MRD = minimal 
residual disease; PR = partial remission; WBC = white blood cell 
a Not in the ELN 2017 guidelines. Modification for the purpose of this protocol. A response could be classified as both CRh and 
CRi if both criteria are met.
Source: Based on ELN 2017 guidelines {Dohner 2017}, with modifications for the purposes of this protocol.
Appendix Table 11. Additional Response Definitions Used in This Study (2003 IWG 
Criteria)
Definitions
Response Criteria
Neutrophils
Platelets
Bone Marrow Blasts
Other
Cytogenetic CR 
(cCR)
> 1.0  10
9/L
> 100  10
9/L
< 5%
Cytogenetics 
normal and no 
evidence of 
extramedullary 
disease
cCR = cytogenetic complete remission; CR = complete remission; IWG = International Working Group
Source: {Cheson 2003}
Treatment Failure
Treatment failure is defined as failure to achieve complete remission (CR) before the fifth cycle 
of magrolimab+venetoclax+azacitidine in Cohort 1 and before the third cycle of 
magrolimab + MEC in Cohort 2.


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Appendix 8.
Cockcroft-Gault Method for Estimating Creatinine Clearance
Formulas for calculating the estimated creatinine clearance (eCcr) are provided in the table 
below. The formula appropriate to the units in which serum creatinine was measured and the 
patient’s gender should be used.
Serum 
Creatinine 
Units
Gender
Formula
(140-subject age [years])  subject weight [kilograms]  1
72  subject serum creatinine [mg/dl]
(140-subject age [years])  subject weight [kilograms]  0.85
mg/dL
Males
Females
     eCcr              =
[mL/min]
     eCcr              =
[mL/min]
72  subject serum creatinine [mg/dl]
(140-subject age [years])  subject weight [kilograms]  1.23
Subject serum creatinine [mg/dl]
(140-subject age [years])  subject weight [kilograms]  1.04
M/dL
Males
Females
     eCcr              =
[mL/min]
     eCcr              =
[mL/min]
Subject serum creatinine [mg/dl]
eCcr=estimated creatinine clearance
Source: {Cockcroft 1976}


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Appendix 9.
World Health Organization (WHO) Classification of AML
AML with recurrent genetic abnormalities 
•
AML with a translocation between chromosomes 8 and 21 [t(8;21)]
•
AML with a translocation or inversion in chromosome 16 [t(16;16) or inv(16)]
•
APL with the PML-RARA fusion gene
•
AML with a translocation between chromosomes 9 and 11 [t(9;11)]
•
AML with a translocation between chromosomes 6 and 9 [t(6;9)]
•
AML with a translocation or inversion in chromosome 3 [t(3;3) or inv(3)]
•
AML (megakaryoblastic) with a translocation between chromosomes 1 and 22 [t(1;22)]
•
AML with the BCR-ABL1 (BCR-ABL) fusion gene
•
AML with mutated NPM1 gene
•
AML with biallelic mutations of the CEBPA gene (that is, mutations in both copies of the 
gene)
•
AML with mutated RUNX1 gene
AML with myelodysplasia-related changes
AML related to previous chemotherapy or radiation
AML not otherwise specified (This includes cases of AML that do not fall into one of the above 
groups.)


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Appendix 10.
Amendment History
A high-level summary of this amendment is provided in tabular form in the subsection below. 
Minor changes such as the correction of typographic errors, grammar, or formatting are not 
detailed.
Separate summary of change documents for earlier amendments are available upon request.
A separate tracked change (red-lined) document comparing Amendment 5 with this amendment 
will be made available upon the publication of this protocol.
Amendment 6 (02 November 2023)
Rationale for Key Changes Included in Amendment 6
Affected Sections
The rationale and risk/benefit assessment for the study have been updated to align 
with the information in Edition 12 of the Investigator’s Brochure
Sections 1.6.1, 1.6.2, and 
1.8
Long-term follow-up and survival follow-up have been removed as collection of 
efficacy data after the end-of-treatment (EOT) visit is no longer required.
Sections 3.4, 3.5, 3.6, 5.2, 
6.4, 6.12, and 
Appendix Table 9
Guidance for the use of corticosteroids as premedication for the first few infusions 
of magrolimab has been incorporated to align with the information in Edition 12 
of the Investigator’s Brochure.
Section 5.1.4, 
Appendix Table 4, 
Appendix Table 5
Guidance for the management of infusion-related reactions has been updated to 
incorporate the use of corticosteroids as premedication during the first few 
infusions of magrolimab, and to incorporate guidance for discontinuation of 
magrolimab in certain cases. This was done to align with the information in 
Edition 12 of the Investigator’s Brochure.
Section 7.8.1.2, Table 15
Toxicity management section for magrolimab has been updated to include 
guidelines for dose delay and discontinuation in case of severe neutropenia and 
serious infections to align with the information in Edition 12 of the Investigator’s 
Brochure.
Sections 7.8.1.3 and 7.8.1.4
Event-free survival definition has been updated to align with other studies of 
magrolimab in patients with acute myeloid leukemia (AML).
Section 8.1.3 and 
Appendix 7
Contraception appendix has been updated to reflect latest nonclinical embryo-fetal 
development toxicity data.
Appendix 5
Global Patient Safety (GLPS) has been updated to Patient Safety (PS) to reflect 
the new department name.
Throughout the protocol, as 
required


Protocol GS-US-546-5920 amd-6
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
02-Nov-2023
20:35:39
PPD

SAP_001.pdf: 
Study Title: 
Name of Test Drug: 
Study Number: 
Protocol Version (Date): 
Analysis Type: 
Analysis Plan Version: 
Analysis Plan Date: 
Analysis Plan Author(s): 
(r} GILEAU 
STATISTICAL ANALYSIS PLAN 
A Phase 2 Multi-Ann Study ofMagrolimab Combinations in 
Patients with Myeloid Malignancies 
Magrolimab 
GS-US-546-5920 
Original: 
Amendment 1: 
Amendment 2: 
Amendment 3: 
Amendment 4: 
Amendment 5: 
10 December 2020 
15 June 2021 
20 September 2021 
27 January 2022 
09 May 2022 
11 November 2022 
Amendment 6: 02 November 2023 
Final Analysis 
Version 3.0 
31 May 2024 
PPD 
CONFIDENTIAL AND PROPRIETARY INFORMATION 


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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................4
LIST OF IN-TEXT FIGURES........................................................................................................................................4
LIST OF ABBREVIATIONS.........................................................................................................................................5
PHARMACOKINETIC ABBREVIATIONS.................................................................................................................7
1.
INTRODUCTION..................................................................................................................................................8
1.1.
Study Objectives and Endpoints................................................................................................................8
1.1.1.
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML 
Mag+Ven+Aza).......................................................................................................................8
1.1.2.
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML Mag+MEC) ...............................10
1.1.3.
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-Chemo Maint 
Mag+CC-486 [Onureg])........................................................................................................11
1.2.
Study Design ...........................................................................................................................................12
1.3.
Sample Size and Power ...........................................................................................................................16
2.
TYPE OF PLANNED ANALYSIS......................................................................................................................17
2.1.
Interim Analyses......................................................................................................................................17
2.2.
Primary Analysis .....................................................................................................................................17
2.3.
Final Analysis..........................................................................................................................................17
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES.............................................................................18
3.1.
Analysis Sets ...........................................................................................................................................18
3.1.1.
All Enrolled Analysis Set ......................................................................................................18
3.1.2.
Full Analysis Set....................................................................................................................18
3.1.3.
Safety Analysis Set................................................................................................................18
3.1.4.
Dose-Limiting Toxicity (DLT) Evaluable Analysis Set .......................................................19
3.1.5.
Pharmacokinetic Analysis Set ...............................................................................................19
3.1.6.
Immunogenicity Analysis Set................................................................................................19
3.2.
Subject Grouping.....................................................................................................................................19
3.3.
Strata and Covariates...............................................................................................................................19
3.4.
Examination of Subject Subgroups .........................................................................................................19
3.5.
Adjustment for Multiplicity.....................................................................................................................19
3.6.
Missing Data and Outliers.......................................................................................................................20
3.6.1.
Missing Data..........................................................................................................................20
3.6.2.
Outliers ..................................................................................................................................20
3.7.
Data Handling Conventions and Transformations ..................................................................................20
3.8.
Analysis Visit Windows..........................................................................................................................21
3.8.1.
Definition of Study Day ........................................................................................................21
3.8.2.
Analysis Visit Windows........................................................................................................21
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window .................................................................................................................................23
3.9.
Assessment of COVID-19 Impact...........................................................................................................24
4.
PROTOCOL DEVIATIONS................................................................................................................................25
5.
SUBJECT INFORMATION ................................................................................................................................26
5.1.
Patient Enrollment and Disposition.........................................................................................................26
5.2.
Extent of Study Drug Exposure...............................................................................................................27
5.2.1.
Duration of Exposure to Study Drug.....................................................................................27


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5.2.2. 
Relative Dose Intensity .......................................................................................................... 27 
5.3. 
Demographics and Baseline characteristics ............................................................................................ 29 
5 .4. 
Medical Histo1y ....................................................................................................................................... 30 
5.5. 
Prior Anti-Cancer Therapy ...................................................................................................................... 30 
5.6. 
Post Study Treatment Stem Cell Transplant ........................................................................................... 30 
5.7. 
Prior and Concomitant Radiation therapy ............................................................................................... 30 
5.8. 
Sw·geries and Procedures ........................................................................................................................ 31 
5.9. 
Prior Study Transfusion ........................................................................................................................... 31 
5.10. 
Prior and Concomitant Medications ........................................................................................................ 31 
5.10.1. 
Prior Medications .................................................................................................................. 31 
5.10.2. 
Conco1nitant Medications ...................................................................................................... 31 
5.11. 
Post Treatment Anti-cancer Therapy ....................................................................................................... 32 
6. 
EFFICACY ANALYSES ..................................................................................................................................... 33 
6.1. 
Pri1nruy Efficacy Endpoints .................................................................................................................... 33 
6.1. 1. 
Definition of the Prima1y Efficacy Endpoints ....................................................................... 33 
6.1.2. 
Statistical Hypothesis for the Primruy Efficacy Endpoint ..................................................... 33 
6.1.3. 
Analysis of the Prima1y Efficacy Endpoint ........................................................................... 33 
6.1.4. 
Sensitivi 
Anal sis of the Primru Efficac End oint.. ....................................................... 33 
6.1.5. 
. ...................................................... 33 
6.1.6. 
Additional Analysis Supp01ting the Prima1y Efficacy Endpoint .......................................... 33 
6.2. 
Secondruy Efficacy Endpoints ................................................................................................................ 34 
6.2.1. 
Definition of Seconda1y Efficacy Endpoints ......................................................................... 34 
6.2.2. 
Anal sis Methods for Secondru Efficac End oints ........................................................... 38 
6.3. 
6.4. 
Changes From Protocol-Specified Efficacy Analyses ............................................................................ 38 
7. 
SAFETY ANALYSES ......................................................................................................................................... 39 
7.1. 
Adverse Events and Deaths ..................................................................................................................... 39 
7.1. 1. 
Adverse Event Dictiona1y ..................................................................................................... 39 
7.1.2. 
Adverse Event Severity ......................................................................................................... 39 
7.1.3. 
Relationship of Adverse Events to Study Treatment ............................................................ 39 
7.1.4. 
Serious Adverse Events ......................................................................................................... 39 
7.1.5. 
Treatinent-Emergent Adverse Events .................................................................................... 39 
7.1.6. 
Summaries of Adverse Events and Deaths ............................................................................ 40 
7.1.7. 
Additional Analysis of Adverse Events ................................................................................ 43 
7.2. 
Laborato1y Evaluations .......................................................................................................................... .45 
7.2.1. 
Summaries of Numeric Labora.t01y Results ......................................................................... .45 
7.2.2. 
Graded Laborato1y Values ................................................................................................... .46 
7.2.3. 
Shifts Relative to the Baseline Grade .................................................................................... 46 
7.3. 
Body Weight and Vita.I Signs ................................................................................................................. .47 
7.4. 
Electrocru·diogra1n Results ...................................................................................................................... .47 
7.5. 
Premedication ......................................................................................................................................... .47 
7 .6. 
Other Safety Measures ........................................................................................................................... .47 
7.7. 
Changes From Protocol-Specified Safety Analyses ............................................................................... .47 
8. 
CHANGES FROM PROTOCOL-SPECIFIED ANALYSES ............................................................................. .48 
9. 
PHARMACOKINETIC (PK) AND IMMUNOGENICITY ANALYSES .......................................................... 49 
9.1. 
PK Sample Collection ............................................................................................................................ .49 
9.2. 
PK Analyses ........................................................................................................................................... .49 
9.3. 
Irmnunogenicity Ana.lysis ........................................................................................................................ 50 
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10.
BIOMARKER ANALYSIS .................................................................................................................................52
11.
REFERENCES.....................................................................................................................................................53
12.
SOFTWARE.........................................................................................................................................................54
13.
SAP REVISION...................................................................................................................................................55
Appendix 1.
Estimands for Primary and Key Secondary Endpoints ...........................................................56
Appendix 2.
Disease Response Criteria Based on European Leukemia Net (ELN) and 
International Working Group (IWG) Criteria..........................................................................58
LIST OF IN-TEXT TABLES
Table 3-1.
Analysis Visit Windows for Lab (Excluding Hemoglobin) By-visit Summary......................22
Table 3-2.
Analysis Visit Windows for Hemoglobin By-visit Summary.................................................22
Table 6-1.
Censoring Rules for EFS .........................................................................................................36
LIST OF IN-TEXT FIGURES
Figure 1.
Study Schema ..........................................................................................................................13


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LIST OF ABBREVIATIONS
ADA
anti-drug antibody
AE
adverse event
AEI
adverse events of interest
ALT
alanine aminotransferase
AML
acute myeloid leukemia
AST
aspartate aminotransferase
BICR
blinded independent central review
BLQ
below the limit of quantitation
BMI
body mass index
CBC
complete blood count
CC-486
Onureg
cCR
cytogenetic complete remission
CFR
Code of Federal Regulations
CI
confidence interval
CK
creatine kinase
COVID-19
Coronavirus disease 2019
CR
complete remission
CRh
complete remission with partial hematologic recovery
CRi
complete remission with incomplete hematologic recovery
CRMRD−
complete remission without minimal residual disease
CRMRD+/unk
complete remission with positive or unknown minimal residual disease
CRF
case report form
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
DILI
drug-induced liver injury
DLT
dose-limiting toxicity
DMC
data monitoring committee
DOR
duration of response
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
EFS
event-free survival
EOT
end of treatment 
FAS
Full Analysis Set
Hb
hemoglobin
HLT
high-level term
ICH
International Conference on Harmonization (of Technical Requirements for Registration of 
Pharmaceuticals for Human Use)
IV
intravenous
ITT
intent to treat


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LTT
lower-level term
LOQ
limit of quantitation
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary for Regulatory Activities
MEC
mitoxantrone, etoposide, and cytarabine
MLFS
morphologic leukemia-free state
MRD
minimal residual disease
MST
MedDRA Search Term 
ORR
overall response rate
OS
overall survival
PK
pharmacokinetic
PR
partial remission
PRO
Patient reported outcome 
PT
preferred term
Q1, Q3
first quartile, third quartile
QRS
electrocardiographic deflection between the beginning of the Q wave and termination of the 
S wave representing time for ventricular depolarization
QT
electrocardiographic interval between the beginning of the Q wave and termination of the 
T wave representing the time for both ventricular depolarization and repolarization to occur
QTc
QT interval corrected for heart rate
QTcF
QT interval corrected for heart rate using Fridericia’s formula
RBC
red blood cell
RDI
relative dose intensity
RO
receptor occupancy
RP2D
recommended Phase 2 dose
RR
electrocardiographic interval representing the time measurement between the R wave of one 
heartbeat and the R wave of the preceding heartbeat
SAP
statistical analysis plan
SCT
stem cell transplantation
SI (units)
international system of units
SMQ
Standardised MedDRA Queries
SOC
system organ class
StD
standard deviation
TEAE
treatment-emergent adverse event
TF
treatment failure
TFLs
tables, figures, and listings
ULN
upper limit of normal
WHO
World Health Organization


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PHARMACOKINETIC ABBREVIATIONS
AUClast
area under the concentration versus time curve from time zero to the last quantifiable 
concentration
AUCtau
area under the concentration versus time curve over the dosing interval
Clast
last observed quantifiable concentration of the drug 
Cmax
maximum observed concentration of drug 
Ctau
observed drug concentration at the end of the dosing interval
CLss/F
apparent oral clearance after administration of the drug:
at steady state: CLss/F = Dose/AUCtau , where “Dose” is the dose of the drug
t1/2
estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 
2 by the terminal elimination rate constant (z)
Tlast
time (observed time point) of Clast
Tmax
time (observed time point) of Cmax
z
terminal elimination rate constant, estimated by linear regression of the terminal elimination 
phase of the concentration of drug versus time curve


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1.
INTRODUCTION
This statistical analysis plan (SAP) describes the statistical analysis methods and defines key 
elements including variable definitions for analysis of data of Study GS-US-546-5920 in support 
of the clinical study report (CSR). This SAP is based on the study protocol amendment 6 dated 
02 November 2023. Any changes made after the finalization of the SAP will be documented in 
the CSR.
1.1.
Study Objectives and Endpoints
Objectives and endpoints are presented by cohort in Sections 1.1.1, 1.1.2, and 1.1.3.
1.1.1.
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (1L Unfit AML 
Mag+Ven+Aza)
Primary, secondary, 
 objectives and endpoints for patients with newly diagnosed, 
previously untreated acute myeloid leukemia (AML) who are ineligible for intensive 
chemotherapy are as follows:
Primary Objective(s)
Primary Endpoint(s)
Efficacy
•
To evaluate the efficacy of magrolimab in combination 
with the anti-leukemia therapy venetoclax + azacitidine 
as determined by the complete remission (CR) rate 
(Phase 2 Cohort 1)
•
CR rate, defined as the proportion of patients who 
achieve CR as determined by the investigator based on 
prespecified criteria (Phase 2 Cohort 1)
Safety
•
To evaluate the safety and tolerability, and to determine 
the recommended Phase 2 dose (RP2D) of magrolimab 
in combination with the anti-leukemia therapy 
venetoclax + azacitidine (Safety Run-in Cohort 1)
•
Incidence of dose-limiting toxicities (DLTs), treatment-
emergent adverse events (AEs), and laboratory 
abnormalities according to the National Cancer Institute 
(NCI) Common Terminology Criteria for Adverse 
Events (CTCAE) Version 5.0 (Safety Run-in Cohort 1)
CCI


Magrolimab 
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Statistical Analysis Plan- Final Analysis 
Secondary Objective(s) 
Version 3.0 
Secondary Endpoint(s) 
Efficacy/Safety/PK delineate objectives and endpoints as appropriate. 
• 
To evaluate additional measures of efficacy of 
magrolimab in combination with the anti-leukemia 
therapy venetoclax + azacitidine 
• 
To evaluate the safety and tolerability of magrolimab in 
combination with the anti-leukemia therapy venetoclax 
+ azacitidine (Phase 2 Coho,t I) 
• 
To evaluate the pharmacokinetics (PK) of magrolimab 
in combination with the anti-leukemia therapy 
venetoclax + azacitidine 
• 
To evaluate the immunogenicity of magrolimab in 
combination with the anti-leukemia therapy venetoclax 
+ azacitidine 
• 
Overall response rate (ORR), including CR, complete 
remission with incomplete hematologic recove,y (CRi), 
complete remission with partial hematologic recovery 
(CRh), partial remission (PR), and morphologic 
leukemia-free state (MLFS) 
• 
CR/CRi rate 
• 
Complete remission without minimal residual disease 
(CRMRD-) rate 
• 
Complete remission or complete remission with partial 
hematologic recovery (CR/CRh) rate 
• 
Cytogenetic complete remission (cCR) 
• 
Duration of responses (DOR) 
• 
Duration of CR 
• 
Duration of CR/CRi 
• 
Duration of CR/CRh 
• 
Event-free survival (EFS) 
• 
Overall survival (OS) 
• 
Red blood cell (RBC) transfusion independence rate 
• 
Platelet transfusion independence rate 
• 
Incidence of treatment-emergent AEs and laborato,y 
abnonualities according to the NCI CTCAE Version 5.0 
(Phase 2 Coho,t I) 
• 
Magrolimab concentrations over time 
• 
Rate and magnitude of anti-magrolimab antibodies 
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1.1.2.
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (R/R AML Mag+MEC)
Primary, secondary, 
 objectives and endpoints for patients with relapsed or 
refractory (R/R) AML are as follows:
Primary Objective(s)
Primary Endpoint(s)
Efficacy
•
To evaluate the efficacy of magrolimab in 
combination with the anti-leukemia therapy 
mitoxantrone, etoposide, and cytarabine (MEC) as 
determined by the CR rate (Phase 2 Cohort 2)
•
CR rate, defined as the proportion of patients who 
achieve CR as determined by the investigator 
based on prespecified criteria (Phase 2 Cohort 2)
Safety
•
To evaluate the safety and tolerability, and to 
determine the RP2D of magrolimab in 
combination with the anti-leukemia therapy MEC 
(Safety Run-in Cohort 2)
•
Incidence of DLTs, treatment-emergent AEs, and 
laboratory abnormalities according to the 
NCI CTCAE Version 5.0 (Safety Run-in Cohort 2)
Secondary Objective(s)
Secondary Endpoint(s)
Efficacy/Safety/PK delineate objectives and endpoints as appropriate.
•
To evaluate additional measures of efficacy of 
magrolimab in combination with the anti-leukemia 
therapy MEC
•
To evaluate the safety and tolerability of 
magrolimab in combination with the anti-leukemia 
therapy MEC (Phase 2 Cohort 2) 
•
To evaluate the PK of magrolimab in combination 
with the anti-leukemia therapy MEC
•
To evaluate the immunogenicity of magrolimab in 
combination with the anti-leukemia therapy MEC
•
ORR, including CR, CRi, CRh, PR, and MLFS
•
CR/CRi rate
•
CRMRD− rate
•
CR/CRh rate
•
cCR
•
DOR
•
Duration of CR
•
Duration of CR/CRi
•
Duration of CR/CRh
•
EFS
•
OS
•
RBC transfusion independence rate
•
Platelet transfusion independence rate
•
Incidence of treatment-emergent AEs and 
laboratory abnormalities according to the NCI 
CTCAE Version 5.0 (Phase 2 Cohort 2)
•
Magrolimab concentrations over time
•
Rate and magnitude of anti-magrolimab antibodies
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I 
I 
I 
I 
I 
1.1.3. 
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-Chemo Maint 
Mag+CC-486 [Onureg]) 
Prirmuy, secondaiy,_ 
objectives and endpoints for patients with newly diagnosed 
AML who are in CR~RD positivity following intensive chemotherapy ai·e as 
follows: 
Primary Objective(s) 
Efficacy 
• 
To evaluate the efficacy of magrolimab in 
combination with anti-leukemia therapy CC-486 
(Onureg) as detennined by the MRD negative CR 
rate (Phase 2 Cohort 3) 
Safety 
• 
To evaluate the safety and tolerability, and to 
detennine the RP2D of magrolimab in 
combination with the anti-leukemia therapy 
CC-486 (Safety Run-in Coho1t 3) 
Primary Endpoint( s) 
• 
MRD negative CR rate, defined as the proportion 
of patients who maintain CR as determined by the 
investigator based on prespecified criteria and 
reach MRD negative disease status as determined 
using multi.parameter flow cytometty with a 
sensitivity of< 0.1 % (Phase 2 Cohort 3) 
• 
fucidence ofDLTs, treattnent-emergent AEs, and 
laborato1y abnonnalities according to the 
NCI CTCAE Version 5.0 (Safety Run-in Coho1t 3) 
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Secondary Endpoint(s) 
Efficacy/Safety!PK delineate objectives and endpoints as appropriate. 
• 
• 
• 
• 
1.2. 
To evaluate additional measmes of efficacy of 
magrolimab in combination with the anti-leukemia 
therapy CC-486 
To evaluate the safety and tolerability of 
magrolimab in combination with the anti-leukemia 
therapy CC-486 (Phase 2 Coho1t 3) 
To evaluate the PK of magrolimab in combination 
with the anti-leukemia therapy CC-486 
To evaluate the immunogenicity of magrolimab in 
combination with the anti-leukemia therapy 
CC-486 
Study Design 
• 
• 
• 
• 
• 
• 
• 
• 
MRD negative CR/CRi rate 
Relapse-free survival (RFS) 
OS 
Dmation of MRD negative CR 
Dmation of MRD negative CR/CRi 
RBC transfusion independence rate 
Platelet transfusion independence rate 
Incidence of treatment-emergent AEs and 
laboratory abnonnalities according to the NCI 
CTCAE Version 5.0 (Phase 2 Cohort 3) 
• 
Magrolimab concentrations over time 
• 
Rate and magnitude of anti-magrolimab antibodies 
I 
I 
I 
I 
I 
This is a Phase 2, open-label, multicenter, multi-ann study to evaluate magrolimab in 
combination with anti-leukemia therapies in patients with AML. This ti·ial includes safety nm-in 
coho1is and Phase 2 coho1is. 
The study schematic is presented in Figure 1. 
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Figure 1.
Study Schema
AML = acute myeloid leukemia; MEC = mitoxantrone, etoposide, and cytarabine; MRD = minimal residual disease; 
RP2D = recommended Phase 2 dose
Up to approximately 164 patients will be enrolled in the study, with up to 54 patients in the 
safety run-in cohorts and approximately 110 patients in the Phase 2 cohorts. 
Initially, 6 patients will be enrolled into Safety Run-in Cohorts 1, 2, and 3, respectively. A DLT 
assessment period of 1 cycle (28 days) will occur. 
Dose de-escalation decisions will be made as follows: 
•
If no more than 2 patients in a safety run-in cohort experience a DLT in Cycle 1, enrollment 
into the corresponding Phase 2 cohort will begin at this dose level. 
•
If 3 or more (> 33%) patients in a safety run-in cohort experience a DLT up to the end of 
Cycle 1, another 6 patients will be enrolled in that cohort at a lower dose and evaluated in the 
same manner to define the RP2D. 
After completion of each safety run-in cohort and identification of the RP2D for that cohort, the 
corresponding Phase 2 cohort may be enrolled, with 40 patients in Phase 2 Cohorts 1 and 3 each 
and 30 patients in Cohort 2.
Cohort 1: 
1L Unfit AML Mag+Ven+Aza: 
Newly diagnosed, 
previously untreated AML 
patients, ineligible for 
intensive induction 
chemotherapy 
Cohort 2: 
R/R AML Mag+MEC: 
AML patients who are 
refractory or relapsed 
after intensive induction 
chemotherapy 
Cohort 3: 
Post-chemo Maint Mag+CC-486: 
AML patients in CR or CRi 
with intensive induction 
chemotherapy who are 
MRD+ 
Safety run-in (N=6) 
Safety 
~-----------, evaluation and 
Magrolimab + 
venetoclax + azacitidine 
Safety run-in (N=6) 
RP2D 
Phase 2 
Magrolimab + venetoclax 
+ azacitidine 
N = 40 
Phase 2 
Safety 
~-----------, evaluation and I 
RP2D 
. 
Magrolimab + MEC 
Magrolimab + MEC 
L----------~ 
N = 30 
Safety run-in (N=6) 
Safety 
Phase 2 
Magrolimab + CC-486 
evaluation and I 
RP2D 
Magrolimab + CC-486 
L----------~ 
N = 40 


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Study treatment regimens comprise the following:
Safety Run-in Cohort 1 and Phase 2 Cohort 1
•
Magrolimab 1 mg/kg intravenous (IV) 
•
Magrolimab 15 mg/kg IV 
•
Magrolimab 30 mg/kg IV
•
Azacitidine 75 mg/m2 subcutaneous or IV
•
Venetoclax 100 mg oral tablets
•
Venetoclax 200 mg oral tablets
•
Venetoclax 400 mg oral tablets
Safety Run-in Cohort 2 and Phase 2 Cohort 2
•
Magrolimab 1 mg/kg IV 
•
Magrolimab 15 mg/kg IV 
•
Magrolimab 30 mg/kg IV
•
Mitoxantrone 8 mg/m2 IV
•
Etoposide 100 mg/m2 IV
•
Cytarabine 1000 mg/m2 IV
Safety Run-in Cohort 3 and Phase 2 Cohort 3
•
Magrolimab 1 mg/kg IV 
•
Magrolimab 15 mg/kg IV 
•
Magrolimab 30 mg/kg IV
•
CC-486 300 mg oral tablets
Details about study treatments for each safety run-in cohort, dose de-escalation plans for each 
safety run-in cohort, and schedules of treatment administration are presented in the study 
protocol section 3.2.


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Duration of treatment will be as follows: 
•
Cohorts 1 and 3: treatment until discontinuation criteria is met.
•
Cohort 2: treatment for up to 12 months.
Clinical response will be assessed by the investigator using prespecified criteria (Appendix 2, 
also protocol Appendix 7).
Response assessments will be done in conjunction with bone marrow assessments, according to 
the schedule of assessments (protocol Appendix Table 2 and Appendix Table 3). Bone marrow 
assessments (including aspirate and core/trephine biopsy) are required for response assessments 
and may be used for blast evaluation, MRD assessment, cytogenetics, RO (to be collected at 
selected study sites), and correlative studies. Peripheral blood smears for blasts should be done 
on the day of the bone marrow assessments. 
If the patient is cytopenic at the time of the bone marrow assessment, complete blood count 
(CBC) is to be monitored at least once per week until optimal count recovery is reached. The 
best accompanying laboratory CBC result within the ± 2-week window is to be used to support 
an efficacy response assessment, with the date of response assigned as the date of bone marrow 
assessment. If a patient achieves a CR, subsequent bone marrow biopsies are still required to be 
performed in accordance with the schedule of assessments.
Bone marrow aspirate and biopsy slides or blocks for efficacy assessments will be prepared for 
potential evaluation of response assessments by independent central review.
Response assessment will be obtained at the EOT visit, unless a prior response assessment has 
been performed within the last 30 days or progressive disease has been documented.


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1.3.
Sample Size and Power
Sample size calculations for each of the Phase 2 cohorts are as follows:
•
For Cohort 1, a sample size of 46 (40 patients in Phase 2 Cohort 1 together with 6 patients in 
Safety Run-in Cohort 1) provides an 83.6% power for a 1-group Chi-square test at 1-sided 
alpha of 0.1 level to detect a CR rate of ≥ 53% for the combination compared with a 
historical control CR rate of 36.7% {DiNardo 2020}.
•
For Cohort 2, a sample size of 36 (30 patients in Phase 2 Cohort 2 together with 6 patients in 
Safety Run-in Cohort 2) provides a 83.1% power for a 1-group Chi-square test at 1-sided 
alpha of 0.1 level to detect a CR rate of ≥ 35% for the combination compared with a 
historical control CR rate of 19% {Greenberg 2004}.
•
For Cohort 3, a sample size of 46 (40 patients in Phase 2 Cohort 3 together with 6 patients in 
Safety Run-in Cohort 3) provides a 78.4% power for a 1-group Chi-square test at 1-sided 
alpha of 0.1 level to detect an MRD negative CR rate of ≥ 33% for the combination 
compared with a historical control MRD negative CR rate of 20% {Roboz 2020}.


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2.
TYPE OF PLANNED ANALYSIS
2.1.
Interim Analyses
Prior to the final analysis, interim analyses may be conducted, and the analyses may be 
submitted to regulatory agencies to seek guidance for the overall clinical development program.
2.2.
Primary Analysis
The primary analysis will be conducted after all patients have discontinued the study or have 
been on study for at least 24 weeks and completed the Week 24 response assessments, 
outstanding data queries have been resolved or adjudicated as unresolvable, and the data have 
been cleaned and finalized for the analysis. 
The primary analysis was conducted using data extracted on October 18, 2023 with the data 
cutoff date of June 1, 2023.
2.3.
Final Analysis
The final analysis will be performed after all patients have discontinued the study, outstanding 
data queries have been resolved or adjudicated as unresolvable, and the data have been cleaned 
and finalized.


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3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES
Analysis results will be presented using descriptive statistics. For categorical variables, the 
number and percentage of patients in each category will be presented; for continuous variables, 
the number of patients (n), mean, standard deviation (StD) or standard error (SE), median, first 
quartile (Q1), third quartile (Q3), minimum, and maximum will be presented.
By-patient listings will be presented for all patients in the All Enrolled Analysis Set, unless 
otherwise specified, and sorted by patient ID number, visit date, and time (if applicable). Data 
collected on log forms, such as AEs, will be presented in chronological order within the patient. 
Age at Day 1 (ie, visit day 1, study day 1, first dosing date of study drug), sex at birth, race, and 
ethnicity will be included in the listings, as space permits.
3.1.
Analysis Sets
Analysis sets define the patients to be included in an analysis. Analysis sets and their definitions 
are provided in this section. The analysis set will be identified and included as a subtitle of each 
table, figure, and listing.
For each analysis set, the number and percentage of patients eligible for inclusion will be 
summarized by cohort.
A listing of reasons for exclusion from analysis sets will be provided by patient.
3.1.1.
All Enrolled Analysis Set
The All-Enrolled Analysis Set includes all patients who receive a study patient identification 
(ID) number in the study after screening. This will be the primary analysis set for analyses of 
patient demographics and baseline characteristics, enrollment, and disposition.
3.1.2.
Full Analysis Set
The Full Analysis Set (FAS) includes all enrolled patients who receive at least 1 dose of any 
study treatment, with treatment group designated according to the assigned treatment. This is the 
primary analysis set for efficacy analysis.
3.1.3.
Safety Analysis Set
The Safety Analysis Set includes all patients who receive at least 1 dose of study treatment, with 
treatment assignments designated according to the actual treatment received. This analysis set 
will be used in the analyses of safety endpoints, as well as study treatment administration.


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3.1.4.
Dose-Limiting Toxicity (DLT) Evaluable Analysis Set
The DLT Evaluable Analysis Set includes all patients in the Safety Analysis Set who are 
enrolled in the safety run-in cohorts, have safety assessments through the protocol-specified DLT 
assessment window (first 4 weeks of study dosing, inclusive), and fulfill the criteria for 
evaluation for DLT specified in the protocol Section 3.1.1.
During the DLT assessment window, if a patient fails to receive sufficient study treatment for 
reasons other than DLT, another patient will be enrolled at the same dose level for replacement. 
For patients who are replaced but received at least 1 dose of any study drug, they will be 
included in the Safety Analysis Set and not in the DLT Evaluable Analysis Set.
3.1.5.
Pharmacokinetic Analysis Set
The Pharmacokinetic (PK) Analysis Set includes all enrolled patients who receive at least 1 dose 
of magrolimab and have at least 1 measurable (non-below the limit of quantitation [BLQ] 
numeric values) post-treatment serum concentration of magrolimab.
3.1.6.
Immunogenicity Analysis Set
The Immunogenicity Analysis Set includes all enrolled patients who receive at least 1 dose of 
magrolimab and have at least 1 reported anti-magrolimab antibody test result.
3.2.
Subject Grouping
For analyses based on the Full Analysis Set, patients will be grouped according to the treatment 
to which they were assigned. For analyses based on the Safety Analysis Set, patients will be 
grouped according to the actual treatment received. The actual treatment received will differ 
from the assigned treatment only when their actual treatment differs from assigned treatment for 
the entire treatment duration.
For the PK Analysis Set and the Immunogenicity Analysis Set, patients will be grouped 
according to the actual treatment they received.
3.3.
Strata and Covariates
This study does not use a stratified randomization schedule when enrolling patients. 
No covariates will be included in efficacy and safety analyses.
3.4.
Examination of Subject Subgroups
Subgroup analyses based on baseline characteristics will not be explored.
3.5.
Adjustment for Multiplicity
This study is 
/proof-of-concept in nature and therefore no formal adjustments for 
multiplicity are made.
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3.6.
Missing Data and Outliers
3.6.1.
Missing Data
In general, missing data will not be imputed unless methods for handling missing data are 
specified. Exceptions are presented in this document.
Imputation rules for missing date of birth are described in Section 3.7. For missing last dosing 
date of study drug, imputation rules are described in Section 5.2.1. The handling of missing or 
incomplete dates for initial AML diagnosis is described in Section 5.4, for date of death and the 
start date of new anti-AML therapy in Section 6.2.1, for AE onset in Section 7.1.5.2, and for 
prior and concomitant medications in Sections 5.10.1 and 5.10.2, respectively.
3.6.2.
Outliers
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data will be included in the data analysis.
3.7.
Data Handling Conventions and Transformations
The following conventions will be used for the imputation of date of birth when it is partially 
missing or not collected:
•
If only month and year of birth is collected, then “15” will be imputed as the day of birth
•
If only year of birth is collected, then “01 July” will be imputed as the day and month of birth
•
If year of birth is missing, then date of birth will not be imputed
In general, age collected at Day 1 (in years) will be used for analyses and presented in listings. If 
age at Day 1 is not available for a patient, then age derived based on year of birth and the Day 1 
visit date will be used instead. If an enrolled patient was not dosed with any study drug, the 
enrollment date will be used instead of the Day 1 visit date. For screen failures, the date the first 
informed consent was signed will be used for the age derivation. Age required for longitudinal 
and temporal calculations and analyses (e.g., estimates of creatinine clearance, age at date of AE) 
will be based on age derived from date of birth and the date of the measurement or event, unless 
otherwise specified.
Non-PK data that are continuous in nature but are less than the lower limit of quantitation (LOQ) 
or above the upper LOQ will be imputed as follows:
•
A value that is 1 unit less than the lower LOQ at the same precision level of the originally 
reported value will be used to calculate descriptive statistics if the datum is reported in the 
form of “ x” (where x is considered the lower LOQ). For example, if the values are reported 
as < 50 and < 5.0, values of 49 and 4.9, respectively, will be used to calculate summary 
statistics. An exception to this rule is any value reported as < 1 or < 0.1, etc. For values 
reported as < 1 or < 0.1, a value of 0.9 or 0.09, respectively, will be used to calculate 
summary statistics.


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•
A value that is 1 unit above the upper LOQ will be used to calculate descriptive statistics if 
the datum is reported in the form of “> x” (where x is considered the upper LOQ). Values 
with decimal points will follow the same logic as above.
•
The lower or upper LOQ will be used to calculate descriptive statistics if the datum is 
reported in the form of “≤ x” or “≥ x” (where x is considered the lower or upper LOQ, 
respectively).
If methods based on the assumption that the data are normally distributed are not adequate, 
analyses may be performed on transformed data or nonparametric analysis methods may be used, 
as appropriate.
3.8.
Analysis Visit Windows
3.8.1.
Definition of Study Day
Study day will be calculated from the first dosing date of study drug (ie, the first dosing date of 
any study drug) and derived as follows:
•
For postdose study days: Assessment Date – First Dosing Date + 1
•
For days prior to the first dose: Assessment Date – First Dosing Date 
Therefore, study day 1 is the day of first dose of any study drug administration. 
3.8.2.
Analysis Visit Windows
Patient visits might not occur on protocol-specified days. Therefore, for the purpose of analysis, 
observations will be assigned to analysis windows. The analysis windows for lab are provided in 
Table 3-1 and Table 3-2. 


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Table 3-1.
Analysis Visit Windows for Lab (Excluding Hemoglobin) By-visit 
Summary
Visit Window Study Day
Analysis Visit
Nominal Study Day
Lower Limit
Upper Limit
Baseline
1a
Week 1
8
1b
11
Week 2
15
12
18
Week 3
22
19
25
Week 4
29
26
32
Week 5
36
33
39
Week 6
43
40
46
Week 7
50
47
53
Week 8
57
54
63
Week 10
71
64
77
Week xx (every other 
week from Week 10)
xx*7 + 1
xx*7-6
xx*7+7
a
Prior to first dose date/time of any study drug
b
Post first dose date/time of any study drug
Table 3-2.
Analysis Visit Windows for Hemoglobin By-visit Summary
Visit Window Study Day
Analysis Visit
Nominal Study Visit or 
Study Day
Lower Limit
Upper Limit
Baseline
1a
Day 1 post-dose
Set 1 Day 1, post-dose
Unscheduledc, post-dose
1b
1
Day 2
2
2
2
Day 3
3
3
3
Day 4 pre-dose
Set 1 Day 4, pre-dose
Unscheduledd, pre-dose
NA
NA
Day 4 post-dose
Set 1 Day 4, post-dose
Unschedulede, post-dose
NA
NA
Week 1
8
5
11
Week 2
15
12
18
Week 3
22
19
25
Week 4
29
26
32
Week 5
36
33
39


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Visit Window Study Day
Analysis Visit
Nominal Study Visit or 
Study Day
Lower Limit
Upper Limit
Week 6
43
40
46
Week 7
50
47
53
Week 8
57
54
63
Week 10
71
64
77
Week xx (every other 
week from Week 10)
xx*7 + 1
xx*7-6
xx*7+7
a
Prior to first magrolimab date/time if the patient is infused with magrolimab, otherwise use first dose date/time of any study 
drug
b
Post first magrolimab date/time if the patient is infused with magrolimab, otherwise use first dose date/time of any study 
drug
c
Hemoglobin collected at unscheduled post-dose visit on the same day of Set 1 Day 1 post-dose visit is mapped to Day 1 
post-dose. 
d
Hemoglobin collected at unscheduled pre-dose visit on the same day of Set 1 Day 4 pre-dose visit is mapped to Day 4 
pre-dose.
e
Hemoglobin collected at unscheduled post-dose visit on the same day of Set 1 Day 4 post -dose visit is mapped to Day 4 
post -dose.
Any data relating to unscheduled visits will not be assigned to a particular visit or time point. 
However, the following exceptions will be made:
•
An unscheduled visit prior to the first dosing of study drug will be included in the calculation 
of the baseline value, if applicable.
•
Unscheduled visits after the first dosing of study drug will be included in determining the 
maximum postbaseline toxicity grade and anti-magrolimab antibody status.
•
Response assessments performed at unscheduled visits after the date of first dose of study 
drug will be included in the analyses of the efficacy endpoints.
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window
If multiple valid, nonmissing measurements exist in an analysis window, records will be chosen 
based on the following rules if a single value is needed:
•
For baseline, except hemoglobin, the last nonmissing value on or prior to the first dosing date 
of study drug will be selected, unless specified differently. If there are multiple records with 
the same time or no time recorded on the same day, the baseline value will be the arithmetic 
average of the measurements for continuous data, or the measurement with the lowest 
severity (eg, normal will be selected over abnormal for safety electrocardiogram [ECG] 
findings) for categorical data.


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•
For hemoglobin baseline (numerical value or grade), if a subject was not infused with 
magrolimab, the last nonmissing value on or prior to the first dosing date of study drug will 
be selected. If a subject was infused with magrolimab, the last nonmissing hemoglobin value 
on or prior to the first magrolimab dosing date will be selected. If there are multiple records 
with the same time or no time recorded on the same day, the baseline value will be the 
arithmetic average of the measurements for continuous data, or the measurement with the 
lowest severity for categorical data.
•
For postbaseline values:
The record closest to the nominal day for that visit will be selected.
If there are 2 records that are equidistant from the nominal day, the later record will be 
selected.
If there is more than 1 record on the selected day, the arithmetic average will be taken for 
continuous data and the worse severity will be taken for categorical data, unless 
otherwise specified.
3.9.
Assessment of COVID-19 Impact
This study was ongoing during the novel coronavirus (COVID-19) pandemic which has an 
impact on the study conduct. Some patients may have been unable to attend onsite visits due to 
shelter in place guidelines, site closures, or other reasons. The following special situations due to 
COVID-19 will be handled in the analysis:
•
Study treatment discontinuation due to COVID-19
•
Protocol deviations due to COVID-19
•
Missed or Virtual Visits due to COVID-19
•
Adverse events due to COVID-19


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4.
PROTOCOL DEVIATIONS 
A by-patient listing will be provided for those patients who did not meet at least 1 eligibility 
(inclusion or exclusion) criterion but enrolled in the study. The listing will present the eligibility 
criterion (or criteria if more than 1 deviation) that patients did not meet and related comments, if 
collected.
Protocol deviations occurring after patients entered the study are documented during routine 
monitoring. The number and percentage of patients with important protocol deviations, and the 
number and percentage of patients with important protocol deviations by deviation reason 
(e.g., nonadherence to study drug, violation of select inclusion/exclusion criteria) will be 
summarized by cohort for the All Enrolled Analysis Set. A by-patient listing will be provided for 
those patients with important protocol deviation.


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5.
SUBJECT INFORMATION
5.1.
Patient Enrollment and Disposition
A summary of patient enrollment will be provided by cohort for each country, investigator and 
overall. The summary will present the number and percentage of patients enrolled. For each 
column, the denominator for the percentage calculation will be the total number of patients 
analyzed for that column.
A summary of patient disposition will be provided by cohort. This summary will present the 
number of patients screened, the number of patients enrolled, and the number of patients in each 
of the categories listed below:
•
All Enrolled Analysis Set
•
Full Analysis Set 
•
Safety Analysis Set 
•
DLT-evaluable Analysis Set
•
Completed study treatment (magrolimab, azacitidine, venetoclax, mitoxantrone, etoposide, 
cytarabine)
•
Discontinued study treatment (magrolimab, azacitidine, venetoclax, mitoxantrone, etoposide, 
cytarabine) with reasons for discontinuation
•
Completed Study
•
Discontinued study with reasons for discontinuation
For the status of study drug and study completion and reasons for discontinuation, the number 
and percentage of patients in each category will be provided. The denominator for the percentage 
calculation will be the total number of patients in the Full Analysis Set corresponding to that 
column. 
The following information will be provided in by-patient listings by patient ID number in 
ascending order to support the above summary tables:
•
Reasons for study drug discontinuation
•
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5.2.
Extent of Study Drug Exposure 
Extent of exposure to study drug will be examined by assessing the total duration of exposure to 
study drug and relative dose intensity. Each variable will be calculated for magrolimab, 
venetoclax, azacitidine, mitoxantrone, etoposide and cytarabine. No formal statistical testing is 
planned.
5.2.1.
Duration of Exposure to Study Drug 
Total duration of exposure to study drug (magrolimab, venetoclax, azacitidine, mitoxantrone, 
etoposide and cytarabine) will be defined for a patient as last dosing date minus first dosing date 
plus 1 day, regardless of any temporary interruptions in study drug administration, and will be 
expressed in weeks using up to 1 decimal place (eg, 4.5 weeks). 
The total duration of exposure to each study drug will be summarized using descriptive statistics 
for continuous variables, as well as using the number and percentage of patients exposed for at 
least the following time periods: 1 day, 1 week, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 
20 weeks, 24 weeks, etc. Summaries will be provided for the Safety Analysis Set. If the last 
study drug dosing date is missing, 
•
If the study drug is permanently withdrawn, the latest date among the study drug end date, 
start date of AE leading to study treatment discontinuation, clinical visit date, laboratory 
sample collection date, and vital signs assessment date that occurred during the on-treatment 
period will be used for subjects included in the final analyses or the last available date in the 
database for subjects who were still on treatment at the time of final analysis.
•
If the study drug completion status is unknown, the earlier of the date of death or data 
snapshot date for analysis will be used.
The number of cycles patients were exposed to venetoclax, azacitidine, mitoxantrone, etoposide 
and cytarabine will be summarized using descriptive statistics, as well as the number and 
percentage of subjects exposed to a given cycle category (eg, ≥1, ≥2, ≥3, etc).
The number and percentage of patients who have planned dose level different from the standard 
protocol dose level, infusion interruption, dose modification, dose delay, or dose missed for 
study drug and the reasons will be summarized.
A by-patient listing of magrolimab administration will be provided by cohort, patient ID number 
(in ascending order) and visit (in chronological order). 
5.2.2.
Relative Dose Intensity
Relative dose intensity (RDI) is the percentage of the total amount of study drug administered 
relative to the total amount of study drug expected to be administered during a patient’s actual 
on-treatment period based on the study drug regimen. 


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For magrolimab:
The relative dose intensity is the percentage of the total amount of study drug administered 
relative to the total amount of study drug expected to be administered, and will be calculated for 
each cohort, respectively:
Relative dose intensity (%) = 
Cumulative Dosage of Magrolimab Administered (in mg/kg)
Magrolimab Dosage Expected to be Administered on Treatment (in mg/kg)  x 100
Cumulative dosage (mg/kg) received for each patient is defined as the sum of dosages (mg/kg) of 
all infusions the patient received from Day 1 and onward. 
Magrolimab dosage expected to be administered on treatment (mg/kg) for each patient is defined 
as the product of the assigned dose of magrolimab and number of doses the patient was 
scheduled to receive during the treatment period from Day 1, and it will include number of 
infusions administered plus the number of infusions not administered.
For venetoclax:
Relative dose intensity (%) = 
Total Amount of Venetoclax Administered (mg)
Venetoclax Expected to be Administered on Treatment (mg)  x 100
For azacitidine, mitoxantrone, etoposide and cytarabine, take azacitidine RDI for example:
Relative dose intensity (%) = 
Total Amount of Azacitidine Administered (mg/m2)
Azacitidine Expected to be Administered on Treatment (mg/m2)  x 100
For each study drug, descriptive statistics for the relative dose intensity with the number and 
percentage of patients belonging to relative dose intensity categories (eg, < 75%, ≥ 75 to < 90%, 
≥ 90%) will be provided by treatment group for the Safety Analysis Set.
5.2.2.1.
On-Treatment Intensity Per Cycle
The level of on-treatment intensity per cycle will be determined by considering doses and 
durations of treatment cycle that a subject receives may vary between cycles or deviate from the 
planned 28-day cycle length. For each study drug venetoclax, azacitidine, mitoxantrone, 
etoposide and cytarabine, the actual cycle length of a cycle, except the last cycle of the treatment, 
is determined as the interval from Day 1 of the cycle to Day 1 of the subsequent cycle; the actual 
length of last cycle is determined by Day 1 of the last cycle, to the death date and last dosing 
date.
(-------) 
(------) 
( 
) 


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For azacitidine, mitoxantrone, etoposide and cytarabine:
On-Treatment Intensity per 28-day Cycle (%) =
Amount of Doses Administered within a Cycle (mg/m2) 
Amount of Doses Specified by Protocol within the Cycle (mg/m2)  x 100,
averaged across all cycles treated.
On-Treatment Intensity per Actual Cycle Duration (%) =
Amount of Doses Administered within a Cycle (mg/m2) /Actual Cycle Length
Amount of Doses Specified by Protocol within the Cycle (mg/m2) /28 Days  x 100,
averaged across all cycles treated.
For venetoclax:
On-Treatment Intensity per 28-day Cycle (%)= ( Number of Days on Venetoclax within a Cycle
28 Days
×100) ,
averaged across all cycles treated
On-Treatment Intensity per Actual Cycle Duration (%)
= ( Number of Days on Venetoclax within a Cycle
Actual Cycle Length (Days)
x100),
 averaged across all cycles treated
Additionally, the average dosing of venetoclax per cycle will be calculated as: 
Average Dosing per 28-day Cycle (mg)= ∑Dose of Venetoclax (mg) × Number of Days on Venetoclax within a Cycle
28 Days
, 
averaged across all cycles treated.
Average Dosing per Actual Cycle Duration (mg)= ∑Dose of Venetoclax (mg) ×  Number of Days on Venetoclax within a Cycle
Actual Cycle Length (Days)
, 
averaged across all cycles treated.
5.3.
Demographics and Baseline characteristics
Patient demographic variables (eg, age, sex, race, ethnicity) and baseline characteristics 
(eg, body weight [in kg], height [in cm], body mass index [BMI; in kg/m2], Body Surface Area 
[BSA; in m2]) and Eastern Cooperative Oncology Group [ECOG] status at baseline will be 
summarized by cohort and overall using descriptive statistics for continuous variables and using 
number and percentage of patients for categorical variables. The ECOG status at baseline is the 
ECOG status at screening. The summary of demographic data will be provided for the All 
Enrolled Analysis Set.


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A by-patient demographic listing, including the informed consent date, will be provided by 
cohort and patient ID number in ascending order.
Other baseline characteristics, including but not limited to ECOG performance status will also be 
listed.
5.4.
Medical History
Medical history (i.e. conditions not specific to the disease being studied) will be collected at 
screening for disease-specific and general conditions. A by-patient listing of medical history will 
be provided by cohort and patient ID number in ascending order.
AML diagnosis history will be summarized by cohort based on the All Enrolled Analysis Set. 
Time since AML diagnosis (months) will be calculated by (date of first dosing date of study drug 
(or enrollment date if patient is not treated with any study drug) – date of diagnosis) / 30.4375. 
Time since AML relapse diagnosis will be calculated as well, if applicable. Time since diagnosis 
will be summarized using summary statistics for a continuous variable. No formal statistical 
testing is planned. A by-patient listing of disease-specific medical history will be provided.
In deriving time since disease diagnosis, partial dates of diagnosis will be imputed as follows:
•
If day and month are missing but year is available, then the imputed day and month will be 
01 Jan.
•
If day is missing but the month and year are available, then the imputed day will be the first 
day of the month.
•
Partial date will not be imputed if the year is missing.
5.5.
Prior Anti-Cancer Therapy
Prior anti-cancer therapies that patients received, including prior anti-AML therapy and prior 
anti-MDS therapy, will be listed separately. The details of prior anti-cancer therapy will be listed 
by patient ID number in ascending order including, regimen name, regimen start/stop date and 
best response of the regimen.
5.6.
 Post Study Treatment Stem Cell Transplant
Number and percentage of patients who received post study treatment stem cell transplant will be 
summarized. 
The details of SCT will be listed by patients ID number in ascending order, including date and 
type of SCT.
5.7.
Prior and Concomitant Radiation therapy
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5.8.
Surgeries and Procedures
No summary or listing of surgeries and procedures will be provided.
5.9.
Prior Study Transfusion
Number and percentage of patients who received prior transfusions will be summarized. The 
number of transfusion received within 4 weeks and 8 weeks prior to the first dose will be 
summarized for whole blood/RBC and platelet as well.
A by-patient listing of transfusion will be provided by cohort and patient ID number in ascending 
order.
5.10.
Prior and Concomitant Medications
Medications collected at screening and during the study will be coded using the current version 
of the World Health Organization (WHO) Drug dictionary.
5.10.1.
Prior Medications
Prior medications are defined as any medications begun before a subject took the first study 
drug.
No summary of prior medications will be provided.
For the purposes of analysis, any medication with a start date prior to the first dosing date of 
study drug will be included in the prior medication regardless of when the stop date is. If a 
partial start date is entered the medication will be considered prior unless the month and year 
(if day is missing) or year (if day and month are missing) of the start date are after the first 
dosing date. Medications with a completely missing start date will be included in the prior 
medication, unless otherwise specified.
5.10.2.
Concomitant Medications
Concomitant medications are defined as medications taken while a patient took study drug.
No summary of concomitant medications will be provided.
For the purposes of analysis, any medications with a start date prior to or on the first dosing date 
of study drug and continued to be taken after the first dosing date, or started after the first dosing 
date but prior to or on the last dosing date of study drug will be considered concomitant 
medications. Medications started and stopped on the same day as the first dosing date or the last 
dosing date of study drug will also be considered concomitant. Medications with a stop date prior 
to the date of first dosing date of study drug or a start date after the last dosing date of study drug 
will be excluded from the concomitant medication summary. If a partial stop date is entered, any 
medication with the month and year (if day is missing) or year (if day and month are missing) 
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medication summary. If a partial start date is entered, any medication with the month and year (if 
day is missing) or year (if day and month are missing) after the study drug stop date will be 
excluded from the concomitant medication summary. Medications with completely missing start 
and stop dates will be included in the concomitant medication summary, unless otherwise 
specified. 
All prior and concomitant medications (other than per-protocol study drugs) will be provided in a 
by-patient listing sorted by cohort, patient ID number and administration date in chronological 
order.
5.11.
Post Treatment Anti-cancer Therapy
Post treatment anti-cancer therapies will not be summarized. A by-patient listing will be sorted 
by cohort, patient ID number and administration date in chronological order.


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6.
EFFICACY ANALYSES
6.1.
Primary Efficacy Endpoints
6.1.1.
Definition of the Primary Efficacy Endpoints
The primary endpoints are as follows:
•
CR Rate (Cohorts 1 and 2): The CR rate is defined as the proportion of patients who achieve 
CR (CRMRD− or complete remission with positive or unknown MRD [CRMRD+/unk]) as 
determined by the investigator based on prespecified criteria (Appendix 2) while on study 
prior to initiation of any new anti-AML therapy (including SCT).
6.1.2.
Statistical Hypothesis for the Primary Efficacy Endpoint 
The primary efficacy hypothesis for Cohort 2 to be tested is:
𝐻0: CR rate ≤ 19%
𝐻1: CR rate >  19%
6.1.3.
Analysis of the Primary Efficacy Endpoint
The analyses of primary efficacy endpoint will be based on the FAS. 
The point estimates of the CR rate and the corresponding 2-sided exact 95% CIs based on the 
Clopper-Pearson method will be provided for Cohorts 1 and 2. The CR data will also be tested 
against the historical control rates 19% (Cohort 2) at 1-sided alpha of 0.1 significance level using 
1-group Chi-square test. 
6.1.4.
Sensitivity Analysis of the Primary Efficacy Endpoint
No sensitivity analysis for the primary efficacy endpoint is planned.
 
6.1.6.
Additional Analysis Supporting the Primary Efficacy Endpoint 
Assessments for peripheral blood smear, which are used for response criteria for the primary 
efficacy endpoint will be summarized using: 
•
Baseline value 
•
Postbaseline maximum value
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•
Postbaseline minimum value
•
Change and percentage change from baseline to postbaseline maximum value
•
Change and percentage change from baseline to postbaseline minimum value
In addition, by-patient data listings will be provided.
6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
The secondary efficacy endpoints are as follows:
•
ORR (Cohorts 1 and 2): The ORR is the proportion of patients who achieve CR (CRMRD− or 
CRMRD+/unk), CRi, CRh, PR, or MLFS as determined by the investigator based on 
prespecified criteria (Appendix 2) while on study prior to initiation of any new anti-AML 
therapy (including SCT).
•
CR/CRi Rate (Cohorts 1 and 2): The CR/CRi rate is the proportion of patients who achieve 
CR (CRMRD− or CRMRD+/unk) or CRi as determined by the investigator based on prespecified 
criteria (Appendix 2) while on study prior to initiation of any new anti-AML therapy 
(including SCT).
•
CRMRD− Rate (Cohorts 1 and 2): The CRMRD− rate is the proportion of patients who achieve a 
CRMRD− as determined by the investigator based on prespecified criteria (Appendix 2) while 
on study prior to initiation of any new anti-AML therapy (including SCT).
•
CR/CRh Rate (Cohorts 1 and 2): The CR/CRh rate is the proportion of patients who achieve 
CR (CRMRD− or CRMRD+/unk) or CRh as determined by the investigator based on prespecified 
criteria (Appendix 2) while on study prior to initiation of any new anti-AML therapy 
(including SCT).
•
cCR Rate (Cohorts 1 and 2): The cCR rate is the proportion of patients who achieve cCR 
determined by investigator based on the prespecified criteria (Appendix 2) while on study 
prior to initiation of any new anti-AML therapy (including SCT).
•
DOR (Cohorts 1 and 2): The DOR is measured from the time assessment criteria are met for 
CR (CRMRD− or CRMRD+/unk), CRi, CRh, PR, or MLFS, whichever is first recorded, until the 
first date of AML relapse, progressive disease, or death (including assessments post SCT). 
Those who are not observed to have a relapse, progressive disease, or death will be censored 
at the date of their last response assessment. If patients start taking new anti-AML therapies 
(except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of 
response will be censored at the last response assessment before the initiation of the new 
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•
Duration of CR (Cohorts 1 and 2): The duration of CR is measured from the time the 
assessment criteria are first met for CR (CRMRD− or CRMRD+/unk) until the first date of AML 
relapse or death (including assessments post SCT). Those who are not observed to have 
relapsed disease or death will be censored at the date of their last response assessment. If 
patients start taking new anti-AML therapies (except SCT and post SCT maintenance 
treatment) before relapse/death, duration of CR will be censored at the last response 
assessment before the initiation of the new anti-AML therapies.
•
Duration of CR/CRi (Cohorts 1 and 2): The duration of CR/CRi is measured from the time 
the assessment criteria are first met for CR (CRMRD− or CRMRD+/unk) or CRi until the first date 
of AML relapse or death (including assessments post SCT). Those who are not observed to 
have relapsed disease or death will be censored at the date of their last response assessment. 
If patients start taking new anti-AML therapies (except SCT and post SCT maintenance 
treatment) before relapse/death, duration of CR/CRi will be censored at the last response 
assessment before the initiation of the new anti-AML therapies.
•
Duration of CR/CRh (Cohorts 1 and 2): The duration of CR/CRh is measured from the time 
the assessment criteria are first met for CR (CRMRD− or CRMRD+/unk) or CRh until the first date 
of AML relapse or death (including assessments post SCT). Those who are not observed to 
have relapsed disease or death will be censored at the date of their last response assessment. 
If patients start taking new anti-AML therapies (except SCT and post SCT maintenance 
treatment) before relapse/death, duration of CR/CRh will be censored at the last response 
assessment before the initiation of the new anti-AML therapies.
•
EFS (Cohorts 1 and 2): EFS is defined as the time from the date of the first dose of study 
treatment to the earliest date of documented relapse from CR, treatment failure (TF) defined 
as failure to achieve CR during the response assessment window (the first treatment dosing 
date until before the fifth cycle of magrolimab+venetoclax+azacitidine in Cohort 1 and the 
first treatment dosing date until before the third cycle of magrolimab + MEC in Cohort 2), or 
death from any cause. Response assessments post SCT or new anti-AML therapies will be 
excluded from deriving treatment failure. Table 6-1 summarizes the details of the EFS 
derivation algorithm.


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Table 6-1.
Censoring Rules for EFS
Situation
Event/Censored
Event/Censored Date
No relapse or death
Censored
Last assessment date
Achieved CR within the 
response assessment window*
Had relapse or death
Event
(Relapse/death)
Relapse date or death 
date which occurs earlier
Had progression, death or new 
anti-AML therapies within the 
window
Event
(TF)
Day 1 of treatment
No progression, death or new 
anti-AML therapies within the 
window, and have been on 
study beyond the up limit of 
the window
Event
(TF)
Day 1 of treatment
Within the response 
assessment window, had at 
least one post-baseline 
response assessment, but didn’t 
achieve the CR 
No progression, death or new 
anti-AML therapies within the 
window, and haven’t been on 
study beyond the up limit of 
the window
Censored
Day 1 of treatment
Had death or new anti-AML 
therapies within the window
Event
(TF)
Day 1 of treatment
Within the response 
assessment window, had no 
post-baseline response 
assessment
No death or new anti-AML 
therapies within the window
Censored
Day 1 of treatment
*Response assessment window: the first treatment dosing date to the fifth cycle of magrolimab+venetoclax+azacitidine in 
Cohort 1 and the first treatment dosing date to the third cycle of magrolimab + MEC in Cohort 2
•
OS: The OS is measured from the date of the first dose of study treatment to the date of death 
from any cause. Those who are not observed to die during the study will be censored at last 
date they are known to be alive.
•
RBC Transfusion Independence Rate: The RBC transfusion independence rate is the 
proportion of patients who have a 56-day or longer period with no RBC or whole blood 
transfusion at any time between the date of the first dose and discontinuation of study 
treatment among all patients who are RBC transfusion-dependent at baseline, defined as 
having received an RBC or whole blood transfusion within the 28 days prior to the first dose 
of study treatment (conversion rate), and among all patients who are RBC 
transfusion-independent at baseline (maintenance rate).
•
Platelet Transfusion Independence Rate: The platelet transfusion independence rate is the 
proportion of patients who have a 56-day or longer period with no platelet transfusions at any 
time between the date of the first dose and discontinuation of study treatment among all 
patients who are platelet transfusion-dependent at baseline, defined as having received a 
platelet transfusion within the 28 days prior to the first dose of study treatment (conversion 
rate), and among all patients who are platelet transfusion independent at baseline 
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The date of the last known alive will be determined by selecting the last available visit date, 
including unscheduled visits, across all datasets.
Every attempt will be made to ensure that complete death dates are recorded. In those rare 
instances where complete death dates are not recorded, the following algorithm will be used:
•
If day is missing but the month and year are available, then the imputed date will be the first 
day of the month or the last known alive date + 1, whichever is later.
•
If day and month are missing but year is available, then the imputed date will be 01Jan of 
that year or the last known alive date + 1, whichever is later.
When the date of initiation of a new anti-AML therapy/SCT other than the study treatment is 
incomplete or missing, the following algorithm will be followed:
•
If the day is missing but the month and year are available, then the imputed day will be the 
first day of the month or last dose date of study drug +1, whichever is later.
•
If day and month are missing but year is available, then the imputed day and month will be 
01Jan, first dose date of study drug +1, or the last day of the month for the last adequate 
disease assessment if they have the same year, whichever is later.


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The point estimates of the ORR, CR rate, CR/CRi rate, CRMRD- rate, cCR rate, and CR/CRh rate 
and the coITesponding 2-sided exact 95% Cls based on the Clopper-Pearson method will be 
provided for Coho1ts 1 and 2. The analyses of RBC and platelet transfusion independence rates 
(conversion rate and maintenance rate) will be similar to those of ORR. 
Medians, first quaitile (Ql), and third quaitile (Q3) of EFS distribution, and the propo1tion of 
patients who ai·e event free at Weeks 12, 24, and 48 from the first dosing date will be estimated 
by coho1t using the KM method and the coITesponding 95% Cls will be repo1ted. Kaplan-Meier 
plots will be provided. Analyses of OS will be similar to those of EFS. 
For the time-to-event endpoints of duration of CR, duration of CR/CRi, duration of CR/CRh, 
DOR, analyses will be conducted on the subsets for which the outcome measures ai·e defined. 
Specifically, the duration of CR, duration of CR/CRi, duration of CR/CRh, and DOR will be 
based on patients in Coho1ts 1 and 2 who achieve CR, CR/CRi, CR/CRh, and OR, respectively. 
The KM method will be used to estimate median durations and 95% Cls, and KM plots will be 
provided. 
6.4. 
Changes From Protocol-Specified Efficacy Analyses 
The following changes are made from the protocol-specified efficacy analyses: 
• 
Analyses on Coho1t 3 will not be conducted since no patients ai·e emolled in the cohort. 
• 
Given the sample size calculation detennined by patients in both Safety Run-in and Phase 2 
in Coho1ts 1 and 2 and all safety Run-in patients were dosed with the Recommended Phase 2 
Dose for both coho1ts 1 and 2, the Primaiy analysis of CR will be conducted on Patients in 
Coho1ts 1 and 2, including patients in both Safety Run-in and Phase 2. Since the enrollment 
of Coho1t 1 terminated eai·lier, and the number of patients enrolled in Coho1t 1 is smaller 
than the sample size, hypothesis testing of CR rate in Coho1t 1 will not be conducted. 
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7.
SAFETY ANALYSES
7.1.
Adverse Events and Deaths
All Adverse Events (AEs) will be listed. The focus of AE summarization will be on 
treatment-emergent adverse events (TEAEs).
7.1.1.
Adverse Event Dictionary
Clinical and laboratory adverse events (AEs) will be coded using the current version of 
MedDRA. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), 
preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. 
7.1.2.
Adverse Event Severity
Adverse events are graded by the investigator as Grade 1, 2, 3, 4, or 5 according to NCI CTCAE 
Version 5.0. The severity grade of events for which the investigator did not record severity will 
be categorized as “missing” for tabular summaries and data listings. The missing category will 
be listed last in summary presentation.
7.1.3.
Relationship of Adverse Events to Study Treatment
Related AEs are those for which the investigator selected “Related” on the AE CRF to the 
question of “Related to Study Treatment.” Relatedness will always default to the investigator’s 
choice, not that of the medical monitor. Events for which the investigator did not record 
relationship to study drug will be considered related to study drug for summary purposes. 
However, by-patient data listings will show the relationship as missing.
7.1.4.
Serious Adverse Events
Serious adverse events (SAEs) will be identified and captured as SAEs if the AEs met the 
definitions of SAEs that were specified in the study protocol. SAEs captured and stored in the 
clinical database will be reconciled with the SAE database from the Gilead Drug Safety and 
Public Health Department before data finalization.
7.1.5.
Treatment-Emergent Adverse Events 
7.1.5.1.
Definition of Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any AEs with an onset date on or 
after the study drug start date and no later than 70 days after the study drug last dosing date or 
the day before initiation of new anticancer therapy including SCT, whichever comes first.


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7.1.5.2.
Missing or incomplete Dates
If the onset date of the AE is incomplete and the AE stop date is not prior to the first dosing date 
of study drug, then the month and year (or year alone if month is not recorded) of onset 
determine whether an AE is treatment emergent. The event is considered treatment emergent if 
both of the following 2 criteria are met:
•
The AE onset is the same as or after the month and year (or year) of the first dosing date of 
study drug, and
•
The AE onset date is the same as or before the month and year (or year) of the date 
corresponding to the cutoff date of TEAE period, which is defined as the 70 days after the 
study drug last dose date or the day before initiation of new anticancer therapy including 
SCT, whichever comes first.
An AE with completely missing onset and stop dates, or with the onset date missing and a stop 
date later than the first dosing date of study drug, will be considered to be treatment emergent. In 
addition, an AE with the onset date missing and incomplete stop date with the same or later 
month and year (or year alone if month is not recorded) as the first dosing date of study drug will 
be considered treatment emergent.
In case when the AE onset date is incomplete and needs to be imputed, the following algorithm 
will be followed:
•
If the day is missing but the month and year are available, then the imputed day will be the 
first day of the month or the first dosing date if they have the same month and year, 
whichever is later.
•
If the day and month are missing but year is available, then the imputed day and month will 
be 01Jan or the first dosing date if they have the same year, whichever is later.
7.1.6.
Summaries of Adverse Events and Deaths
TEAEs and deaths will be summarized by cohort based on the Safety Analysis Set.
7.1.6.1.
Summaries of TEAEs
A brief, high-level summary of the number and percentage of patients who experienced at least 
1 TEAE in the categories described below will be provided. All deaths observed in the study will 
also be included in this summary. Similar brief summaries will be provided for each category of 
adverse events of interest and other important safety topics listed in Section 7.1.7.3, 7.1.7.4 and 
7.1.7.5.
•
TEAEs 
•
TEAEs with Grade 3 or higher


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•
TE treatment-related AEs for any study drug and for each study drug, including magrolimab, 
venetoclax, azacitidine, mitoxantrone, etoposide and cytarabine
•
TE treatment-related AEs with Grade 3 or higher for any study drug and for each study drug 
•
TE SAEs
•
TE treatment-related SAEs for any study drug and for each study drug 
•
Infusion related reaction AE by investigators
•
TEAEs leading to discontinuation of any study drug and each study drug
•
TEAEs leading to interruption of any study drug and for each study drug
•
TEAEs leading to dose reduction of any study drug and for each study drug
•
TEAEs leading to death
For the TEAE categories described below, summaries will be provided by SOC and PT (and 
maximum severity where applicable):
•
TEAEs 
•
TEAEs with Grade 3 or higher (by SOC, PT and severity)
•
TE treatment-related AEs for any study drug and for magrolimab 
•
TE treatment-related AEs with Grade 3 or higher for magrolimab
•
TE SAEs
•
TE treatment-related SAEs for any study drug and for magrolimab 
•
TEAEs leading to discontinuation of any study drug and for magrolimab 
•
TEAEs leading to interruption of any study drug and for magrolimab 
•
TEAEs leading to dose reduction of any study drug and for magrolimab 
•
TEAEs leading to death
The number and percentage of patients who experienced at least 1 TEAE will be provided and 
summarized by PT and severity in descending order of total frequency:
•
TEAEs by PT and Severity 
•
TE treatment-related AEs for magrolimab 


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For the AE categorizes described below, summaries will be provided by PT in descending order 
of total frequency:
•
TEAEs
•
Grade 3 or higher TEAEs 
•
TE treatment-related AEs for magrolimab 
•
TE SAEs 
•
TEAEs leading to discontinuation of any study drug and for magrolimab
•
TEAEs leading to death
Multiple episodes of the same event will be counted only once per patient in each summary. 
Adverse events will be summarized and listed first in alphabetic order of SOC and then by PT in 
descending order of total frequency within each SOC. For summaries by PT, multiple events will 
be counted only once per patient for each preferred term. For summaries by severity, the highest 
severity will be used for those AEs that occurred more than once in a given patient during the 
study. 
In addition, by-patient data listings will be provided for the following:
•
All AEs
•
All SAEs
•
All AEs leading to death 
•
All AEs with severity of Grade 3 or higher
•
Infusion related reaction AE by investigators
A flag will be included in the listings to indicate whether the event is treatment emergent.
7.1.6.2.
Summaries of Deaths
A summary (number and percentage of patients) of all deaths will be provided. The summary 
will include the following categories:
•
All deaths
•
Deaths within 30 days of the first dosing of study drug
•
Deaths within 60 days of the first dosing of study drug


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•
Deaths within 30 days of the last dosing of study drug
•
Deaths within 70 days of the last dosing of study drug
•
Deaths beyond 30 days of the last dosing of study drug
•
Deaths beyond 70 days of the last dosing of study drug
•
Deaths after stem cell transplant.
A by-patient listing of all deaths occurred during this study will be listed by cohort and patient 
ID number in ascending order.
7.1.7.
Additional Analysis of Adverse Events
7.1.7.1.
Dose Limiting Toxicity
A DLT is defined as any Grade 4 or higher hematologic toxicity or Grade 3 or higher 
nonhematologic toxicity (that has worsened in severity from pretreatment baseline) during the 
4-week DLT assessment period and is related to magrolimab or magrolimab combination.
For each cohort being evaluated for safety and tolerability based on DLT assessment, DLT 
evaluable patients are identified as those who either experienced a DLT any time during the DLT 
Assessment Period or completed at least certain amount of the drug administration during the 
DLT Assessment Period. A summary of DLT will be presented by Preferred Term and Severity. 
A listing of the DLT AEs will be provided by cohort including cohort number, patient ID, actual 
dose amount prior to or on the start date of the AE, DLT term from investigator as well as 
CTCAE term and associated severity grade, if available.
7.1.7.2.
Infusion Reaction Adverse Events (IRAEs)
The incidence of infusion reaction AEs will be examined. Infusion reaction AEs are defined by 
the NCI CTCAE Version 5.0 (under the category “General disorders and administration site 
conditions”) as “a disorder characterized by adverse reaction to the infusion of pharmacological 
or biological substances”. For the purpose of this study, they are defined as AEs that occur 
within the 24-hour period beginning from the start of the infusion.
A by-patient listing of infusion reaction AEs will be listed by cohort and patient ID number in 
ascending order.


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7.1.7.3.
Treatment-Emergent Adverse Events of Interest (AEI)
Number and percentage of subjects with the following TEAEs of interest will be summarized by 
PT: 
•
Anaemia (MedDRA Search Term [MST]-Anemia Extravascular Transient Hemolysis) 
(Gilead’s MST)
•
Infusion Related Reaction (IRR) (SMQ-Hypersensitivity Narrow Terms + within one day of 
the latest infusion of any study drug)
•
Severe Neutropenia (PT - Neutrophil Count Decreased, Neutropenia and Febrile Neutropenia 
with Grade 3 or Higher)
•
Serious Infections (SOC - Infections and infestations with Serious AE)
•
Transfusion reactions due to magrolimab interference with RBC typing (MST-Transfusion 
reactions due to magrolimab interference with RBC typing) (Gilead’s MST)
•
Thromboembolic Events (SMQ- Embolic and Thrombotic Events Broad Terms)
•
Pneumonitis (SMQ- Interstitial Lung Disease Broad Terms)
Number and percentage of subjects with the following TEAEs of interest will also be 
summarized by AE onset time within 2 weeks, >2weeks to 2 months, >2 months to 6 months, 
>6 months to 12 months, and >12 months of first dosing of any study drug.
7.1.7.4.
Other Important Safety Topics
Number and percentage of patients with the following AEs of important safety topics will be 
summarized by PT: 
•
Immune-Mediated Events (SMQ-Immune-mediate and autoimmune disorder Narrow Terms)
•
Hemorrhages (SMQ – Haemorrhages Broad Terms)
Number and percentage of patients with the following AEs of important safety topics will also be 
summarized by AE onset time within 2 weeks, >2weeks to 2 months, >2 months to 6 months, 
>6 months to 12 months, and >12 months of first dosing of study drug.
7.1.7.5.
Regrouped Treatment-Emergent Adverse Events
For the regrouped AE PT terms described below, summaries will be provided by cohort:
•
Regrouped Thrombocytopenia and Platelet Count Decreased
•
Regrouped Neutropenia and Neutrophil Count Decreased
•
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7.2.
Laboratory Evaluations
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected up to and including the date of last dose of 
study drug plus 70 days or the day before initiation of any new anticancer therapy including 
SCT, whichever comes first. The analysis will be based on values reported in conventional units. 
When values are below the LOQ, they will be listed as such, and the closest imputed value will 
be used for the purpose of calculating summary statistics as specified in Section 3.7. 
A by-patient listing for laboratory test results will be provided by cohort, patient ID number and 
time point in chronological order for hematology, serum chemistry, and coagulation, separately. 
Values falling outside of the relevant reference range and/or having a severity grade of 1 or 
higher on the CTCAE severity grade will be flagged in the data listings, as appropriate.
Line plots for selected lab test results over time will be provided by cohort and patient for the 
Safety Analysis Set.
No formal statistical testing is planned.
7.2.1.
Summaries of Numeric Laboratory Results
Descriptive statistics will be provided by cohort for laboratory tests (eg, chemistry, hematology, 
coagulation) as follows:
•
Baseline value 
•
Postbaseline maximum value
•
Postbaseline minimum value
•
Change and percentage change from baseline to postbaseline maximum value
•
Change and percentage change from baseline to postbaseline minimum value
A baseline laboratory value will be defined as the last measurement obtained on or prior to the 
date/time of first dose of study drug. Change from baseline to a postbaseline visit will be defined 
as the postbaseline value minus the baseline value. The mean, median, Q1, Q3, minimum, and 
maximum values will be displayed to the reported number of digits; StD values will be displayed 
to the reported number of digits plus 1.
Median (Q1, Q3) of the observed values will be plotted using a line plot by cohort and visit for 
the laboratory tests including but not limited to hemoglobin, platelet and absolute neutrophil 
counts.
In the case of multiple values associated with a visit, data will be selected for analysis as 
described in Section 3.8.3.


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7.2.2.
Graded Laboratory Values
The CTCAE Version 5.0 will be used to assign toxicity grades (0 to 4) to laboratory results for 
analysis. Grade 0 includes all values that do not meet the criteria for an abnormality of at least 
Grade 1. For laboratory tests with criteria for both increased and decreased levels, analyses for 
each direction (ie, increased, decreased) will be presented separately.
Local labs will be graded based on central lab normal ranges with in-house macro. 
7.2.2.1.
Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last 
dose of study drug plus 70 days or the day before initiation of any new anticancer therapy 
including SCT, whichever comes first. If the relevant baseline laboratory value is missing, any 
abnormality of at least Grade 1 observed within the time frame specified above will be 
considered treatment emergent.
7.2.2.2.
Summaries of Laboratory Abnormalities
Laboratory data that are categorical will be summarized using the number and percentage of 
patients in the study with the given response at baseline and each scheduled postbaseline time 
point.
The following summaries (number and percentage of patients) for treatment-emergent laboratory 
abnormalities will be provided by lab test and cohort; patients will be categorized according to 
the most severe postbaseline abnormality grade for a given lab test:
•
Graded TE laboratory abnormalities
•
TE Grade 3 or 4 laboratory abnormalities
For all summaries of laboratory abnormalities, the denominator is the number of patients with 
nonmissing postbaseline values up to 70 days after the last dosing date or the day before 
initiation of any new anticancer therapy including SCT, whichever comes first.
A by-patient listing of treatment-emergent Grade 3 or 4 laboratory abnormalities will be 
provided by patient ID number and visit in chronological order. This listing will include all test 
results that were collected throughout the study for the lab test of interest, with all applicable 
severity grades displayed. 
7.2.3.
Shifts Relative to the Baseline Grade
Shift tables will be presented by showing change in severity grade from baseline to the worst 
postbaseline grade for hematology, chemistry and coagulation laboratory tests. 


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7.3.
Body Weight and Vital Signs
No summary or listing of body weight and vital signs will be provided.
7.4.
Electrocardiogram Results
No summary or listing of Electrocardiogram (ECG) analysis results will be provided.
7.5.
Premedication
Premedication is required prior to the administration of the first 4 doses of magrolimab and in 
case of reintroduction with repriming. Premedication during subsequent infusions may be 
continued based on the treating physician’s clinical judgment and the presence/severity of prior 
infusion-related reactions. In the case of a Grade 3 infusion-related reaction, a premedication 
regimen for subsequent infusions is required.
Prior to first dose of venetoclax, patients must be provided with prophylactic measures including 
adequate hydration and antihyperuricemic agents and continue during the ramp-up phase 
(Days 1, 2, and 3).
Premedications for mitoxantrone, etoposide, and cytarabine can be administered per local 
institutional guidelines.
A by-patient listing of premedication will be provided by patient ID number in ascending order.
7.6.
Other Safety Measures
A by-patient listing of ECOG performance status will be provided by cohort and patient 
ID number in ascending order.
7.7.
Changes From Protocol-Specified Safety Analyses
The following changes are made from the protocol-specified safety analyses:
•
AEs occurring one day before initiation of new anticancer therapy (including SCT) is added 
in TEAE definition to be aligned with magrolimab studies.
•
AEs occurring within the date of last dose of study drug plus 70 days or the day before 
initiation of new anticancer therapy (including SCT) is added in TE lab abnormality 
definition to be aligned with TEAE definition change. 


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8.
CHANGES FROM PROTOCOL-SPECIFIED ANALYSES
No additional changes are made from protocol-specified analyses.


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9.
PHARMACOKINETIC (PK) AND IMMUNOGENICITY 
ANALYSES
9.1.
PK Sample Collection
Blood samples for evaluating magrolimab serum concentrations will be collected as described in 
Protocol Appendix Table 4.
9.2.
PK Analyses 
The magrolimab PK concentration will be summarized for the PK Analysis Set. Individual 
subject’s concentration data for magrolimab will be listed based on the sampling time point. 
Magrolimab PK data will be summarized per nominal time point using descriptive statistics. 
Summary statistics (n, mean, SD, coefficient of variation [%CV], median, min, max, Q1, and 
Q3) will be presented for magrolimab serum concentration data at time point. 
The sample size (number of patients) at each time point will be based on the number of patients 
with non-missing concentration data at that time point. Missing concentration values will be 
reported as is in data listings. The number of patients with concentration BLQ will be presented 
for each time point. For summary statistics, BLQ values will be treated as 0.
Sparse PK concentration values that are BLQ will be presented as “BLQ” in the concentration 
data listing. 
At predose, if all concentration values are BLQ, then the mean, and order statistics (minimum, 
Q1, median, Q3, and maximum) will be displayed as 0 and the rest of the summary statistics 
(ie, SD and CV) will be missing. If any values are non-BLQ, then the number of samples, order 
statistics, and all summary statistics will be displayed.
At any given postdose time point, if more than one-third of the patients have a concentration 
value of BLQ, then only the number of samples and order statistics will be displayed; otherwise, 
order statistics and summary statistics will be displayed.
The following conventions will be used for the presentation of order statistics for postdose time 
points: 
•
If at least 1 subject has a concentration value of BLQ for the time point, the minimum value 
will be displayed as “BLQ.”
•
If more than 25% of the patients have a concentration data value of BLQ for a given time 
point, the minimum and Q1 values will be displayed as “BLQ.” 
•
If more than 50% of the patients have a concentration data value of BLQ for a given time 
point, the minimum, Q1, and median values will be displayed as “BLQ.” 


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•
If more than 75% of the patients have a concentration data value of BLQ for a given time 
point, the minimum, Q1, median, and Q3 values will be displayed as “BLQ.” 
•
If all patients have concentration data values of BLQ for a given time point, all order 
statistics (minimum, Q1, median, Q3, and maximum) will be displayed as “BLQ.”
Due to the sparse nature of PK collection, PK parameters will not be calculated.
9.3.
Immunogenicity Analysis
The rate and magnitude of anti-drug antibody (ADA) prevalence, incidence, persistence, and 
transience will be summarized for the Immunogenicity Analysis Set. Neutralizing antibody 
(NAb) occurrence rate will also be summarized. 
ADA Prevalence: the proportion of patients who had at least one positive ADA sample (baseline 
or post-baseline) based on the Immunogenicity Analysis Set.
Treatment-Induced ADA Rate: the proportion of patients who had negative baseline ADA 
sample and at least one positive post-treatment ADA sample based on patients who had both 
non-missing baseline and at least one post-treatment ADA result reported (i.e. ADA Incidence 
Analysis Set).
Treatment-Boosted ADA Rate: the proportion of patients who had positive baseline ADA 
sample and at least one positive post-treatment ADA sample and the (max titer of the 
post-treatment ADA) / (titer of baseline ADA) >= 4 based on the ADA Incidence Analysis Set.
ADA Incidence (treatment-emergent ADA): the proportion of patients who had 
treatment-induced or treatment-boosted ADA based on patients who had non-missing baseline 
ADA sample and at least one post-treatment ADA result reported in Immunogenicity Analysis 
Set.
Persistent ADA is defined as:
a) Treatment-Induced ADA detected at two or more sampling time points during the treatment 
(including follow-up period if any), where the first and last ADA-positive sample 
(irrespective of any negative samples in between) are separated by a period of 16 weeks or 
longer. 
or
b) Treatment-Induced ADA detected in the last sampling time point of the treatment study 
period.
ADA Persistence Rate: the proportion of patients who had persistent ADA based on the ADA 
Incidence Analysis Set.


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Transient ADA is defined as: 
Version 3.0 
Treatment-Induced ADA that does not meet the definition of persistent ADA The propo1iion of 
patients who had transient ADA is based on the patients evaluable for ADA incidence. 
Neutralizing antibody (NAb) Incidence: the propo1iion of patients who had at least one 
positive neutralizing antibody result repo1ied based on the treatment-emergent ADA 
(treatment-induced or treatment-boosted ADA) among the patients evaluable for ADA incidence. 
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11.
REFERENCES
Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised 
recommendations of the International Working Group for Diagnosis, 
Standardization of Response Criteria, Treatment Outcomes, and Reporting 
Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 
2003;21 (24):4642-9.
DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, et al. Azacitidine and 
Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med 
2020;383 (7):617-29.
Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, et al. Diagnosis and 
management of AML in adults: 2017 ELN recommendations from an 
international expert panel. Blood 2017;129 (4):424-47.
Greenberg PL, Lee SJ, Advani R, Tallman MS, Sikic BI, Letendre L, et al. Mitoxantrone, 
etoposide, and cytarabine with or without valspodar in patients with relapsed or 
refractory acute myeloid leukemia and high-risk myelodysplastic syndrome: a 
phase III trial (E2995) (Author Manuscript). J Clin Oncol 2004;22 (6):1078-86.
Roboz GJ, Ravandi F, Wei AH, Dombret H, Dohner H, Thol F, et al. CC-486 Prolongs Survival 
for Patients with Acute Myeloid Leukemia (AML) in Remission after Intensive 
Chemotherapy (IC) Independent of the Presence of Measurable Residual Disease 
(MRD) at Study Entry: Results from the QUAZAR AML-001 Maintenance Trial. 
Blood 2020;136 (Supplement 1):32-3.


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12.
SOFTWARE
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA.


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13.
SAP REVISION
Revision Date
(DD MMM YYYY)
Section
Summary of Revision
Reason for Revision
17 OCT 2023
6.2.1
EFS censoring rules
Update EFS algorithm
31 MAY 2024
1.2
7.1.7.3, 
7.1.7.4
9
universal
Removed response assessments in 
long-term follow-up
Updated AE of interest and 
important safety topics
Added PK/ADA analyses
Reduced outputs for final 
synoptic CSR
Reflect changes in protocol 
amendment 6
Consistent within Magrolimab 
studies
Update for final synoptic CSR
Update for final synoptic CSR


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Appendix 1.
Estimands for Primary and Key Secondary Endpoints
Following the ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials, 
a summary of the primary and key secondary endpoints is presented in the estimand framework. 
Appendix Table 1 summarizes the attributes of estimands and estimators defined for main 
analyses. 
For all the estimands listed in the tables except for the variable of RBC/platelet transfusion 
independence, the target population attribute is the AML patients defined by the study inclusion 
and exclusion criteria. For RBC/platelet transfusion independence, the target population attribute 
is the AML patients defined by the inclusion and exclusion criteria with transfusion dependence 
at baseline.


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Appendix Table 1.
List of Estimands and Estimators of Main Analyses 
Treatments
Variable
(Endpoint)
Intercurrent Events & Strategies
Population Level Summary
Estimators
magrolimab + 
venetoclax + 
azacitidine, 
magrolimab + 
MEC
OS
•
Discontinuation of treatment: treatment policy
•
SCT, New anti-cancer therapy: treatment 
policy 
Kaplan-Meier estimates 
(medians, Q1, and Q3 of OS 
distribution, and the proportion 
of patients who are event free at 
Weeks 24, 48, and 96 from the 
first dosing date)
Main Estimator: median 
OS and 95% CI for each 
cohort.
magrolimab + 
venetoclax + 
azacitidine, 
magrolimab + 
MEC
EFS
•
Discontinuation of treatment: treatment policy
•
Death, Treatment failure: composite
•
SCT, New anti-cancer therapy: treatment 
policy 
Kaplan-Meier estimates 
(medians, Q1, and Q3 of EFS 
distribution, and the proportion 
of patients who are event free at 
Weeks 12, 24, and 48 from the 
first dosing date)
Main Estimator: median 
EFS and 95% CI for each 
cohort.
magrolimab + 
venetoclax + 
azacitidine, 
magrolimab + 
MEC
CR rate / 
CRMRD− rate / 
rate of 
CR+CRi /
rate of 
CR+CRh/
ORR
•
Discontinuation of treatment: treatment policy
•
SCT, New anti-cancer therapy: 
while-on-treatment
•
Loss to follow-up: while-on-treatment
Point estimates of the rate and 
the corresponding 2-sided exact 
95% CIs
Main Estimator: Estimate 
rate and CIs based on the 
Clopper-Pearson method for 
each cohort;
Test rate against the 
historical control rate using 
1-group Chi-square test for 
each cohort separately.
magrolimab + 
venetoclax + 
azacitidine, 
magrolimab + 
MEC
RBC/platelet 
transfusion 
independence
•
Discontinuation of treatment: 
while-on-treatment
•
Dose reduction or temporary delay: treatment 
policy
•
Loss to follow-up: while-on-treatment
Point estimates of the rate and 
the corresponding 2-sided exact 
95% CIs
Main Estimator: Estimate 
rate and CIs based on the 
Clopper-Pearson method for 
each cohort.


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Appendix 2.
Disease Response Criteria Based on European Leukemia Net (ELN) 
and International Working Group (IWG) Criteria
Assessment of leukemia response in patients with acute myeloid leukemia (AML) will be 
conducted based on the European Leukemia Net (ELN) 2017 recommendations for AML 
{Dohner 2017}, with modifications for the purposes of this protocol (protocol 
Appendix Table 10). Response classifications include complete remission without minimal 
residual disease (CRMRD-), complete remission with positive or unknown minimal residual 
disease (CRMRD+/unk), complete remission with incomplete hematologic recovery (CRi), 
morphologic leukemia-free state (MLFS), partial remission (PR), and stable disease (SD).
In addition, CR with partial hematologic recovery (CRh) will be assessed for AML, as defined as 
patients who achieve a CR per AML ELN 2017 recommendations{Dohner 2017}, but with only 
partial recovery of peripheral blood counts (platelets > 50  109 /L and absolute neutrophil count 
ANC > 0.5  109 /L).
Cytogenetic CR (cCR) will be assessed by 2003 IWG criteria as CR with normal cytogenetics 
(protocol Appendix Table 11) {Cheson 2003}.
The date of the bone marrow assessment should be used as the date of response assessment. 
Complete blood count results used for the response assessment will be derived from the best 
accompanying laboratory CBC result within the ± 2-week window of the bone marrow 
assessment used to support the efficacy response assessment. All components (eg, platelets, 
absolute neutrophils) should come from the same test. If PD or relapse is assessed based on CBC 
assessments or new extramedullary disease, other than bone marrow blast assessments, then the 
date of the corresponding CBC or new extramedullary disease assessment date will be used as 
the date of response assessment.


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Appendix Table 2.
Response Criteria in Acute Myeloid Leukemia (Based on ELN 2017 
Recommendations with Modifications) 
Definitions
Response 
Criteria
Neutrophils
Platelets
Bone Marrow 
Blasts
Other
Complete 
remission without 
minimal residual 
disease (CRMRD−) 
> 1.0 × 109/L
> 100 × 109/L
< 5%
MRD negative (determined using 
multiparameter flow cytometry with 
a sensitivity of < 0.1%). Absence of 
circulating blasts and blasts with 
Auer rods; absence of 
extramedullary disease.
Complete 
remission with 
positive or 
unknown minimal 
residual disease 
(CRMRD+/unk)
> 1.0 × 109/L
> 100 × 109/L
< 5%
MRD positive (determined using 
multiparameter flow cytometry with 
a sensitivity of < 0.1%) or 
unknown. Absence of circulating 
blasts and blasts with Auer rods; 
absence of extramedullary disease.
Complete 
remission with 
incomplete 
hematologic 
recovery (CRi)
Neutrophils > 1.0 × 109/L
OR
Platelets > 100 × 10
9/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease. (All CR 
criteria except residual neutropenia 
[< 1.0 × 109/L] or thrombocytopenia 
[< 100 × 109/L]).
Complete 
remission with 
partial 
hematologic 
recovery (CRh)
> 0.5 × 109/L
> 50 × 109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease.
Morphologic 
leukemia-free 
state (MLFS)a 
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; no 
hematologic recovery required; 
marrow should not merely be 
“aplastic”; at least 200 cells should 
be enumerated or cellularity should 
be at least 10%.
Partial remission 
(PR) 
> 1.0 × 109/L
> 100 × 109/L
Decrease of bone 
marrow blast 
percentage to 5% 
to 25%; and 
decrease of 
pretreatment 
bone marrow 
blast percentage 
by at least 50%
Blasts < 5% with Auer rods may 
also be considered a PR
Stable disease
Absence of CRMRD-, CRMRD+/unk, CRi, CRh, PR, MLFS; and criteria for progressive disease 
not met


Magrolimab
GS-US-546-5920
Statistical Analysis Plan- Final Analysis
Version 3.0
31 May 2024
GILEAD CONFIDENTIAL INFORMATION
Page 60 of 60
Definitions
Response 
Criteria
Neutrophils
Platelets
Bone Marrow 
Blasts
Other
Progressive 
disease 
Evidence for an increase in bone marrow blast percentage and/or increase of absolute blast 
counts in the blood: 
•
≥ 50% increase in marrow blasts over baseline (a minimum 15% point increase is 
required in cases with < 30% blasts at baseline; or persistent marrow blast percentage of 
> 70% over at least 3 months; without at least a 100% improvement in ANC to an 
absolute level > 0.5 × 109/L [500/μL], and/or platelet count to > 50 × 109/L [50,000/μL] 
non-transfused); or 
•
≥ 50% increase in peripheral blasts (WBC × % blasts) to> 25 × 109/L (> 25,000/μL) 
(in the absence of differentiation syndrome); or 
•
New extramedullary disease. 
Hematologic 
relapse (after 
CRMRD−, 
CRMRD+/unk, CRi, 
CRh)
Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of 
extramedullary disease.
ANC = absolute neutrophil count; CRh = complete remission with partial hematologic recovery; CRi = complete remission with 
incomplete hematologic recovery; CRMRD− = complete remission without minimal residual disease; CRMRD+/unk = complete 
remission with positive or unknown minimal residual disease; MLFS = morphologic leukemia-free state; MRD = minimal 
residual disease; PR = partial remission; WBC = white blood cell. 
a
Not in the ELN 2017 guidelines. Modification for the purpose of this protocol. A response could be classified as both CRh 
and CRi if both criteria are met.
Source: Based on ELN 2017 guidelines {Dohner 2017}, with modifications for the purposes of this protocol.
Appendix Table 3.
Additional Response Definitions Used in This Study (2003 IWG 
Criteria) 
Definitions
Response Criteria
Neutrophils
Platelets
Bone Marrow Blasts
Other
Cytogenetic CR 
(cCR)
> 1.0 × 109/L
> 100 × 109/L
< 5%
Cytogenetics 
normal and no 
evidence of 
extramedullary 
disease
cCR = cytogenetic complete remission; CR = complete remission; IWG = International Working Group
Source: {Cheson 2003}
Treatment Failure
Treatment failure is defined as failure to achieve complete remission or complete remission with 
incomplete hematologic recovery (CR) before the fifth cycle of 
magrolimab+venetoclax+azacitidine in Cohort 1 and before the third cycle of 
magrolimab + MEC in Cohort 2.


GS-US-546-5920-Final-SAP-V3.0
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Global Development
Lead (GDL) eSigned
31-May-2024
16:34:25
Biostatistics eSigned
31-May-2024
20:55:31
PPD
PPD-