A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
Sponsor: Incyte Corporation

Official Title: 
A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, 
Pharmacokinetics, and Efficacy of Combination Therapy With the 
Anti-CD19 Monoclonal Antibody Tafasitamab and the PI3K Inhibitor 
Parsaclisib in Adult Participants With Relapsed/Refractory 
Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia 
(topMIND) 
NCT Number: 
NCT04809467 
Document Date: 
Protocol INCMOR 0208-101 Am 2 Version 3 13 SEP 2022 
 
 
 

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Protocol INCMOR 0208-101 Am 2 
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CONFIDENTIAL 
Clinical Study Protocol 
 
TITLE PAGE 
INCMOR 0208-101 
A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, 
Pharmacokinetics, and Efficacy of Combination Therapy With the 
Anti-CD19 Monoclonal Antibody Tafasitamab and the PI3K Inhibitor 
Parsaclisib in Adult Participants With Relapsed/Refractory 
Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia 
(topMIND) 
 
Product: 
INCMOR0208 (tafasitamab) 
INCB050465 (parsaclisib) 
IND Number: 
121,474 
EudraCT Number: 
2020-005591-35 
Phase of Study: 
1b/2a 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE, USA 19803 
Original Protocol: 
14 DEC 2020 
Amendment 1: 
08 OCT 2021 
Amendment 2: 
13 SEP 2022 
 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws 
and country-specific regulations in which the study is being conducted. 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without prior 
written consent. 

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INVESTIGATOR'S AGREEMENT 
I have read the INCMOR 0208-101 Protocol Amendment 2 (dated 13 SEP 2022) and agree to 
conduct the study as outlined.  I agree to maintain the confidentiality of all information received 
or developed in connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 

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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ................................................................................................2 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ........................................................................................................10 
1. 
PROTOCOL SUMMARY ..........................................................................................14 
2. 
INTRODUCTION ......................................................................................................22 
2.1. 
Background .................................................................................................................22 
2.1.1. 
B-Cell Malignancies ...................................................................................................22 
2.1.1.1. 
Diffuse Large B-Cell Lymphoma ...............................................................................22 
2.1.1.2. 
Mantle Cell Lymphoma ..............................................................................................23 
2.1.1.3. 
Follicular Lymphoma .................................................................................................24 
2.1.1.4. 
Marginal Zone Lymphoma .........................................................................................25 
2.1.1.5. 
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma ............................27 
2.1.2. 
Tafasitamab .................................................................................................................28 
2.1.2.1. 
Tafasitamab Pharmacokinetics ...................................................................................29 
2.1.2.2. 
Tafasitamab Immunogenicity .....................................................................................29 
2.1.3. 
Parsaclisib ...................................................................................................................29 
2.1.3.1. 
Parsaclisib Pharmacokinetics ......................................................................................30 
2.1.3.2. 
Parsaclisib Phase 2 Studies .........................................................................................30 
2.1.4. 
PI3Kδ and CD19/CD20 Combinations .......................................................................32 
2.1.5. 
Preclinical ...................................................................................................................32 
2.1.5.1. 
Tafasitamab + Idelalisib  in Relapsed/Refractory Chronic Lymphocytic 
Leukemia (COSMOS Study) ......................................................................................32 
2.1.5.2. 
Parsaclisib + Rituximab  in Relapsed/Refractory B-Cell Non-Hodgkin 
Lymphoma (Study CITADEL-112) ...........................................................................33 
2.2. 
Study Rationale ...........................................................................................................33 
2.2.1. 
Justification for Dose ..................................................................................................33 
2.3. 
Benefit/Risk Assessment ............................................................................................34 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................36 
4. 
STUDY DESIGN .......................................................................................................38 
4.1. 
Overall Design ............................................................................................................38 
4.2. 
Overall Study Duration ...............................................................................................39 

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4.3. 
Study Termination ......................................................................................................39 
5. 
STUDY POPULATION .............................................................................................40 
5.1. 
Inclusion Criteria ........................................................................................................40 
5.2. 
Exclusion Criteria .......................................................................................................42 
5.3. 
Lifestyle Considerations .............................................................................................43 
5.4. 
Screen Failures ............................................................................................................43 
5.5. 
Replacement of Participants .......................................................................................44 
5.6. 
Data Safety Monitoring Board ....................................................................................44 
6. 
STUDY TREATMENT ..............................................................................................45 
6.1. 
Study Treatments Administered .................................................................................45 
6.2. 
Preparation, Handling, and Accountability ................................................................45 
6.2.1. 
Tafasitamab .................................................................................................................46 
6.2.1.1. 
Reconstitution .............................................................................................................47 
6.2.1.2. 
Dilution .......................................................................................................................47 
6.2.1.3. 
Administration ............................................................................................................47 
6.2.2. 
Parsaclisib ...................................................................................................................48 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................48 
6.4. 
Study Treatment Compliance .....................................................................................48 
6.5. 
Dose-Limiting Toxicity and Determination of the Recommended Phase 2 
Dose ............................................................................................................................48 
6.5.1. 
Definition of a Dose-Limiting Toxicity ......................................................................48 
6.5.2. 
Procedures for Cohort Review ....................................................................................49 
6.5.3. 
Dose-Limiting Toxicity Stopping Rules .....................................................................50 
6.6. 
Dose Modifications .....................................................................................................50 
6.6.1. 
Management of Dose-Limiting Toxicities or Other Urgent Situations ......................50 
6.6.2. 
Criteria and Procedures for Dose Interruptions and Adjustments of Study 
Drug ............................................................................................................................50 
6.6.2.1. 
Tafasitamab Dose Modifications for Cytokine Release Syndrome and 
Infusion-Related Reactions .........................................................................................52 
6.6.2.2. 
Dose Modifications for Parsaclisib .............................................................................53 
6.6.2.3. 
Supportive Care Guidelines for Diarrhea/Colitis .......................................................56 
6.6.2.4. 
Supportive Care Guidelines for Neutropenia and Thrombocytopenia .......................57 
6.6.2.5. 
Management of Hypogammaglobulinemia ................................................................57 

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6.6.3. 
Criteria for Permanent Discontinuation of Study Drug ..............................................58 
6.7. 
Concomitant Medications and Procedures .................................................................58 
6.7.1. 
Permitted Medications and Procedures ......................................................................58 
6.7.1.1. 
Premedication for Tafasitamab Infusions/Infusion-Related Reaction 
Prophylaxis .................................................................................................................58 
6.7.1.2. 
Pneumocystis jirovecii Pneumonia Prophylaxis .........................................................58 
6.7.1.3. 
Supportive Care Measures ..........................................................................................59 
6.7.2. 
Prohibited Medications and Procedures .....................................................................59 
6.7.2.1. 
Anticancer Therapy ....................................................................................................59 
6.7.2.2. 
Live Vaccines .............................................................................................................59 
6.7.2.3. 
Potent CYP3A4 Inhibitors and Inducers ....................................................................59 
6.7.3. 
Restricted Medications and Procedures ......................................................................59 
6.8. 
Treatment After the End of the Study .........................................................................60 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
WITHDRAWAL ........................................................................................................60 
7.1. 
Discontinuation of Study Treatment ...........................................................................60 
7.1.1. 
Reasons for Discontinuation .......................................................................................60 
7.1.2. 
Discontinuation Procedures ........................................................................................61 
7.2. 
Participant Withdrawal From the Study .....................................................................61 
7.3. 
Lost to Follow-Up.......................................................................................................61 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................62 
8.1. 
Administrative and General Procedures .....................................................................62 
8.1.1. 
Informed Consent Process ..........................................................................................62 
8.1.2. 
Screening Procedures ..................................................................................................63 
8.1.2.1. 
Tumor or Lymph Node Sample ..................................................................................63 
8.1.2.2. 
Bone Marrow Biopsy and Examination .....................................................................64 
8.1.3. 
Interactive Response Technology System ..................................................................64 
8.1.4. 
Distribution of Reminder Cards ..................................................................................64 
8.1.5. 
Demography and Medical History ..............................................................................64 
8.1.5.1. 
Demographics and General Medical History .............................................................64 
8.1.5.2. 
Disease Characteristics and Treatment History ..........................................................65 
8.1.5.3. 
Prior and Concomitant Medications and Procedures ..................................................65 
8.2. 
Efficacy Assessments .................................................................................................65 

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8.2.1. 
Computed Tomography Scan or Magnetic Resonance Imaging ................................65 
8.2.2. 
Fluorodeoxyglucose–Positron Emission Tomography ...............................................65 
8.2.3. 
Confirmatory Bone Marrow Biopsy and Examination ...............................................66 
8.2.4. 
Independent Review Committee .................................................................................66 
8.2.5. 
Medical Resource Utilization and Health Economics ................................................66 
8.3. 
Safety Assessments .....................................................................................................66 
8.3.1. 
Adverse Events ...........................................................................................................67 
8.3.2. 
Physical Examinations ................................................................................................67 
8.3.3. 
Vital Signs ..................................................................................................................68 
8.3.4. 
Eastern Cooperative Oncology Group Performance Status ........................................68 
8.3.5. 
B Symptoms/Constitutional Symptoms ......................................................................68 
8.3.6. 
Electrocardiograms .....................................................................................................68 
8.3.7. 
Left Ventricular Ejection Fraction Assessments ........................................................68 
8.3.8. 
Laboratory Assessments .............................................................................................68 
8.3.8.1. 
Pregnancy Testing ......................................................................................................71 
8.3.8.2. 
Viral Serology Testing ................................................................................................71 
8.4. 
Pharmacokinetic Assessments ....................................................................................71 
8.4.1. 
Urine Sample Collection .............................................................................................72 
8.6. 
Unscheduled Visits .....................................................................................................73 
8.7. 
End of Treatment and/or Early Termination ..............................................................73 
8.8. 
Follow-Up ...................................................................................................................74 
8.8.1. 
Safety Follow-Up ........................................................................................................74 
8.8.2. 
Post-Treatment Disease Follow-Up ............................................................................74 
8.8.3. 
Survival Follow-Up ....................................................................................................74 
8.8.4. 
Participant Completion of Study ................................................................................75 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................76 

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9.1. 
Definition of Adverse Event .......................................................................................76 
9.2. 
Definition of Serious Adverse Event ..........................................................................77 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........78 
9.4. 
Reporting of Serious Adverse Events .........................................................................80 
9.5. 
Events of Clinical Interest ..........................................................................................81 
9.5.1. 
Adverse Events of Special Interest .............................................................................82 
9.6. 
Emergency Unblinding of Treatment Assignment .....................................................82 
9.7. 
Pregnancy ...................................................................................................................82 
9.8. 
Warnings and Precautions ..........................................................................................83 
9.9. 
Product Complaints ....................................................................................................83 
9.10. 
Treatment of Overdose ...............................................................................................84 
10. 
STATISTICS ..............................................................................................................84 
10.1. 
Sample Size Determination ........................................................................................84 
10.2. 
Populations for Analysis .............................................................................................85 
10.3. 
Level of Significance ..................................................................................................86 
10.4. 
Statistical Analyses .....................................................................................................86 
10.4.1. 
Safety Analyses ..........................................................................................................86 
10.4.2. 
Efficacy Analyses .......................................................................................................87 
10.4.2.1. 
Overall Response Rate ................................................................................................87 
10.4.2.2. 
Complete Response Rate ............................................................................................87 
10.4.2.3. 
Progression-Free Survival ..........................................................................................87 
10.4.2.4. 
Duration of Response .................................................................................................88 
10.4.2.5. 
Overall Survival ..........................................................................................................88 
10.4.3. 
Exploratory Analyses ..................................................................................................88 
10.5. 
Interim Analysis ..........................................................................................................88 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................89 
11.1. 
Investigator Responsibilities .......................................................................................89 
11.1.1. 
Identification of the Coordinating Principal Investigator ...........................................90 
11.2. 
Data Management .......................................................................................................90 
11.3. 
Data Quality Assurance ..............................................................................................92 

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11.4. 
Data Privacy and Confidentiality of Study Records ...................................................93 
11.5. 
Financial Disclosure ...................................................................................................93 
11.6. 
Publication Policy .......................................................................................................94 
11.7. 
Study and Site Closure................................................................................................94 
12. 
REFERENCES ...........................................................................................................95 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS AND DEFINITIONS ............................................99 
APPENDIX B. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE SCORES .....................................................................................101 
APPENDIX C. LUGANO CLASSIFICATION FOR RESPONSE ASSESSMENT ...............102 
APPENDIX D. IWCLL RESPONSE DEFINITIONS ..............................................................104 
APPENDIX E. CYP3A4 INHIBITORS AND INDUCERS .....................................................105 
APPENDIX F. INSTRUCTION TO PARTICIPANTS FOR HANDLING 
PARSACLISIB .........................................................................................................112 
APPENDIX G. MANAGEMENT OF POTENTIAL HY'S LAW CASES ..............................113 
APPENDIX H. PANDEMIC MITIGATION STRATEGIES AND INSTRUCTIONS ...........117 
APPENDIX I. PROTOCOL AMENDMENT SUMMARY OF CHANGES ...........................119 
 
LIST OF TABLES 
Table 1: 
Primary Objectives and Endpoints .............................................................................14 
Table 2: 
Key Study Design Elements .......................................................................................15 
Table 3: 
Schedule of Activities .................................................................................................18 
Table 4: 
Disease Cohorts in Basket Study INCMOR 0208-101...............................................33 
Table 5: 
Objectives and Endpoints ...........................................................................................36 
Table 6: 
Study Treatment Information .....................................................................................45 
Table 7: 
Definition of Dose-Limiting Toxicity ........................................................................49 
Table 8: 
Guidelines for Interruption and Restarting of Study Treatment .................................51 
Table 9: 
Management of Infusion-Related Reactions/Cytokine Release Syndrome ................52 
Table 10: Toxicity Management Guidelines for Parsaclisib .......................................................54 
Table 11: Dose Levels for Parsaclisib ........................................................................................56 
Table 12: Dose Modifications for Parsaclisib for Diarrhea/Colitis ............................................57 
Table 13: Required Laboratory Analytes ....................................................................................70 
Table 14: Pharmacokinetic Blood Sample Timing .....................................................................72 

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Table 15: Two-Sided 95% Confidence Interval for Different ORR Estimates ..........................85 
Table 16: Populations for Analysis .............................................................................................86 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schema .................................................................................................17 
 

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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
ADA 
antidrug antibody 
AE 
adverse event 
ALP 
alkaline phosphatase 
ALT 
alanine transaminase 
ANC 
absolute neutrophil count 
ASCT 
autologous stem cell transplantation 
AST 
aspartate transaminase 
AUCt 
area under curve 
BTK 
Bruton tyrosine kinase 
CFR 
Code of Federal Regulations 
CHOP 
cyclophosphamide, doxorubicin, vincristine, and prednisone 
CI 
confidence interval 
CLL 
chronic lymphocytic leukemia 
Cmax 
maximum observed plasma or serum concentration 
Cmin 
minimum observed plasma or serum concentration 
CMR 
complete metabolic response 
CMV 
cytomegalovirus 
CNS 
central nervous system 
COVID-19 
coronavirus disease 2019 
CR 
complete response   
CRR 
complete response rate 
CRS 
cytokine release syndrome 
CSR 
Clinical Study Report 
CT 
computed tomography 
CTC 
common toxicity criteria 
CTCAE 
Common Terminology Criteria for Adverse Events 
Ctrough 
trough concentration 
CxDx 
Cycle x Day x 
CYP 
cytochrome P450 
DLBCL 
diffuse large B-cell lymphoma 
DLT 
dose-limiting toxicity 
DNA 
deoxyribonucleic acid 
DOR 
duration of response 
DSMB 
Data Safety Monitoring Board 

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Abbreviations and 
Special Terms 
Definition 
ECG 
electrocardiogram 
ECI 
event of clinical interest 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EOT 
end of treatment   
FACS 
fluorescence-activated cell sorting 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FDG 
fluorodeoxyglucose 
FFPE 
formalin-fixed, paraffin-embedded 
FL 
follicular lymphoma 
FSH 
follicle-stimulating hormone 
G-CSF 
granulocyte colony-stimulating factor 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
GI 
gastrointestinal 
HBcAb 
hepatitis B core antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
human immunodeficiency virus 
HRT 
hormonal replacement therapy 
IB 
Investigator's Brochure 
IC90 
90% inhibitory concentration 
ICF 
informed consent form  
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
iDSMB 
internal Data Safety Monitoring Board 
IEC 
independent ethics committee 
IRB 
institutional review board 
IRC 
independent review committee 
IRR 
infusion-related reaction 
IRT 
interactive response technology 
IV 
intravenous 

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Abbreviations and 
Special Terms 
Definition 
iwCLL 
International Workshop on Chronic Lymphocytic Leukemia 
LVEF 
left ventricular ejection fraction 
mAb 
monoclonal antibody 
MALT 
mucosa-associated lymphoid tissue 
MCL 
mantle cell lymphoma 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRD 
minimal residual disease 
MRI 
magnetic resonance imaging 
MZL 
marginal zone lymphoma 
NCI 
National Cancer Institute 
NGS 
next-generation sequencing 
NHL 
Non-Hodgkin lymphoma 
NK 
natural killer 
ORR 
overall response rate  
OS 
overall survival 
PD 
progressive disease 
PET 
positron emission tomography 
PFS 
progression-free survival 
PHL 
Potential Hy's Law 
PI3K 
phosphoinositide 3-kinase 
PJP 
Pneumocystis jirovecii pneumonia 
PK 
pharmacokinetic 
PMR 
partial metabolic response 
PR 
partial response 
QD 
once daily 
QW 
once weekly 
R/R 
relapsed or refractory 
R-CHOP 
rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone 
RNA 
ribonucleic acid 
RP2D 
recommended Phase 2 dose 
RSI 
Reference Safety Information 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SD 
stable disease 

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Abbreviations and 
Special Terms 
Definition 
SLL 
small lymphocytic lymphoma 
SoA 
schedule of activities 
SOP 
standard operating procedure 
t(11;14) 
translocation t(11;14)(q13;q32) 
TEAE 
treatment-emergent adverse event 
Tmax 
time to maximum concentration 
ULN 
upper limit of normal 
WHO 
World Health Organization 
WOCBP 
woman of childbearing potential 

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1. 
PROTOCOL SUMMARY 
Protocol Title: 
A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy 
of Combination Therapy With the Anti-CD19 Monoclonal Antibody Tafasitamab and the PI3K 
Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non-Hodgkin Lymphoma 
or Chronic Lymphocytic Leukemia (topMIND) 
Protocol Number:  INCMOR 0208-101 
Objectives and Endpoints: 
Table 1 presents the primary objectives and endpoints. 
Table 1: 
Primary Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
Dose confirmation period (Phase 1b): 
To determine the safety, tolerability, and DLTs of 
combination therapy with 
tafasitamab + parsaclisib in participants with R/R 
NHL or CLL who have been previously treated 
with at least 2 prior lines of systemic 
antilymphoma therapy. 
Incidence and severity of TEAEs and incidence of 
DLTs. 
Dose expansion period (Phase 2a): 
To assess the preliminary efficacy of combination 
therapy with tafasitamab + parsaclisib in 
participants with R/R NHL or CLL who have 
been previously treated with at least 2 prior lines 
of systemic antilymphoma therapy. 
ORR, defined as the percentage of participants 
having best response of CR/CMR or PR/PMR per 
investigator assessment.   
Overall Design: 
Table 2 presents the key study design elements.    

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Table 2: 
Key Study Design Elements 
Study Phase 
Phase 1b/2a 
Clinical Indication 
Treatment of patients with R/R B-cell malignancies who have been previously 
treated with at least 2 prior lines of systemic antilymphoma/antileukemia 
therapy. 
Population 
Male and female participants at least 18 years of age who have R/R B-cell 
malignancies including R/R DLBCL, R/R MCL, R/R FL, R/R MZL, or R/R 
CLL/SLL.   
Participants must have been adequately pretreated and have failed to respond 
to at least 2 prior lines of systemic antilymphoma/antileukemia therapy. 
Number of 
Participants 
A total of approximately 100 participants will be enrolled into the 5 different 
disease-specific cohorts (up to 20 evaluable participants per cohort). 
• 
The dose confirmation period will include up to 50 evaluable 
participants in 5 cohorts (10 evaluable participants per cohort). 
• 
The dose expansion period will include up to 50 additional participants 
in 5 cohorts (10 evaluable participants per cohort). 
Study Design 
This is a single-arm, open-label, Phase 1b/2a, multicenter basket study that 
includes 5 disease-specific cohorts to which participants will be assigned based 
on the histology of their underlying disease. 
Estimated Duration 
of Study 
Participation 
 The estimated study duration for a study participant includes the following: 
• 
Up to 28 days for screening 
• 
Continuous treatment in consecutive 28-day cycles until treatment 
discontinuation criteria are met (disease progression, withdrawal by 
physician/participant decision, unacceptable toxicity) 
• 
Safety follow-up, 90 days after discontinuing study treatment 
• 
Survival follow-up until study completion criteria are met  
It is estimated that an individual will participate for approximately 24 months. 
Participants who are receiving long-term benefit may be transferred to a 
company-sponsored rollover study after completion of this study. 
DSMB 
Yes (internal) 
Coordinating 
Principal 
Investigator 
TBD 

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Treatment Groups and Duration: 
The safety, tolerability, PK, and preliminary efficacy of combination therapy with tafasitamab 
and parsaclisib will be assessed in a dose confirmation period followed by a dose expansion 
period.  Participants will be assigned to 1 of 5 disease-specific cohorts based on the histology of 
their underlying disease:  
• Cohort 1:  R/R DLBCL 
• Cohort 2:  R/R MCL 
• Cohort 3:  R/R FL 
• Cohort 4:  R/R MZL 
• Cohort 5:  R/R CLL/SLL 
During the dose confirmation period, participants will be enrolled in 1 of the 5 cohorts in a 
parallel fashion.  Each cohort will enroll 10 evaluable participants, and each participant will be 
observed for a DLT evaluation period of 1 cycle (28 days).  Participants must have received at 
least 3 of 4 doses of tafasitamab and 21 days of treatment with parsaclisib 20 mg QD during the 
first cycle (28 days) or have experienced a DLT to be considered evaluable for the dose 
confirmation period.  Participants who are considered not evaluable will be replaced. 
An iDSMB will review data once the 10th DLT-evaluable participant from any cohort completes 
the DLT evaluation period (C1D28 or experiences a DLT).  Reviews will be repeated every 
4 months thereafter.  The occurrence of 2 DLTs within the first 10 DLT-evaluable participants 
will also trigger iDSMB review of overall safety data and specifics from the case. 
The decision to continue enrollment into each of the malignancy subtype cohorts will be based 
on the frequency of DLTs observed in the first 10 evaluable participants and review of ongoing 
safety data.  After the safety review is completed and the dose confirmation decision is made, the 
dose expansion period for that cohort will begin, and up to 10 additional participants will be 
enrolled (up to a total of 20 evaluable participants in each cohort across both study periods; see 
Figure 1). 
Tafasitamab will be administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 
and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward.  Parsaclisib will be self-
administered at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. 
No dose escalation will be performed in this study. 
Study treatment will be administered until progression of disease, withdrawal of consent, or 
unacceptable toxicity (see Section 7.1).  Data on OS will be collected until study completion 
criteria are met (see Section 8.8.3).   
Study assessments are provided in Table 3.  Appendix H provides guidance on performing 
assessments during the current COVID-19 global pandemic. 
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct. 

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Figure 1: 
Study Design Schema 

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Table 3: 
Schedule of Activities 
Visit Day (Range) 
Screening 
Treatment 
EOT 
Follow-up 
Notes 
Days 
−28 to −1 
Cycles 1-3 
Cycle 4 Onward 
Safety 
Disease 
Survival 
Day 1 
Day 8  
(± 1 d) 
Day 15  
(± 1 d) 
Day 22 
(± 1 d) 
Day 1  
(± 1 d) 
Day 15 
(± 1 d) 
EOT + 
90 d 
Post-
Treatment 
Last Visit + 
12 Wk  
(± 7 d) 
Administrative procedures 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
Contact IRT 
X 
X 
 
 
 
X 
 
X 
X 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
Verify eligibility on 
C1D1. 
General/disease medical 
history 
X 
 
 
 
 
 
 
 
 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
X 
 
 
 
PJP prophylaxis 
 
X 
 
 
 
 
Required while 
receiving study 
treatment and for 
2-6 months after the 
last dose of study 
treatment. 
Dispense parsaclisib 
 
X 
 
 
 
X 
 
 
 
 
 
 
Administer parsaclisib 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
20 mg QD:   
Cycle 1, 2: Days 1-28.  
 
2.5 mg QD: 
C3D1 onward 
Given on-site on PK 
assessment days. 
IRR prophylaxis 
 
X* 
X* 
X* 
X 
X 
X 
 
 
 
 
*Mandatory for first 
3 doses. 
Administer tafasitamab 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
12 mg/kg IV 
Cycles 1-3:  
Days 1, 8, 15, and 22  
Cycle 4 onward:  Days 
1 and 15 only 
Distribute reminder cards 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Assess treatment 
compliance 
 
 
X 
X 
X 
X 
X 
X 
 
 
 
 

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Table 3: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Treatment 
EOT 
Follow-up 
Notes 
Days 
−28 to −1 
Cycles 1-3 
Cycle 4 Onward 
Safety 
Disease 
Survival 
Day 1 
Day 8  
(± 1 d) 
Day 15  
(± 1 d) 
Day 22 
(± 1 d) 
Day 1  
(± 1 d) 
Day 15 
(± 1 d) 
EOT + 
90 d 
Post-
Treatment 
Last Visit + 
12 Wk  
(± 7 d) 
Safety assessments 
AE assessments 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Physical examination 
X 
 
 
 
 
 
 
X 
X 
X 
 
Height at screening 
only. 
Vital signs/weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
ECOG performance 
status 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
B symptoms/ 
constitutional symptoms 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
12-lead ECG 
X 
X* 
X 
 
 
 
*Repeat only if 
indicated. 
LVEF assessment 
X 
 
 
 
 
 
 
 
 
 
 
 
OS 
 
 
 
 
 
 
 
 
 
 
X 
Repeat every 
12 weeks (± 7 d). 
Efficacy assessments 
Bone marrow core 
biopsy and bone marrow 
aspirate 
X 
 
 
 
 
 
 
X* 
 
 
 
*If positive at 
screening and within 
28 days of achieving 
a radiologic CR. 
PET of the neck, chest, 
abdomen, and pelvis 
X 
 
 
 
 
 
 
X* 
 
 
 
*Only if FDG-avid 
disease at baseline:  if 
a radiologic CR is 
achieved based on CT 
or MRI earlier than 
EOT, confirmatory 
PET must be 
performed within 
28 days (± 14 days). 
Combined PET/CT 
and PET/MRI may be 
used if the CT or MRI 
is performed with 
contrast. 

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Table 3: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Treatment 
EOT 
Follow-up 
Notes 
Days 
−28 to −1 
Cycles 1-3 
Cycle 4 Onward 
Safety 
Disease 
Survival 
Day 1 
Day 8  
(± 1 d) 
Day 15  
(± 1 d) 
Day 22 
(± 1 d) 
Day 1  
(± 1 d) 
Day 15 
(± 1 d) 
EOT 
+ 90 d 
Post-
Treatment 
Last Visit + 
12 Wk  
(± 7 d) 
Contrast-enhanced CT or 
MRI of the neck, chest, 
abdomen, and pelvis 
X* 
Every 8 weeks (± 1 week) for Year 1   
Every 12 weeks (± 2 weeks) for Year 2-3 
Every 24 weeks (± 2 weeks) for Year 4 onward 
X 
 
X** 
 
*Participants with 
suspected CNS 
involvement or those 
with a known history 
of CNS lymphoma 
must undergo 
CT/MRI of the head 
at screening to 
exclude active CNS 
disease. 
**Participants 
discontinuing study 
treatment prior to 
disease progression 
must be followed with 
CT/MRI per the same 
schedule. 
Local laboratory assessments 
Hematology 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Serum chemistry 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
HBV/HCV 
X 
 
 
 
 
 
 
 
 
 
 
 
HIV 
X* 
 
 
 
 
 
 
 
 
 
 
*Required outside of 
the United States 
only. 
CMV 
X 
X 
 
 
 
X* 
 
X 
 
 
 
*Day 1 of Cycles 4-12 
and then every 
12 weeks (± 1 week) 
thereafter (C15D1, 
C18D1, etc). 
Pregnancy testing 
(serum) 
X 
 
 
 
 
 
 
X 
 
 
 
WOCBP only; repeat 
after screening if urine 
pregnancy test is 
positive. 
Pregnancy testing (urine) 
 
X 
 
 
 
X 
 
 
X 
 
 
WOCBP only 

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Table 3: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Treatment 
EOT 
Follow-up 
Notes 
Days 
−28 to −1 
Cycles 1-3 
Cycle 4 Onward 
Safety 
Disease 
Survival 
Day 1 
Day 8  
(± 1 d) 
Day 15  
(± 1 d) 
Day 22 
(± 1 d) 
Day 1  
(± 1 d) 
Day 15 
(± 1 d) 
EOT + 
90 d 
Post-
Treatment 
Last Visit + 
12 Wk  
(± 7 d) 
Urinalysis 
X 
 
 
 
 
 
 
X 
 
 
 
 
Coagulation 
X 
 
 
 
 
 
 
X 
 
 
 
 
Lipid panel 
X 
 
 
 
 
 
 
X 
 
 
 
 
Endocrine function 
X 
 
 
 
 
 
 
X 
 
 
 
 
EDTA = ethylenediaminetetraacetic acid. 

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2.
INTRODUCTION
2.1. 
Background
2.1.1. 
B-Cell Malignancies
Non-Hodgkin lymphoma is the most common hematologic malignancy in adults.  The majority 
of NHLs are of B-cell origin, with multiple different histological subtypes that confer different 
clinical outcomes (Habermann et al 2006, Shingleton et al 2020, Swerdlow et al 2016).  Apart 
from the histopathologic classification of NHLs, they are also commonly categorized as indolent 
or aggressive lymphomas based on their clinical characteristics. 
•
Indolent lymphomas are slowly progressing and responsive to therapy; however, they
are generally considered incurable; indolent lymphomas include FL, MZL, CLL/SLL,
and others (Sehn 2016).
•
Aggressive lymphomas are rapidly progressing but usually responsive to therapy and
often curable; aggressive lymphomas include DLBCL, MCL, and others (Swerdlow
et al 2016).
Diffuse Large B-Cell Lymphoma
2.1.1.1. 
Diffuse large B-cell lymphoma is the most common NHL, representing approximately 40% of all 
NHLs.  Its rate of incidence continues to increase, with a median age at diagnosis of 64 years.  
Diffuse large B-cell lymphoma is an aggressive B-cell NHL, and the majority of patients present 
with advanced disease.  Diffuse large B-cell lymphoma is increasingly recognized as a 
heterogeneous disorder with distinct cell of origin subtypes, each arising from different stages of 
normal B-cell development.  Several studies have shown that the distinct cell of origin subtypes, 
germinal center B-cell type and activated B-cell type, have unique mutational profiles and 
different prognostic outcomes (Flowers et al 2010, Lenz et al 2008, Schmitz et al 2018, Vaidya 
and Witzig 2014). 
2.1.1.1.1. First-Line Therapy 
The immunochemotherapy regimen consisting of the anti-CD20 mAb rituximab plus CHOP 
chemotherapy is the current standard of care for the treatment of newly diagnosed DLBCL (Sehn 
et al 2018).  Although the addition of rituximab to CHOP dramatically improves outcomes 
compared with CHOP alone, 30% to 40% of cases of DLBCL are still primarily refractory or 
relapse (Coiffier et al 2010, Habermann et al 2006).   
2.1.1.1.2. Treatment for Relapsed/Refractory Disease 
Patients with disease that progresses or relapses after first-line treatment are evaluated for their 
eligibility for intensified salvage treatment strategies that can lead to long-term remissions.  
Examples of such salvage chemotherapy include DHAP (cisplatin, cytarabine, dexamethasone), 
VIM (etoposide, ifosfamide, methotrexate or mitoxantrone), ICE (ifosfamide, carboplatin, 
etoposide), and ESHAP (etoposide, methylprednisolone, cytarabine, cisplatin).  For patients with 
chemotherapy-sensitive disease, ASCT as consolidation therapy significantly improves the 

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outcome of second-line therapy.  Approximately 10% to 50% of patients treated with an 
intensified regimen as second-line therapy achieve long-term remission and cure (Philip 
et al 1995). 
Unfortunately, only approximately 50% of patients with R/R DLBCL are eligible for an 
intensified treatment strategy, mainly due to cardiac comorbidities, decreased hematopoietic 
reserve, reduced hepatic function, or advanced age, restricting the benefit of this aggressive 
approach to a relatively small subset of patients (Morrison et al 2015).  Similarly, only younger 
and fit patients can be evaluated for allogeneic stem cell transplantation (Truelove et al 2015). 
Several treatment regimens have been described for patients who have a relapse after intensified 
second-line treatment or who are not eligible for an intensified second-line regimen.  None of 
these regimens, however, have a confirmed potential for long-term remission or cure.  The 
median survival for patients who have had a relapse after second-line therapy is < 1 year, and 
median survival for those not responding to second-line therapy is < 6 months (Colosia 
et al 2014).  For elderly patients in particular, participation in a clinical study is recommended in 
this situation (Pfreundschuh 2010). 
In summary, although some patients with R/R DLBCL can achieve remission with second-line 
chemotherapy followed by consolidation with high-dose chemotherapy and ASCT, the majority 
will die of the disease.  Thus, the development of a more effective initial therapy is essential to 
improve long-term outcomes. 
2.1.1.2. 
Mantle Cell Lymphoma 
Mantle cell lymphoma accounts for approximately 3% to 6% of all NHL cases (Cheah 
et al 2016) in Western countries.  Approximately 3 out of 4 patients with MCL are male, and the 
disease occurs approximately twice as frequently in white patients as compared with black 
patients.  The median age at diagnosis is 68 years (Schulz et al 2007).  The most common form 
of MCL, referred to as classic MCL, is genetically characterized by the reciprocal t(11;14) that 
leads to the overexpression of CCND1, which drives tumor growth and division (Campo and 
Rule 2015).   
The median OS for treated patients with MCL is approximately 8 to 10 years.  Currently 
available treatments are not considered curative (Schulz et al 2007); therefore, an unmet medical 
need exists for patients with MCL. 
2.1.1.2.1. First-Line Therapy 
Most patients with MCL (70%) have advanced-stage disease at diagnosis (Argatoff et al 1997).  
There is currently no method to guide treatment, but the Mantle Cell Lymphoma International 
Prognostic Index has been developed to facilitate risk-adapted treatment (Hoster et al 2008).  
This index is based on 4 factors:  age, performance status, lactate dehydrogenase level, and 
leukocyte count.  Additional prognostic factors evaluated include Ki-67, gene expression 
profiling, MRD, MCL cell type, peripheral blood absolute monocyte count at diagnosis, and 
beta2-microglobulin level (Leukemia & Lymphoma Society 2014). 
Multiple approaches are used in the first-line treatment of MCL, but treatment typically consists 
of chemotherapy plus an immunotherapy (ie, chemoimmunotherapy).  Treatment options include 
conventional chemoimmunotherapy alone or followed by maintenance rituximab, conventional 

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chemoimmunotherapy followed by high-dose chemotherapy and ASCT, intensive 
chemoimmunotherapy, and conventional chemoimmunotherapy plus involved-field radiation 
therapy.  Unfortunately, none of these modalities are curative (Cheah et al 2016). 
2.1.1.2.2. Treatment for Relapsed/Refractory Disease 
Most patients will experience serial relapse and can use any number of approved therapies or 
unapproved therapies in clinical studies.  The best order of treatment for these therapies is not 
known, and choice of therapy will depend on a number of factors, including prior treatment, 
patient comorbidities and performance status, and expected toxicities.  In the United States, 
approved therapies for MCL include ibrutinib, lenalidomide, and bortezomib.  Ibrutinib (Wang 
et al 2013), lenalidomide (Goy et al 2013), and bortezomib (Fisher et al 2006) received 
accelerated approval based on the ORR observed in single-arm, Phase 2 studies; bortezomib (in 
combination with chemotherapy) was also approved in a randomized Phase 3 study of previously 
untreated participants with MCL (Robak et al 2015).  In the European Union, ibrutinib, 
lenalidomide, and temsirolimus (Hess et al 2009) are approved for the treatment of adult patients 
with R/R MCL; bortezomib (in combination with chemotherapy) is approved for the treatment of 
adult patients with previously untreated MCL who are unsuitable for hematopoietic stem cell 
transplantation. 
2.1.1.3. 
Follicular Lymphoma 
Follicular lymphoma is defined as a lymphoma of germinal center B cells, including centrocytes 
and centroblasts, that has at least a partially follicular pattern.  These bone marrow–derived cells 
undergo somatic hypermutation and class switching of the B-cell receptors, which leads to 
immunoglobulin diversity and selects B cells that produce high-affinity antibodies (Kahl and 
Yang 2016).  Central to the early transformation and pathophysiology of FL is the 
t(14;18)(q32;18) translocation found in approximately 90% of cases of FL and that leads to 
overexpression of BCL2 (Pastore et al 2015).  Follicular lymphoma is also positive for the B-cell 
markers CD10, CD19, CD22, and usually CD20 but is always negative for CD5 (Barekman 
et al 2001). 
Although FL is a biologically heterogeneous disease with widely varying outcomes, the 
prognosis for individual patients can be made based on clinical and laboratory findings.  The 
most widely used risk model for FL is the Follicular Lymphoma International Prognostic Index, 
which includes 5 adverse prognostic factors:  age older than 60 years, Ann Arbor Stage III to IV, 
hemoglobin level < 120 g/L, 4 or more involved nodal areas, and elevated serum lactate 
dehydrogenase level (Solal-Céligny et al 2004).  Following treatment, patients can be assessed 
for MRD, which refers to the small number or cancer cells that may remain after treatment and 
may lead to relapse. 
2.1.1.3.1. First-Line Therapy 
Some patients with early-stage FL (Ann Arbor Stage I or II) who develop symptoms may be 
treated with radiation therapy alone.  Advanced-stage (Ann Arbor Stage III-IV), Grade 1 to 3a 
FL is often treated according to the degree of tumor burden (low vs high) and the presence or 
absence of FL symptoms (eg, fever, night sweats, unexplained weight loss, etc).  Asymptomatic 
patients with a low tumor burden may be candidates for watchful waiting, whereas those with a 
high tumor burden may receive R-CHOP.  Symptomatic patients with a low tumor burden may 

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receive either single-agent rituximab or R-CHOP, whereas patients with a high tumor burden 
may receive R-CHOP or CHOP.   
Based on an analysis of 588 patients receiving R-CHOP as initial FL therapy, approximately 
20% of patients experienced early PD, defined as PD within 2 years of diagnosis.  The 5-year OS 
was 50% in the early PD group compared with 90% in patients without early PD (Casulo 
et al 2015). 
2.1.1.3.2. Treatment for Relapsed/Refractory Disease 
There are several options for patients with FL who experience relapse after initial treatment 
(Kahl and Yang 2016).  The use of single-agent bendamustine was approved by the FDA in 2008 
for use in patients with indolent B-cell NHL that progressed within 6 months of treatment with 
rituximab (Treanda® 2013).  In 2016, the FDA and the European Commission approved the use 
of obinutuzumab in combination with bendamustine followed by maintenance therapy with 
obinutuzumab in patients with FL whose disease progressed within 6 months of prior 
rituximab-based therapy (Gazyva® 2016, Sehn 2016).  Autologous stem cell transplantation is 
another option available to some patients after relapse. 
The first-in-class PI3Kδ inhibitor idelalisib (Zydelig® 2016) was granted accelerated approval in 
2014 by the FDA based on a single-arm study enrolling participants with FL (N = 72) with 
disease that was refractory to at least 2 prior therapies (Gopal et al 2014).  The approved 
indication was for the treatment of patients with relapsed follicular B-cell NHL who had received 
at least 2 prior systemic therapies.  Idelalisib was also approved in Europe, based on the same 
study, for the treatment of adult patients with FL that is refractory to 2 prior lines of treatment.  
In September 2017, a pan PI3K inhibitor, copanlisib (Aliqopa® 2017), was also granted 
accelerated approval by the FDA based on a single-arm study enrolling participants with FL 
(N = 104) who had received at least 2 prior systemic therapies.  The ORR for idelalisib in a 
double-refractory FL population was 54% (Zydelig® 2016); the ORR for copanlisib in 
participants with R/R FL who had received at least 2 prior therapies was 59% (Aliqopa® 2017).  
Other agents (eg, lenalidomide, venetoclax, ibrutinib) are being evaluated in clinical studies. 
Although the majority of patients will respond to these first-line therapies, the natural history of 
FL is characterized by continuous relapse.  Thus, despite significant progress in the management 
of patients with FL, an unmet need still exists. 
2.1.1.4. 
Marginal Zone Lymphoma 
Marginal zone lymphomas, a group of indolent (slow-growing) NHL B-cell lymphomas, account 
for approximately 10% of all histologically diagnosed NHL cases in Western countries (Cuneo 
and Castoldi 2006).  The average age at diagnosis is 60 years, and it is slightly more common in 
women than in men (Lymphoma Research Foundation 2017). 
Marginal zone lymphomas originate from memory B lymphocytes normally present in a distinct 
microanatomic compartment called the "marginal zone" of the secondary lymphoid follicles 
(Zinzani 2012).  The subtypes of MZL share a similar immunophenotype that is positive for the 
B-cell markers CD19, CD20, and CD22 and negative for CD5, CD10, and usually CD23 
(Swerdlow et al 2016). 

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The latest lymphoma classification identifies 3 subtypes of MZL according to the involved site 
and characteristic molecular findings (Swerdlow et al 2016): 
• Extranodal MZL (MALT) 
• Nodal MZL 
• Splenic MZL 
2.1.1.4.1. First-Line Therapy 
Treatment selection for patients with MZL depends on disease characteristics, including type, 
stage, and location, as well as other patient characteristics, such as age and overall health.  
Because MZL is most often a slow-growing disease, a watch-and-wait approach is appropriate 
until symptoms appear. 
Helicobacter pylori–positive gastric extranodal MZL/MALT lymphoma is initially treated with 
antibiotics in combination with proton pump inhibitors.  In patients with symptomatic nongastric 
MALT lymphoma, treatment may include surgery for certain sites (lung, breast) or radiation 
therapy.  Initial treatment for advanced disease usually includes immunotherapy and 
chemotherapy, including bendamustine plus rituximab and R-CHOP. 
When treatment is necessary in patients with symptomatic nodal MZL, options include radiation 
therapy, chemotherapy and/or immunotherapy, and other treatments commonly used in other 
types of slow-growing lymphomas, such as FL. 
Some patients with splenic MZL may undergo a splenectomy.  Patients ineligible for surgery 
may receive low-dose radiation of the spleen or rituximab with or without chemotherapy.  In 
some cases, because of the association of this type of lymphoma with HCV, interferon with or 
without antiviral therapy may be given to patients who show evidence of HCV infection. 
2.1.1.4.2. Treatment for Relapsed/Refractory Disease 
Asymptomatic patients may be observed (watch-and-wait), and radiotherapy may be considered 
for patients with MZL who have localized relapses.  If systemic treatment is required, 
chemoimmunotherapy can be repeated after long initial remissions (≥ 24 months).  Autologous 
stem cell transplantation may be considered in fit patients with clinically aggressive relapse.  In 
other cases, an alternate chemoimmunotherapy regimen can be used (Zucca et al 2020). 
In a Phase 2 trial, single-agent therapy with ibrutinib showed antilymphoma activity in MZL, 
including nodal MZL.  In January 2017, ibrutinib was granted accelerated approval from the 
FDA for the treatment of patients with MZL who require systemic therapy and have received at 
least 1 prior anti-CD20–based therapy.  The PI3K inhibitor copanlisib has also demonstrated 
significant efficacy and a manageable safety profile in heavily pretreated patients with R/R MZL 
(Zucca et al 2020). 
Several other drugs and drug combinations are being studied in clinical trials of MZL and 
include chemotherapy agents (bendamustine), mAbs (blinatumomab, obinutuzumab, 
pembrolizumab, and ibritumomab), antibody drug conjugate (brentuximab), small molecules 
(idelalisib, copanlisib, duvelisib, TGR-1202, and venetoclax), proteasome inhibitors 
(bortezomib), immunomodulators (lenalidomide and ublituximab), and radioimmunotherapy 
strategies (90Y-ibritumomab tiuxetan). 

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2.1.1.5. 
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma 
Chronic lymphocytic leukemia is the most common leukemia in the Western world, and the 
median age at diagnosis is 72 years.  The overall incidence is 4.2 cases per 100,000 people/year; 
however, it increases to > 30 cases per 100,000 people/year for people older than 80 years.  In 
the WHO classification, SLL and CLL are considered to be a single entity.  The diagnosis of 
CLL is established by the following criteria (Hallek et al 2018): 
• Presence of ≥ 5000 monoclonal B lymphocytes/μL in the peripheral blood (clonality 
of these B lymphocytes needs to be confirmed by flow cytometry). 
• Blood smear showing leukemic cells as small, mature-appearing lymphocytes with a 
narrow border of cytoplasm and a dense nucleus lacking discernible nucleoli and 
having partially aggregated chromatin.  Larger, atypical lymphocytes or 
prolymphocytes must not exceed 55%. 
Chronic lymphocytic leukemia cells express CD5, CD19, CD20, and CD23.  Surface 
immunoglobulin, CD20, and CD79b usually have lower expression compared to normal B cells. 
The diagnosis of SLL requires the presence of lymphadenopathy and/or splenomegaly with a 
peripheral B-lymphocyte count of < 5 × 109/L and should be confirmed by histopathologic 
evaluation of a lymph node biopsy.  Small lymphocytic lymphoma cells show the same 
immunophenotype as CLL. 
2.1.1.5.1. First-Line Therapy 
Studies have shown that early treatment with chemotherapeutic agents does not improve OS in 
patients with low- and intermediate-risk CLL (Rai 0, I-II), so treatment should only be initiated 
in patients with symptomatic, active disease as defined by significant disease-related symptoms 
(B symptoms), threatened end-organ function, steroid-refractory autoimmune cytopenias, and/or 
progressive bulky disease, anemia, or thrombocytopenia (NCCN 2021).  In high-risk CLL (Rai 
III-IV), progressive cytopenia constitutes treatment indication. 
First-line treatment is usually stratified by patient-specific and disease-related factors 
(NCCN 2021), particularly by the presence or absence of the del(17p)/TP53 mutation, which is 
associated with a more aggressive disease course and refractoriness to many conventional 
therapies. 
• For patients with CLL/SLL without the del(17p)/TP53 mutation, treatment with 
ibrutinib, acalabrutinib and/or obinutuzumab, or venetoclax + obinutuzumab is 
recommended.  Other treatment options include immunochemotherapy with 
bendamustine, chlorambucil, or other regimens plus anti-CD20 mAbs such as 
rituximab and obinutuzumab.  For patients younger than 65 years who have no 
significant comorbidities, chemotherapy regimens including fludarabine in 
combination with anti-CD20 mAbs are recommended. 
• For patients with CLL/SLL with the del(17p)/TP53 mutation, treatment with 
ibrutinib, acalabrutinib and/or obinutuzumab, venetoclax + obinutuzumab, 
alemtuzumab and/or rituximab, high-dose methylprednisolone + rituximab, or 
obinutuzumab monotherapy is recommended. 

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2.1.1.5.2. Treatment for Relapsed/Refractory Disease 
Similar to first-line therapy, treatment at relapse should only be initiated when patients are 
symptomatic. 
First-line treatment may be repeated if the relapse or progression occurs at least 24 to 36 months 
after therapy and if the TP53 mutation was excluded.  In patients with disease that is refractory to 
first-line therapy or if relapse occurs within 2 to 3 years after therapy, the therapeutic regimen 
should be changed.  In addition to the treatment regimens recommended for first-line therapy, 
PI3K inhibitors such as duvelisib or idelalisib in combination with rituximab can be used 
(NCCN 2021).  Other recommended regimens include alemtuzumab and/or rituximab, high-dose 
methylprednisolone + rituximab, lenalidomide and/or rituximab, or monotherapy with idelalisib 
or obinutuzumab. 
2.1.2. 
Tafasitamab 
Tafasitamab, also known as INCMOR00208, MOR00208, and XmAb®5574, is an Fc-engineered 
mAb that binds to the human B-cell surface antigen CD19 and is produced by recombinant DNA 
technology in Chinese hamster ovary cells.  Tafasitamab is being developed for use in patients with 
CD19+ B-cell malignancies, including R/R ALL, R/R NHL such as DLBCL, R/R indolent NHL such 
as FL and MZL, treatment-naive DLBCL, treatment-naive CLL/SLL/PLL, R/R CLL/SLL/PLL, and 
RT.  Tafasitamab in combination with lenalidomide, is approved for the treatment of adult 
patients with R/R DLBCL not otherwise specified, including DLBCL arising from low-grade 
lymphoma, who are not eligible for ASCT, in the US, Canada, the European Union, and other 
countries.  For an overview of clinical studies of tafasitamab, please refer to the tafasitamab IB. 
CD19 is expressed on a variety of B-cell lymphomas and normal B cells and has been shown to 
be expressed also in cases where rituximab is ineffective due to CD20 downregulation or other 
factors (Davis et al 1999, Gerber et al 2009).  Due to its lineage-specific expression pattern, 
targeting CD19 has clinical utility as a therapeutic approach to NHL (Hammer 2012).  The 
increased binding of tafasitamab to FcγR, due to its Fc region, significantly enhances in vitro 
antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, and its 
direct cytotoxic effects (apoptosis) on the tumor cells compared with the nonengineered parental 
murine antibody.  Tafasitamab has not been shown to mediate complement-dependent 
cytotoxicity (tafasitamab IB). 
In a Phase 1 study of 27 participants with relapsed/refractory CLL who received 1 prior line of 
therapy (XmAb5574-01), tafasitamab monotherapy at doses ranging from 0.3 mg/kg (n = 1) to 
12 mg/kg (n = 16) was generally well tolerated, with Grade 1/2 infusion reactions reported as the 
most common AEs.  Grade 3 and 4 toxicities occurred in 5 participants and included 
neutropenia, thrombocytopenia, increased aspartate aminotransferase, febrile neutropenia, and 
tumor lysis syndrome.  Preliminary efficacy was also observed:  on the basis of physical 
examination and laboratory studies, 18 participants (66.7%) achieved PR and the remaining 
9 participants (33.3%) achieved SD.  Using CT criteria as well as examination and laboratory 
data, 8 participants (29.6%) achieved a PR, with an additional 16 participants (59.3%) achieving 
SD by physical examination criteria and laboratory studies (Woyach et al 2014). 
MOR208C201 is a Phase 2a, open-label, multicenter study of single-agent tafasitamab in 
participants with R/R NHL.  As of the data cutoff date of 28 SEP 2018, responses as assessed by 

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the investigator were seen in 3 of the 4 studied subgroups:  25.7% of participants with DLBCL, 
29.4% with FL, and 27.3% with other indolent NHLs.  In a sensitivity analysis excluding 
participants without a postbaseline response assessment, the ORR was 36.0% in the DLBCL, 
32.3% in the FL, and 30.0% in the other indolent NHL subgroups.  The safety profile of 
tafasitamab was favorable, with only 4 of 92 participants (4%) experiencing a serious adverse 
reaction, no treatment-related deaths, and no evidence for significant late toxicities. 
2.1.2.1. 
Tafasitamab Pharmacokinetics 
2.1.2.2. 
Tafasitamab Immunogenicity 
No treatment-emergent or treatment-boosted ADAs were detected for tafasitamab, and the 
pre-existing antibodies did not affect the PK, safety, or efficacy of tafasitamab.  The ADA results 
are summarized in the tafasitamab IB. 
2.1.3. 
Parsaclisib 
Parsaclisib (INCB050465) is a potent, selective inhibitor of PI3Kδ (50% inhibitory 
concentration = 1.1 ± 0.5 nM), with approximately 20,000-fold selectivity for the other PI3K 
family members.  Parsaclisib does not significantly inhibit (< 30% inhibition) a broad panel of 
kinases when tested at a concentration of 100 nM (refer to the parsaclisib IB).  Parsaclisib is 
potent (50% inhibitory concentration of ≤ 10 nM) in cell-based assays relevant to the 
pathogenesis of B-cell malignancies, such as PI3Kδ-mediated signaling and growth of human 
B-cell lines. 
As of the data cutoff date of 30 MAR 2021, parsaclisib is being evaluated in 10 ongoing clinical 
studies, and is also available in a Phase 2, open-label, multicenter rollover study.  Parsaclisib was 
evaluated in 1035 unique participants as monotherapy and/or in combination therapy in 
participants with advanced malignancies, B-cell malignancies, advanced solid tumors, and pSS 
in 7 completed studies, and in healthy participants in 2 completed studies. 
Additional trial design and safety information from these trials can be found in the parsaclisib IB. 

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2.1.3.1. 
Parsaclisib Pharmacokinetics 
Based on an ex vivo whole blood assay, parsaclisib 20 mg QD provided exposure ranging from 
approximately 2-fold above the IC90 at trough to 19-fold above the IC90 at peak.   
Study INCB 50465-101 was a Phase 1/2 study that examined parsaclisib monotherapy dose 
escalation (5-45 mg QD) and dose expansion (20 mg and 30 mg QD).  In this study, the vast 
majority (93%) of responses occurred by the first assessment (~ 9 weeks) in participants with 
R/R DLBCL (n = 23), FL (n = 14), MZL (n = 9), or MCL (n = 9; data cutoff date of 
18 AUG 2017).  For the participants with NHL who received parsaclisib monotherapy, an 
objective response was achieved by 7 of 23 participants (30%) with DLBCL, 10 of 14 
participants (71%) with FL, 7 of 9 participants (78%) with MZL, and 6 of 9 participants (67%) 
with MCL.  Among the 72 participants treated with parsaclisib monotherapy, the most common 
(≥ 30%) nonhematologic TEAEs of any grade were diarrhea/colitis (36%), nausea (36%), fatigue 
(31%), and rash (31%).  New or worsened Grade 3/4 neutropenia occurred in 19% of participants 
based on laboratory data.  The tmax of parsaclisib was 0.5 to 1 hour, the terminal half-life was 
approximately 8.6 to 11.5 hours, and the exposure appeared to be dose-proportional between 
5 mg and 45 mg QD at steady state.  The PK analyses demonstrated robust and sustained 
pathway inhibition at all dose levels tested (Forero-Torres et al 2019, parsaclisib IB). 
The continuation of parsaclisib at a daily but lower dose (2.5 mg) is expected to provide 
sufficient exposure (estimated to be approximately 1 × IC90 at peak) to maintain PI3K pathway 
inhibition while minimizing the frequency of late-onset AEs that may lead to study treatment 
withdrawal.  Evaluation of this dosing regimen is ongoing in 3 Phase 2 studies in participants 
with FL (INCB 50465-203), MZL (INCB 50465-204), and MCL (INCB 50465-205).  
Preliminary data from participants receiving this regimen suggest that continuous QD dosing has 
demonstrated benefit in both aggressive and indolent NHL, and the emerging safety profile is 
consistent with that known for parsaclisib. 
2.1.3.2. 
Parsaclisib Phase 2 Studies 
In Study INCB 50465-203 (FL) and Study INCB 50465-204 (MZL), participants were 
randomized to receive 20 mg QD for 8 weeks followed by either 20 mg QD (Treatment A) or 
2.5 mg QD (Treatment B).  The primary efficacy endpoint is ORR, as determined by an IRC 
assessment of response according to CT-based response criteria for lymphomas.   
In Study INCB 50465-203, eligible participants had histologically confirmed Grade 1, 2, or 3a 
FL previously treated with at least 2 prior systemic therapies with documented progression or 
documented failure to achieve a response after the most recent systemic treatment regimen.   
A per-protocol interim futility analysis was conducted when the first 50 participants 
(Treatment A and Treatment B combined) were treated and had at least 9 weeks of follow-up.  
The cutoff date for this interim analysis was 20 MAY 2019.  Among the 50 participants, the 
ORR as determined by the IRC was 62.0% (95% CI:  47.2%, 75.3%), with 25 of 50 participants 
achieving a PR and 6 achieving a CR.   
An ad hoc analysis was subsequently performed (data cutoff date of 17 JAN 2020).  Among 
96 participants evaluable for efficacy (Treatment A, n = 22; Treatment B, n = 74), the 
IRC-assessed ORR was 69.8% (95% CI:  59.6, 78.7) and the CRR was 13.5%.  The median time 
to response for participants achieving a PR or CR was 8 weeks, with 74.6% of the responses 

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occurring at the first disease assessment (Week 8).  The median DOR was not reached (95% CI:  
9.2 months, not estimable) among responders overall, and the median PFS was 15.8 (95% CI:  
11.3, 15.8) months overall.  Enrollment was ongoing at the time of data cutoff.   
In Study INCB 50465-204, eligible participants had pathologically confirmed nodal, extranodal, 
or splenic MZL previously treated with at least 1 prior systemic treatment regimen, including at 
least 1 anti-CD20 mAb, with documented progression or documented failure to achieve a 
response after the most recent systemic treatment regimen.  A per-protocol interim futility 
analysis was conducted on Cohort 2 (BTK inhibitor–naive) after the first 30 participants were 
treated (Treatment A and Treatment B combined) and had at least 9 weeks of follow-up.  The 
cutoff date for this interim analysis was 08 JAN 2019.  Among the 30 participants, the ORR as 
determined by the IRC was 46.7% (95% CI:  28.3%, 65.7%), with 14 of 30 participants 
achieving a PR.  An ad hoc analysis was subsequently performed (data cutoff date of 
17 JAN 2020).  Among 94 participants evaluable for efficacy (Treatment A, n = 28; Treatment 
B, n = 66), the IRC-assessed ORR was 54.3% (95% CI:  43.7, 64.6) and the CRR was 6.4%.  
The median time to response for participants achieving a PR or CR was 8 weeks, with 72.5% of 
the responses occurring at the first disease assessment (Week 8).  The median DOR was 9.3 
(95% CI:  6.2, not estimable) months among responders overall, and the median PFS was 13.8 
(95% CI:  8.8, not estimable) months overall.  Enrollment was ongoing at the time of data cutoff.   
The open-label, multicenter, Phase 2 study INCB 50465-205 is evaluating parsaclisib in 
participants with R/R MCL.  Eligible participants had pathologically confirmed MCL, with 
documentation of either overexpression of cyclin D1 or t(11;14); at least 1 but no more than 
3 prior systemic treatment regimens; and documented failure to achieve at least PR with, or 
documented disease progression after, the most recent treatment regimen.  The primary efficacy 
endpoint is ORR, as determined by a blinded IRC assessment of response according to CT-based 
response criteria for lymphomas.  The study was divided into 2 cohorts:  ibrutinib-experienced 
(Cohort 1) and BTK inhibitor–naive (Cohort 2).  Participants were assigned to receive 20 mg QD 
for 8 weeks followed by either 20 mg QD (Treatment A) or 2.5 mg QD (Treatment B).  In a 
per-protocol interim futility analysis for Cohort 2 (BTK inhibitor–naive, n = 30 participants, data 
cutoff date of 08 JAN 2019), an IRC-assessed ORR of 66.7% (95% CI:  47.2%, 82.7%) and a 
CRR of 16.7% was observed.  The futility boundary was not crossed, and the study continued.  
In an additional ad hoc analysis for Cohort 2 (n = 92 participants, data cutoff date of 
17 JAN 2020), the IRC-assessed ORR was 66.3% (95% CI:  55.7, 75.8) and the CRR was 
15.2%.  The median time to response for participants achieving a PR or CR was 7.9 weeks, with 
88.5% of the responses occurring at the first disease assessment (Week 8).  The median DOR 
was 11.0 (95% CI:  6.6, 14.7) months among responders overall, and the median PFS was 
11.1 (95% CI:  5.8, 16.6) months overall.  Enrollment was ongoing at the time of data cutoff 
(17 JAN 2020). 
In summary, parsaclisib has demonstrated a compelling ORR in these ongoing Phase 2 studies 
with an acceptable safety profile.   

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2.1.4. 
PI3Kδ and CD19/CD20 Combinations 
2.1.5. 
Preclinical  
In vitro experiments on CLL cell line MEC-1 or primary CLL cells showed synergistic potential 
of tafasitamab in combination with idelalisib, a PI3Kδ inhibitor (tafasitamab IB). 
Inhibition of PI3Kδ does not significantly affect the effector mechanisms induced by anti-CD20 
mAbs such as rituximab or obinutuzumab and provides an effective in vivo therapeutic 
combination (Palazzo et al 2018).  Combination treatment of idelalisib and anti-CD20 mAb have 
shown clinical benefit compared to anti-CD20 mAb alone for patients with relapsed CLL in 
Phase 3 studies (Jones et al 2017, Sharman et al 2019).  The combination treatments of idelalisib 
plus rituximab and duvelisib monotherapy are approved for patients with relapsed CLL in the 
United States and European Union. 
2.1.5.1. 
Tafasitamab + Idelalisib  in Relapsed/Refractory Chronic Lymphocytic 
Leukemia (COSMOS Study) 
An open-label, multicenter, Phase 2 study (COSMOS Study, NCT02639910) was performed to 
evaluate the safety and preliminary clinical activity of tafasitamab combined with idelalisib or 
venetoclax in 2 independent cohorts of study participants with R/R CLL who were pretreated 
with a BTK inhibitor.  Tafasitamab 12 mg/kg was administered as an IV infusion weekly for 
Cycles 1 to 3 (with an additional loading dose on Day 4 in Cycle 1), every other week for 
Cycles 4 to 6, and monthly from Cycle 7 onward (with each cycle lasting 28 days). 
As of the data cutoff date of 08 OCT 2019, all 11 participants treated with tafasitamab and 
idelalisib were included in the safety analysis set and experienced TEAEs (244 events).  Most 
TEAEs reported were Grade 1 or 2 severity (181/244 events).  The most common TEAEs were 
anemia (63.6%), dyspnea (54.5%), and cough (54.5%).  The most common ≥ Grade 3 TEAEs 
were hematologic and included neutropenia (45.5%), anemia (27.3%), and thrombocytopenia 
(27.3%).  Eight participants (72.7%) had 19 treatment-emergent SAEs.  Hematologic SAEs 
included anemia (1 patient, Grade 3), thrombocytopenia (1 patient, Grade 3), and pancytopenia 
(1 patient, Grade 2).  The most common nonhematologic SAE was pneumonia (2 patients, 
≥ Grade 3).  Four participants (36.4%) had SAEs suspected to be related to tafasitamab (cardiac 
failure, acute pancreatitis, pneumonia, arthralgia), and 7 participants (63.6%) had SAEs 
suspected to be related to idelalisib (cardiac failure, pneumonia, bronchitis, septic shock, upper 
respiratory tract infection, acute pancreatitis, increased C-reactive protein level, pancytopenia).  
Tafasitamab treatment was interrupted due to TEAEs in 10 participants (90.9%), mainly due to 
IRRs (in 5/11 participants, 45.5%).  The IRRs were Grade 2 in 4 of 5 participants and Grade 3 in 
1 participant.  No participants discontinued tafasitamab permanently due to IRRs.  Idelalisib 
treatment was interrupted due to TEAEs in 9 participants (81.8%), and 5 participants (45.5%) 
permanently discontinued idelalisib due to TEAEs. 
A best response of CR or PR was achieved in 10 of 11 participants (90.9%; CR: n = 1, PR: 
n = 9).   

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2.1.5.2. 
Parsaclisib + Rituximab  in Relapsed/Refractory B-Cell Non-Hodgkin 
Lymphoma (Study CITADEL-112) 
Study INCB 50465-112 (CITADEL-112; NCT03424122) is an ongoing Phase 1, open-label, 
dose-finding study to evaluate the safety and tolerability of parsaclisib combined with rituximab 
and other therapies in participants with previously treated B-cell lymphoma.  As of the data 
cutoff date (30 MAR 2020), 13 participants in this study received the combination of parsaclisib 
20 mg QD for 8 weeks followed by 20 mg QW plus rituximab, and 7 participants remained 
ongoing with treatment.  Treatment-emergent AEs were reported in all 13 participants; the most 
frequently occurring TEAEs were neutropenia (7 participants, 53.8%) and anemia, back pain, 
increased blood creatinine level, diarrhea, hypomagnesemia, and IRR (3 participants each, 
23.1%).  There were no reported fatal TEAEs.  Serious TEAEs occurred in 3 participants 
(23.1%) and included abdominal sepsis, diarrhea, pneumonia, pneumonitis, and streptococcal 
pneumonia in 1 participant (7.7%) each.  A TEAE of diarrhea in 1 participant (7.7%) led to 
parsaclisib discontinuation (parsaclisib IB). 
2.2. 
Study Rationale 
These preliminary data from combinations of tafasitamab with a PI3Kδ inhibitor and parsaclisib 
with an anti-CD20 mAb have demonstrated encouraging efficacy signals with a manageable 
safety profile in patients with B-cell malignancies.  Further examination of the safety, 
tolerability, PK, and efficacy of the combination of tafasitamab and parsaclisib for R/R NHL and 
R/R CLL is required and provides the scientific and clinical rationale for this study. 
This basket study is designed to evaluate the combination treatment of tafasitamab and 
parsaclisib in participants with R/R NHL or CLL.  Both study drugs will be tested at their 
established doses and dosing regimens in 5 different disease cohorts (see Table 4): 
Table 4: 
Disease Cohorts in Basket Study INCMOR 0208-101 
Cohort 1 
R/R DLBCL 
Cohort 2 
R/R MCL 
Cohort 3 
R/R FL 
Cohort 4 
R/R MZL 
Cohort 5 
R/R CLL or SLL 
After confirmation of the safety and tolerability of combination therapy in the dose confirmation 
period of the study (up to n = 10 evaluable participants in each cohort), each cohort will be 
opened separately for inclusion of additional participants in the dose expansion period of the 
study (up to a total of n = 20 evaluable participants in each cohort for both study periods). 
2.2.1. 
Justification for Dose 
The RP2D have been identified for each individual drug that will be combined in this study.  
• Tafasitamab will be administered at 12 mg/kg IV on Days 1, 8, 15, and 22 for 
Cycles 1 to 3; starting with Cycle 4 and continuing through subsequent cycles, 
tafasitamab will be administered at the same 12 mg/kg IV dose only on Days 1 
and 15. 

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• Parsaclisib will be self-administered at a dose of 20 mg QD for 8 weeks, followed by 
a dose of 2.5 mg QD. 
Based on the mechanisms of action of both drugs and previously described results from the 
COSMOS study, the combination of tafasitamab and parsaclisib is not expected to result in 
drug-drug interactions or exacerbate the known safety profile of either individual drug.  
Therefore, full doses of both agents when given as monotherapy will be studied in combination 
in the current study. 
2.3. 
Benefit/Risk Assessment 
Based on the available data from nonclinical and clinical studies of tafasitamab and parsaclisib, 
the potential benefit of combination therapy with both compounds outweighs potential risks.  
Tafasitamab administered at 12 mg/kg with initial weekly administrations as monotherapy or in 
various combination therapies was generally well-tolerated and showed a manageable safety 
profile in the clinical development program of this drug.  Parsaclisib has demonstrated a 
well-tolerated and manageable safety profile in both aggressive and indolent NHL. 
Safety data from clinical trials with tafasitamab monotherapy and combination therapy showed 
that the most frequent AE is IRR, which occurred with tafasitamab in combination with idelalisib 
or venetoclax.  Most of the IRRs were nonserious AEs of Grade 1 or 2, and participants were 
able to complete their dose after intermittent pausing of the infusion and symptomatic treatment.   
Further frequent effects observed during tafasitamab treatment, regardless of causality and 
severity, included hematologic events of neutropenia, thrombocytopenia, anemia, leukopenia, 
and febrile neutropenia and nonhematologic events of diarrhea, nausea, rash, asthenia, peripheral 
edema, headache, upper and lower respiratory tract infection, urinary tract infection, cough, 
dyspnea, pyrexia, fatigue, hypokalemia, and tumor lysis syndrome. 
Adverse events were observed in participants administered parsaclisib monotherapy in 
inflammatory and autoimmune indications (N = 35), with the most common (in ≥ 10% of 
participants) being diarrhea and pyrexia (22.9% each); headache and rash (14.3% each); and 
autoimmune hemolytic anemia, nausea, and peripheral edema (11.4% each).  Parsaclisib has 
effects on the immune system and serious infection events have occurred in patients treated with 
parsaclisib, including PJP, CMV, and COVID-19.  Due to the severity, these events may impact 
the benefit-risk balance of parsaclisib if not managed appropriately.  Furthermore, a 
pharmacological effect of concurrent corticosteroid use or recent rituximab therapy can 
contribute to further immunosuppression, and such effects pose an additional risk of infection.  
In an effort to manage this risk, guidelines for managing serious infections have been 
implemented in this study and include careful monitoring and supportive care measures.  If 
supportive care interventions are unsuccessful and causes other than parsaclisib-related 
infections have been ruled out, then either parsaclisib dose modification or permanent 
discontinuation is recommended.  Participants are required to receive a standard PJP prophylaxis 
regimen while receiving parsaclisib as described in Section 6.7.1.2.  Information regarding the 
additional risks of diarrhea or colitis, neutropenia, and severe cutaneous reactions is outlined in 
the Warnings and Precautions section of the parsaclisib IB.  Dose modification guidance and 
supportive care guidelines for these AEs have been implemented in this study, and participants 
will be closely monitored for evidence of toxicities, including long-term toxicities. 

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More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of parsaclisib may be found in the parsaclisib IB. 
Based on current experience with each compound in combination therapies similar to those in 
this study (tafasitamab + idelalisib in R/R CLL; parsaclisib + rituximab in R/R B-NHL), the 
observed safety profiles of tafasitamab and parsaclisib were consistent with their known safety 
profiles, and no synergistic toxicity is expected in this clinical basket study. 
Considering the hypothesized activity of combination therapy with tafasitamab and parsaclisib in 
each of the diseases to be evaluated in this clinical basket study, and the expected safety profiles 
of tafasitamab and parsaclisib to be consistent with the described safety profiles for each drug, 
the benefit/risk evaluation of this combination is considered favorable and allows the evaluation 
of clinical safety and efficacy in this study. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of tafasitamab and parsaclisib may be found in the tafasitamab IB and parsaclisib 
IB, respectively. 

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3. 
OBJECTIVES AND ENDPOINTS 
Table 5 presents the objectives and endpoints.  All efficacy endpoints will be evaluated 
according to investigator assessment using the Lugano criteria (Cheson et al 2014; see 
Appendix C) for NHL and the iwCLL criteria (Hallek et al 2018; see Appendix D) for CLL.   
A post hoc independent review of radiologic scans and supporting data may be conducted for 
independent efficacy analyses, if appropriate.   
Table 5: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
Dose confirmation period (Phase 1b): 
To determine the safety, tolerability, and DLTs of 
combination therapy with 
tafasitamab + parsaclisib in participants with R/R 
NHL or CLL who have been previously treated 
with at least 2 prior lines of systemic 
antilymphoma therapy. 
Incidence and severity of TEAEs and incidence of 
DLTs. 
Dose expansion period (Phase 2a): 
To assess the preliminary efficacy of combination 
therapy with tafasitamab + parsaclisib in 
participants with R/R NHL or CLL who have 
been previously treated with at least 2 prior lines 
of systemic antilymphoma therapy. 
ORR, defined as the percentage of participants 
having best response of CR/CMR or PR/PMR per 
investigator assessment.   
Secondary 
To estimate the PK of tafasitamab when given as 
combination therapy with parsaclisib. 
PK parameters of tafasitamab when given in 
combination with parsaclisib.  Ctrough (ie, predose), 
Cmax, tmax, Cmin, and AUCt will be summarized by 
descriptive statistics. 
Exploratory 

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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 

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4. 
STUDY DESIGN 
4.1. 
Overall Design 
Key elements of the study design are described in Table 2. 
The overall objective of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to 
evaluate whether the anti-CD19 mAb tafasitamab and the PI3K inhibitor parsaclisib can be 
safely combined at the RP2D and dosing regimen that was established for each of the 
2 compounds as a treatment option for adult participants with R/R B-cell malignancies.   
The safety, tolerability, PK, and preliminary efficacy of combination therapy with tafasitamab 
and parsaclisib will be assessed in a dose confirmation period followed by a dose expansion 
period.  Participants will be assigned to 1 of 5 disease-specific cohorts based on the histology of 
their underlying disease:  
• Cohort 1:  R/R DLBCL 
• Cohort 2:  R/R MCL 
• Cohort 3:  R/R FL 
• Cohort 4:  R/R MZL 
• Cohort 5:  R/R CLL/SLL 
During the dose confirmation period, participants will be enrolled in 1 of the 5 cohorts in a 
parallel fashion.  Each cohort will enroll 10 evaluable participants, and each participant will be 
observed for a DLT evaluation period of 1 cycle (28 days).  Participants must have received at 
least 3 of 4 doses of tafasitamab and 21 days of treatment with parsaclisib 20 mg QD during the 
first cycle (28 days) or have experienced a DLT to be considered evaluable for the dose 
confirmation period.  Participants who are considered not evaluable will be replaced. 
An iDSMB will review data once the 10th DLT-evaluable participant from any cohort completes 
the DLT evaluation period (C1D28 or experiences a DLT).  Reviews will be repeated every 
4 months thereafter.  The occurrence of DLTs in 2 or more of the first 10 DLT-evaluable 
participants will also trigger iDSMB review of overall safety data and specifics from the case. 
The decision to continue enrollment into each of the malignancy subtype cohorts will be based 
on the frequency of DLTs observed in the first 10 evaluable participants and review of ongoing 
safety data.  After the safety review is completed and the dose confirmation decision is made, the 
dose expansion period for that cohort will begin, and up to 10 additional participants will be 
enrolled (up to a total of 20 evaluable participants in each cohort across both study periods; see 
Figure 1). 
Tafasitamab will be administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 
and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward.  Parsaclisib will be 
self-administered at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD 
thereafter. 
No dose escalation will be performed in this study. 

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Study treatment will be administered until progression of disease, withdrawal of consent, or 
unacceptable toxicity (see Section 7.1).  Data on OS will be collected until study completion 
criteria are met (see Section 8.8.3).   
Study assessments are provided in Table 3. 
4.2. 
Overall Study Duration 
The study begins when the first participant signs the study ICF.  The end of the study is defined 
as the date of receipt of the last data point from the last participant that is required for OS 
analysis.   
Up to 28 days are permitted for screening.  Treatment will be administered in consecutive 28-day 
cycles as long as participants are receiving benefit and have not met any criteria for treatment 
discontinuation, and a safety follow-up visit will occur 90 days after the last dose of study drug.  
It is estimated that an individual will participate for approximately 24 months. 
4.3. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator is to notify the IRB/IEC of the study's 
completion or early termination in writing, send a copy of the notification to the sponsor or 
sponsor's designee, and retain 1 copy for the site study regulatory file. 
The sponsor may terminate the study electively if, for example, required by regulatory decision 
or upon advice of the iDSMB (see Section 5.6).  If the study is terminated prematurely, the 
sponsor will notify the investigators, the IRBs and IECs, and the regulatory bodies of the 
decision and reason for termination of the study. 

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5. 
STUDY POPULATION 
Deviations from eligibility criteria are not permitted because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or participant safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential.  Prospective approval of 
Protocol deviations to recruitment and enrollment criteria, also known as Protocol waivers or 
exemptions, are not permitted.   
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Men and women aged ≥ 18 years at the time of consent. 
2. Ability to comprehend and willingness to sign a written ICF and comply with all study 
visits and procedures. 
3. Histologically confirmed R/R B-cell malignancy of the following types: 
a. Cohort 1:  DLBCL not otherwise specified, T-cell/histiocyte-rich large B-cell 
lymphoma, Epstein-Barr virus–positive DLBCL of the elderly, Grade 3b FL, 
high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements 
(double-hit or triple-hit lymphoma), histological transformation from an earlier 
diagnosis of low-grade lymphoma (such as FL, MZL, CLL) into DLBCL 
b. Cohort 2:  MCL with documentation of either overexpression of cyclin D1 or t(11;14) 
c. Cohort 3:  FL Grade 1, 2, and 3a 
d. Cohort 4:  MZL, including extranodal, nodal, and splenic subtypes 
e. Cohort 5:  CLL or SLL 
4. Willingness to undergo biopsy requirements for the study, including an incisional, 
excisional, or core needle lymph node or tissue biopsy (or have archival lymph node or 
tissue from the most recent biopsy) and undergo bone marrow biopsy/aspirate collections 
as appropriate.   
5. Received at least 2 prior systemic treatment regimens as follows: 
a. Cohorts 1 and 2 (DLBCL, MCL):  Must have been previously treated with at least 
1 prior chemoimmunotherapy regimen that included an anti-CD20 antibody.  This 
includes treatments such as chemotherapy plus rituximab or obinutuzumab, with or 
without rituximab or obinutuzumab maintenance.  Note:  At least 6 doses of 
anti-CD20 chemoimmunotherapy must have been given in prior therapy. 
b. Cohorts 3 and 4 (FL, MZL):  Must have been previously treated with at least 1 prior 
chemoimmunotherapy or immunotherapy regimen that included an anti-CD20 
antibody.  This includes treatments such as rituximab or obinutuzumab monotherapy 
or chemotherapy plus rituximab or obinutuzumab, with or without rituximab or 
obinutuzumab maintenance.  Note:  At least 6 doses of anti-CD20 immunotherapy 
must have been given in prior therapy. 
c. Cohort 5 (CLL/SLL):  Must have been previously treated with at least 1 prior 
systemic therapy including a BTK inhibitor regimen or chemoimmunotherapy 
regimen that included an anti-CD20 antibody. 

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6. Relapsed, progressive, or refractory NHL or CLL: 
a. Relapsed:  PD after response of CR to prior therapy. 
b. Progressive:  PD after response of PR or stable disease to prior therapy. 
c. Refractory:  achieved less than PR to the last prior therapy, or achieved a CR or PR 
that lasted < 6 months before PD. 
7. For Cohorts 1 to 4 and Cohort 5/SLL:  radiographically measurable lymphadenopathy or 
extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures 
> 1.5 cm in the longest transverse diameter  and ≥ 1.0 cm in the longest perpendicular 
diameter as assessed by CT or MRI. 
8. ECOG performance status of 0 to 2. 
9. Life expectancy > 3 months.  
10. LVEF ≥ 50%.  
11. Laboratory results at screening as follows: 
a. Hemoglobin level ≥ 8 g/dL (unless secondary to bone marrow involvement by 
NHL/CLL, as demonstrated by recent bone marrow aspiration and bone marrow 
biopsy). 
b. ANC ≥ 1.5 × 109/L (unless secondary to bone marrow involvement by NHL/CLL, as 
demonstrated by recent bone marrow aspiration and bone marrow biopsy). 
c. Platelet count ≥ 75 × 109/L (unless secondary to bone marrow involvement by 
NHL/CLL, as demonstrated by recent bone marrow aspiration and bone marrow 
biopsy). 
d. Total serum bilirubin level ≤ 1.5 × ULN, or ≤ 5 × ULN in cases of Gilbert syndrome 
or documented liver involvement by lymphoma. 
e. ALT, AST, and alkaline phosphatase level ≤ 3 × ULN, or ≤ 5 × ULN in cases of 
documented liver involvement. 
f. Serum creatinine clearance ≥ 50 mL/min either measured or calculated using a 
standard Cockcroft and Gault formula (Cockcroft and Gault 1976). 
12. Willingness to avoid pregnancy or fathering children based on the following criteria. 
a. Male participants with childbearing potential must agree to take appropriate 
precautions to avoid fathering children (with at least 99% certainty) from screening 
through 6 months after the last dose of study treatment and must refrain from 
donating sperm during this period.  Permitted methods that are at least 99% effective 
in preventing pregnancy (see Appendix A) should be communicated to the 
participants and their understanding confirmed. 
b. Female participants with childbearing potential must have a negative serum 
pregnancy test at screening and must agree to take appropriate precautions to avoid 
pregnancy (with at least 99% certainty) from screening through 90 days (or 180 days 
if required by local regulations) after the last dose of study treatment.  They must also 
agree to regular urine pregnancy testing through the study treatment period.  They 
must also refrain from breastfeeding and donating oocytes during the course of the 
study and for 3 months after the last dose of study treatment.  Permitted methods that 
are at least 99% effective in preventing pregnancy (see Appendix A) should be 
communicated to the participants and their understanding confirmed. 

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c. Female participants without childbearing potential (ie, surgically sterile with a 
hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at 
least 50 years of age) are eligible. 
d. Note:  Female participants who have been amenorrheic for at least 12 months 
resulting from chemo/radiotherapy are considered of childbearing potential and 
should agree to use adequate contraceptive measures (see Appendix A). 
5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Any other histological type of lymphoma according to the WHO 2016 classification of 
lymphoid neoplasms, for example, primary mediastinal B-cell lymphoma, Burkitt 
lymphoma, B-cell lymphoma, unclassifiable, with features intermediate between DLBCL 
and classical Hodgkin lymphoma (gray zone lymphoma); primary effusion lymphoma; 
primary cutaneous DLBCL, leg type; intravascular B cell lymphoma. 
2. History of or evidence of CNS lymphoma (primary and secondary). 
3. Any anticancer and/or investigational therapy (eg, chemotherapy, radiation therapy, 
surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization) 
within 30 days or 5 half-lives (whichever is greater) prior to the first dose of study 
treatment (C1D1). 
4. Inadequate recovery (> Grade 1) from toxicity and/or complications from a major surgery 
before C1D1. 
5. Use or expected use during the study of any prohibited medications, including potent 
CYP3A4 inhibitors or inducers, within 14 days or 5 half-lives (whichever is longer) 
before C1D1. 
6. Allogeneic stem cell transplantation within the past 6 months, or ASCT within 3 months 
before C1D1. 
7. Previous treatment with CD19-targeted therapy (eg, CD19-CAR-T therapies, other CD19 
mAbs, including bispecific and antibody-drug conjugates) or PI3K inhibitors. 
8. Treatment with corticosteroids at doses greater than physiologic doses (prednisone 
equivalent dose > 10 mg/day) within 7 days of starting study treatment. 
9. Clinically significant cardiac disease, including unstable angina, acute myocardial 
infarction, New York Heart Association Class II to IV congestive heart failure, 
uncontrolled arrhythmia, and/or cardiac conduction issues, within 6 months of C1D1. 
10. Clinically significant concurrent, uncontrolled medical condition, including, but not 
limited to, renal, hepatic, hematologic, GI, endocrine, pulmonary, neurological, cerebral, 
or psychiatric disease. 
11. Current or previous other malignancy within 3 years of study entry, except cured basal or 
squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, 
or carcinoma in situ of the cervix. 
12. Active graft-versus-host disease. 

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13. History of stroke or intracranial hemorrhage within 6 months before C1D1. 
14. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or 
antiviral treatment within 30 days of C1D1. 
15. Any of the following: 
a. Known positive test result for hepatitis C (HCV antibody serology testing) and a 
positive test result for HCV RNA.  Participants with positive serology must have been 
tested locally for HCV RNA and are eligible in case of negative HCV RNA test 
results. 
b. Known positive test results for chronic HBV infection (defined by HBsAg positivity).  
Participants with occult or prior HBV infection (defined as negative HBsAg and 
positive total HBcAb) may be included if HBV DNA was undetectable (local test 
result), provided that they are willing to undergo ongoing DNA testing.  Antiviral 
prophylaxis may be administered as per institutional guidelines.  Participants who 
have protective titers of HBsAb after vaccination or prior but cured hepatitis B are 
eligible. 
c. Known seropositive for or history of active viral infection with HIV. 
16. Inability to swallow and retain oral medication, malabsorption syndrome, disease 
significantly affecting GI function, total resection of the stomach or small bowel, 
ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel 
obstruction. 
17. History of hypersensitivity to compounds of similar biological or chemical composition 
to tafasitamab, parsaclisib, and/or the excipients contained in the study treatment 
formulations (refer to the tafasitamab IB and the parsaclisib IB for more details). 
18. History of serious allergic reactions, including anaphylaxis and toxic epidermal 
necrolysis. 
19. History or evidence of interstitial lung disease. 
20. Exposure to vaccination with live vaccine within 30 days prior to C1D1, or anticipated 
need for such vaccination during treatment.   
21. Currently pregnant or breastfeeding. 
22. Any condition that would, in the investigator's judgment, interfere with full participation 
in the study, including administration of study treatment and attending required study 
visits; pose a significant risk to the participant; or interfere with interpretation of study 
data. 
5.3. 
Lifestyle Considerations 
No restrictions to diet or lifestyle are required.   
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but do 
not subsequently receive study treatment.   

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Tests with results that fail eligibility requirements may be repeated once during screening if the 
investigator believes the result to be in error.  Additionally, a participant who fails screening may 
repeat the screening process 1 time if the investigator believes there has been a change in 
eligibility status.  Participants who rescreen must reconsent and be assigned a new participant 
number. 
5.5. 
Replacement of Participants 
Participants who do not experience a DLT and do not receive at least 3 doses of tafasitamab and 
21 days of treatment with parsaclisib 20 mg QD will be replaced to ensure that there are 
10 evaluable participants within each disease-specific cohort. 
5.6. 
Data Safety Monitoring Board 
An iDSMB will review data once the 10th DLT-evaluable participant from any cohort completes 
the DLT evaluation period (C1D28 or experiences a DLT).  Reviews will be repeated every 
4 months thereafter.  The occurrence of DLTs in 2 or more of the first 10 DLT-evaluable 
participants will also trigger an iDSMB review.  Details regarding the composition and 
responsibilities of the iDSMB are provided in the charter. 

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6. 
STUDY TREATMENT 
6.1. 
Study Treatments Administered 
Table 6 presents the study treatment information. 
Table 6: 
Study Treatment Information 
 
Study Drug 1 
Study Drug 2 
Study drug: 
Tafasitamab 
Parsaclisib 
Mechanism of action: 
Dosage formulation: 
Unit dose strength(s)/ 
dosage level(s): 
Administration 
instructions: 
Packaging and 
labeling: 
Storage: 
Status of treatment in 
participating 
countries: 
6.2. 
Preparation, Handling, and Accountability 
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatments received and any discrepancies are reported and 
resolved before use. 
Only participants enrolled in the study may receive study treatment, and only authorized site 
staff may supply or administer study treatment.  All study treatment must be stored in a secure, 

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environmentally controlled, and monitored (manual or automated) area in accordance with the 
labeled storage conditions with access limited to the investigator or authorized site staff. 
The investigator (or designee) is responsible for study treatment accountability, reconciliation, 
and record maintenance (ie, receipt, reconciliation, and final disposition records).  Inventory and 
accountability records must be maintained and readily available for inspection by the study 
monitor and are open to inspection at any time by any applicable regulatory authorities.  The 
investigator or designee must maintain records that document the following: 
• Delivery of study drugs to the study site. 
• Inventory of study drugs at the site. 
• Participant use of the study drugs, including pill and vial counts from each supply 
dispensed. 
• Lot numbers and/or vial numbers of study drug. 
• Return of study drug to the investigator or designee by participants   
The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the participants were provided the 
specified study drug.  These records should include dates, quantities, and any available batch or 
serial numbers or unique code numbers assigned to the investigational product and study 
participants. 
Completed accountability records will be archived by the site.  The investigator or designee will 
be expected to collect and retain all used, unused, and partially used containers of study drug 
until verified by the study monitor (unless otherwise agreed to by the sponsor).  At the 
conclusion of the study, the investigator or designee will oversee shipment of any remaining 
study drug back to the sponsor or its designee for destruction according to institutional SOPs.  If 
local procedures mandate on-site destruction of the investigational supply, the site should (where 
local procedures allow) maintain the investigational supply until the study monitor inspects the 
accountability records in order to evaluate compliance and accuracy of accountability by the 
investigative site.  At sites where the study drug is destroyed before monitor inspection, the 
monitors rely on documentation of destruction per the site SOP. 
6.2.1. 
Tafasitamab 
Tafasitamab will be dosed at 12 mg/kg based on actual body weight via IV infusion.  
Tafasitamab will be administered on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 
and 15 of each 28-day cycle from Cycle 4 onward.  Lyophilized powder must be reconstituted 
and diluted prior to infusion. 

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6.2.1.1. 
Reconstitution 
Reconstitution of tafasitamab should be performed as follows: 
6.2.1.2. 
Dilution 
Dilution of tafasitamab should be performed as follows: 
6.2.1.3. 
Administration 

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6.2.2. 
Parsaclisib 
Participants will self-administer parsaclisib as an oral treatment.  Parsaclisib will be administered 
as 20 mg QD for 8 weeks followed by 2.5 mg QD. 
Parsaclisib should be taken at approximately the same time each day.   
Administration of parsaclisib will be calendar-based.  Delays or interruptions in study treatment 
will not affect the dosing schedule of parsaclisib; 20 mg QD will be administered only during the 
first 8 weeks (Days 1-56); all participants will switch to 2.5 mg QD on Day 57. 
Treatment with parsaclisib will continue until a criterion is met for treatment discontinuation. 
Parsaclisib will be administered in the study clinic on days when blood samples are collected for 
PK as indicated in Table 3 and Section 8.4. 
See Appendix F for instructions to participants for handling parsaclisib. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
All participants will be centrally assigned to study treatment using an IRT system.  Instructions 
for the IRT system will be provided to each site prior to study initiation.  Full details will be 
provided in the IRT Manual. 
Study treatment will be dispensed and administered at the study visits in accordance with the 
SoA in Table 3.  Returned study treatment should not be redispensed. 
This is an open-label study; there is no randomization, and no comparisons will be made between 
participants or against historical controls.  Measurements of safety and efficacy are objective 
measurements, and only comparisons to pretreatment conditions will be made. 
6.4. 
Study Treatment Compliance 
Compliance with all study-related treatments should be emphasized to the participant by site 
personnel, and appropriate steps should be taken to optimize compliance during the study.  
Compliance with parsaclisib will be calculated by the sponsor based on the drug accountability 
(eg, tablet counts) documented by the site staff and monitored by the sponsor/designee.  
Participants will be instructed to bring all unused study drugs with them to the study visits in 
order for site personnel to conduct tablet counts to assess study drug accountability.   
Compliance with tafasitamab administration will be calculated by the sponsor based on study 
drug accountability and infusion records documented by the site staff and monitored by the 
sponsor/designee. 
6.5. 
Dose-Limiting Toxicity and Determination of the Recommended 
Phase 2 Dose 
6.5.1. 
Definition of a Dose-Limiting Toxicity 
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities in Table 7 up to 
and including Day 28 (Cycle 1/Day 28), except those with a clear alternative explanation.  All 
DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.   

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During the DLT evaluation period, participants who receive at least 3 of 4 doses of tafasitamab 
and 21 days of parsaclisib 20 mg QD or have a DLT will be considered evaluable for the dose 
confirmation period. 
Dose reductions for individual participants may be made based on events observed at any time 
during the treatment period; however, for the purposes of opening each expansion cohort, 
decisions will be made based on events that are observed from the first day of study treatment 
administration through and including the final day of Cycle 1 (Cycle 1/Day 28). 
An event clearly associated with the underlying disease, disease progression, a concomitant 
medication, or comorbidity will not be considered a DLT. 
Table 7: 
Definition of Dose-Limiting Toxicity 
Toxicity 
Definition 
Nonhematologic 
• Any liver function abnormalities that meet the definition of Hy's lawa. 
• ≥ Grade 4 tumor lysis syndrome or Grade 3 tumor lysis syndrome requiring 
dialysis. 
• ≥ Grade 4 fatigue lasting for ≥ 7 days. 
• ≥ Grade 4 IRR. 
• ≥ Grade 3 CRS. 
• Any other ≥ Grade 3 nonhematologic toxicity except nausea, vomiting, 
electrolyte abnormality, or liver function abnormality 
Hematologic 
• ≥ Grade 3 hematologic toxicities lasting for > 3 days excluding neutropenia and 
lymphocytopenia (also excluding thrombocytopenia in Groups 3 and 5). 
• Grade 4 neutropenia (ANC < 0.5 × 109/L) lasting for ≥ 7 days in participants 
with pretreatment ANC > 1 × 109/L under appropriate use of G-CSF (if G-CSF 
is required to manage neutropenia, the neutropenia is considered a DLT in 
Cohorts 1 and 2). 
• Grade ≥ 4 thrombocytopenia in Cohorts 3 and 5. 
• Febrile neutropenia. 
General 
• Any death not clearly due to the underlying disease or extraneous causes. 
• Any toxicity other than described above that (in the opinion of the investigator) 
is potentially life-threatening and cannot be controlled with standard measures. 
• Any other toxicity that a primary investigator and the sponsor agree on being 
reported as a DLT. 
a Hy's law is defined as 1) ALT or AST elevation > 3 × ULN, 2) total bilirubin > 2 × ULN without initial findings of 
cholestasis (elevated serum alkaline phosphatase), and 3) no other apparent possible causes of aminotransferase 
elevation and hyperbilirubinemia, including but not limited to viral hepatitis, pre-existing chronic or acute liver 
disease, or the administration of other drug(s) known to be hepatotoxic. 
6.5.2. 
Procedures for Cohort Review 
Telephone conferences will be scheduled by the sponsor with study investigators to review 
cohort-specific data and overall safety data, to adjudicate individual high-grade AEs as 
potentially dose-limiting, and guide other major study decisions. 
The decision to continue enrollment into each of the malignancy subtype cohorts will be based 
on the frequency of DLTs in the first 10 DLT-evaluable participants and review of ongoing 

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safety data.  After the safety review is completed and the dose confirmation decision is made, the 
dose expansion period for that cohort will begin, and up to 10 additional participants will be 
enrolled (up to a total of 20 evaluable participants in each cohort across both study periods). 
6.5.3. 
Dose-Limiting Toxicity Stopping Rules 
Participants in each of the disease-specific cohorts will be assessed for safety and tolerability 
using a continuous monitoring approach.   
During the dose confirmation period, the occurrence of a DLT in ≥ 2 participants in a 
disease-specific cohort will trigger an iDSMB review.  Enrollment will be halted in only that 
specific cohort until the iDSMB review is complete and the determination to continue enrollment 
(with or without protocol modifications) is made.  The iDSMB review will result in nonbinding 
recommendations on further study conduct, that is, continue without modifications, continue 
with modifications, or terminate enrollment in the cohort.  Please refer to the iDSMB charter for 
additional details.   
Any DLT should be monitored until it resolves to baseline or appears to have stabilized for a 
minimum of 7 days.  Participants should be seen as often as medically indicated to ensure 
appropriate management of the event. 
6.6. 
Dose Modifications 
Treatment interruptions and modifications may occur for individual study participants. 
6.6.1. 
Management of Dose-Limiting Toxicities or Other Urgent Situations 
Investigators may employ any measures or concomitant medications necessary to manage a DLT 
or other urgent situation after discussion with the sponsor (whenever possible). 
6.6.2. 
Criteria and Procedures for Dose Interruptions and Adjustments of Study Drug 
Safety concerns should be discussed with the sponsor immediately upon occurrence or awareness 
of an event that may affect whether or not a participant should continue on study treatment. 
Adverse events that have a clear alternative explanation or transient (≤ 72 hours) abnormal 
laboratory values without associated clinically significant signs or symptoms may be exempt 
from dose reduction rules. 
Because participants may enter the study with extensive pretreatment and/or severe bone marrow 
infiltration by the primary disease, dose modifications listed in Table 8 are provided as general 
guidance.  Individual decisions regarding dose reduction should be made using clinical judgment 
and in consultation with the sponsor's medical monitor, taking into account relatedness of the AE 
to the study drug(s) and the participant's underlying condition.   

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Table 8: 
Guidelines for Interruption and Restarting of Study Treatment 
Adverse Event 
Value or Grade 
Recommendation 
Grade 3/4 neutropenia 
judged to be related to 
study drugs 
ANC decreases to < 1.0 × 109/L for at 
least 7 days 
     OR 
ANC decreases to < 1.0 × 109/L with an 
associated body temperature ≥ 38.5°C 
(101.3°F) 
     OR 
ANC decreases to < 0.5 × 109/L  
Interrupt tafasitamab and parsaclisib 
dosing.   
Follow CBC every 7 days.   
Growth factors (eg, G-CSF) and 
antimicrobial prophylaxis are to be used, 
as per local guidelines. 
ANC returns to ≥ 1.0 × 109/L 
Provided all other criteria are fulfilled, 
resume dosing of tafasitamab and/or 
parsaclisib at the same dose. 
Monitor as clinically indicated. 
Grade 2-4 
thrombocytopenia judged 
to be related to study 
drugs 
Platelet count decreases to < 75 × 109/L  
Interrupt tafasitamab and parsaclisib 
dosing.   
Follow CBC every 7 days. 
Platelet count decreases to ≥ 75 × 109/L 
Provided all other criteria are fulfilled, 
resume dosing of tafasitamab and/or 
parsaclisib at the same dose. 
Monitor as clinically indicated. 
Other clinically 
significant toxicities 
judged to be related to 
study drugs 
Grade 3 
Interrupt the administration of the study 
drug(s) to which the toxicity is judged to 
be related to up to 28 days until the 
toxicity has resolved to ≤ Grade 1. 
Toxicities resolve to ≤ Grade 1 
Restart tafasitamab and parsaclisib at the 
same doses.  If assessed as related to 
parsaclisib, restart at the next lower dose 
of parsaclisib (see Table 11). 
Monitor as clinically indicated. 
Recurrent Grade 3 after 2 dose 
reductions of parsaclisib 
Discontinue tafasitamab and parsaclisib 
administration and follow-up per 
Protocol.  Exceptions require approval of 
sponsor.   
Grade 4 
Discontinue tafasitamab and parsaclisib 
administration and follow-up per 
Protocol.  Exceptions require approval of 
sponsor.   
CBC = complete blood count.   
Note:  If, based on medical judgment, the treating physician considers a laboratory parameter change or AE not to be a study 
drug– related toxicity, but to represent a natural fluctuation in or progression of the underlying disease, then it is at the 
physician's discretion and assessment of the individual risk/benefit ratio to determine whether the participant should be dosed.  
The decision and rationale behind the decision should be documented in the source data. 

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6.6.2.1. 
Tafasitamab Dose Modifications for Cytokine Release Syndrome and 
Infusion-Related Reactions 
Dose reductions of tafasitamab are not permitted.  Drug interruptions or discontinuation may 
occur in the case of severe IRRs, allergic reactions, infections, febrile neutropenia, or severe 
hematologic toxicity.  Delaying the tafasitamab dose is permitted for no more than 2 days (eg, if 
dosing was planned on Day 8, delaying that dose is allowed up to Day 10).  Alternatively, an 
infusion of tafasitamab may be skipped completely, and the next scheduled dose will be 
administered (eg, if an infusion is skipped on Day 8, the next dose will be administered on 
Day 15).  In the event tafasitamab administration is interrupted due to toxicity, other regularly 
scheduled assessments should still be performed.   
Some mAb treatments in NHL have been associated with Grade 3 IRRs during the first infusion 
in participants.  These IRRs have been ameliorated or eliminated by fractionating the dose into 
2 infusions separated by at least 24 hours.  If the full dose of tafasitamab cannot be administered 
in 1 day, the dose may be split into a second administration that must be given on the subsequent 
day.  After the occurrence of a first-dose Grade 3 IRR, the next 3 infusions for this participant 
will be split:  one-third of the dose administered on the original schedule followed by the 
remaining two-thirds on the next day, with each infusion administered over 2 hours.  If there are 
no IRRs with the 3 consecutive split infusions, then the investigator can consider reverting to a 
single 2-hour infusion for the subsequent infusions. 
Infusion-related reactions have commonly been reported for participants with CLL or NHL 
treated with tafasitamab.  Infusion-related reaction will be defined according to the NCI CTCAE 
v5.0 definition of IRR and CRS.  Table 9 provides guidance for the management of IRRs by 
grade.   
Table 9: 
Management of Infusion-Related Reactions/Cytokine Release Syndrome 
IRR Grade 
CRS Grade 
Interventions 
2 
1 
The infusion should be stopped immediately. 
The participant should receive appropriate treatment with an 
antihistamine and/or acetaminophen or methylprednisolone (or 
equivalent) as clinically indicated. 
Once the symptoms have been resolved or reduced to Grade 1 (IRR 
only) according to investigator assessment, the infusion can be 
continued at an infusion rate of 50% of the speed so far.  If, after 1 hour, 
the participant's symptoms do not return and vital signs are stable, the 
infusion rate may be increased every 30 minutes, as tolerated, to the 
baseline rate. 
If a participant who developed a Grade 2 IRR or Grade 1 CRS receives 
further infusions of tafasitamab, then premedication should be given 
before all subsequent infusions of tafasitamab throughout the study. 

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Table 9: 
Management of Infusion-Related Reactions/Cytokine Release Syndrome 
(Continued) 
IRR Grade 
CRS Grade 
Interventions 
3 
2 
The infusion should be stopped immediately. 
The participant must receive appropriate treatment with an antihistamine 
and/or acetaminophen or methylprednisolone (or equivalent) and, if 
necessary, further medications (ie, epinephrine, bronchodilator). 
After the complete resolution of all symptoms, and after having received 
appropriate prophylactic medication(s) as described above, the infusion 
may be resumed at an infusion rate of 25% of the speed so far.  If, after 
1 hour, the participant's symptoms do not return and vital signs are 
stable, the infusion rate may be increased to a maximum of 50% of the 
baseline speed.   
If, after the resumption of the infusion, symptoms return (irrespective of 
grade), the infusion must be stopped immediately and the infusion 
tubing should be disconnected from the participant.  Based on the 
investigator's decision, the participant may receive further tafasitamab 
provided clinically appropriate precautions were undertaken. 
If a participant who developed a Grade 3 IRR or Grade 2 CRS receives 
further infusions, then premedication should be given before all 
subsequent infusions of tafasitamab throughout the study.   
If precluded from further tafasitamab administrations, the participant 
may continue treatment with parsaclisib.   
4 
3 or 4 
The infusion should be stopped immediately and the infusion tubing 
should be disconnected from the participant. 
The participant must receive appropriate treatment with an antihistamine 
and/or acetaminophen or methylprednisolone (or equivalent) and, if 
necessary, further medications (ie, epinephrine, bronchodilator). 
The participant must not receive any further tafasitamab infusions but 
may continue treatment with parsaclisib as per protocol. 
6.6.2.2. 
Dose Modifications for Parsaclisib 
Dose modification guidance for AEs that have been previously observed in participants receiving 
parsaclisib or are potential class-effect AEs are provided in Table 10.   
The starting dose and dose reduction levels of parsaclisib are provided in Table 11 and Table 12. 

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Table 10: 
Toxicity Management Guidelines for Parsaclisib 
Adverse Event 
Recommendation 
Chemistry 
AST and/or ALT is Grade 3 
(> 5.0 × ULN). 
Note:  In participants with liver 
metastasis–related elevations at 
baseline, contact sponsor to 
discuss clinical management. 
Step 1:  Interrupt both tafasitamab and parsaclisib.  Monitor 
weekly until the toxicity has resolved to ≤ Grade 1 
(< 3.0 × ULN). 
Step 2:  Restart tafasitamab at the same dose and parsaclisib at 
next lower dose with medical monitor approval.  Monitor as 
clinically indicated. 
Other toxicities 
Diarrhea (Grade 1) 
Step 1:  Treat with antimotility agents (eg, 2 mg loperamide 
followed by 2 mg every 4 hours or after every unformed stool) 
and initiate supportive care.  Monitor approximately every 
48 hours until resolved.  If not improved after 48 hours, treat per 
guidance for Grade 2. 
Diarrhea (Grade 2) 
Step 1:  Interrupt tafasitamab and parsaclisib.  Perform workup 
for infection (including CMV, Clostridium difficile, etc) 
immediately.  Initiate or continue supportive care.  Monitor 
approximately every 48 hours until resolution. 
Step 2:  If improved within 48 hours and/or infection* is 
confirmed, restart tafasitamab and parsaclisib at the same 
schedule and dose after resolved to ≤ Grade 1 and continue to 
monitor. 
*For infectious diarrhea/colitis, follow institutional standard of 
care guidelines and restart parsaclisib according to clinical 
judgment after resolved to ≤ Grade 1.  Consult with medical 
monitor if needed. 
Step 3:  If not improved within 48 hours and infection is ruled 
out, start oral steroids, or consider IV steroids if participant is 
being given IV fluids.  If no improvement with oral steroids, 
switch to IV steroids. 
Step 4:  When diarrhea resolves to ≤ Grade 1, continue 
supportive care and taper steroids according to institutional 
standards of care.  When taper is complete (eg, no steroid or 
≤ 10 mg/day prednisolone or equivalent) and diarrhea is 
≤ Grade 1, restart parsaclisib at the next lower dose with approval 
of the medical monitor. 
Step 5:  If Grade 2 diarrhea reoccurs, treat per guidance for 
diarrhea (≥ Grade 3)/noninfectious colitis. 
Step 6:  If ≥ Grade 2 diarrhea reoccurs a third time, permanently 
discontinue parsaclisib. 

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Table 10: 
Toxicity Management Guidelines for Parsaclisib (Continued) 
Adverse Event 
Recommendation 
Diarrhea (≥ Grade 3) 
Noninfectious colitis (any grade; 
confirmed or suspected) 
Step 1:  Interrupt tafasitamab and parsaclisib.  Perform workup 
for infection (including CMV, C difficile, etc) immediately.  
Initiate or continue supportive care.  Consider colonoscopy with 
biopsy for diarrhea ≥ Grade 3 and/or if symptomsa are suggestive 
of colitis.  Monitor every 48 hours until resolution. 
Step 2:  If infection* is ruled out, start oral steroids, or consider 
IV steroids if participant is being given IV fluids.  If no 
improvement with oral steroids within 48 hours, switch to IV 
steroids. 
*For infectious diarrhea/colitis, follow institutional standard of 
care guidelines and restart parsaclisib according to clinical 
judgment after resolved to ≤ Grade 1.  Consult with medical 
monitor if needed. 
Step 3:  When diarrhea/colitis resolves to ≤ Grade 1, continue 
supportive care and taper steroids according to institutional 
standards of care.  When taper is complete (eg, no steroid or 
≤ 10 mg/day prednisolone or equivalent) and diarrhea/colitis is 
≤ Grade 1, restart tafasitamab and parsaclisib as described herein 
and with approval of the medical monitor.  Continue to monitor. 
Step 4:  If ≥ Grade 3 diarrhea/colitis (any grade) reoccurs, 
permanently discontinue parsaclisib. 
Pneumonitis (Grade 1) 
Step 1:  Interrupt tafasitamab and parsaclisib until the toxicity 
has resolved. 
Step 2:  Restart tafasitamab at the same dose and parsaclisib at 
next lower dose.  Monitor as clinically indicated. 
Pneumonitis (≥ Grade 2) 
Permanently discontinue tafasitamab and parsaclisib. 
Skin toxicity (eg, rash, pruritus, 
etc, unless otherwise specified) 
(Grade 2-3) 
Step 1:  Interrupt tafasitamab and parsaclisib until the toxicity 
has resolved to ≤ Grade 1. 
Step 2:  Restart tafasitamab and parsaclisib at the same dose.  If 
assessed as related to parsaclisib, restart at the next lower dose. 
Exfoliative dermatitis (Grade 1) 
Step 1:  Interrupt tafasitamab and parsaclisib until the toxicity 
has resolved. 
Step 2:  Restart tafasitamab at the same dose and parsaclisib at 
the next lower dose.  Monitor as clinically indicated. 
Exfoliative dermatitis (≥ Grade 2) 
Permanently discontinue tafasitamab and parsaclisib. 
Intestinal perforation (any grade) 
Permanently discontinue tafasitamab and parsaclisib. 
PJP infection 
Interrupt tafasitamab and parsaclisib.  Permanently discontinue 
tafasitamab and parsaclisib if PJP infection is confirmed. 

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Table 10: 
Toxicity Management Guidelines for Parsaclisib (Continued) 
Adverse Event 
Recommendation 
CMV infection 
Participants with CMV viremia without associated clinical signs 
of CMV infection should be carefully monitored.  Consider 
interrupting tafasitamab and parsaclisib for participants with 
CMV viremia and clinical signs of infection until the infection 
has resolved.  Restart tafasitamab at the same dose and 
parsaclisib reduced by 1 dose level if approved by the medical 
monitor. 
Varicella zoster infection 
Interrupt tafasitamab and parsaclisib.  Restart tafasitamab and/or 
parsaclisib only by approval of the medical monitor. 
Any Grade 1 or Grade 2 toxicity 
unless otherwise specified 
Continue tafasitamab and parsaclisib.  Treat the toxicity; monitor 
as clinically indicated. 
a Diarrhea accompanied by abdominal pain and/or mucus or blood in stool. 
Table 11: 
Dose Levels for Parsaclisib 
Dose, C1D1 to C2D28 
(Day 1 to Day 56) 
Dose, C3D1 to EOT 
(Day 57 to EOT) 
Starting dose 
20 mg QD 
2.5 mg QD 
First dose reduction 
10 mg QD 
1 mg QD 
Second dose reduction 
5 mg QD 
Not applicable 
6.6.2.3. 
Supportive Care Guidelines for Diarrhea/Colitis  
Participants should be instructed to immediately report any event of diarrhea, irrespective of 
grade.  Treatment with parsaclisib may be modified according to the guidelines in Table 12 to 
allow for resolution of diarrhea/colitis.   
Participants should receive appropriate supportive care measures as deemed necessary by the 
investigator.  For any ≥ Grade 1 diarrhea, participants should be advised to drink liberal 
quantities of clear fluids.  If sufficient oral fluid intake is not feasible, fluid and electrolytes 
should be substituted via IV infusion.  Participants should try to eat 5 to 6 small meals per day; 
low-fat, high-protein foods; and cooked instead of raw vegetables.  Participants may supplement 
their diet with bananas, rice, applesauce, and toast to reduce the number of bowel movements 
and may also try crackers, gelatin, noodles, or oatmeal.  Participants should avoid fried, fatty, 
greasy, or spicy foods; milk, milk products, and acidic drinks; high-fiber foods and foods that 
cause gas; and alcohol, caffeine, and herbal supplements. 
For each occurrence, attempts should be made to rule out other causes, such as metastatic disease 
or bacterial or viral infections (including CMV), which might require additional supportive care.   
It may be necessary to perform additional procedures, such as colonoscopy with biopsy, as part 
of evaluation of the event.  Note that several courses of steroid tapering may be necessary 
because symptoms may worsen when the steroid dose is decreased.  Any procedure performed 
must be captured in the appropriate eCRF.   

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Participants should be carefully monitored for signs and symptoms of enterocolitis (such as 
diarrhea, abdominal pain or cramping, blood or mucus in stool, with or without fever) and of 
bowel perforation (such as peritoneal signs and ileus). 
Table 12: 
Dose Modifications for Parsaclisib for Diarrhea/Colitis 
Parsaclisib Current Dose  
Dose Modification  
≥ 2.5 mg QD  
20 mg QW 
1 mg QD  
20 mg QW or 10 mg QW 
20 or 10 mg QW  
Restart next lower dose 
10 mg QW or 5 mg QW 
5 mg QW  
Permanently discontinue 
6.6.2.4. 
Supportive Care Guidelines for Neutropenia and Thrombocytopenia  
Neutropenia and thrombocytopenia are known adverse reactions for tafasitamab and also appear 
to be PI3Kδ class-effect toxicities.  Investigators should ensure that participants understand the 
need to seek medical care when they have conditions that could become life-threatening in the 
presence of cytopenias (eg, neutropenic fever or bleeding with low platelet count).  Participants 
should be instructed to report immediately any signs of infection, unexpected bleeding, or 
sudden, extremely painful headaches. 
6.6.2.5. 
Management of Hypogammaglobulinemia 
Hypogammaglobulinemia induced by depletion of normal B-cells is a potential on-target toxicity 
of the anti-CD19 mAb tafasitamab.  In the clinical development program for tafasitamab, cases 
of hypogammaglobulinemia have been observed as follows: 
• In 3 studies with tafasitamab monotherapy (XmAb5574-01 [NCT01161511] in R/R 
CLL, MOR208C201 [NCT01685008] in R/R NHL, and MOR208C202 
[NCT01685021] in R/R B-cell acute lymphoblastic leukemia), 2 of 141 total 
participants (1.4%) experienced Grade 2 hypogammaglobulinemia. 
• In Study L-MIND (MOR208C203 [NCT02399085] in R/R DLBCL), 5 of 81 
participants (6.2%) experienced hypogammaglobulinemia (Grade 1: n = 3, Grades 2 
and 3: n = 1 each), with 2 of these cases (2.5%; Grade 1: n = 1, Grade 3: n = 1) 
occurring during the combination treatment phase with tafasitamab + lenalidomide. 
In this study, immunoglobulin levels (IgG, IgA, IgM) will be measured at the timepoints listed in 
Table 3.  Study participants experiencing hypogammaglobulinemia should be managed in 
accordance with local guidelines. 

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6.6.3. 
Criteria for Permanent Discontinuation of Study Drug 
The occurrence of unacceptable toxicity will require that the study drug be permanently 
discontinued.  Unacceptable toxicity is defined as follows: 
• The occurrence of an AE related to the study drug that, in the judgment of the 
investigator or the sponsor's medical monitor, compromises the participant's ability to 
continue study-specific procedures or is considered not to be in the participant's best 
interest. 
• A persistent AE requiring a delay of study treatment for more than 14 days unless a 
greater delay has been approved by the sponsor. 
6.7. 
Concomitant Medications and Procedures 
All concomitant medications and treatments (including over-the-counter or prescription 
medicines, vitamins, vaccines, and/or herbal supplements) must be recorded in the eCRF.  Any 
prior medication received up to 28 days before the first dose of study treatment and 90days after 
the last dose of study treatment, or until the participant begins a new anticancer therapy, 
whichever occurs first, will be recorded in the eCRF.  Any change in the dose of these 
medications will also be recorded.  Concomitant medications administered for treatment of SAEs 
should be recorded even if the SAE is reported beyond 90 days after the last dose of study 
treatment.  Concomitant treatments/procedures that are required to manage a participant's 
medical condition during the study will also be recorded in the eCRF.  The medical monitor 
should be contacted if there are any questions regarding concomitant or prior therapy. 
6.7.1. 
Permitted Medications and Procedures 
6.7.1.1. 
Premedication for Tafasitamab Infusions/Infusion-Related Reaction Prophylaxis 
Tafasitamab infusions should be administered to participants after premedication with oral 
acetaminophen (eg, 650-1000 mg), an antihistamine such as diphenhydramine hydrochloride 
(eg, 50-100 mg), and glucocorticosteroids (eg, 100 mg IV prednisone or prednisolone or 
equivalent) 30 to 60 minutes prior to starting each infusion. 
Premedication is mandatory for the first 3 doses.  For participants who do not experience 
≥ Grade 2 IRRs or ≥ Grade 1 CRS to tafasitamab during the first cycle, premedication will be 
optional for subsequent antibody infusions at the discretion of the investigator.  Otherwise, 
premedication should be continued for subsequent administrations. 
6.7.1.2. 
Pneumocystis jirovecii Pneumonia Prophylaxis  
All participants are required to receive a standard PJP prophylaxis regimen which is determined 
by the investigator.  Examples of standard PJP prophylaxis therapies for this population include 
trimethoprim-sulfamethoxazole, atovaquone, dapsone (diaminodiphenyl sulfone) with or without 
pyrimethamine, and pentamidine (NCCN 2021).  Because of reports of cross-sensitivity between 
sulfonamides and dapsone, all participants who have a known or suspected allergy to 
sulfonamides must receive either inhaled pentamidine or atovaquone for PJP prophylaxis.  
Prophylaxis should be given while participants are receiving study treatment and should continue 
for at least 2 to 6 months after the last dose of study treatment. 

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Pneumocystis jirovecii pneumonia prophylaxis will be locally sourced and reimbursed by the 
sponsor.  The contents of the label will be in accordance with all applicable regulatory 
requirements.  Further details are available in the Pharmacy Manual. 
6.7.1.3. 
Supportive Care Measures 
Supportive care should be administered to participants as per the institutional policy at the site 
for the standard therapy that the participant will receive.  Additional information may be 
available in the appropriate package inserts.  This includes the use of prophylactic growth 
factors, which should be based on the American Society of Clinical Oncology guidelines for the 
use of prophylactic growth factors (Smith et al 2015) and the investigator's clinical judgment. 
6.7.2. 
Prohibited Medications and Procedures 
6.7.2.1. 
Anticancer Therapy 
No radiotherapy (including limited-field radiotherapy) is permitted after the screening PET/CT 
scan for initial disease assessment has been performed. 
The use of concurrent antineoplastic therapies, including but not limited to chemotherapies, 
hormonal therapy, immunotherapy, biological response modifiers, mAbs with or without 
conjugation, radioisotope therapies, stem cell transplant, and targeted small molecules, is not 
permitted during the treatment period of this study. 
After disease progression has been reported, additional antineoplastic therapies are permitted at 
the discretion of the investigator and in accordance with the local treatment guidelines.  New 
antineoplastic therapy should be recorded in the eCRF as appropriate.   
6.7.2.2. 
Live Vaccines 
Because of the immunosuppressive effects of study treatment, administration of any live vaccine 
is not recommended during the treatment period and at least 6 months after EOT.  Thereafter, the 
decision to administer live vaccines is at the investigator's discretion.   
6.7.2.3. 
Potent CYP3A4 Inhibitors and Inducers 
Use of potent inhibitors and inducers of CYP3A4 is prohibited (see Appendix E).  Based on the 
low overall bioavailability of topical ketoconazole, there are no restrictions on topical 
ketoconazole.   
6.7.3. 
Restricted Medications and Procedures  
Restricted medications and procedures include the following:  
• Outside of tafasitamab infusion prophylaxis, the use of systemic corticosteroid doses 
≤ 10 mg/day prednisone (or equivalent) is permitted but discouraged from the 
screening visit through EOT.   
• Outside of tafasitamab infusion prophylaxis, short courses of systemic corticosteroid 
doses > 10 mg/day prednisone or equivalent are permitted only in the case of severe 
or life-threatening complications that cannot be controlled with other drugs but are 
otherwise discouraged from the screening visit through EOT.   

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• The use of moderate inhibitors and inducers of CYP3A4 (see Appendix E) is 
permitted with caution.   
• Localized radiotherapy will be permitted if administered as treatment for pain or 
impending compression fractures and with prior approval of the medical monitor.   
6.8. 
Treatment After the End of the Study 
Participants who are receiving continued benefit at the end of the study may be transferred to a 
company-sponsored rollover study after completion of this study. 
7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
The decision to discontinue study treatment will not constitute study completion.  If study 
treatment is discontinued, the treatment period will be considered complete, and the follow-up 
period will begin.   
7.1.1. 
Reasons for Discontinuation 
Participants must be discontinued from study treatment for the following reasons: 
• The participant becomes pregnant.   
• Progression of disease per Lugano criteria (Cheson et al 2014) for NHL or the iwCLL 
criteria (Hallek et al 2018) for CLL. 
• Initiation of new anticancer therapy.   
• Consent is withdrawn.   
Note:  Consent withdrawn means that the participant has explicitly indicated that 
he/she does not want to be followed any longer; in this case, no further data, except 
data in the public domain, may be solicited from or collected on the participant.  
Participants may choose to discontinue study treatment and remain in the study to be 
followed for progression and survival; however, this must be appropriately 
documented in both source documentation and the eCRF. 
• Further participation would be injurious to the participant's health or well-being, in 
the investigator's medical judgment. 
• Unacceptable toxicity. 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority, IRB, or IEC. 

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A participant may be discontinued from study treatment as follows: 
• If, during the course of the study, a participant is found not to have met eligibility 
criteria, the medical monitor, in collaboration with the investigator, will determine 
whether the participant should be withdrawn from study treatment. 
• If a participant is noncompliant with study procedures or study treatment 
administration in the investigator's opinion, the sponsor should be consulted for 
instruction on handling the participant. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue study treatment, the EOT visit 
should be conducted.  Reasonable efforts should be made to have the participant return for a 
follow-up visit.  The last date of the last dose of study treatment and the reason for study 
treatment discontinuation will be recorded in the eCRF. 
If a participant is discontinued from study treatment: 
• The study monitor or sponsor must be notified. 
• The reason(s) for discontinuation must be documented in the participant's medical 
record and the primary reason for discontinuation must be included in the eCRF. 
• The EOT visit should be performed. 
• The status of the participant should be updated to EOT in the IRT system. 
• Participants must be followed for safety until the time of the follow-up visit or until 
study treatment–related toxicities resolve, return to baseline, or are deemed 
irreversible, whichever is longest. 
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons.   
If a participant withdraws from the study, he/she may request destruction of any samples taken 
and not tested, and the investigator must document this in the site study records.  If the 
participant withdraws consent for disclosure of future information, the sponsor may retain and 
continue to use any data collected before such a withdrawal of consent. 
See Table 3 for data to be collected at the time of study withdrawal and follow-up and for any 
further evaluations that need to be completed. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he/she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 

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The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant's last known mailing address 
or local equivalent methods).  These contact attempts should be documented in the 
participant's medical record. 
• Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
• The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study. 
− Informed consent must be obtained before any study-related procedures are 
conducted, unless otherwise specified by the Protocol. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the countries in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  The level of disclosure 
must also be explained to the participant. 

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• The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained.  The authorized person obtaining the informed consent must 
also sign the ICF. 
• Participants must provide consent to the most current version of the ICF during their 
participation in the study. 
• A copy of the ICF(s) must be provided to the participant or the participant's legally 
authorized representative. 
• Participants who are rescreened are required to sign a new ICF. 
8.1.2. 
Screening Procedures 
Screening is the interval between signing the ICF and enrollment into the study.  Screening may 
not exceed 28 days.  Assessments that are required to demonstrate eligibility may be performed 
over the course of 1 or more days during the screening process. 
Procedures conducted as part of the participant's routine clinical management (eg, blood count, 
imaging study) and obtained before signing of the ICF may be used for screening or baseline 
purposes provided the procedure meets the Protocol-defined criteria and has been performed in 
the screening timeframe (ie, after providing consent and within 28 days of C1D1).  Assessments 
may occur outside the 28-day window for those that are suitable for enrollment but may not be 
feasible to repeat.  For participants who are enrolled in the study, information associated with 
eligibility requirements must be entered into the appropriate eCRF pages. 
Results from the screening visit evaluations will be reviewed to confirm eligibility before 
enrollment or the administration of study treatment.  Tests with results that fail eligibility 
requirements may be repeated once during screening if the investigator believes the results to be 
in error.  For screening assessments that are repeated, the most recent available result before 
treatment assignment will be used to determine eligibility.  Treatment should start as soon as 
possible but within 3 days after the date of enrollment. 
See Sections 5.4 and 5.5 for information regarding screen failures and replacement of 
participants, respectively. 
8.1.2.1. 
Tumor or Lymph Node Sample  
Participant eligibility will be based on the site's local assessment of the pathologic diagnosis.  Of 
important note, excisional/incisional or core needle biopsy are acceptable methods of 
assessment; however, a pathologic diagnosis based on fine-needle aspiration is not acceptable for 
eligibility.  All participants must have an archival tumor or lymph node tissue specimen available 
for submission to central pathology; if an archival specimen is not available for submission, then 
a repeat biopsy is required before enrollment.   

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All tumor specimens must be reviewed locally and then sent to central pathology, preferably 
during the screening period and no later than 8 weeks after enrollment. 
8.1.2.2. 
Bone Marrow Biopsy and Examination  
For all participants, a bone marrow core biopsy and aspirate must be obtained as indicated in the 
SoA (see Table 3) and should be evaluated locally except in the following circumstances:  
• Baseline PET scan showed that the participant has FDG-avid disease in the bone 
marrow (PET-avid bone marrow; see Section 8.2.2), or  
• Participant had a bone marrow examination performed as per standard of care within 
approximately 60 days of enrollment, or  
• Participant had a bone marrow examination performed after the last treatment for FL 
or MZL, and the results showed lymphoma involvement of the bone marrow.   
All bone marrow examinations should include a unilateral biopsy and an aspiration.  If no such 
recent bone marrow samples are available, then repeat biopsy will be required.  All bone marrow 
aspirate samples must be submitted to central pathology, preferably during the screening period 
but no later than 8 weeks after enrollment.   
The pathology report result from the site's local bone marrow examination will be captured in the 
eCRF.   
8.1.3. 
Interactive Response Technology System 
Each participant will be identified in the study by a participant ID number, which is a 
combination of the site ID and participant number.  Site staff should contact the IRT to obtain the 
participant ID number during screening.  Upon determining that the participant is eligible for 
study entry, the IRT will be contacted to obtain the treatment assignment.  Additionally, the IRT 
will be contacted at each regular study visit to update the study drug supply.  Additional details 
are provided in the IRT Manual. 
8.1.4. 
Distribution of Reminder Cards 
Participants will be provided with a reminder card at each visit.  The reminder card will indicate 
the date/time of the next visit and will also remind the participant that they should not take their 
morning dose of parsaclisib at home on days when PK samples will be drawn, because they will 
take it in the clinic after samples have been collected.  The reminder cards for visits when PK 
samples are drawn will have an area on which the date and time of the last dose taken (from the 
previous day) and the time and contents of their last meal before the visit should be recorded. 
8.1.5. 
Demography and Medical History 
8.1.5.1. 
Demographics and General Medical History 
Demographic data and general medical history will be collected at screening by the investigator 
or qualified designee and will include year of birth/age, race, ethnicity, medical and surgical 
history, and current illnesses.  Medical history will include relevant medical or surgical treatment 
within the last 10 years that are considered to be clinically significant by the investigator. 

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8.1.5.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical and treatment history will be collected at screening.  Details 
regarding the participant's malignancy under study, including date of diagnosis, initial and 
current cancer stage, tumor histology, relevant disease characteristics, and prior treatments, 
including systemic treatments, radiation, and surgical procedures, will be collected in the eCRF. 
8.1.5.3. 
Prior and Concomitant Medications and Procedures 
Data regarding prior and concomitant medications and procedures as described in Section 6.7 
will be collected in the eCRF.   
8.2. 
Efficacy Assessments 
8.2.1. 
Computed Tomography Scan or Magnetic Resonance Imaging 
Objective assessment of tumor status is required using appropriate disease-specific techniques in 
order to determine responses, which will be logged into the eCRF.  The criteria of Cheson 
et al (2014) or Hallek et al (2018) will be used, and the recommended method for measuring and 
following tumor burden will be CT scan to include the neck, chest, abdomen, and pelvis.  For 
radiologic assessment, a CT scan with contrast (if contrast is possible) will be performed.  
Contrast-enhanced MRI will be performed if CT scan with contrast is medically contraindicated 
as assessed by the investigator or if the frequency of CT scan defined in the SoA is not accepted 
by local IRBs/IECs.  Of important note, participants with suspicion of CNS involvement or those 
with a known history of CNS lymphoma must undergo CT/MRI of the head at screening to 
exclude active CNS disease. 
If CT (or MRI) scan was performed as standard of care before signing the ICF but within 28 days 
of enrollment, then the results from that assessment may be recorded in the eCRF in lieu of a 
study-specific assessment.  All CT (or MRI) scan assessments will be scheduled from the date of 
enrollment and will be calendar-based.  Delays or interruptions in study treatment administration 
will not affect the SoA.  The same imaging modality (CT or MRI) and technique (eg, the use of 
contrast, slice thickness for scans) that was used at screening should be used throughout the 
study for each participant. 
The schedule for CT/MRI assessments is shown in Table 3.  This schedule also applies to 
participants who discontinue study treatment for reasons other than disease progression until 
disease progression, withdrawal of consent, end of the study, or death, whichever occurs first. 
8.2.2. 
Fluorodeoxyglucose–Positron Emission Tomography 
Positron emission tomography of the neck, chest, abdomen, and pelvis using [18F]-FDG is 
required in all participants to evaluate disease burden, including disease involvement in the bone 
marrow, at screening and at subsequent postbaseline timepoints (see Table 3).  
Fluorodeoxyglucose-PET assessments performed as standard of care before signing the ICF but 
within 28 days of enrollment may be used in lieu of a study-specific assessment.  Combined 
PET/CT or combined PET/MRI may be used for radiologic assessment provided that the CT or 
MRI is performed with contrast (see Section 8.2.1).   

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If a participant with FDG-avid disease in the bone marrow (PET-avid bone marrow) at baseline 
achieves a radiologic CR based on CT or MRI earlier than EOT, a PET scan must be performed 
to confirm the assessment of CR within 28 days (± 14 days) of the participant fulfilling the 
criteria for radiologic CR.  If a PET scan is performed to confirm a CR prior to Week 24, then no 
additional PET scans are required. 
For CT scans or MRI indicating PD before the EOT visit, PET/CT or PET/MRI assessment must 
also be performed within 4 weeks (± 2 weeks) for confirmation.   
Response assessment will be performed each time a radiologic assessment (CT scan/MRI or 
PET/CT or PET/MRI) is performed using the appropriate criteria for the participant's disease. 
8.2.3. 
Confirmatory Bone Marrow Biopsy and Examination 
In participants who achieve a radiologic CR, a confirmatory bone marrow biopsy will be 
collected for local pathology assessment, except in the following circumstances:  
• Participant has no lymphoma involvement in the bone marrow based on either bone 
marrow examination or PET at baseline, or  
• Participant has lymphoma involvement in the bone marrow based on PET at baseline 
(in which case, confirmatory PET will be performed [see Section 8.2.2]).   
The confirmatory bone marrow biopsy should be performed within 28 days of the participant 
fulfilling the criteria for radiologic CR.   
All bone marrow examinations should include a unilateral biopsy and, if clinically feasible, an 
aspiration.   
The pathology report result from the site's local bone marrow examination will be captured in the 
eCRF.   
Sample collection requirements and processing instructions will be provided in the Central 
Laboratory Manual. 
8.2.4. 
Independent Review Committee  
All radiologic imaging (CT or MRI and PET) will be submitted to a central radiology vendor for 
review.  An exploratory analysis of imaging data and applicable clinical data may be performed 
using the Lugano criteria (Cheson et al 2014) for NHL and the iwCLL criteria (Hallek 
et al 2018) for CLL.  Scans should be submitted within 4 weeks of completion. 
8.2.5. 
Medical Resource Utilization and Health Economics 
Not applicable. 
8.3. 
Safety Assessments 
See Section 6.6 for dose modification guidelines for relevant laboratory or other safety 
assessment abnormalities. 

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8.3.1. 
Adverse Events 
Adverse events will be monitored from the time the participant signs the ICF until at least 
90 days after the last dose of study treatment or until the start of new anticancer therapy.  
Adverse events for enrolled participants that begin or worsen after informed consent should be 
recorded on the Adverse Events Form in the eCRF regardless of the assumption of a causal 
relationship with the study treatment.  Conditions that were already present at the time of 
informed consent should be recorded on the Medical History Form in the eCRF.  Adverse events 
(including laboratory abnormalities that constitute AEs) should be described using a diagnosis 
whenever possible rather than by individual underlying signs and symptoms. 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative).  The investigator and any 
qualified designees are responsible for detecting, documenting, and recording events that meet 
the definition of an AE or SAE and remain responsible for following up on AEs that are serious, 
are considered related to the study treatment/procedures, or caused the participant to discontinue 
study treatment.  Care will be taken not to introduce bias when detecting AEs and/or SAEs.  
Open-ended and nonleading verbal questioning of the participant, such as "How are you 
feeling?", is the preferred method to inquire about AE occurrences.  Adverse events may also be 
detected when they are volunteered by the participant during the screening process or between 
visits or through physical examinations, laboratory tests, or other assessments.  The definition, 
reporting, and recording requirements for AEs are described in Section 9. 
All SAEs will be reported to the sponsor or designee within 24 hours.  The investigator will 
submit any updated SAE data to the sponsor within 24 hours of it being available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
8.3.2. 
Physical Examinations 
Physical examinations must be performed by a medically qualified individual, such as a licensed 
physician, physician assistant, or an advanced registered nurse practitioner, as local law permits.  
Abnormalities identified after the first dose of study treatment constitute an AE if they are 
considered clinically meaningful, induce clinical signs or symptoms, require concomitant 
therapy, or require changes in study treatment.  Investigators should pay special attention to 
clinical signs related to previous serious illnesses. 
At the screening visit, a comprehensive physical examination should be conducted.  The 
comprehensive physical examination will include height (screening only) and body weight and 
assessment(s) of the following organ or body systems:  skin; head, eyes, ears, nose, and throat; 
thyroid; lungs; cardiovascular system; abdomen (liver, spleen); extremities; and lymph nodes; as 
well as a brief neurological examination.  Additional physical examinations will be performed at 
the timepoints indicated in Table 3.  
During the study, participants will be assessed by the investigator or medically qualified 
designee per institutional standard of care.  These assessments should be an evaluation as 
indicated by participant symptoms, AEs, or other findings and documented on the AE eCRF. 

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8.3.3. 
Vital Signs 
Vital sign measurements (to be taken before blood collection for laboratory tests) include blood 
pressure, pulse, respiratory rate, weight, and body temperature.  If vital signs cannot be taken 
before blood collection for laboratory tests, there must be a minimum of 30 minutes from the 
completion of the blood collection procedures to the beginning of the vital signs collection.  
Blood pressure and pulse will be taken with the participant in the recumbent, semirecumbent, or 
sitting position after 5 minutes of rest. 
Abnormal vital sign results identified after the first dose of study treatment may constitute an AE 
if they are considered clinically meaningful, induce clinical signs or symptoms, require 
concomitant therapy, or require changes in study treatment. 
8.3.4. 
Eastern Cooperative Oncology Group Performance Status 
Eastern Cooperative Oncology Group performance status (Oken et al 1982; see Appendix B) will 
be assessed at the timepoints listed in Table 3.  Performance status must be assessed by a 
medically qualified individual and recorded in the eCRF. 
8.3.5. 
B Symptoms/Constitutional Symptoms 
B symptoms will be assessed at screening and throughout the conduct of the study (see Table 3).  
B symptoms include fever > 38°C (100.4°F), night sweats, and weight loss > 10% within the 
prior 6 months.  For participants with CLL or SLL, assessment of constitutional symptoms will 
also include assessment of fatigue (Hallek et al 2018). 
8.3.6. 
Electrocardiograms 
Single 12-lead ECGs will be obtained as outlined in Table 3 using an ECG machine that 
automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.  All 
12-lead ECGs will be performed with the participant in a recumbent or semirecumbent position 
after 5 minutes of rest. 
8.3.7. 
Left Ventricular Ejection Fraction Assessments 
A 2-dimensional echocardiogram or cardiac multigated acquisition scan will be obtained during 
the screening period to evaluate cardiac function and assess LVEF. 
8.3.8. 
Laboratory Assessments 
See Table 13 for the list of clinical laboratory tests to be performed and Table 3 for the timing 
and frequency.  A certified laboratory local to the investigative site will perform all clinical 
laboratory assessments for safety (eg, blood chemistries, hematology assessments, coagulation 
tests, endocrine function, and urinalysis).  The investigative site will enter the laboratory results 
and laboratory normal ranges into the eCRF.  Additional testing may be required by the sponsor 
based on emerging safety data.  Additional tests may also be performed if clinically indicated. 
Clinically significant abnormal laboratory findings are those that are not associated with the 
underlying disease, unless judged by the investigator to be more severe than expected for the 
participant's condition.  All laboratory tests with values considered clinically significantly 
abnormal during participation in the study or within 90 days after the last dose of study treatment 

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should be repeated until the values return to normal or baseline or are no longer considered 
clinically significant by the investigator or medical monitor. 
Screening laboratory assessments must be performed within 28 days before C1D1.  If performed 
more than 28 days before C1D1, then the tests must be repeated and eligibility confirmed before 
study treatment administration on C1D1. 
Laboratory sample collection on C1D1 must be performed prior to administration of study 
treatment.  After Cycle 1, predose laboratory procedures can be conducted before study 
treatment administration (within the allotted visit window), and results should be reviewed by the 
investigator or qualified designee and found to be acceptable before a new cycle of treatment is 
initiated. 
See Section 9.1 for information regarding laboratory abnormalities that should be recorded as 
AEs in the eCRF.  Additionally, if laboratory values from laboratory assessments performed at 
the institution's local laboratory require a change in participant management (eg, require 
treatment) or are considered clinically significant by the investigator (eg, SAE, AE, dose 
modification), then the result(s) of the specific laboratory assessment(s) must be recorded in the 
eCRF.

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Table 13: 
Required Laboratory Analytes 
Chemistry 
Hematology 
Urinalysis With Microscopic 
Examination (only if blood in 
urine is suspected) 
Virus Serology 
Coagulation 
Sodium 
Potassium 
Calcium 
Chloride 
Phosphate 
 
Creatinine 
Blood urea nitrogen 
Uric acid 
 
ALT 
AST 
Total bilirubin 
Direct bilirubin 
(if total bilirubin > ULN) 
 
Amylase 
Lipase 
 
C-reactive protein 
Total protein 
Albumin 
Alkaline phosphatase 
Lactate dehydrogenase 
Glucose 
Complete blood count: 
• Hemoglobin 
• Hematocrit 
• Platelet count 
• Red blood cell count 
• White blood cell count  
 
Differential count: 
• Neutrophils 
(ANC must be provided) 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
 
Color and appearance 
pH and specific gravity 
Bilirubin 
Glucose 
Ketones 
Leukocytes 
Nitrite 
Occult blood 
Protein 
HBsAg 
Anti-HBs 
Anti-HBc 
HBV-DNA 
 
Anti-HCV 
HCV-RNA 
 
HIV 
CMV 
PT 
aPTT 
INR 
Lipid Panel 
Endocrine Function 
Pregnancy Testing 
Total cholesterol 
Triglycerides 
LDL 
HDL 
TSH 
T4 
T3/FT3 
Female participants of 
childbearing potential only.   
 
Immunoglobulins 
Serum IgG 
Serum IgA 
Serum IgM 
anti-HBc = antibody to hepatitis B core antigen; anti-HBs = antibody to hepatitis B surface antigen; anti-HCV = antibody to hepatitis C virus; aPTT = activated partial 
thromboplastin time; HDL = high-density lipoprotein; IgA = immunoglobulin A; IgG = immunoglobulin G; IgM = immunoglobulin M; INR = international normalized ratio; 
LDL = low-density lipoprotein; PT = prothrombin time; T3/FT3 = triiodothyronine/free triiodothyronine; T4 = thyroxine; TSH = thyroid-stimulating hormone. 
Note:  Laboratory studies will be performed locally.  Additional tests may be required, as agreed by the investigator and sponsor, based on emerging safety data or to rule out a 
diagnosis.

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8.3.8.1. 
Pregnancy Testing 
A serum pregnancy test will be required for all WOCBP during screening and at the EOT visit.   
Urine pregnancy tests will be performed locally as outlined in Table 3, as medically indicated 
(eg, in case of loss of menstrual cycle, when pregnancy is suspected), or per country-specific 
requirement (note that country-required urine pregnancy testing will be outlined and 
communicated to investigational sites under separate cover).  If a urine pregnancy test is positive, 
the results should be confirmed with a serum pregnancy test. 
If the serum pregnancy test is negative after a urine test was positive, the investigator will assess 
the potential benefit/risk to the participant and determine whether it is in the participant's best 
interest to resume study treatment and continue participation in the study. 
If a pregnancy is confirmed by a serum pregnancy test, see Section 9.7 for reporting 
requirements. 
8.3.8.2. 
Viral Serology Testing 
8.3.8.2.1. Hepatitis 
Hepatitis screening assessments will be performed at the screening visit to rule out hepatitis 
infection; required analytes are shown in Table 13.  Hepatitis tests should be performed early in 
the screening process due to the length of time needed to obtain the results. 
8.3.8.2.2. Human Immunodeficiency Virus   
Participants enrolled outside of the United States must have an HIV immunoassay test at 
screening to ensure negative HIV status.  Human immunodeficiency virus testing is optional for 
participants enrolled in the United States. 
8.3.8.2.3. Cytomegalovirus 
Samples for CMV DNA will be collected at screening and at the timepoints listed in Table 3.  
Participants with CMV viremia without associated clinical signs of CMV infection should be 
carefully monitored during the conduct of the study.   
8.4. 
Pharmacokinetic Assessments 
Whole blood samples will be collected from all enrolled participants for the measurement of 
serum concentrations of tafasitamab and plasma concentrations of parsaclisib as specified in 
Table 14.  The exact date and time of each sample will be recorded in the eCRF, along with the 
date and time of the last dose of study drug preceding the blood draw and the time of the most 
recent meal.  Instructions for the collection and handling of biological samples will be provided 
in the Laboratory Manual. 
After the predose PK sample is drawn, participants will begin study treatment.   

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Table 14: 
Pharmacokinetic Blood Sample Timing 
Drug 
Study Visit 
Timing of Sample 
Tafasitamab 
Parsaclisib 
8.4.1. 
Urine Sample Collection 
Urine samples will be collected at the timepoints listed in Table 3 for the analytes listed in 
Table 13.    
 
 
 
 

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8.6. 
Unscheduled Visits 
Unscheduled visits may occur as clinically indicated and can also be used for visits that occur 
outside of visit windows; these visits should be noted in the eCRF as an unscheduled visit. 
8.7. 
End of Treatment and/or Early Termination 
When the participant permanently discontinues study treatment (ie, tafasitamab and parsaclisib), 
the EOT visit should be conducted.  If the EOT visit coincides with a regular study visit, the 
EOT evaluations will supersede those of that scheduled visit, and the data should be entered in 
the EOT visit in the eCRF.  The participant should be encouraged to return for the follow-up 
visit. 

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8.8. 
Follow-Up 
8.8.1. 
Safety Follow-Up 
The safety follow-up period is the interval between the EOT visit and the scheduled follow-up 
visit, which should occur 90 days after the EOT visit (or after the last dose of study treatment if 
the EOT visit was not performed).  Adverse events and SAEs must be reported up until 1) at 
least 90 days after EOT/last dose of study treatment or the start of a new anticancer therapy or 
2) until toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.  
Reasonable efforts should be made to have the participant return for the follow-up visit and 
report any AEs that may occur during this period. 
If a participant is scheduled to begin a new anticancer therapy before the end of the safety 
follow-up period, the safety follow-up visit should be performed before a new anticancer therapy 
is started.  Once a new anticancer therapy has been initiated, the participant will move into the 
survival follow-up period. 
8.8.2. 
Post-Treatment Disease Follow-Up 
Participants who discontinue study treatment for reasons other than disease progression will 
move into the disease status follow-up period and should be assessed by radiologic imaging as 
specified in Table 3 to monitor disease status.  Every effort should be made to collect imaging 
information regarding disease status until the start of new anticancer therapy or disease 
progression. 
Sites are still required to submit imaging tumor assessments for independent review. 
8.8.3. 
Survival Follow-Up 
Once a participant has received the last dose of study treatment and has confirmed disease 
progression or starts a new anticancer therapy, the participant will move into the survival 
follow-up period and should be contacted by telephone, email, or visit at least every 12 weeks 
(+ 7 days) to assess for survival status until death, withdrawal of consent, or the end of the study, 
whichever occurs first. 
For participants who entered the survival follow-up period of the study, the site will use 
continuing participant records to supply data on subsequent treatment regimens, tumor 
assessments (if discontinued treatment for a reason other than progression), and OS in the eCRF.  
For participants who do not intend to return to the study investigator for their ongoing care, 
follow-up should be maintained by phone contact, patient records, and public records/databases 
as specified in Table 3. 

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8.8.4. 
Participant Completion of Study 
Participants will be considered as having completed the study if the participant: 
• withdraws consent from further survival follow-up, or  
• is lost to follow-up, or  
• death occurs. 
All participants will be considered as having completed the study should the sponsor decide to 
terminate the study. 

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9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING 
9.1. 
Definition of Adverse Event 
Adverse Event Definition 
• An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or 
not it is considered drug-related. 
• An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study 
treatment. 
Additional Guidance for Events Meeting the Adverse Event Definition 
• Any safety assessments (eg, ECG, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of the investigator 
(ie, not related to progression of underlying disease) are to be reported as an AE. 
• Abnormal laboratory test results are to be reported as an AE if they are considered clinically 
meaningful, induce clinical signs or symptoms, require concomitant therapy, or require changes in 
study treatment.  Whenever possible, a diagnosis (eg, anemia, thrombocytopenia) should be recorded 
in the eCRF rather than the abnormal laboratory test result (eg, low hemoglobin, platelet count 
decreased). 
• Exacerbation of a chronic or intermittent pre-existing condition/disease, including either an increase 
in the frequency and/or intensity of the condition, is to be reported as an AE. 
• New conditions detected or diagnosed after the start of study treatment administration are to be 
reported as an AE. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction are to be reported as 
an AE. 
• Signs and/or symptoms from dosing errors of a study treatment (eg, overdose) or a concomitant 
medication are to be reported as an AE. 
• "Lack of efficacy," "disease progression," or "failure of expected pharmacological action" will not be 
reported as an AE or SAE.  Such instances will be captured in the efficacy assessments. 
• A condition that leads to a medical or surgical procedure (eg, endoscopy, appendectomy) will be 
reported as an AE if it occurs after obtaining informed consent.  If the condition is present before 
entering the study, then it should be captured as medical history.   
• Pre-existing diseases or conditions with expected fluctuations in signs or symptoms should be 
reported as an AE only if the investigator judges the fluctuation to have worsened more than 
expected during study participation. 

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9.2. 
Definition of Serious Adverse Event 
If an event is not an AE per the definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death due 
to progression of disease). 
A serious adverse event is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term "life-threatening" in the definition of "serious" refers to an adverse drug experience that 
places the participant, in the opinion of the initial reporter, at immediate risk of death from the adverse 
experience as it occurs.  This does not include an adverse drug experience that, had it occurred in a 
more severe form, might have caused death. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (involving at least an 
overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have 
been appropriate in the physician's office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other serious criteria, 
the event is serious.  When in doubt as to whether hospitalization occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment or planned surgery (eg, stent replacement, hip surgery) is not 
considered an SAE. 
Hospitalization for a medical intervention in which no unfavorable medical occurrence occurred 
(ie, elective procedure or routine medical visit) is not considered an SAE. 
d. Results in persistent or significant disability/incapacity 
• The term "disability" means a substantial disruption of a person's ability to conduct normal life 
functions.  This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental 
trauma (eg, sprained ankle), that may interfere with or prevent everyday life functions but do not 
constitute a substantial disruption. 
e. Is a congenital anomaly/birth defect 
f. Is an important medical event 
An important medical event is an event that may not result in death, be immediately life-
threatening, or require hospitalization but may be considered serious when, based on appropriate 
medical judgment, the event may jeopardize the participant and may require medical or surgical 
intervention to prevent one of the outcomes listed in the above definition.  Examples of such events 
include new invasive or malignant cancers, secondary malignancies, intensive treatment in an 
emergency department or at home for allergic bronchospasm, blood dyscrasias, convulsions that do 
not result in hospitalization, development of drug dependency or drug abuse, or suspected 
transmission of an infectious agent via a medicinal product.  Secondary malignancies should 
always be considered SAEs. 

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9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Adverse Event and Serious Adverse Event Recording 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF.  AEs/SAEs should be reported for enrolled participants, but only 
SAEs need to be reported for screen failure participants.  Conditions that were present at the time 
informed consent was given should be recorded on the Medical History Form in the eCRF.  For 
detailed information, refer to the eCRF guidelines. 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostic reports) related to the event. 
• The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records 
in lieu of completing the Adverse Event Form in the eCRF. 
• There may be rare instances when copies of medical records for certain cases are requested.  In this 
case, all participant identifiers, with the exception of the participant number, will be redacted by the 
site staff on the copies of the medical records before submission.  These records can be submitted to 
Incyte Pharmacovigilance by email/fax per the contact information listed in the Study Reference 
Manual.   
• The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information.  Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE.  When a clear diagnosis cannot be identified, each sign or 
symptom should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine the following: 
• The severity grade (CTCAE v5.0 Grade 1 to 5).  See below for further instructions on the assessment 
of intensity. 
• Whether there is at least a reasonable possibility that the AE is related to the study treatment:  
suspected (yes) or not suspected (no).  See below for further instructions on the assessment of 
causality. 
• The start and end dates, unless unresolved at the final safety follow-up visit. 
• The action taken with regard to study treatment as a result of the AE/SAE(s). 
• The event outcome (eg, not recovered/not resolved, recovered/resolved, recovering/resolving, 
recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per the SAE definition provided in Section 9.2. 
• The action taken with regard to the event.  Note:  If an AE is treated with a concomitant medication 
or nondrug therapy, this action should be recorded on the Adverse Event Form and the treatment 
should be specified on the appropriate eCRF.   
Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v5.0 Grades 1 through 5.  If an event is not 
classified by CTCAE, the severity of the AE will be graded according to the scale below to estimate the 
grade of severity. 
The investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories: 

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• Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment 
not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate 
activities of daily living. 
• Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4:  Life-threatening consequences; urgent treatment indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study treatment and each occurrence 
of each AE/SAE.  The relationship to each study drug must be assessed.  The relationship to the 
combination may be assessed as well. 
• A "reasonable possibility" of a relationship conveys that there are medical facts, evidence, and/or 
arguments to suggest a causal relationship, rather than that a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the possibility of a relationship. 
• The investigator will also consult the RSI in the parsaclisib IB and the tafasitamab IB in making 
his/her assessment. 
• Alternative causes, such as underlying or concurrent disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study treatment administration, will be 
considered and investigated. 
• For each AE/SAE, the investigator must document in the medical notes that he/she has reviewed the 
AE/SAE and has provided an assessment of causality. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report.  However, the causality assessment is one of the criteria 
used when determining regulatory reporting requirements.  Therefore, it is very important that 
the investigator always make an assessment of causality based on the available information 
for every event before the initial transmission of the SAE. 
− The investigator may change his/her opinion of causality in light of follow-up information and 
submit the updated causality assessment. 
Follow-Up of Adverse Events and Serious Adverse Events 
• The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor to elucidate the nature 
and/or causality of the AE or SAE as fully as possible.  This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health care 
professionals. 
• Once an AE is detected, it should be followed in the AE eCRFs until it has resolved or until it is 
judged to be permanent; assessment should be made at each visit (or more frequently if necessary) of 
any changes in severity, the suspected relationship to the study treatment, the interventions required 
to treat the event, and the outcome. 
• When the severity of an AE changes over time for a reporting period (eg, between visits), each 
change in severity will be reported as a separate AE. 

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• Updated SAE information will be recorded in the originally completed eCRF and reported to Incyte 
Pharmacovigilance (in the SAE eCRF) until resolution, stabilization, the event is otherwise 
explained, or the participant is lost to follow-up. 
• Any updated SAE data (including SAEs being downgraded to nonserious) will be submitted to the 
sponsor (or designee) within 24 hours of receipt of the information. 
See Appendix G for the management of potential Hy's Law cases. 
9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study treatment or study procedures), all 
SAEs occurring after the participant has signed the ICF through the last safety visit or at least 
90 days after the last dose of study treatment or until the participant starts a new anticancer 
therapy must be reported to the sponsor (or designee) immediately, without undue delay but not 
later than within 24 hours of obtaining knowledge of its occurrence unless otherwise specified 
by the Protocol.  The investigator will submit any updated SAE data to the sponsor (or designee) 
immediately, without undue delay but not later than within 24 hours of it being available.   
Investigators are not obligated to actively seek SAE information after the safety follow-up visit 
or 90 days after the last dose of study treatment.  If the investigator learns of any SAE, including 
death, at any time during this period and he/she considers the event to be reasonably related to 
study treatment or study participation, then the investigator must notify the sponsor (or designee) 
within 24 hours of becoming aware of the event.   
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor regarding an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a study 
treatment under clinical investigation are met. 
If the SAE is not documented in the RSI of the parsaclisib IB or the tafasitamab IB and is 
thought to be related to the study treatment, the sponsor or its designee may urgently require 
further information from the investigator for expedited reporting to health authorities.  The 
sponsor or its designee may need to issue an Investigator Notification to inform all investigators 
involved in any study with the same drug that this SAE has been reported.  Suspected 
unexpected serious adverse reactions will be collected and reported to the competent authorities 
and relevant ethics committees in accordance with Directive 2001/20/EC or as per national 
regulatory requirements in participating countries. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of the study treatment under clinical investigation.  The 
sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
according to local regulatory requirements and sponsor policy and forwarded to investigators as 
necessary. 

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An investigator who receives an investigator safety report describing an SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate, according to local requirements. 
Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator must report within 24 hours of learning of its occurrence any SAE via the EDC 
system (primary method) or by completing the Serious Adverse Event Report Form in English (only 
if the EDC system is not available).  The contact information for Incyte Pharmacovigilance by 
email/fax is listed in the Study Reference Manual. 
• In circumstances where the EDC system is not accessible for reporting SAE information (initial 
and/or follow-up SAE information) to the sponsor within 24 hours, refer to the Incyte Reference 
Guide for Completing the Serious Adverse Report Form.  Once the EDC system is functional, the 
SAE report should be retrospectively added to the EDC system and follow-up should be completed 
through the EDC.  The original copy of the Serious Adverse Event Report Form and the email or 
facsimile confirmation sheet must be kept at the study site (refer to the Incyte Reference Guide for 
Completing the Serious Adverse Report Form). 
• Follow-up information is also recorded in the eCRF and transmitted to Incyte Pharmacovigilance via 
the EDC system.  The follow-up report should include information that was not provided previously, 
such as the outcome of the event, treatment provided, action taken with study drug(s) because of the 
SAE (eg, dose reduced, interrupted, or discontinued), or participant disposition (eg, continued or 
withdrew from study participation).  Each recurrence, complication, or progression of the original 
event should be reported as follow-up to that event, regardless of when it occurs. 
9.5. 
Events of Clinical Interest 
An ECI is an AE (serious or nonserious) that Incyte wishes to document in an organized manner 
for monitoring or understanding.  An ECI does not require rapid communication by an 
investigator to Incyte unless it meets criteria for rapid communication as an SAE (see 
Section 9.2).      
The following laboratory abnormalities and/or clinical AEs are considered ECIs:  
• Tafasitamab:   
− Tumor lysis syndrome 
− IRRs 
− Allergic reactions to study drug ≥ Grade 3 
− CRS 
− Secondary primary malignancy 
− Hepatitis B reactivation 
− Progressive multifocal leukoencephalopathy. 

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• Parsaclisib:  
− ALT ≥ 5 × ULN 
− AST ≥ 5 × ULN 
− Colitis 
− Diarrhea ≥ Grade 3 
− Intestinal perforation 
− Rash ≥ Grade 3 
− Exfoliative dermatitis 
− Pneumonitis 
− PJP infection 
− CMV infection 
− Herpes simplex virus infection 
− Varicella zoster virus infection 
9.5.1. 
Adverse Events of Special Interest 
Not applicable. 
9.6. 
Emergency Unblinding of Treatment Assignment 
Not applicable. 
9.7. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that the study 
treatment may have interfered with the effectiveness of a contraceptive medication or method.  
When a pregnancy has been confirmed in a participant during maternal or paternal exposure to 
study treatment, the following procedures should be followed in order to ensure safety: 
• The study treatment must be discontinued immediately (female participants only). 
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy Form 
to the sponsor or its designee within 24 hours of learning of the pregnancy. 
Data on fetal outcome are collected for regulatory reporting and drug safety evaluation.  
Follow-up should be conducted for each pregnancy to determine outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications, by following until the first 
well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported 
by the investigator to the sponsor or its designee.  Pregnancy follow-up information should be 
recorded on the same form and should include an assessment of the possible causal relationship 
to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the first well-baby 
visit or the duration specified in local regulations, whichever is later.  Refer to the Incyte 
Reference Guide for Completing the Clinical Trial Pregnancy Form. 

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Any SAE occurring during pregnancy of a study participant must be recorded on the 
Serious Adverse Event Report Form and submitted to the sponsor or its designee. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4.  If an abnormal pregnancy outcome is reported in a 
study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 
9.8. 
Warnings and Precautions 
Special warnings or precautions for the study drugs, derived from safety information collected by 
the sponsor or its designee, are presented in the parsaclisib IB and the tafasitamab IB.  Additional 
safety information collected between IB updates will be communicated in the form of 
Investigator Notifications.  Any important new safety information should be discussed with the 
participant during the study as necessary.  If new significant risks are identified, they will be 
added to the ICF. 
Infection with SARS-CoV-2, the coronavirus that causes COVID-19, is more frequent and 
severe in patients with hematologic dysfunction (Jee et al 2022).  The presence of hematologic 
malignancy, baseline neutropenia and lymphopenia, B-cell depletion, and other factors have been 
identified as risk factors for loss of humoral immunity to COVID-19, poor vaccine response, 
viral persistence, and severe disease (Lee et al 2022, Lyudovyk et al 2022, Shree et al 2022).  
Targeting B-cell function, proliferation, and survival with various therapies are current strategies 
for improving the outcome of several hematologic malignancies.  PI3Kδ inhibition with 
parsaclisib alone or in combination with other therapies, which may also suppress humoral 
immunity, has the potential to negatively impact SARS-CoV-2 infection risk, vaccine 
effectiveness, recovery from COVID-19, and disease severity (Cheson 2022).  Investigators and 
participants participating in trials of parsaclisib, alone or in combination, need to be aware of 
these potential risks and consider the local standards of care and available therapies for disease 
prevention, vaccination, and infection management of COVID-19. 
9.9. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 
The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be recorded as described in Section 9.3. 
If the investigator is asked to return the product for investigation, he/she will return a copy of the 
product complaint communication with the product. 

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9.10. 
Treatment of Overdose 
Overdose is not an SAE unless it meets the criteria of an SAE (see Section 9.3). 
Overdose of parsaclisib is defined as any daily dose > 20 mg within the first 8 weeks of the study 
and > 2.5 mg for the rest of the study within a 24-hour time period (± 4 hours).    
Overdose of tafasitamab is defined as any dose > 120% of the protocol-specified dose per single 
infusion. 
Overdose with concomitant medication will not be recorded in the eCRF unless it resulted in an 
AE. 
In the event of an overdose, the investigator should do the following: 
• Contact the medical monitor immediately. 
• Closely monitor the participant for any AE/SAE and laboratory abnormalities. 
• Obtain a plasma sample for PK analysis if requested by the medical monitor. 
• Document the quantity of the excess dose as well as the duration of the overdose in 
the eCRF. 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant.  Incyte 
does not recommend specific treatment for an overdose; treatment of overdose for either study 
drug should consist of general supportive measures. 
10. 
STATISTICS 
10.1. 
Sample Size Determination 
Up to 10 evaluable participants will be treated in each of the 5 disease-specific cohorts during the 
dose confirmation period.  Enrollment into a cohort will be halted if the dose is not considered 
tolerable or once 10 evaluable participants have been treated for 28 days. 
If the dose confirmation period for a disease-specific cohort confirms the dose is tolerable, that 
particular cohort will be opened for enrollment into the dose expansion period.  Up to 
10 additional participants will be enrolled up to a total of 20 evaluable participants in each of the 
5 disease-specific cohorts (up to 100 evaluable participants in the whole study). 
With 10 participants in each disease-specific cohort during the dose confirmation period, there is 
approximately 89.3% probability of observing at least 1 DLT if the underlying DLT rate is 20% 
and 97.2% probability of observing at least 1 DLT if the underlying DLT rate is 30%.  If ≤ 1 of 
10 participants in each disease-specific cohort during the dose confirmation period experience a 
DLT, the upper limit of the 95% 1-sided CI for the underlying DLT rate will not be > 39.5%.  If 
none of 10 participants experience a DLT in each disease-specific cohort during the dose 
confirmation period, the upper limit of the 95% 1-sided CI for the underlying DLT rate will not 
be > 25.9%.   
With 10 participants in each disease-specific cohort, there is approximately 97.2% probability of 
observing at least 1 objective response during the dose confirmation period if the underlying 

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response rate is 30%.  For a reference of the precision of the ORR estimate with 10 or 
20 participants in each disease-specific cohort, the 2-sided 95% CIs for different observed ORRs 
ranging from 10% to 100% are provided in Table 15. 
Table 15: 
Two-Sided 95% Confidence Interval for Different ORR Estimates 
Sample Size 
Observed ORR 
95% CI 
n = 10 
10% 
(0.3%, 44.5%) 
20% 
(2.5%, 55.6%) 
30% 
(6.7%, 65.3%) 
40% 
(12.2%, 73.8%) 
50% 
(18.7%, 81.3%) 
60% 
(26.2%, 87.8%) 
70% 
(34.8%, 93.3%) 
80% 
(44.4%, 97.5%) 
90% 
(55.5%, 99.8%) 
100% 
(69.2%, 100.0%) 
n = 20 
10% 
(1.2%, 31.7%) 
20% 
(5.7%, 43.7%) 
30% 
(11.9%, 54.3%) 
40% 
(19.1%, 63.9%) 
50% 
(27.2%, 72.8%) 
60% 
(36.1%, 80.9%) 
70% 
(45.7%, 88.1%) 
80% 
(56.3%, 94.3%) 
90% 
(68.3%, 98.8%) 
100% 
(83.2%, 100.0%) 
10.2. 
Populations for Analysis 
The populations for analysis are provided in Table 16. 

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Table 16: 
Populations for Analysis 
Population 
Description 
All-screened set 
All participants who signed the ICF. 
FAS 
The FAS includes all participants who received at least 1 dose of study drug. 
The FAS will be used for the summary of demographics, baseline characteristics, 
participant disposition, and analyses of all safety and efficacy data. 
DLT evaluable 
set 
The DLT evaluable set will include all participants who received at least 3 of 
4 doses of tafasitamab and 21 days of treatment with parsaclisib 20 mg QD during 
the first cycle (28 days) or have experienced a DLT.  Participants who are 
considered not evaluable will be replaced. 
Efficacy 
evaluable set 
The efficacy evaluable population includes all participants enrolled in the study 
who have received at least 1 dose of study drug and completed a baseline scan and 
meet at least one of the following criteria: 
• ≥ 1 post baseline scan 
• The participant has participated in the study for a minimum of 42 days 
• The participant has discontinued from treatment or died prior to the first 
scheduled postbaseline scan 
PK evaluable set The PK evaluable population will include all participants who received at least 
1 dose of study drug and provided at least 1 postdose PK plasma sample. 
Immunogenicity 
analysis set  
All participants who received at least 1 dose of study treatment and have at least 
1 evaluable anti-tafasitamab antibody (ADA) assessment. 
10.3. 
Level of Significance 
This is an exploratory study, and no formal statistical tests will be performed.  Unless otherwise 
specified, all CIs will be 95%. 
10.4. 
Statistical Analyses 
All statistical analyses are exploratory in nature.  Continuous variables will be summarized using 
means, medians, standard deviations, minimums, and maximums.  Categorical variables will be 
summarized using frequency counts and percentages. 
10.4.1. 
Safety Analyses 
Safety analyses will be conducted for the FAS.   
Adverse events will be coded by the MedDRA dictionary, and TEAEs (ie, AEs reported for the 
first time or worsening of a pre-existing event after first dose of study treatment until 90 days 
after the last dose of study treatment) will be tabulated by preferred term and system organ class 
for all events, treatment-related events, events of Grade 3 or higher, serious events, fatal events, 
and events leading to treatment discontinuation or modification.  Dose-limiting toxicities will be 
listed for participants during the dose confirmation period of the study. 

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Quantitative safety variables and their changes from baseline (laboratory, vital signs, ECG, etc) 
will be summarized with descriptive statistics.  Abnormal values will be flagged and tabulated 
based on predefined criteria. 
The clinical laboratory data will be analyzed using summary statistics.  Descriptive statistics of 
the value and change from baseline at each assessment time will be provided.  For laboratory 
parameters that have CTC grading, shift tables will be provided showing change in CTC grade 
from baseline to the worst postbaseline grade.  In addition, distributions of key laboratory 
parameters may be plotted over time; these values will also be classified into NCI CTCAE 
toxicity grades and tabulated. 
Descriptive statistics and mean change from baseline will be determined for vital signs at each 
assessment time.  Vital sign results will be reviewed for clinically notable abnormalities. 
Descriptive statistics and mean change from baseline will be determined for each ECG parameter 
at each assessment time.  Electrocardiogram results will be reviewed for clinically notable 
abnormalities.  Participants exhibiting clinically notable ECG abnormalities will be listed. 
Measures of exposure (eg, days of exposure, dose intensity, etc) of tafasitamab and parsaclisib 
will be summarized using summary statistics. 
10.4.2. 
Efficacy Analyses 
All efficacy endpoints will be analyzed using the FAS.   
10.4.2.1. Overall Response Rate 
Overall response rate is defined as the percentage of participants experiencing a best overall 
response of CR/CMR or PR/PMR according to the Lugano criteria (Cheson et al 2014) for NHL 
and the iwCLL criteria (Hallek et al 2018) for CLL based on investigator assessment at any time 
during the study before disease progression and start of a new antilymphoma treatment.   
The ORR and its 95% exact binomial CIs will be summarized.  Participants whose baseline 
disease assessment or on-study response assessments cannot be adequately assessed for response 
will be considered as nonresponders.  These participants will be included in the denominators in 
the calculations of ORR. 
10.4.2.2. Complete Response Rate 
Complete response rate is defined as the percentage of participants experiencing a best overall 
response of CR/CMR according to the Lugano criteria (Cheson et al 2014) for NHL and the 
iwCLL criteria (Hallek et al 2018) for CLL based on investigator assessment at any time during 
the study before disease progression and start of a new antilymphoma treatment.  The CRR and 
its 95% exact binomial CIs will be summarized.  Participants whose baseline disease assessment 
or on-study response assessments cannot be adequately assessed for response will be considered 
as nonresponders.  These participants will be included in the denominators in the calculations of 
CRR. 
10.4.2.3. Progression-Free Survival 
Progression-free survival is defined as the time from the date of first dose of study treatment 
until the first documented disease progression according to the Lugano criteria (Cheson 

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et al 2014) for NHL and the iwCLL criteria (Hallek et al 2018) for CLL per investigator 
assessment or death due to any cause, whichever occurs first.  Censoring of PFS will follow FDA 
guidance (FDA 2015, FDA 2018).  Details will be provided in the SAP.  The total number of 
participants whose disease progressed or who died and the number of participants censored will 
be summarized.  Kaplan-Meier estimation of median PFS and its 95% CIs will be summarized. 
10.4.2.4. Duration of Response 
Duration of response is defined as the time from first documented CR/CMR or PR/PMR until the 
date of first documented disease progression or death due to any cause, whichever occurs first, 
among participants who achieve a CR/CMR or PR/PMR according to the Lugano criteria 
(Cheson et al 2014) for NHL and the iwCLL criteria (Hallek et al 2018) for CLL per investigator 
assessment.  Censoring of DOR will follow the same algorithm as the censoring of PFS noted 
above.  Total number of objective responders, number of participants whose disease progressed 
or who died, and number of participants censored will be summarized.  Kaplan-Meier estimation 
of median DOR and its 95% CIs will be summarized. 
10.4.2.5. Overall Survival 
Overall survival is defined as the time from the date of first dose of study treatment until death 
due to any cause.  Details will be provided in the SAP.  Total number of participants who died 
and number of participants censored will be summarized.  Kaplan-Meier estimation of median 
OS and its 95% CIs will be summarized. 
10.4.3. 
Exploratory Analyses 
10.5. 
Interim Analysis 
Not applicable. 

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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Investigator Responsibilities 
• The Protocol, Protocol Amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC and health authorities before the study is 
initiated. 
• The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements, the 
policies and procedures established by the IRB/IEC, and institutional requirements. 
• Any amendments to the Protocol will require approval from both health authorities 
and the IRB/IEC before implementation of changes made to the study design, except 
for changes necessary to eliminate an immediate hazard to study participants. 
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC. 
− Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
− Providing oversight of the conduct of the study at the site and adherence to GCP, 
IRB/IEC requirements, institutional requirements, and applicable laws and 
country-specific regulations. 
• Adhering to the Protocol as described in this document and agreeing that changes to 
the Protocol procedures, with the exception of medical emergencies, must be 
discussed and approved, first, by the sponsor or its designee and, second, by the 
IRB/IEC.  Each investigator is responsible for enrolling participants who have met 
the specified eligibility criteria. 
• Retaining records in accordance with all local, national, and regulatory laws but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 
− The investigator must not destroy any records during the retention period 
associated with the study without receiving approval from the sponsor.  The 
investigator must notify the sponsor or its designee in the event of accidental loss 
or destruction of any study records.  If the investigator leaves the institution where 
the study was conducted, the sponsor or its designee must be contacted to arrange 
alternative record storage options. 

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− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations.  
The sponsor will retain the original eCRF data and audit trail. 
11.1.1. 
Identification of the Coordinating Principal Investigator 
A coordinating principal investigator will be appointed by the sponsor before the end of the 
study.  As part of their responsibilities, the coordinating principal investigator will review the 
final CSR.  Agreement with the final CSR will be documented by the dated signature of the 
coordinating principal investigator. 
11.2. 
Data Management 
Data management will be performed in a validated EDC system.  The investigator will be 
provided with access to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided with eCRF completion guidelines for instructions on data entry in the 
eCRF.  The study monitor will reference the Monitoring Plan in order to ensure that each issue 
identified is appropriately documented, reported, and resolved in a timely manner in accordance 
with the plan's requirements.  Other data outside the EDC system required in the study conduct 
of the Protocol, such as documents or results transmitted to the sponsor via a central laboratory 
or specialized technical vendors and as designated by the sponsor, will have their own data flow 
management plans, study charters, or biomarker plans, as applicable. 
The sponsor (or designee) will be responsible for the following: 
• Managing the integrity of the data and the quality of the conduct of the study, such as 
ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved Protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Managing and reconciling the data generated and/or collected, including documents 
and results such as laboratory or imaging data analyzed centrally by a designated 
vendor of the sponsor. 
The investigator will be responsible for the following: 
• Recording, or ensuring the recording of, all relevant data relating to the study in the 
eCRF. 
• Delivering, or ensuring the delivery of, all other results, documents, data, know-how, 
or formulas relating to the study to the sponsor or designee electronically and/or 
centrally (eg, laboratory data, imaging data, biomarker data, photographs, diary data) 
or as otherwise specified in the Protocol. 

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• Maintaining adequate and accurate source documents and trial records that include all 
pertinent observations on each of the site's trial participants.  Source data should be 
attributable, legible, contemporaneous, original, accurate, and complete.  Changes to 
source data should be traceable, should not obscure the original entry, and should be 
explained if necessary (eg, via an audit trail).  Source data are, in general, all 
information in original records and certified copies of original records of clinical 
findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial.  Source data are contained in source 
documents (original records or certified copies).   
• Verifying that data entries are accurate and correct by physically or electronically 
signing the eCRF. 
• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF, sent to a central vendor designated by the sponsor, or as 
described in other study and data flow manuals. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed and 
available at the investigator's site.  Examples of source documents are original 
documents, data, and records (eg, hospital records; electronic hospital records; 
clinical and office charts; laboratory notes; memoranda; participants' diaries or 
evaluation checklists; pharmacy dispensing records; recorded data from 
automated instruments; copies or transcriptions certified after verification as 
being accurate copies; microfiches; photographic negatives; microfilm or 
magnetic media; x-rays; participants' files; and e-records/records kept at the 
pharmacy, at the laboratories, and at medico-technical departments involved in 
the clinical trial).   
− Data entered in the eCRF that are transcribed from source documents must be 
consistent with the source documents or the discrepancies must be explained.  The 
investigator may need to request previous medical records or transfer records, 
depending on the study.  Current applicable medical records must be available. 
• Sending participants' data, either as unique samples, copies, or photographs, to be 
evaluated centrally or analyzed centrally, or both, by a qualified vendor designated by 
the sponsor.   
− As required by privacy and data protection regulations and Incyte's privacy 
policies, if any photographs of participants are to be taken, the photographs must 
be limited to the area of the face or the body that is strictly necessary and the 
photographs should be masked (ie, identifying features such as eyes, mouth, scars, 
tattoos, or unique markings or features should be either obscured with a black bar 
or digitally pixelated so as to not permit the reidentification of the participants and 
preserve their confidentiality) by a specially designated photography vendor prior 
to sending the photographs to Incyte or any other third-party vendors for analysis 
or further processing. 

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− In accordance with French regulations, sites in France must perform the masking 
before the photographs are transferred, including to any specially designated 
photography vendor, Incyte, or any other third party vendors for analysis or 
further processing. In addition, the participant's specific consent for photographs 
shall be collected. 
• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
participant records at each monitoring visit. 
− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all participants. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
11.3. 
Data Quality Assurance 
The sponsor assumes accountability for actions delegated to other individuals (eg, contract 
research organizations).  The sponsor or designee is responsible for the data management of this 
study, including quality checking of the data.  Further, monitoring details describing strategy, 
including definition of study-critical data items and processes (eg, risk-based initiatives in 
operations and quality such as risk management and mitigation strategies and analytical risk-
based monitoring), methods, responsibilities, and requirements, including handling of 
noncompliance issues, Protocol deviations, and monitoring techniques (eg, central, remote, or 
on-site monitoring) are provided in the monitoring plan. 
Quality tolerance limits will be predefined in the operational manual to identify systematic issues 
that can impact participants' safety, efficacy results and analysis, and/or reliability of study 
results.  These predefined parameters will be monitored during the study and can be adjusted 
during the study upon data review.  Important deviations from the quality tolerance limits and 
remedial actions taken, including reporting to IRBs/IECs and health authorities if applicable, will 
be summarized in the CSR. 

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11.4. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data protection laws 
and regulations.  The investigator and the sponsor or its designee are responsible for ensuring 
that personal information is handled in accordance with local data protection laws (including but 
not limited to HIPAA and GDPR) as applicable, and the sponsor operates comprehensive data 
privacy and data security programs that are applicable to this study.  Appropriate notice, or 
notice and consent (as may be required by each applicable jurisdiction), for collection, use, 
disclosure and/or transfer (if applicable) of personal information must be obtained in accordance 
with local data protection laws. Appropriate data protection terms that comply with applicable 
laws will be included in relevant study agreements. 
To ensure confidentiality of records and protect personal data, participant names will not be 
supplied to the sponsor or its designee.  Only the participant number will be recorded in the 
eCRF; if the participant's name appears on any other document (eg, laboratory report), it must be 
obliterated on the copy of the document to be supplied to the sponsor or its designee.  Study 
findings stored on a computer will be stored in accordance with appropriate technical and 
organizational measures as required by local data protection laws. 
In the event of a data breach involving participant data, the sponsor or its designee will follow 
the sponsor's incident response procedures.  The precise definition of a data breach varies in 
accordance with applicable law but may generally be understood as a breach of security leading 
to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, 
personal data.  In accordance with its incident response procedures, the sponsor will assess the 
breach to consider its notification and remediation obligations under applicable law.   
11.5. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 CFR Part 54 – Financial Disclosure by Clinical Investigators (ie, "covered 
studies") are required to submit a completed Clinical Investigator Financial Disclosure Form that 
sufficiently details any financial interests and arrangements that apply.  For the purpose of this 
regulation, "clinical investigator" is defined as any investigator or subinvestigator who is directly 
involved in the treatment or evaluation of research participants, including the spouse and each 
dependent child of the clinical investigator or subinvestigator.  These requirements apply to both 
US and foreign clinical investigators conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Clinical Investigator Financial Disclosure Form.  During a covered clinical 
study, any changes to the financial information previously reported by a clinical investigator 
must be reported to the sponsor or its designee.  At the conclusion of the covered clinical study, 
the clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 

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11.6. 
Publication Policy 
By signing the study Protocol, the investigator and their institution agree that the results of the 
study may be used by the sponsor, Incyte Corporation, for the purposes of national and 
international registration, publication, and information for medical and pharmaceutical 
professionals.  Study results will be published in accordance with applicable local and national 
regulations.  If necessary, the authorities will be notified of the investigator's name, address, 
qualifications, and extent of involvement.  The terms regarding the publication of study results 
are contained in the agreement signed with the sponsor or its designee.  A signed agreement will 
be retained by the sponsor or its designee. 
The results of this study may be published or presented at scientific meetings.  If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.  
This allows the sponsor to protect proprietary information and to provide comments. 
The sponsor will comply with the requirements for publication of study results.  In accordance 
with standard editorial and ethical practice, the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data.  In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.7. 
Study and Site Closure 
The sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor.  Study sites will be closed upon study 
completion.  A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
• Failure of the investigator to comply with the Protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further study treatment development. 

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12. 
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Cheah CY, Seymour JF, Wang ML. Mantle cell lymphoma. J Clin Oncol 2016;34:1256-1269. 
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Clinical Trials Facilitation and Coordination Group. Recommendations related to contraception 
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Davis TA, Czerwinski DK, Levy R. Therapy of B-cell lymphoma with anti-CD20 antibodies can 
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European Medicines Agency. Guidance of the management of clinical trials during the 
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Fisher RI, Bernstein SH, Kahl BS, et al. Multicenter phase II study of bortezomib in patients 
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Flowers CR, Sinha R, Vose JM. Improving outcomes for patients with diffuse large B-cell 
lymphoma. CA Cancer J Clin 2010;60:393-408. 
Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval 
of Cancer Drugs and Biologics. 2018. 
Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval 
of Non-Small Cell Lung Cancer Drugs and Biologics. 2015. 
Forero-Torres A, Ramchandren R, Yacoub A, et al. Parsaclisib, a potent and highly selective 
PI3Kδ inhibitor, in patients with relapsed or refractory B-cell malignancies. Blood 
2019;133:1742-1752. 
Gazyva [prescribing information]. South San Francisco, CA: Genentech, Inc; 2016. 
Gerber HP, Kung-Sutherland M, Stone I, et al. Potent antitumor activity of the anti-CD19 
auristatin antibody drug conjugate hBU12-vcMMAE against rituximab-sensitive and -resistant 
lymphomas. Blood 2009;113:4352-4361. 
Gopal AK, Kahl BS, de Vos S, et al. PI3Kδ inhibition by idelalisib in patients with relapsed 
indolent lymphoma. N Engl J Med 2014;370:1008-1018.  
Goy A, Sinha R, Williams ME, et al. Single-agent lenalidomide in patients with mantle-cell 
lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 
(EMERGE) study. J Clin Oncol 2013;31:3688-3695.  
Habermann TM, Weller EA, Morrison VA, et al. Rituximab-CHOP versus CHOP alone or with 
maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol 
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Hallek M, Cheson BD, Catovsky D, et al. iwCLL guidelines for diagnosis, indications for 
treatment, response assessment, and supportive management of CLL. Blood 
2018;131:2745-2760. 
Hammer O. CD19 as an attractive target for antibody-based therapy. MAbs 2012;4:571-577. 
Hess G, Herbrecht R, Romaguera J, et al. Phase III study to evaluate temsirolimus compared 
with investigator's choice therapy for the treatment of relapsed or refractory mantle cell 
lymphoma. J Clin Oncol 2009;27:3822-3829.  
Hoster E, Dreyling M, Klapper W, et al. A new prognostic index (MIPI) for patients with 
advanced-stage mantle cell lymphoma. Blood 2008;111:558-565. 
Jee J, Foote MB, Lumish M, et al. Chemotherapy and COVID-19 outcomes in patients with 
cancer. J Clin Oncol 2022;38:3538-3546. 
Jones JA, Robak T, Brown JR, et al. Efficacy and safety of idelalisib in combination with 
ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised 
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Kahl BS, Yang DT. Follicular lymphoma: evolving therapeutic strategies. Blood 
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Lee CY, Shah MK, Hoyos D, et al. Prolonged SARS-CoV-2 infection in patients with lymphoid 
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Lenz G, Wright G, Dave SS, et al; Lymphoma/Leukemia Molecular Profiling Project. Stromal 
gene signatures in large-B-cell lymphomas. N Engl J Med 2008;359:2313-2323. 
Leukemia & Lymphoma Society. Mantle cell lymphoma facts. 2014.  
Lymphoma Research Foundation. Getting the Facts. Marginal zone lymphoma. 2017.  
Lyudovyk O, Kim JY, Qualls D, et al. Impaired humoral immunity is associated with prolonged 
COVID-19 despite robust CD8 T cell responses. Cancer Cell 2022;40:738-753.  
Morrison VA, Hamlin P, Soubeyran P, et al. Diffuse large B-cell lymphoma in the elderly: 
impact of prognosis, comorbidities, geriatric assessment, and supportive care on clinical practice. 
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National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Chronic 
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Palazzo A, Herter S, Grosmaire L, et al. The PI3Kδ-selective inhibitor idelalisib minimally 
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Parsaclisib Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
Pastore A, Jurinovic V, Kridel R, et al. Integration of gene mutations in risk prognostication for 
patients receiving first-line immunochemotherapy for follicular lymphoma: a retrospective 
analysis of a prospective clinical trial and validation in a population-based registry. Lancet Oncol 
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Pfreundschuh M. How I treat elderly patients with diffuse large B-cell lymphoma. Blood 
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Schmitz R, Wright GW, Huang DW, et al. Genetics and pathogenesis of diffuse large B-cell 
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Schulz H, Bohlius JF, Trelle S, et al. Immunochemotherapy with rituximab and overall survival 
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when combined with rituximab in previously untreated diffuse large B-cell lymphoma patients: 
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Sharman JP, Coutre SE, Furman RR, et al. Final results of a randomized, phase III study of 
rituximab with or without idelalisib followed by open-label idelalisib in patients with relapsed 
chronic lymphocytic leukemia. J Clin Oncol 2019;37:1391-1402. 
Shingleton J, Wang J, Baloh C, et al. Non-Hodgkin lymphomas: malignancies arising from 
mature B cells. Cold Spring Harb Perspect Med 2020:a034843. 
Shree T, Shankar V, Lohmeyer JJK, et al. CD20-targeted therapy ablates de novo antibody 
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Blood 2004;104:1258-1265. 
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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS AND DEFINITIONS 
Definitions 
WOCBP:  A woman who is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below). 
Women in the following categories are not considered WOCBP: 
• Premenarchal 
• Premenopausal with 1 of the following:a 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
• Postmenopausal 
− A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. 
o A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in 
women not using hormonal contraception or HRT.  However, in the absence of 12 months of 
amenorrhea, confirmation with 2 FSH measurements in the postmenopausal range is required.   
− Women on HRT and whose menopausal status is in doubt will be required to use 1 of the nonhormonal, 
highly effective contraception methods if they wish to continue their HRT during the study.  Otherwise, 
they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment. 
For male participants of reproductive potentialb 
The following methods during the Protocol-defined timeframe in Section 5.1 are highly effective: 
• Use of a male condom plus partner use of an additional contraceptive method when having penile-vaginal 
intercourse with a woman of childbearing potential who is not currently pregnant. 
• Vasectomy with medical assessment of the surgical success (verified by site personnel's review of the 
participant's medical records) 
• Sexual abstinencec  
− Abstinence from penile-vaginal intercourse  
The following are not acceptable methods of contraception: 
• Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), 
spermicides only, and lactational amenorrhea method. 
• Male condom with cap, diaphragm, or sponge with spermicide. 
• Male and female condom used together. 
Note:  Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal 
intercourse or use a male condom during each episode of penile penetration.   

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For female participants who are WOCBP 
The following methods during the Protocol-defined timeframe in Section 5.1 that can achieve a failure rate of 
< 1% per year when used consistently and correctly are considered as highly effective birth control methods: 
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of 
ovulation.d 
− oral 
− intravaginal  
− transdermal   
• Progestogen-only hormonal contraception associated with inhibition of ovulationd   
− oral 
− injectable 
− implantablee 
• Intrauterine devicee 
• Intrauterine hormone-releasing systeme 
• Bilateral tubal occlusione 
• Vasectomized partnere,f 
• Sexual abstinencec  
a Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical 
history interview. 
b If the male participant has a partner with childbearing potential, the partner should also use contraceptives. 
c In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study treatment.  The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the 
participant.   
d Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may reduce the 
efficacy of the contraception method.   
e Contraception methods that in the context of this guidance are considered to have low user dependency. 
f Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual partner of the 
WOCBP study participant and that the vasectomized partner has received medical assessment of the surgical success. 
Source:  Clinical Trials Facilitation and Coordination Group 2020. 

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APPENDIX B. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE SCORES 
Grade  
Performance Status  
0  
Fully active, able to carry on all predisease performance without restriction.   
1  
Restricted in physically strenuous activity but ambulatory and able to carry out work 
of a light or sedentary nature, eg, light house work, office work.   
2  
Ambulatory and capable of all self-care but unable to carry out any work activities.  
Up and about more than 50% of waking hours.   
3  
Capable of only limited self-care, confined to bed or chair more than 50% of waking 
hours.   
4  
Completely disabled.  Cannot carry on any self-care.  Totally confined to bed or chair.   
5  
Dead.   
Source:  Oken et al 1982. 

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APPENDIX C. LUGANO CLASSIFICATION FOR RESPONSE 
ASSESSMENT 
Site 
PET-Based Response 
CT-Based Response 
 
CMR 
Complete Radiologic Response 
(All of the Following) 
Lymph nodes and 
extralymphatic sites  
Score 1, 2, or 3 with or without a 
residual mass on a 5-point scalea  
Target nodes/nodal masses must regress 
to ≤ 1.5 cm in LDi  
Nonmeasured lesion  
Not applicable  
Absent  
Organ enlargement  
Not applicable  
Regress to normal  
New lesions  
None  
None  
Bone marrow  
No evidence of FDG-avid disease in 
marrow  
Normal by morphology; if 
indeterminate, immunohistochemistry 
negative  
 
PMR 
PR 
(All of the Following) 
Lymph nodes and 
extralymphatic sites  
• Score 4 or 5a with reduced uptake 
compared with baseline and residual 
mass(es) of any size  
• At interim, these findings suggest 
responding disease  
• At EOT, these findings suggest 
residual disease  
 
• ≥ 50% decrease in SPD of up to 
6 target measurable nodes and 
extranodal sites  
• When a lesion is too small to 
measure on CT, assign 5 mm × 5 mm 
as the default  
• When no longer visible, 0 × 0 mm  
For a node > 5 mm × 5 mm but smaller 
than normal, use actual measurement  
Nonmeasured lesions  
Not applicable  
Absent/regressed, but no increase  
Organ enlargement  
Not applicable  
Spleen must have regressed by > 50% 
in length beyond normal  
New lesions  
None  
None  
Bone marrow  
Residual uptake higher than uptake in 
normal marrow but reduced compared 
with baseline (diffuse uptake 
compatible with reactive changes from 
chemotherapy allowed).  If there are 
persistent focal changes in the marrow 
in the context of a nodal response, 
consider further evaluation with MRI or 
biopsy.  
Not applicable  
 
No Metabolic Response 
Stable Disease 
Target nodes/nodal masses, 
extranodal lesions  
Score of 4 or 5a with no significant 
change in FDG uptake from baseline at 
interim or EOT  
< 50% decrease from baseline in SPD 
of up to 6 dominant, measurable nodes 
and extranodal sites; no criteria for 
progressive disease are met  
Nonmeasured lesions  
Not applicable  
No increase consistent with progression  

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Organ enlargement  
Not applicable  
No increase consistent with progression  
New lesions  
None  
None  
Bone marrow  
No change from baseline  
Not applicable  
 
Progressive Metabolic Disease 
PD (Requires at Least  
1 of the Following) 
Individual target 
nodes/nodal lesions  
Individual target nodes/nodal lesions:  
• Score 4 or 5a with an increase in 
intensity of uptake from baseline 
and/or  
• New FDG-avid foci consistent with 
lymphoma at interim or EOT 
assessment  
Extranodal lesions:  
• New FDG-avid foci consistent with 
lymphoma at interim or EOT 
assessment  
New lesions:  
• New FDG-avid foci consistent with 
lymphoma rather than another 
etiology (eg, infection, 
inflammation).  If uncertain 
regarding etiology of new lesions, 
biopsy or interval scan may be 
considered.  
Bone marrow:  
• New or recurrent FDG-avid foci  
 
PPD progression:  
• An individual node/lesion must be 
abnormal with all of the following:  
− LDi > 1.5 cm  
− Increase by ≥ 50% from PPD 
nadir  
− Increase in LDi or SDi from 
nadir:  
o 0.5 cm for lesions ≤ 2 cm  
o 1 cm for lesions > 2 cm  
• In the setting of splenomegaly, the 
splenic length must increase by 
> 50% of the extent of its prior 
increase beyond baseline (eg, a 
15 cm spleen must increase to 
> 16 cm).  If no prior splenomegaly, 
must increase by at least 2 cm from 
baseline  
• New or recurrent splenomegaly  
• New or clear progression of 
pre-existing nonmeasured lesions  
• Regrowth of any previously 
resolved lesions  
• A new node > 1.5 cm in any axis  
• A new extranodal site > 1.0 cm in 
any axis; if < 1.0 cm in any axis, its 
presence must be unequivocal and 
must be attributable to lymphoma  
• 
Assessable disease of any size 
unequivocally attributable to 
lymphoma  
• 
New or recurrent involvement of the 
bone marrow  
LDi = longest transverse diameter of lesion; PPD = cross-product of the longest transverse diameter and perpendicular diameter; 
SDi = shortest axis perpendicular to the longest transverse diameter; SPD = sum of the product of the perpendicular diameters 
for multiple lesions. 
a 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately 
> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. 

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APPENDIX D. iwCLL RESPONSE DEFINITIONS 
Group 
Parameter 
CR 
PR 
PD 
SD 
A 
Lymph nodes 
None ≥ 1.5 cm 
Decrease ≥ 50% 
(from baseline)a 
Increase ≥ 50% 
from baseline or 
from response 
Change of −49% 
to +49% 
Liver and/or 
spleen sizeb 
Spleen size <13 
cm; liver size 
normal 
Decrease ≥ 50% 
(from baseline) 
Increase ≥ 50% 
from baseline or 
from response 
Change of −49% 
to +49% 
Constitutional 
symptoms 
None 
Any 
Any 
Any 
Circulating 
lymphocyte count 
Normal 
Decrease ≥ 50% 
from baseline 
Increase ≥ 50% 
over baseline  
Change of −49% 
to +49% 
B 
Platelet count 
≥ 100 × 109/L 
≥ 100 × 109/L or 
increase ≥ 50% 
over baseline 
Decrease of  
≥ 50% from 
baseline 
secondary to CLL 
Change of −49% 
to +49% 
Hemoglobin 
≥ 11 g/dL 
(untransfused and 
without 
erythropoietin) 
≥ 11 g/dL or 
increase ≥ 50% 
over baselines 
Decrease of  
≥ 2 g/dL from 
baseline 
secondary to CLL 
 
Increase 
< 11.0 g/dL or 
<50% over 
baseline, or 
decrease < 2 g/dL 
Marrow 
Normocellular,  
no CLL cells, no 
B-lymphoid 
nodules 
Presence of CLL 
cells, or of 
B-lymphoid 
nodules, or not 
done 
Increase of CLL 
cells by ≥ 50% on 
successive 
biopsies 
No change in 
marrow infiltrate 
CR = complete remission (all of the criteria have to be met); PD = progressive disease (at least 1 of the criteria of Group A or 
Group B has to be met); PR = partial remission (at least 2 of the parameters of Group A and 1 parameter of Group B need to 
improve if previously abnormal; if only 1 parameter of both Groups A and B is abnormal before therapy, only 1 needs to 
improve); SD = stable disease (all of the criteria have to be met; constitutional symptoms alone do not define PD). 
a Sum of the products of 6 or fewer lymph nodes (as evaluated by CT scans and physical examination in clinical trials or by 
physical examination in general practice). 
b Spleen size is considered normal if 13 cm.  There is not firmly established international consensus of the size of a normal liver; 
therefore, liver size should be evaluated by imaging and manual palpation in clinical trials and be recorded according to the 
definition used in a study protocol. 

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APPENDIX E. CYP3A4 INHIBITORS AND INDUCERS 
CYP3A4 inhibitors or inducers may alter parsaclisib concentration.  These include, but are not 
limited, to the drugs listed below. 
CYP3A4 Inhibitors 
Inhibitor 
Therapeutic Class 
Potent Inhibitors 
VIEKIRA PAK 
Antivirals  
indinavir/ritonavir 
Protease inhibitors  
tipranavir/ritonavir  
Protease inhibitors  
ritonavir  
Protease inhibitors  
cobicistat (GS-9350)  
None  
ketoconazole  
Antifungals  
indinavir  
Protease inhibitors  
troleandomycin  
Antibiotics  
telaprevir  
Antivirals  
danoprevir/ritonavir  
Antivirals  
elvitegravir/ritonavir  
Treatments of AIDS  
saquinavir/ritonavir  
Protease inhibitors  
lopinavir/ritonavir  
Protease inhibitors  
itraconazole  
Antifungals  
voriconazole  
Antifungals  
mibefradil  
Calcium channel blockers  
LCL161  
Cancer treatments  
clarithromycin  
Antibiotics  
posaconazole  
Antifungals  
telithromycin  
Antibiotics  
grapefruit juice DS  
Food products  
conivaptan  
Diuretics  
nefazodone  
Antidepressants  
nelfinavir  
Protease inhibitors  
saquinavir  
Protease inhibitors  
ribociclib  
Kinase inhibitors  
idelalisib  
Kinase inhibitors  
boceprevir  
Antivirals  
Moderate Inhibitors 
erythromycin  
Antibiotics  
fluconazole  
Antifungals  
atazanavir/ritonavir  
Protease inhibitors  

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Inhibitor 
Therapeutic Class 
darunavir  
Protease inhibitors  
diltiazem  
Calcium channel blockers  
darunavir/ritonavir  
Protease inhibitors  
dronedarone  
Antiarrhythmics  
crizotinib  
Kinase inhibitors  
atazanavir  
Protease inhibitors  
letermovir  
Antivirals  
GSK2647544  
Alzheimer disease & dementia treatments  
aprepitant  
Antiemetics  
casopitant  
Antiemetics  
amprenavir  
Protease inhibitors  
faldaprevir  
Antivirals  
imatinib  
Antineoplastic agents  
verapamil  
Calcium channel blockers  
netupitant  
Antiemetics  
nilotinib  
Kinase inhibitors  
grapefruit juice  
Food products  
tofisopam  
Benzodiazepines  
cyclosporine  
Immunosuppressants  
ACT-178882  
Renin inhibitors  
ciprofloxacin  
Antibiotics  
Magnolia vine (Schisandra sphenanthera)  
Herbal medications  
isavuconazole  
Antifungals  
cimetidine  
H2-receptor antagonists  
FK1706  
Central nervous system agents  
Weak Inhibitors 
tabimorelin  
Hormone replacements  
amlodipine  
Calcium channel blockers  
ranolazine  
Cardiovascular drugs  
breviscapine  
Herbal medications  
lomitapide  
Other antilipemics  
fosaprepitant (IV)  
Antiemetics  
Seville orange (Citrus aurantium) juice  
Food products  
amiodarone  
Antiarrhythmics  
diosmin  
Herbal medications  
chlorzoxazone  
Muscle relaxants  
M100240  
Antihypertensive agents  
fluvoxamine  
Antidepressants  

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Inhibitor 
Therapeutic Class 
ranitidine  
H2-receptor antagonists  
goldenseal  
Herbal medications  
clotrimazole  
Antifungals  
tacrolimus  
Immunosuppressants  
palbociclib  
Kinase inhibitors  
cilostazol  
Antiplatelets  
ticagrelor  
Antiplatelets  
peppermint oil  
Food products  
ivacaftor  
Cystic fibrosis treatments  
GSK2248761  
Transcriptase inhibitors  
Guan Mai Ning  
Herbal medications  
osilodrostat  
Adrenal steroidogenesis inhibitors  
AZD2327  
Depression treatments  
piperine  
Food products  
resveratrol  
Food products  
roxithromycin  
Antibiotics  
suvorexant  
Hypnotics - sedatives  
propiverine  
Anticholinergics  
isoniazid  
Antibiotics  
berberine  
Herbal medications  
oral contraceptives  
Oral contraceptives  
delavirdine  
NNRTIs   
daclatasvir  
Antivirals  
simeprevir  
Protease inhibitors  
atorvastatin  
HMG CoA reductase inhibitors (Statins)  
tolvaptan  
Vasopressin antagonists  
almorexant  
Hypnotics - sedatives  
GSK1292263  
Other antilipemics  
evacetrapib 
CETP inhibitors  
linagliptin  
Dipeptidyl peptidase 4 inhibitors  
grazoprevir (ingredient of Zepatier)  
Antivirals  
lacidipine  
Calcium channel blockers  
cranberry juice  
Food products  
pazopanib  
Kinase inhibitors  
fostamatinib  
Other  
everolimus  
Immunosuppressants  
blueberry juice  
Food products  
flibanserin  
Central nervous system agents  

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Inhibitor 
Therapeutic Class 
lapatinib  
Kinase inhibitors  
brodalumab  
Immunomodulator biologics  
goldenseal  
Herbal medications  
clotrimazole  
Antifungals  
tacrolimus  
Immunosuppressants  
palbociclib  
Kinase inhibitors  
cilostazol  
Antiplatelets  
ticagrelor  
Antiplatelets  
peppermint oil  
Food products  
ivacaftor  
Cystic fibrosis treatments  
GSK2248761  
Transcriptase inhibitors  
Guan Mai Ning  
Herbal medications  
osilodrostat  
Adrenal steroidogenesis inhibitors  
AZD2327  
Depression treatments  
piperine  
Food products  
resveratrol  
Food products  
roxithromycin  
Antibiotics  
suvorexant  
Hypnotics - sedatives  
propiverine  
Anticholinergics  
isoniazid  
Antibiotics  
berberine  
Herbal medications  
oral contraceptives  
Oral contraceptives  
delavirdine  
NNRTIs  
daclatasvir  
Antivirals  
simeprevir  
Protease inhibitors  
atorvastatin  
HMG CoA reductase inhibitors (Statins)  
tolvaptan  
Vasopressin antagonists  
almorexant  
Hypnotics - sedatives  
GSK1292263  
Other antilipemics  
evacetrapib  
CETP inhibitors  
linagliptin  
Dipeptidyl peptidase 4 inhibitors  
grazoprevir (ingredient of Zepatier®)  
Antivirals  
lacidipine  
Calcium channel blockers  
cranberry juice  
Food products  
pazopanib  
Kinase inhibitors  
fostamatinib  
Other  
everolimus  
Immunosuppressants  
blueberry juice  
Food products  

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Inhibitor 
Therapeutic Class 
flibanserin  
Central nervous system agents  
lapatinib  
Kinase inhibitors  
brodalumab  
Immunomodulator biologics  
AMD070  
Fusion inhibitors  
alprazolam  
Benzodiazepines  
Tong Xin Luo  
Herbal medications  
glecaprevir and pibrentasvir  
Antivirals  
bicalutamide  
Antiandrogens  
sitaxentan  
Endothelin receptor antagonists  
azithromycin  
Antibiotics  
obeticholic acid  
Miscellaneous agents  
ginkgo  
Herbal medications  
teriflunomide  
Other immunomodulators  
AMD070  
Fusion inhibitors  
alprazolam  
Benzodiazepines  
Tong Xin Luo  
Herbal medications  
glecaprevir and pibrentasvir  
Antivirals  
bicalutamide  
Antiandrogens  
sitaxentan  
Endothelin receptor antagonists  
azithromycin  
Antibiotics  
obeticholic acid  
Miscellaneous agents  
ginkgo  
Herbal medications  
teriflunomide  
Other immunomodulators  
CYP3A4 Inducers 
Inducers 
Therapeutic Class 
Potent Inducers 
rifampin  
Antibiotics  
mitotane  
Other antineoplastics  
avasimibe  
Other antilipemics  
rifapentine  
Antibiotics  
apalutamide  
Antiandrogens  
phenytoin  
Anticonvulsants  
carbamazepine  
Anticonvulsants  
enzalutamide  
Antiandrogens  
St John's Wort extract  
Herbal medications  
lumacaftor  
Cystic fibrosis treatments  
rifabutin  
Antibiotics  
phenobarbital  
Anticonvulsants  

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Inducers 
Therapeutic Class 
Moderate Inducers 
ritonavir and St.  John's wort  
None  
semagacestat  
Alzheimer disease treatments  
efavirenz  
NNRTIs  
tipranavir and ritonavir  
Protease inhibitors  
dabrafenib  
Kinase inhibitors  
lesinurad  
Antigout and uricosuric agents  
bosentan  
Endothelin receptor antagonists  
genistein  
Food products  
thioridazine  
Antipsychotics  
nafcillin  
Antibiotics  
talviraline  
NNRTIs  
lopinavir  
Protease Inhibitors  
modafinil  
Psychostimulants  
PF-06282999  
Myeloperoxidase inactivators  
etravirine  
NNRTIs  
lersivirine  
NNRTIs  
telotristat ethyl  
Antidiarrheals  
Weak Inducers 
eslicarbazepine  
Anticonvulsants  
telaprevir  
Antivirals  
daclatasvir and asunaprevir and beclabuvir  
Antivirals  
amenamevir  
Antivirals  
garlic  
Food products  
bexarotene  
Other antineoplastics  
sarilumab  
Immunomodulator biologics  
artesunate and mefloquine  
Antimalarials  
amprenavir (fosamprenavir)  
Protease inhibitors  
raltegravir  
HIV-integrase strand transfer inhibitors  
vemurafenib  
Kinase inhibitors  
troglitazone  
Thiazolidinediones  
dicloxacillin  
Antibiotics  
sorafenib  
Kinase inhibitors  
rufinamide  
Anticonvulsants  
sirukumab  
Immunomodulator biologics  
pleconaril  
Antivirals  
ginseng  
Herbal medications  
boceprevir  
Antivirals  
sulfinpyrazone  
Antigout and uricosuric agents  

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Inducers 
Therapeutic Class 
ginkgo  
Herbal medications  
vinblastine  
Vinca alkaloids  
nevirapine  
NNRTIs  
armodafinil (R-modafinil)  
Psychostimulants  
ticagrelor  
Anticoagulants and antiplatelets  
LCL161  
Cancer treatments  
vicriviroc and ritonavir  
Treatments of AIDS  
ritonavir  
Protease inhibitors  
prednisone  
Corticosteroids  
oxcarbazepine  
Anticonvulsants  
danshen  
Herbal medications  
clobazam  
Benzodiazepines  
echinacea  
Herbal medications  
ticlopidine  
Anticoagulants and antiplatelets  
isavuconazole  
Antifungals  
brivaracetam  
Anticonvulsants  
Stribild®  
Treatments of AIDS  
pioglitazone  
Thiazolidinediones  
VIEKIRA PAK  
Antivirals  
dexamethasone  
Corticosteroids  
terbinafine  
Antifungals  
quercetin  
Food products  
glycyrrhizin  
Herbal medications  
aprepitant  
Neurokinin-1 receptor antagonists  
pretomanid (PA-824)  
Antibiotics  
safinamide  
Monoamine oxidase B inhibitors  
oritavancin  
Antibiotics  
AZD 7325  
Anxiolytics  
methylprednisolone  
Corticosteroids  
topiramate  
Anticonvulsants  
AIDS = acquired immunodeficiency syndrome; NNRTI = non-nucleoside reverse transcriptase inhibitor. 

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APPENDIX F. INSTRUCTION TO PARTICIPANTS FOR HANDLING 
PARSACLISIB 
The participant must be instructed in the handling of parsaclisib as follows:  
To store study drug at room temperature.   
• To remove only the number of tablets needed from the study drug bottle at the time of 
administration.   
• Not to remove doses in advance of the next scheduled administration.   
• To make every effort to take doses on schedule.   
• If a dose is missed by more than 12 hours during the once-daily administration, then 
that dose should be skipped, and the next scheduled dose should be taken at the usual 
time.   
• To report any missed doses.   
• To keep study drug in a safe place and out of reach of children.   
• To bring all used and unused study drug bottles to the site at each visit.   

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APPENDIX G. MANAGEMENT OF POTENTIAL HY'S LAW CASES 
INTRODUCTION 
During the course of the study, the investigator will remain vigilant for increases in liver 
biochemistry.  The investigator is responsible for determining whether a participant meets PHL 
criteria at any point during the study. 
The investigator participates, in conjunction with Incyte clinical project and pharmacovigilance 
representatives, in the review and assessment of cases fulfilling PHL criteria to ascertain whether 
there is an alternative explanation for the elevations in liver biochemistry other than 
drug-induced liver injury caused by the study drug. 
The investigator fulfills requirements for the recording of data pertaining to PHL or Hy's law 
cases and AE/SAE reporting according to the outcome of the review and assessment in line with 
standard safety reporting processes. 
DEFINITIONS 
For the purpose of this process, definitions are as follows: 
Potential Hy's Law 
An increase in AST or ALT > 3 × ULN and total bilirubin > 2 × ULN at any point during the 
study.  The elevations do not have to be at the same time or within a specified timeframe. 
Hy's Law 
An increase in AST or ALT ≥ 3 × ULN and total bilirubin > 2 × ULN, where no other reason can 
be found to explain the combination of increases (eg, elevated serum ALP indicating cholestasis, 
viral hepatitis, another drug). 
ACTIONS REQUIRED IN CASES OF AST OR ALT > 3 × ULN OR TOTAL BILIRUBIN 
≥ 2 × ULN 
Identification and Determination of Potential Hy's Law 
To identify cases of AST or ALT > 3 × ULN or total bilirubin > 2 × ULN and consequently 
determine whether the participant meets PHL criteria, please follow the instructions below: 
• Review the laboratory report and if a participant has AST or ALT > 3 × ULN OR 
total bilirubin > 2 × ULN at any visit: 
− Determine without delay whether the participant meets PHL criteria by reviewing 
laboratory reports from all previous visits. 
− Enter the laboratory data into the laboratory eCRF as soon as possible. 

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Potential Hy's Law Criteria Not Met 
If the participant has NOT had AST or ALT ≥ 3 × ULN AND total bilirubin > 2 × ULN at any 
point in the study (the elevations do not have to be at the same time or within a specified 
timeframe), irrespective of ALP, please follow the instruction below: 
• Perform follow-up on subsequent laboratory results according to Table 3. 
Potential Hy's Law Criteria Met 
If the participant has had AST or ALT ≥ 3 × ULN AND total bilirubin > 2 × ULN at any point in 
the study (the elevations do not have to be at the same time or within a specified timeframe), 
irrespective of ALP, please follow the instruction below: 
• Have participant interrupt study drug. 
• Notify Incyte study team without delay. 
− The investigator, or designee, should contact the medical monitor to discuss and 
agree upon an approach for the study participant's follow-up and the continuous 
review of data. 
• Monitor the participant until liver biochemistry parameters and appropriate clinical 
symptoms and signs return to normal or baseline levels, or as medically indicated. 
• Investigate the etiology of the event and perform any relevant diagnostic 
investigations as discussed with the medical monitor. 
• Enter the laboratory data into the laboratory CRF as soon as possible. 
• If at any time (in consultation with the medical monitor) the PHL case meets serious 
criteria, report it as an SAE using standard reporting procedures. 
REVIEW AND ASSESSMENT 
No later than 3 weeks after the biochemistry abnormality is initially detected and the criteria for 
PHL is met, the medical monitor, Incyte pharmacovigilance physician, and investigator will 
discuss and review available data and agree on whether there is an alternative explanation for the 
elevations in liver biochemistry other than drug-induced liver injury caused by the study drug.  
Participant matter experts will be included in the review as appropriate. 
Evaluation of Alternative Causes 
In order to gather additional clinical information to seek other possible causes of the observed 
liver test abnormalities, the following alternative etiologies should be considered, including but 
not limited to: 
• Active viral hepatitis 
• Alcoholic and autoimmune hepatitis 

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• Hepatobiliary disorders 
− Biliary tract disease, such as migration of gallstones or intrahepatic lesions, more 
often causes cholestatic injury initially and should be investigated with 
gallbladder and ductal imaging studies, especially if alkaline phosphatase is 
increased.  Malignant interruption of the biliary tract also should be considered. 
• Concomitant treatment 
• Other causes such as systemic infections (eg, bacterial, fungal, viral), nonalcoholic 
steatohepatitis, and cardiovascular diseases 
Actions After Review and Assessment 
According to outcome of the review and assessment, please follow the instructions below: 
If there is an agreed alternative explanation for the AST or ALT and total bilirubin elevations, a 
determination of whether the alternative explanation is an AE will be made and subsequently 
whether the AE meets the criteria for an SAE. 
• If the alternative explanation is not an AE, record the alternative explanation on the 
appropriate CRF if possible. 
• If the alternative explanation is an AE/SAE, record the AE/SAE in the eCRF 
accordingly and follow the standard study processes. 
• Have participant resume study drug as per Protocol guidelines. 
If it is agreed that there is no explanation that would explain the AST or ALT and total bilirubin 
elevations: 
• Have participant permanently discontinue study drug and perform end-of-treatment 
procedures. 
• Report an SAE (report term "Hy's Law"). 
− The 'medically important' serious criterion should be used if no other serious 
criteria apply. 
− As there is no alternative explanation for the Hy's law case, a causality assessment 
of related should be assigned. 
• If there is an unavoidable delay of over 3 weeks in obtaining the information 
necessary to assess whether or not the case meets the criteria for a Hy's law case, then 
it is assumed that there is no alternative explanation until such time as an informed 
decision can be made.  Report an SAE (report term "Potential Hy's Law") applying 
serious criteria and causality assessment as per above. 

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ACTIONS REQUIRED FOR REPEAT EPISODES OF AST OR ALT > 3 × ULN AND/OR 
TOTAL BILIRUBIN > 2 × ULN 
The requirement to conduct follow-up, review, and assessment of a repeat occurrence(s) of PHL 
is based on the nature of the alternative cause identified for the previous occurrence. 
If the alternative cause for the previous occurrence of PHL was not chronic or progressing 
malignant disease, please follow the process for PHL review and assessment as described in this 
appendix. 
If the alternative cause for the previous occurrence of PHL was chronic or progressing malignant 
disease, please follow the instructions below: 
• Determine whether there has been a significant change* in the participant's condition. 
− If there is no significant change, no action is required. 
− If there is a significant change, follow the process described for PHL review and 
assessment as described in this appendix. 
* A 'significant' change in the participant's condition refers to a clinically relevant change in ALT, AST, or total 
bilirubin, or associated symptoms.  The determination of whether there has been a significant change will be at the 
discretion of the investigator; this may be in consultation with the medical monitor if there is any uncertainty. 

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APPENDIX H. PANDEMIC MITIGATION STRATEGIES AND 
INSTRUCTIONS 
The current COVID-19 global pandemic presents numerous challenges to the ongoing conduct of 
clinical trials.  In line with the European Medicines Agency's Guidance on the Management of 
Clinical Trials During the COVID-19 (Coronavirus) Pandemic (2020), the sponsor has issued the 
following Protocol considerations to ensure participant safety is maintained and appropriate 
benefit/risk analyses are taken into consideration with respect to the completion of study 
procedures and maintaining the investigational product supply chain. 
Recognizing the flexibility required to manage the impact of the pandemic on this clinical trial, 
additional details will be added to respective study manuals and project plan documents and 
communicated to the investigative sites as needed. 
Eligibility 
Although SARS-CoV-2 testing is not mandated for this study, local clinical practice standards 
for testing should be followed.  A participant should be excluded if he/she has a positive test 
result for SARS-CoV-2 infection, is known to have asymptomatic infection, or is suspected of 
having SARS-CoV-2.  Participants with active infections are excluded from study participation 
as per the exclusion criteria (see Section 5.2).  When the infection resolves, the participant may 
be considered for rescreening. 
Study Site Visits 
If local travel restrictions, quarantine requirements, or the investigator's risk/benefit assessment 
preclude a participant's ability to attend study visits on-site, site staff may elect to perform the 
following:  
• In order to minimize participant risk, study visits may be conducted via telemedicine 
modalities (phone or video).  At a minimum, a review of AEs, concomitant 
medications, and study drug compliance must be completed.  Periodic on-site visits 
should resume once possible.  
• In order to support investigator oversight of safety and disease management, the 
participant may be asked to perform some laboratory tests or study procedures 
(eg, ECG) at a local (proximate) hospital laboratory or facility closer to the 
participant's residence rather than at the investigational site.  In this case, the 
investigator will provide the participant with the list of parameters to be checked.  
These tests should be performed in certified laboratories. 
Investigational Medicinal Product Dispensation and Distribution 
In order to ensure the continuity in clinical supplies within the constraints imparted by the 
pandemic, the site staff may supply study drug as follows: 
• Investigators may dispense an additional supply of parsaclisib tablets to compensate 
for an interval between on-site visits that may be longer than required by the SoA 
(see Table 3). 

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• Alternatively, if the participant cannot attend a visit at the study site, an adequate 
supply of parsaclisib may be shipped to the participant by the investigator or 
appropriately delegated staff (eg, the study pharmacy staff) using a third-party service 
if duly authorized by the participant.  The study site may use their own preferred 
courier, provided the courier adheres to certain standards (eg, use of personal 
protection equipment, maintenance of temperature-controlled transit environment), or 
one centrally contracted by the sponsor. 
Clinical Trial Monitoring 
Study monitoring visits may be postponed; however, the study monitor will continue to employ 
off-site monitoring practices such as routine communication methods (eg, phone calls, emails, 
video visits) to review information on trial progress, participant status, and information on issue 
resolution.  The study monitor will remotely review data entered into the EDC for accuracy and 
completeness, and remote source data verification may be implemented with agreement of the 
principal investigator and institution, as applicable. 
If the study monitor cannot be on-site to perform the final drug accountability for reconciliation 
purposes, and the operation cannot be postponed, it may be performed by a pharmacist from the 
hospital pharmacy or by the study coordinator/data manager with suitable training.  The study 
drug can be returned to the sponsor by the hospital pharmacy directly or destroyed in accordance 
with local practices, if applicable, and with sponsor approval. 
Direct Contracts With Third Parties/Specialized Service Companies 
If necessary, direct contracts can be established with third-party local physicians to conduct 
activities related to the clinical management of participants for whom the investigator is 
responsible and maintains oversight.  In such situations, the investigator is required to provide 
the local physician with a delegation letter listing all delegated activities.  The sponsor, through 
the study investigator or institution, will reimburse the local physician for the test/procedures 
conducted outside of the standard of care. 

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APPENDIX I. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Document 
Date 
Amendment 1 
08 OCT 2021 
Amendment 2 
13 SEP 2022 
Amendment 2 (13 SEP 2022) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to include sponsor recommendations regarding 
COVID-19 monitoring and management, to update data privacy requirements in accordance with 
the EU Clinical Trials Regulation directive, and to include revisions made in Administrative 
Changes 2, 3, and 4. 
1. Section 1, Protocol Summary (Table 3: Schedule of Activities) 
Description of change:  Updated the "Survival" column heading to "Last Visit + 12 Wk 
(± 7 d)," added a note to the "Tafasitamab ADA (preinfusion)" row to include collection 
of on-treatment samples every 4 cycles from Cycle 4 (C4D1, C8D1, etc), and updated the 
"MRD and DNA mutational analysis (blood EDTA)" row to include collection of 
on-treatment samples at Cycle 4 Day 1 and Cycle 13 Day 1 only.  
Rationale for change:  To align with the survival follow-up frequency stated in 
Section 8.8.3, to align with new information regarding collection of PK and ADA 
samples at the same timepoints, and to reduce sample collection requirements.  
2. Section 2.3, Benefit/Risk Assessment; Section 9.8, Warnings and Precautions  
Description of change:  Added text related to recommendations for COVID-19 
monitoring and management in patients with hematologic malignancies. 
Rationale for change:  Recommendations arising out of ongoing safety surveillance. 
3. Section 6.6.2, Criteria and Procedures for Dose Interruptions and Adjustments of 
Study Drug 
Description of change:  Deleted repeated paragraph. 
Rationale for change:  Editorial correction. 
4. Section 8.1.2, Screening Procedures 
Description of change:  Added text to allow assessments to occur outside the 28-day 
window for those that are suitable for enrollment but may not be feasible to repeat.  
Rationale for change:  Clarification. 

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5. Section 8.1.2.1, Tumor or Lymph Node Sample; Section 8.1.2.2, Bone Marrow 
Biopsy and Examination; Section 8.2.1, Computed Tomography Scan or Magnetic 
Resonance Imaging; Section 8.2.2, Fluorodeoxyglucose–Positron Emission 
Tomography 
Description of change:  Changed "randomization" to "enrollment" because there is no 
randomization in this study. 
Rationale for change:  Clarification. 
6. Section 10.2, Populations for Analysis (Table 16: Populations for Analysis) 
Description of change:  Add a row defining the DLT evaluable set. 
Rationale for change:  This population set will be defined for analyzing DLT results 
from the dose confirmation part of the study.  This population will be more conservative 
for the calculation of DLT percentage. 
7. Section 11.3, Data Privacy and Confidentiality of Study Records 
Description of change:  Updated text to align with EU Clinical Trials Regulation 
directive. 
Rationale for change:  Updated information. 
8. Incorporation of administrative changes.  Other regulatory guidance and 
administrative changes have been incorporated throughout the Protocol and are noted in 
the redline version of the amendment. 
 

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Amendment 1 (08 OCT 2021) 
Overall Rationale for the Amendment: 
The primary purpose of the amendment is to modify the operating characteristics of the iDSMB, 
update the time interval that must elapse before performing the safety follow-up visit, and update 
the biomarker sample collection schedule.  Additional changes are summarized below. 
1. Section 1, Protocol Summary; Section 4.1, Overall Design; Section 5.6, Data Safety 
Monitoring Board; Section 6.5.2, Procedures for Cohort Review 
Description of change:  Revised operating characteristics to enable iDSMB reviews to 
occur after the 10th DLT-evaluable participant, irrespective of cohort, completes the DLT 
evaluation period.  Revised criteria for cohort review to clarify that aggregated safety 
data will be used to facilitate opening of dose expansion cohorts. 
Rationale for change:  DSMB feedback after initial kickoff meeting. 
2. Section 1, Protocol Summary (Table 2:  Key Study Design Elements; Table 3:  
Schedule of Activities); Section 4.2, Overall Study Duration; Section 6.7, 
Concomitant Medications and Procedures; Section 8.3.1, Adverse Events; 
Section 8.3.8, Laboratory Assessments; Section 8.8.1, Safety Follow-Up; Section 9.4, 
Reporting of Serious Adverse Events; Section 10.4.1, Safety Analyses 
Description of change:  Updated the EOT safety follow-up to 90 days after last dose of 
study treatment. 
Rationale for change:  Standardization across the tafasitamab program for safety 
follow-up requirements to perform visit after 5 half-lives since last dose. 
3. Section 1, Protocol Summary (Table 3:  Schedule of Activities) 
Description of change:  Changed preinfusion medication to IRR prophylaxis regimen. 
Rationale for change:  General clarification. 
4. Section 1, Protocol Summary (Table 3:  Schedule of Activities); Section 8.3.3, Vital 
Signs 
Description of change:  Included measurement of weight to the vital signs assessments. 
Rationale for change:  General clarification to ensure regular monitoring of weight with 
vital sign assessments. 
5. Section 1, Protocol Summary (Table 3:  Schedule of Activities) 
Description of change: Added a column under follow-up period to align with 
post-treatment disease follow-up assessments; added physical examination, vital 
signs/weight, ECOG performance status, B symptoms/constitutional symptoms, 
contrast-enhanced CT or MRI, and hematologic parameters where appropriate as part of 
post-treatment disease follow-up. 
Rationale for change:  To clarify the required assessments for post-treatment disease 
follow-up. 

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6. Section 1, Protocol Summary (Table 3:  Schedule of Activities) 
Description of change:  Revised biomarker sampling schedule, added plasma 
proteomics sample collection at C4D1, and decreased the number of on-treatment 
MRD/DNA mutational and FACS samples to be collected. 
Rationale for change:  To align with the translational research plan after initial protocol. 
7. Section 2.1.2, Tafasitamab 
Description of change:  Updated tafasitamab background. 
Rationale for change:  To align with the most current IB and approval status. 
8. Section 2.1.3, Parsaclisib 
Description of change:  Updated parsaclisib background. 
Rationale for change:  To align with the most current IB. 
9. Section 6.1, Study Treatments Administered (Table 6:  Study Treatment 
Information) 
Description of change:  Updated parsaclisib dosage formulation, and updated approval 
status information due to recent approvals in European Union and Canada. 
Rationale for change:  Editorial clarifications. 
10. Section 6.6.2.1, Tafasitamab Dose Modifications for Cytokine Release Syndrome 
and Infusion-Related Reactions 
Description of change:  Included provisions to split the dose of tafasitamab if the full 
dose cannot be administered in 1 day. 
Rationale for change: Standardization across the tafasitamab program to manage IRRs 
and CRS. 
11. Section 6.6.2.5, Management of Hypogammaglobulinemia 
Description of change:  Added a new section to provide investigators with guidance on 
appropriate management of hypogammaglobulinemia. 
Rationale for change:  Standardization across the tafasitamab program. 
12. Section 6.6.3, Criteria for Permanent Discontinuation of Study Drug 
Description of change:  Added a new section with permanent study drug discontinuation 
criteria. 
Rationale for change:  To provide guidance to investigators on the definitions of 
unacceptable toxicity. 
13. Section 8.3.5, B Symptoms/Constitutional Symptoms 
Description of change:  Updated to include that assessment of constitutional symptoms 
for participants with CLL or SLL will include assessment of fatigue. 
Rationale for change:  Clarification. 

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14. Section 8.8.4, Participant Completion of Study 
Description of change:  Added a new section to clarify participant completion of study 
definitions. 
Rationale for change:  Investigator feedback on initial version. 
15. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

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