A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Phase: PHASE1
Conditions: Diffuse Large B Cell Lymphoma
Sponsor: Incyte Corporation

Official Title: 
A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety 
and Pharmacokinetics of a Modified Tafasitamab IV Dosing 
Regimen Combined With Lenalidomide (LEN) in Patients With 
Relapsed or Refractory Diffuse Large B-Cell Lymphoma 
(R/R DLBCL) [MINDway] 
NCT Number: 
NCT05222555 
Document Date: 
MOR208C115 11 APR 2024 
 
 
 

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TITLE PAGE 
CLINICAL TRIAL PROTOCOL 
 
A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics 
of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide (LEN) in 
Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) 
[MINDway] 
 
 
Clinical Trial Protocol No: 
MOR208C115 
Clinical Trial Protocol Name: MINDway 
Version: 
CTP v7.0, 11 APR 2024 
Clinical Trial Phase: 
Phase 1b/2 
Product Name: 
Tafasitamab 
Sponsor: 
Incyte Corporation 
Sponsor's Address: 
1801 Augustine Cut-Off 
Wilmington, DE 19803 USA 
EU CT No.: 
2023-507993-42-00 
IND No.: 
145,009 
 
The concepts and information contained in this document are considered proprietary and 
are provided for the exclusive use of investigators and other persons involved in the study 
who have a need to know. Subject to the foregoing, the content of this document may not be 
disclosed unless law or regulations require such disclosure, or Incyte Corporation has 
granted prior written approval. 

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INVESTIGATOR'S AGREEMENT 
I have read the MOR208C115 CTP v7.0 (dated 11 APR 2024) 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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PROTOCOL HISTORY 
Version 
Date 
Amended Protocol CTP v7.0 
11 APR 2024 
Amended Protocol CTP v6.0 
18 AUG 2023 
Amended Protocol CTP v5.0 
02 MAY 2023 
Amended Protocol CTP v4.0 
24 AUG 2022 
Amended Protocol CTP v3.0 
16 MAR 2022 
Amended Protocol CTP v2.0-CZ1 
(Czech Republic Local Amendment 1 of CTP v2.0) 
19 JAN 2022 
Amended Protocol CTP v2.0 
18 OCT 2021 
Original Protocol CTP v1.0  
10 AUG 2021 
 
Amended Protocol CTP v7.0 (11 APR 2024) 
Overall Rationale for the Amendment: 

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TABLE OF CONTENTS 
TITLE PAGE .................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ............................................................................................2 
PROTOCOL HISTORY ...............................................................................................................3 
TABLE OF CONTENTS ..............................................................................................................4 
1 
PROTOCOL SYNOPSIS ...............................................................................................9 
2 
SCHEDULE OF ASSESSMENTS (SoA) ...................................................................17 
3 
INTRODUCTION ........................................................................................................20 
3.1 
Study Rationale ...............................................................................................................20 
3.1.1 Disease Overview ..............................................................................................20 
3.1.2 Study Treatment ................................................................................................21 
3.2 
Non-Clinical Background Information ...........................................................................22 
3.3 
Clinical Background .......................................................................................................23 
3.3.1 Tafasitamab Clinical Development ...................................................................23 
3.3.2 Results From L-MIND [Primary Analysis (NOV 2018) and Data 
Cut-Off OCT 2020] ...........................................................................................24 
3.3.3 Safety Profile of Tafasitamab Plus LEN From L-MIND (Cut-Off Date 
OCT 2020) .........................................................................................................25 
3.3.4 Clinical Pharmacokinetics of Tafasitamab ........................................................27 
3.4 
Justification for Dose ......................................................................................................27 
3.5 
Benefit/Risk Assessment ................................................................................................30 
3.5.1 Risk Assessment ................................................................................................30 
3.5.2 Benefit Assessment ...........................................................................................30 
3.5.3 Overall Benefit Risk Conclusion .......................................................................31 
4 
OBJECTIVES, ENDPOINTS AND ESTIMANDS ...................................................32 
4.1 
Objectives and Endpoints ...............................................................................................32 
4.1.1 Primary Estimand ..............................................................................................32 
4.1.2 Supplemental Estimand .....................................................................................33 
5 
STUDY DESIGN...........................................................................................................34 
5.1 
Overall Design ................................................................................................................34 
5.2 
Data and Safety Monitoring Committee .........................................................................35 
6 
STUDY POPULATION ...............................................................................................37 
6.1 
Inclusion Criteria ............................................................................................................37 
6.2 
Exclusion Criteria ...........................................................................................................39 
6.3 
Screen Failures ................................................................................................................42 
7 
STUDY TREATMENT(S) ...........................................................................................43 
7.1 
Investigational Medicinal Products Administered ..........................................................43 
7.1.1 Tafasitamab (IMP) .............................................................................................43 
7.1.2 Lenalidomide (IMP) ..........................................................................................45 
7.1.3 Pre-Medication for Tafasitamab Infusions ........................................................45 
7.1.4 Patient Monitoring During and After Tafasitamab Infusion .............................46 
7.2 
Standard of Care .............................................................................................................46 

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7.3 
Dose Modifications, Drug Interruptions and Discontinuation........................................46 
7.3.1 Tafasitamab Specific Dose Modifications, Drug Interruptions and 
Discontinuation ..................................................................................................46 
7.3.2 LEN Specific Dose Modifications, Drug Interruptions and 
Discontinuation ..................................................................................................48 
7.3.3 General Dose Modifications, Drug Interruptions and Discontinuation 
due to Toxicity ...................................................................................................49 
7.4 
Overdose .........................................................................................................................53 
7.5 
Measures to Minimize Bias: Randomization and Blinding ............................................53 
7.6 
Preparation/Handling/Storage/Accountability ................................................................53 
7.7 
Treatment Compliance ....................................................................................................54 
7.8 
Prior and Concomitant Therapy ......................................................................................54 
7.8.1 Recording of Prior Lines of Anti-Lymphoma Therapy .....................................55 
7.8.2 Growth Factors ..................................................................................................55 
7.8.3 Anticancer Therapies .........................................................................................55 
7.8.4 Systemic Glucocorticosteroids ..........................................................................55 
7.8.5 Concomitant Therapies That May Increase the Risk of Thrombosis ................56 
7.9 
Prohibited Medication/Therapy ......................................................................................57 
7.10 
Rescue Medication ..........................................................................................................57 
7.11 
Restrictions .....................................................................................................................57 
7.11.1 Restrictions Applicable in All Countries Except US ........................................57 
7.11.2 Restrictions Applicable in US ...........................................................................58 
7.12 
Treatment After the End of the Study .............................................................................59 
8 
PATIENT DISCONTINUATION ...............................................................................60 
8.1 
Discontinuation From the Study .....................................................................................60 
8.2 
Discontinuation of Study Treatment ...............................................................................60 
8.3 
Lost to Follow-Up ...........................................................................................................61 
8.4 
Replacement of Patient ...................................................................................................61 
9 
STUDY ASSESSMENTS AND PROCEDURES .......................................................61 
9.1 
Demographic and Baseline Characteristics ....................................................................61 
9.2 
Physical Examinations ....................................................................................................62 
9.3 
Efficacy Assessments .....................................................................................................62 
9.3.1 Radiographic Imaging Assessment ...................................................................62 
9.3.2 Bone Marrow Assessment .................................................................................63 
9.4 
Safety Assessments .........................................................................................................63 
9.4.1 Vital Signs .........................................................................................................63 
9.4.2 Electrocardiograms (ECGs) ...............................................................................64 
9.4.3 Pregnancy ..........................................................................................................64 
9.4.4 Viral Serology ...................................................................................................65 
9.4.5 Clinical Safety Laboratory Assessments ...........................................................66 
9.4.6 Diagnostic Lymphoma Biopsy and Central Pathology Review ........................67 
9.4.7 AEs, SAEs and AESI ........................................................................................68 
9.4.8 B-Symptoms, ECOG Performance Status .........................................................69 
9.4.9 Reporting of Treatment Errors, Misuse or Abuse .............................................70 
9.5 
Pharmacokinetics and Immunogenicity ..........................................................................70 
 
 

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10 
STATISTICAL CONSIDERATIONS ........................................................................72 
10.1 
Sample Size Determination ............................................................................................72 
10.2 
Populations for Analyses ................................................................................................73 
10.2.1 Analysis Set for the Primary Estimand (PAS) ..................................................73 
10.2.2 Enrolled Patients ................................................................................................73 
10.2.3 Full Analysis Set (FAS) .....................................................................................73 
10.2.4 Safety Set (SAF) ................................................................................................73 
10.2.5 PK Analysis Set (PKAS) ...................................................................................73 
10.2.6 Immunogenicity Analysis Set (IAS)..................................................................73 
10.2.7 Per Protocol Set (PPS) .......................................................................................73 
10.3 
Statistical Analyses .........................................................................................................74 
10.3.1 Analysis Time Points .........................................................................................74 
10.3.2 Efficacy Analyses ..............................................................................................75 
10.3.3 Safety Analyses (Primary Endpoint) .................................................................75 
10.3.4 Patient Disposition .............................................................................................76 
10.3.5 Additional Secondary Endpoint Analyses .........................................................76 
 
10.3.7 Additional Safety Analysis ................................................................................77 
10.3.8 Estimands ..........................................................................................................80 
11 
REFERENCES..............................................................................................................81 
12 
APPENDICES ...............................................................................................................83 
12.1 
Appendix 1: List of Abbreviations and Definitions of Terms ........................................83 
12.2 
Appendix 2: Regulatory, Ethical, and Trial Oversight Considerations ..........................88 
12.2.1 Regulatory and Ethical Considerations .............................................................88 
12.2.2 Informed Consent Process .................................................................................88 
12.2.3 Data Protection ..................................................................................................89 
12.2.4 Publication Policy ..............................................................................................89 
12.2.5 Dissemination of Clinical Study Data ...............................................................90 
12.2.6 Data Quality Assurance .....................................................................................90 
12.2.7 Source Documents .............................................................................................90 
12.2.8 Study and Site Closure ......................................................................................91 
12.3 
Appendix 3: Study Specific Definitions .........................................................................92 
12.4 
Appendix 4: International Working Group Resource Criteria for Malignant 
Lymphoma ......................................................................................................................93 
12.5 
Appendix 5: Karnofsky Performance Status Scale .........................................................94 
12.6 
Appendix 6: Cockcroft-Gault Formula ...........................................................................95 
12.7 
Appendix 7: COVID-19: Infection Prophylaxis and Vaccines ......................................96 
12.8 
Appendix 8: Hepatitis Virus Serology ............................................................................97 

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12.9 
Appendix 9: Equivalent Doses for Corticosteroids ........................................................98 
12.10 
Appendix 10: International Prognostic Index and Ann Arbor Staging 
Classification ..................................................................................................................99 
12.11 
Appendix 11: ECOG Performance Status Scale ...........................................................101 
12.12 
Appendix 12: AEs: Definitions and Procedures for Recording, Evaluating, 
Follow-Up, and Reporting ............................................................................................102 
12.12.1 Definition of AE ..........................................................................................102 
12.12.2 Definition of SAE ........................................................................................103 
12.12.3 Recording and Follow-Up of AE and/or SAE .............................................104 
12.12.4 Reporting of SAEs/AESIs ...........................................................................106 
12.13 
Appendix 13: Contraceptive Guidance and Collection of Pregnancy Information ......107 
12.13.1 Definitions ...................................................................................................107 
12.13.2 Contraception Guidance ..............................................................................108 
12.13.3 Collection of Pregnancy Information ..........................................................109 
12.14 
Appendix 14: 
..................................................................................................110 
 
 
LIST OF TABLES 
Table 1: Objectives and Corresponding Endpoints ........................................................................ 9 
 
Table 3: Schedule of Assessments ................................................................................................ 17 
Table 4: Tafasitamab in Combination With LEN Dosing Regimen as per Monjuvi® USPI 
in R/R DLBCL ............................................................................................................... 21 
 
Table 6: Updated Efficacy Analysis Results in L-MIND (Cut-Off Date OCT 2020) .................. 25 
Table 7: Adverse Drug Reactions Observed in L-MIND (Tafasitamab – Lenalidomide 
Combination Therapy in Patients With DLBCL) in ≥ 3.0% Patientsb .......................... 26 
Table 8: Objectives and Corresponding Endpoints ...................................................................... 32 
Table 9: Overview of IMPs in MINDway .................................................................................... 43 
 
Table 11: Infusion Rate Modifications for Tafasitamab Infusion (
) 
in Case of IRR's, Cytokine Release Syndrome (CRS) ................................................... 45 
Table 12: Definition of IRR and CRS NCI-CTCAE Version 5.0: IRR and CRS ........................ 47 
Table 13: LEN Dose Modification Guidelines ............................................................................. 48 
Table 14: Hematological Toxicities .............................................................................................. 50 
Table 15: Non-Hematological Toxicities ...................................................................................... 51 
Table 16: Local Laboratory Assessments ..................................................................................... 67 
Table 17: The Estimand Summary ............................................................................................... 80 
 
 

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LIST OF FIGURES 
 

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1 PROTOCOL SYNOPSIS 
Protocol title 
A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a 
Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide (LEN) in Patients With 
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) [MINDway] 
Objectives, endpoints and estimands 
The following objectives and endpoints will be evaluated in the study, see Table 1: 
Table 1: Objectives and Corresponding Endpoints 
Objectives 
Endpoints 
Primary 
• To evaluate the safety and tolerability of 
tafasitamab administered 
 
 in 
combination with lenalidomide in R/R DLBCL 
patients 
• To determine a recommended dose for 
tafasitamab 
 administration in 
combination with lenalidomide in R/R DLBCL 
patients 
Incidence and severity of TEAEs  
Secondary 
To evaluate the pharmacokinetic profile of 
tafasitamab after 
 dosing in combination 
with lenalidomide 
Tafasitamab serum concentrations after 3 (Ctrough and Cmax) 
and 12 (Ctrough) treatment cycles 
To assess anti-tumor activity of tafasitamab after 
 dosing in combination with 
lenalidomide 
• Best Objective Response Rate (ORR) by investigator 
assessment up to treatment Cycle 12 based on 
Cheson et al. (2007) 
• Duration of Response (DoR) by investigator assessment 
based on Cheson et al. (2007) 
• Progression-Free Survival by investigator assessment 
based on Cheson et al. (2007) 
To assess the incidence of anti-drug antibodies to 
tafasitamab 
Number and percentage of patients developing 
anti-tafasitamab antibodies up to treatment Cycle 12 
Abbreviations: Cmax=maximum concentration; Ctrough=minimum concentration; DLBCL=diffuse large B-cell lymphoma; 
 
; R/R=relapsed/refractory; TEAEs=treatment-emergent 
adverse events. Each treatment cycle is 28 days. 
Estimands 
The primary clinical question of interest is: Given a proposed 
 treatment 
 
with tafasitamab 
, what is the observed incidence and 
severity of treatment emergent adverse events (TEAEs) in R/R DLBCL patients who receive  
? This would allow the assessment of the safety and the 
tolerability of 
. The primary estimand and its attributes 
are described in Section 4. Possible intercurrent events and strategies to capture them are described 
in Section 4. 

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Study design 
MOR208C115 (MINDway) is an open-label, multicenter, phase 1b/2 study of tafasitamab 
combined with lenalidomide (LEN) to evaluate the safety and pharmacokinetics (PK) of a 
 tafasitamab 
 in adult patients with R/R DLBCL. 
Overall, approximately 51 patients will be enrolled in the study. Patients will receive LEN in 
combination with tafasitamab in 28-day cycles. The 
 tafasitamab 
 will be 
investigated in a stepwise design with two sequential cohorts followed by an expansion cohort at 
the recommended dose level. Tafasitamab will be administered as intravenous infusion 
 
 
 (see Table 2). 
LEN (25 mg) will be administered for a maximum of 12 cycles or until disease progression, 
unacceptable toxicity, withdrawal, death or lost to follow up, whichever comes first. After 
Cycle 12 or LEN discontinuation, patients will continue with tafasitamab monotherapy 
 
 until disease progression, unacceptable toxicity, withdrawal, death or lost 
to follow up, whichever comes first. 
No follow-up for overall survival will be performed in this study after end of treatment (EOT). 
A Data and Safety Monitoring Committee (DSMC), consisting of Sponsor representatives and 
investigators, will continuously monitor the study and can recommend to stop enrollment at any 
time based on emerging safety data. In addition, pre-defined DSMC meetings will take place when 
at least 6 patients have completed the 5-week (35 day) safety observation period in Cohort 1 and 
Cohort 2, respectively. 

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Details of specific responsibilities, composition, meeting formats and frequency of the DSMC 
are outlined in the DSMC Charter. 
Study population 
The study will enroll approximately 51 patients with histologically confirmed diagnosis of 
R/R DLBCL (as specified in inclusion criterion 3) based on the local pathology report. 
All patients must meet below listed eligibility criteria to be enrolled in the study. Prospective 
approvals of deviations to eligibility criteria, also known as protocol waivers or exemptions, are 
not permitted. 
Inclusion criteria 
Patients are eligible to be included in the study only if all the following criteria apply: 
1. Capable of giving signed informed consent as described in Appendix 2: Regulatory, 
Ethical, and Trial Oversight Considerations, which includes compliance with the 
requirements and restrictions listed in the informed consent form (ICF) and in this 
protocol. 
2. Patient must be at least 18 years of age and of legal age (whichever is higher) in the 
jurisdiction in which the study is taking place at the time of signing the informed 
consent. 
3. One of the following histologically confirmed diagnoses: 
• DLBCL not otherwise specified (NOS) 
• T cell/histiocyte-rich large B-cell lymphoma (THRLBCL) 
• Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive 
DLBCL) 
• Grade 3b Follicular Lymphoma 
• Composite lymphoma with a DLBCL component with a subsequent DLBCL 
relapse, according to the Revised European American Lymphoma/World 
Health Organization (REAL/WHO) classification. 
Additionally, patients with the evidence of histological transformation to DLBCL 
from an earlier diagnosis of low-grade lymphoma (i.e., an indolent pathology such 
as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) 
into DLBCL with a subsequent DLBCL relapse are also eligible. 
4. Tumor tissue for retrospective central pathology review must be provided as an adjunct 
to participation in this study. If archival formalin fixed paraffin embedded tumor tissue 
acquired ≤3 years prior to screening is not available, a fresh tumor tissue sample from 
the patient should be obtained. Archival formalin fixed- paraffin embedded tumor 
tissue acquired >3 years prior to screening is acceptable only in cases where a fresh 
tumor biopsy cannot be collected due to a safety risk, e.g., due to co-morbidity, or 
inaccessible tumor site. 

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5. Patients must have: 
a. Relapsed and/or refractory disease as defined in Appendix 3: Study Specific 
Definitions 
b. At least one bi-dimensionally measurable disease site. The lesion must have a 
greatest transverse diameter of ≥ 1.5 cm and greatest perpendicular diameter of 
≥ 1.0 cm at baseline. The lesion must be positive on positron emission 
tomography (PET) scan (for definition see Juweid et al., 2007) 
c. Received at least one, but no more than three previous systemic regimens for the 
treatment of DLBCL and one therapy line must have included a cluster of 
differentiation-20 (CD20) targeted therapy (e.g., rituximab [RTX]) 
d. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 
6. Patients that are not eligible to undergo intensive salvage therapy including autologous 
stem cell transplantation (ASCT). The reason for a patient's ineligibility must meet one 
of the criteria described below and documented in the patient's source data: 
a. Inadequate performance status (Karnofsky performance status ≤ 80%; see 
Appendix 5: Karnofsky Performance Status Scale) 
b. Disease not responsive to salvage chemotherapy. Responsiveness is defined as a 
tumor demonstrating either complete response (CR) or partial response (PR) to 
salvage chemotherapy 
c. Inadequate major organ function (any of the below): 
i. symptomatic congestive heart failure 
ii. lung function-forced vital capacity (FVC), forced expiratory volume in 
1 second (FEV-1), and corrected diffusion capacity of the lung for 
carbon monoxide (DLCO) ≤ 60% 
iii. liver function-total serum bilirubin and transaminases > 2 x upper limit 
of normal (ULN) 
d. History or evidence of significant co-morbid medical or psychiatric illness 
which would significantly compromise the patient's clinical care and chances of 
survival 
e. Inability to collect adequate stem cell graft (e.g. < 1–2 x 106 CD34+ cells free 
of tumor contamination/kg recipient body weight) 
7. Patients must meet the following laboratory criteria at screening: 
a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (unless secondary to bone 
marrow involvement by DLBCL as demonstrated by recent bone marrow 
aspiration and bone marrow biopsy) 
b. Platelet count ≥ 75 × 109/L (unless secondary to bone marrow involvement by 
DLBCL as demonstrated by recent bone marrow aspiration and bone marrow 
biopsy) 
c. Total serum bilirubin ≤ 2.5 × ULN unless secondary to Gilbert's syndrome or 
documented liver involvement by lymphoma. Patients with Gilbert's syndrome 
or documented liver involvement by lymphoma may be included if their total 
bilirubin is ≤ 5 × ULN (see exclusion criterion 6g) 

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d. Alanine transaminase (ALT), aspartate transaminase (AST) and alkaline 
phosphatase (ALP) ≤ 3 × ULN or < 5 × ULN in cases of documented liver 
involvement 
e. Serum creatinine CL must be ≥ 60 mL/minute either measured or calculated 
using a standard Cockcroft and Gault formula (see Appendix 6: 
Cockcroft-Gault Formula) 
8. Patients who received previous CD19 targeted therapy (other than tafasitamab) must 
have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior 
CD19 targeted therapy 
9. Patients with primary refractory disease (see Appendix 3: Study Specific Definitions) 
who received at least one, but no more than three previous systemic regimens 
(including a CD20 targeted therapy) for the treatment of DLBCL are eligible. 
Exclusion criteria 
Patients are excluded from the study if any of the following criteria apply: 
1. General provisions: 
a. Patients who are legally institutionalized, or patients under judicial protection 
b. Concurrent enrollment in another interventional clinical study 
2. Patients who have: 
a. Any other histological type of lymphoma including primary mediastinal 
(thymic) large B-cell (PMBL) or Burkitt lymphoma 
b. Known "double/triple hit" genetics (high grade B-cell lymphoma) 
characterized by simultaneous detection of MYC with BCL2 and/or BCL6 
translocation(s) defined by fluorescence in situ hybridization. MYC, BCL2, 
BCL6 testing prior to study enrollment is not required 
3. Patients who have: 
a. Not discontinued (within 14 days prior to Day 1 dosing): CD20 targeted 
therapy, chemotherapy, radiotherapy, investigational anticancer therapy or 
other lymphoma-specific therapy 
b. Undergone major surgery (within 4 weeks prior to Day 1 dosing) or suffered 
from significant traumatic injury 
c. Received live vaccines (within 4 weeks prior to Day 1 dosing) (see 
Appendix 7: COVID-19: Infection Prophylaxis and Vaccines) 
d. Required parenteral antimicrobial therapy for active, intercurrent infections 
(within 14 days prior to Day 1 dosing) 
4. Patients who: 
a. Have, in the opinion of the investigator, not recovered sufficiently from the 
adverse toxic effects of prior therapies 
b. Were previously treated with tafasitamab or IMiDs® (e.g., thalidomide, LEN) 
c. Have a history of hypersensitivity to compounds of similar biological or 
chemical composition to tafasitamab, IMiDs® and/or the excipients contained 
in the study treatment formulations 

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d. Have undergone ASCT within the period ≤ 3 months prior to signing the ICF. 
Patients who have a more distant history of ASCT must exhibit full 
hematological recovery before enrollment into the study 
e. Have undergone previous allogenic stem cell transplantation 
f. Have a history of deep venous thrombosis/embolism, threatening 
thromboembolism or known thrombophilia or are at high risk for a 
thromboembolic event in the opinion of the investigator and who are not 
willing/able to take venous thromboembolism (VTE) prophylaxis during the 
entire treatment period 
g. Concurrently use other anticancer or experimental treatments 
5. History of other malignancy that could affect compliance with the protocol or 
interpretation of results. Exceptions: 
a. Patients with any malignancy appropriately treated with curative intent and 
the malignancy has been in remission without treatment for > 2 years prior to 
enrollment are eligible 
b. Patients with low-grade, early-stage prostate cancer (Gleason score 6 or 
below, Stage 1 or 2) with no requirement for therapy at any time prior to study 
are eligible 
6. Patients with: 
a. Positive hepatitis B and/or C serology (see Appendix 8: Hepatitis Virus 
Serology for details) 
b. Known seropositivity for or history of active viral infection with human 
immunodeficiency virus (HIV) 
c. Central nervous system (CNS) lymphoma involvement – present or past 
medical history 
d. History or evidence of clinically significant cardiovascular, CNS and/or other 
systemic disease that would in the investigator's opinion preclude participation 
in the study or compromise the patient's ability to give informed consent 
e. History or evidence of rare hereditary problems of galactose intolerance, the 
Lapp lactase deficiency or glucose-galactose malabsorption 
f. Gastrointestinal (GI) abnormalities (issue with absorption) including the 
inability to take oral medication 
g. History or evidence of severe hepatic impairment (total serum bilirubin 
> 3 mg/dL), jaundice unless secondary to Gilbert's syndrome or documented 
liver involvement by lymphoma (see inclusion criterion 7c) 
h. History of hypersensitivity to any of the study treatments or its excipients or 
to drugs of similar chemical class 
i. Any other medical condition which, in the investigator's opinion, makes the 
patient unsuitable for the study 

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7. Contraception provisions: 
Females: Due to the teratogenic potential of LEN, FCBP must follow the rules listed 
below (otherwise excluded): 
Applicable in all countries except the US: 
a. Not be pregnant as confirmed by a negative serum pregnancy test at screening 
and a medically supervised urine pregnancy test prior to starting study therapy 
b. Refrain from breast feeding and donating oocytes during the study and for 
3 months after the last dose of study drug or according to local guidelines for 
LEN, whichever is longer 
c. Agree to ongoing pregnancy testing during the course of the study, and after 
study treatment has ended. This includes pregnancy testing and counseling if 
a patient misses her period or if there is any abnormality in her menstrual 
bleeding and applies even if the patient practices complete sexual abstinence 
d. Commit to continued abstinence from heterosexual intercourse if it is in 
accordance with her lifestyle (which must be reviewed on a monthly basis) or 
agree to use and be able to comply with the use of highly effective 
contraception without interruption at least 4 weeks prior to start of study 
drugs, during the study treatment and for 3 months after the last dose of study 
drug, or, for LEN, according to the local guidelines, whichever is longer 
Applicable in the US: 
e. Not be pregnant as confirmed by pregnancy tests performed before treatment 
initiation, within 10-14 days and again within 24 hours of initiating treatment 
(even if true abstinence is the chosen method of birth control) 
f. Refrain from breast feeding and donating oocytes during the study and for 
3 months after the last dose of study drug, or according to US guidelines for 
LEN, whichever is longer 
g. Agree to ongoing pregnancy testing during the study (every 4 weeks in 
women with regular menstrual cycle and every two weeks in women with 
irregular menstrual cycle), and after study therapy has ended (even if true 
abstinence is the chosen method of birth control). This includes pregnancy 
testing and counseling if a patient misses her period or if there is any 
abnormality in her menstrual bleeding. 
h. Not get pregnant while taking the study treatment and for at least 3 months 
after the last dose of study treatments by using at the same time 2 effective 
methods of contraception, at least one highly effective method and one 
additional effective method (see Appendix 13: Contraceptive Guidance and 
Collection of Pregnancy Information), each time engaging in sexual activity 
with a male, starting at least 4 weeks before taking the study treatment, while 
taking the study treatment, during breaks (dose interruptions) and for at least 
3 months after stopping the study treatment, or for LEN, according to the US 
guidelines, whichever is longer. True abstinence from heterosexual sexual 
intercourse is also an acceptable method of contraception. The use of 
emergency contraception is also permitted 

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8. Due to the teratogenic potential of lenalidomide, male participants must follow the 
rules listed below (otherwise excluded): 
Applicable in all countries except the US: 
a. Use an effective barrier method of contraception without interruption if the 
patient is sexually active with a FCBP. Male patients should refrain from 
donating sperm during the study participation and for 3 months after the last 
dose of study treatment, or according to the local guidelines for LEN, 
whichever is longer 
Applicable in the US: 
b. Use a latex or synthetic condom each time they have sex with a FCBP. True 
abstinence from heterosexual sexual intercourse is also an acceptable method 
of contraception. The use of emergency contraception is also permitted. Male 
patients should refrain from donating sperm during the study participation and 
for 3 months after the last dose of study drug, or according to the US 
guidelines for LEN, whichever is longer 
Statistical Analysis 
A Primary analysis will be performed when all enrolled patients have either completed C3D28 or 
discontinued the study prior to C3D28 for any reason. Final analysis will be performed at the end 
of the study. 
Any deviations from the statistical analysis outlined in this protocol will be described, and reasons 
for the deviations listed, in the clinical study report. 
Details of the analyses to be performed on data from this study will be provided in a separate SAP. 
End of Study 
The end of the study is reached when all patients still on study treatment have been followed for 
at least 3 years, or when the final patient on study has completed their last visit, whichever comes 
first. 
Patients who are receiving ongoing treatment at the end of study may continue treatment with 
either of the options below upon assessment of a clinical benefit of continued treatment by the 
investigator and in accordance with the local regulatory guidance: 
• 
commercially available tafasitamab for the approved dose regimen locally; or 
• 
participation in the tafasitamab extension study if above option is not available. 
Upon study closure, Incyte will notify the applicable regulatory agencies in accordance with local 
requirements. 
End of study visit for a patient: An end of study visit for a patient is defined as the visit taking 
place when the patient has completed 90-day safety follow up after the last tafasitamab dose given. 
 

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2 
SCHEDULE OF ASSESSMENTS (SoA) 
Table 3: Schedule of Assessments 
Evaluation or Procedure 
Screening 
Period 
Treatment Period 
(Cycle = 28 days) 
Follow-Up 
Period 
Screening 
≤28 Days 
prior to 
D1 
Cycle 1 
Cycle 2 
Cycle 3 
Cycle 4-12 
Cycle 12 
Cycle 13 
onwards 
End of 
Treatment Visit 
(EOT)15 
90-Day Safety 
Follow-up 
Visit/ End of 
Study Visit14 
Day 
Screen 
D1 
D4 
±1 day 
D8 
±1 day 
D15 
±1 day 
D1 
±1 day 
D15 
±1 day 
D1 
±1 day 
D15 
±1 day 
D1 
±2 days 
D28 
±2 days 
D1 
±2 days 
Within 14 days 
after decision 
on treatment 
discontinuation 
±7 days 
Starting Evaluations and Eligibility 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X1 
 
 
 
 
 
 
 
 
 
 
 
 
Demography 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history/current medical 
condition 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease history/staging/Ann Arbor 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease risk assessment (IPI) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Throughout Evaluations 
Prior/concomitant therapy2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
Physical examination (F – full, L – 
limited) 
F 
L 
 
 
 
 
 
L 
 
L3 
 
L3 
F 
 
ECOG performance status 
X 
X1 
 
 
 
X 
 
X 
 
X 
 
 
X 
 
Body weight/height4  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
B-symptoms 
X 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
 
Vital signs16 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
12-lead resting ECG 
X 
X5 
 
 
X5 
X5 
 
X5 
 
X5a 
 
 
X 
 
Adverse events (AEs, SAEs and AESIs) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
Laboratory 
Urinalysis (local lab) 
X 
X 
 
 
 
X 
 
X 
 
X 
 
 
X 
 
Pregnancy test (FCBP)6 
X 
X1 
 
X1 
X1 
X1 
 
X1 
 
X1 
 
X1 
X 
 
Pregnancy and risks counselling 
X 
X 
 
 
 
X 
 
X 
 
X 
 
 
X 
 
US only: pregnancy and risk interview  
X 
X 
 
 
 
X 
 
X 
 
X 
 
 
X 
 
Hematology and Serum chemistry (local 
lab) 7 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Serology Hepatitis B (local lab) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Evaluation or Procedure 
Screening 
Period 
Treatment Period 
(Cycle = 28 days) 
Follow-Up 
Period 
Screening 
≤28 Days 
prior to 
D1 
Cycle 1 
Cycle 2 
Cycle 3 
Cycle 4-12 
Cycle 12 
Cycle 13 
onwards 
End of 
Treatment Visit 
(EOT)15 
90-Day Safety 
Follow-up 
Visit/ End of 
Study Visit14 
Day 
Screen 
D1 
D4 
±1 day 
D8 
±1 day 
D15 
±1 day 
D1 
±1 day 
D15 
±1 day 
D1 
±1 day 
D15 
±1 day 
D1 
±2 days 
D28 
±2 days 
D1 
±2 days 
Within 14 days 
after decision 
on treatment 
discontinuation 
±7 days 
Serology Hepatitis B, DNA, if indicated 
(local lab) 
X8 
 
 
 
 
X8 
 
X8 
 
X8 
 
 
X8 
 
Serology Hepatitis C (local lab) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Coagulation (aPTT or PTT, PT and/or 
INR) (local) 
X 
 
 
 
 
 
 
 
 
C4D1 
 
 
X 
 
Thyroid Stimulating Hormone (TSH-
local lab)18  
X 
 
 
 
 
 
 
 
 
C4D1 
 
 
X 
 
Tafasitamab ADAs 
 
X1 
 
 
 
X1 
 
X1 
 
X9, 
X17 
 
X15 
 
PK tafasitamab 
 
X10 
X10 
X10 
X10 
X10 
X10 
X10 
X10 
X10a, 
X17 
 
X15 
 
CD19 expression19 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Imaging and Tumor Evaluation 
PET-CT or PET-MRI 
X 
 
 
 
 
 
 
 
 
 
X11 
X11 
X11 
 
CT or MRI  
 
 
 
 
 
 
 
X11a 
 
X11a 
 
X11a 
 
 
Biopsy/Tissue 
Tissue sample collection for central 
pathology review  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Bone marrow aspiration & biopsy 
X12 
 
 
 
 
 
 
 
X12 
X12 
X12 
X12 
 
 
Drug Administration 
LEN capsules allocation 
(Incl. patient home intake record) 
 
X 
 
 
 
X 
 
X 
 
X 
 
 
 
 
Abbreviations: AE=adverse event; ADA=Anti-drug antibodies; AESIs=adverse events of special interest; aPTT= activated partial thromboplastin time; anti-HBc=hepatitis B core antibody; β-HCG=beta-
human chorionic gonadotropin; C=cycle; CT=computed tomography; 
; D=day; ECG=electrocardiogram; ECOG=Eastern Cooperative Oncology Group; eCRF=electronic 
case report form; EOS=end of study; EOT=end of treatment; F=full physical examination; FCBP=female of childbearing potential; HBV=hepatitis B virus; INR=international normalized ratio; 
IPI=International Prognostic Index; IRRs=infusion-related reactions; L=limited physical examination; LEN=lenalidomide;
; MRI=magnetic resonance imaging; 
 
; PE=physical examination; PET=positron emission tomography; PK=pharmacokinetics; PT=prothrombin time; PTT=partial thromboplastin time; SAE=serious adverse event TSH=Thyroid 
stimulating hormone 
1Before study treatment administration. 

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2Previous/Concomitant therapy will be recorded as per Section 7.8. After disease progression only anticancer treatments and other relevant concomitant medications, i.e., used for treatment of an AE (at 
the discretion of the investigator) should be entered. 
3A limited PE (L) will be performed on Day 1 of every other Cycle, e.g., Cycle 5, Cycle 7, Cycle 9, Cycle 11. From Cycle 13 onwards, a limited PE will only be performed at the discretion of the 
investigator if directed by any clinical symptoms or adverse events. 
4Body height will be measured at Cycle 1 Day 1 only. Body weight can be measured up to 24 hours prior to the study treatment administration. 
512-lead resting ECG performed within 3 hours after the end of tafasitamab infusion. 
5aA 12-lead resting ECG will be performed (within 3 hours after the end of tafasitamab infusion.) on D1 of every third cycle until Cycle 12, i.e., Cycle 6, Cycle 9 and Cycle 12. 
6Pregnancy tests: A serum (β-HCG)/urine pregnancy test is mandatory only for females of childbearing potential (FCBP). A serum pregnancy test will be performed locally at Screening and at the End of 
treatment visit. At all other indicated time points, a urine pregnancy test for FCBP will be performed locally and the result must be negative for dosing. At Cycle 1 Day 1 pregnancy test must be performed 
within 24 hours prior to the start of study treatment. For US only, a pregnancy test at screening must be performed within 10 to 14 days prior to the start of study treatment. For US FCBP with irregular 
menstrual cycle a urine pregnancy test will be performed every two weeks. A home urine pregnancy test kit and the home urine pregnancy test diary will be handed out to the US FCBP with irregular 
menstrual cycle on Cycle 2 Day1 to Cycle 12 Day1. Pregnancy testing and counseling must be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. Lenalidomide 
treatment must be discontinued during this evaluation. Patients reaching end of treatment during Cycle 1 – Cycle 12 a serum pregnancy test will be performed at-least 4 weeks after the last dose of study 
drug, in accordance with the Lenalidomide SmPC/USPI. 
7Sample to be collected and evaluated in the local laboratory (can be done on the day before study treatment administration) and reviewed by study treating physician before study treatment administration. 
8HBV-DNA to be measured at screening and re-measured at subsequent visits only if anti-HBc was positive at screening. 
9From Cycle 4 onwards, blood samples for tafasitamab anti-drug antibodies (ADAs) will be collected pre-dose on D1 of every other cycle until Cycle 12, i.e. Cycle 4, Cycle 6, Cycle 8, Cycle 10, 
Cycle 12. 
10Tafasitamab PK sample will be taken pre-dose and 30 min ± 15 min after the end of tafasitamab infusion. 
10aTafasitamab PK samples will be taken pre-dose and 30 min ± 15 min after the end of tafasitamab infusion on C4D1 and afterwards pre-dose on D1 of every other cycle until Cycle 12, i.e. Cycle 6, 
Cycle 8, Cycle 10, Cycle 12. 
11PET-CT or PET-MRI should be performed at screening, at C12D28 (± 4 days) and at EOT visit unless disease progression was already radiologically confirmed prior to the EOT visit. If 
progression/relapse is suspected on the basis of clinical symptoms, PET-CT or PET-MRI should be performed to confirm disease progression. PET/CT or PET-MRI from Cycle 25 onwards should be 
performed only if deemed necessary, and not more than once per year. 
11a CT or MRI should be performed within 4 days prior to C3D1, C5D1, C7D1 and C10D1. From Cycle 13-24 CT or MRI should be performed approximately every 3 months ± 2 days from the previous 
scan. The first assessment during this phase will take place 3 months ± 2 days after C12D28. From Cycle 25 onwards: approximately once every year ± 2 weeks from the previous scan. 
12Repeat bone marrow biopsy only in those patients who had known bone marrow involvement at screening to confirm a CR. If repeat bone marrow biopsy is required to confirm CR, the assessment 
should be done at C3D15 ± 1 day and/or within 15 days after C5D1, C7D1, C10D1 and C12D28. Bone marrow assessment from Cycle 13 to 24 approximately every 3 months ± 2 weeks from the previous 
assessment to be performed to confirm a CR only in those patients who had known marrow involvement at screening. 
13Tafasitamab infusions should be given after pre-medication administration 30–120 minutes prior to starting the infusion. For patients who do not experience any grade 2 or higher IRRs with their first 
four infusions, pre-medication at subsequent treatments may be omitted according to institutional treatment guidelines. 
14Regardless of the reason for study treatment discontinuation, patients will have a safety follow-up visit or phone call scheduled 90 days after the last dose of the study treatment. 
15EOT samples for PK and ADA will not be collected for patients receiving tafasitamab treatment beyond Cycle 12. 
16Vital signs include temperature, systolic and diastolic blood pressure, pulse and respiratory rate. Vital signs are to be obtained immediately pre-tafasitamab infusion, and during infusion (15 ± 5, 
30 ± 10, and then every 60 ±15 minutes), at the end of infusion (± 20 minutes) and as clinically indicated. 
17Samples to be collected on C12D28±2 days, if overlapping with C13D1 visit, samples should be taken prior to study treatment administration on C13D1. 
18TSH test to be performed locally at screening, C4D1 and end of treatment. Additional TSH test maybe performed as clinically indicated based on the symptoms as judged by the investigator. 
19CD19 positive lymphoma (as per local institutional guidelines) on a biopsy taken after completing prior CD19 targeted therapy. The local pathology report indicating DLBCL diagnosis and CD19 
positivity will determine a patient's eligibility for study enrollment. In this patient group, a sample of this most recent biopsy should be provided for central pathology confirmation of both DLBCL 
diagnosis and CD19 expression. Only the most recent biopsy needs to be provided, it is not necessary to provide tissue taken at different stages of disease. 

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3 INTRODUCTION 
3.1 Study Rationale 
3.1.1 Disease Overview 
DLBCL is the most common type of non-Hodgkin lymphoma (NHL), representing approximately 
30-40% of all NHLs with a median age at diagnosis of 64 years. DLBCL is an aggressive B-NHL 
and the majority of patients present with advanced disease. DLBCL is increasingly recognized as 
a heterogeneous disorder disease with distinct molecular subtypes (Lenz et al., 2008; Flowers 
et al., 2010; Vaidya and Witzig, 2014; Schmitz et al., 2018). 
Standard treatment for patients with newly diagnosed DLBCL consists of immuno-chemotherapy 
with the anti-CD20 monoclonal antibody (mAb), RTX, and CHOP administered for 6-8 cycles 
(R-CHOP) (Tilly et al., 2015). The addition of RTX has substantially improved the results of 
CHOP-chemotherapy, yielding complete and sustained remission in about 60% of cases (Coiffier 
et al., 2002). But still approximately 30–40% of patients ultimately will relapse and are not cured 
by first-line therapy with R-CHOP, and approximately 10% of patients are refractory to R-CHOP 
as first-line therapy (primary refractory) (Coiffier et al., 2010). 
In patients progressing or relapsing after first-line treatment, the main consideration for further 
treatment is whether the patient is a candidate for HDT and ASCT. Salvage chemotherapy 
followed by HDT and ASCT is standard treatment for transplant-eligible patients and may offer a 
second chance of cure for about 30–40% of the patients (Crump et al., 2017; Gisselbrecht 
et al., 2010). However, the majority of R/R DLBCL patients are ineligible for ASCT due to 
comorbidities and older age. Despite recent advances, the treatment options for patients who have 
relapsed or progressed after second-line treatment of DLBCL, or who are not eligible for ASCT 
remain limited. 
On 31 JUL 2020, the U.S. Food and Drug Administration (FDA) approved tafasitamab-cxix 
(Monjuvi®) in combination with lenalidomide for the treatment of adult patients with R/R DLBCL 
not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not 
eligible for autologous stem cell transplant. Furthermore tafasitamab (Minjuvi®) was granted 
conditional approval in R/R DLBCL in Europe on 26 AUG 2021, and thereafter in other countries 
(e.g., Israel, South Korea). 
As per Monjuvi® United States prescribing information (USPI) (Monjuvi® 2021) and Minjuvi® 
Summary of product characteristics (SmPC) (Minjuvi® 2024) the recommended dose of 
tafasitamab is 12 mg/kg, administered as intravenous (i.v.) infusion. The current approved dosing 
regimen of tafasitamab in combination with LEN until disease progression or unacceptable toxicity 
is presented in Table 4. 

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Table 4: Tafasitamab in Combination With LEN Dosing Regimen as per Monjuvi® USPI in 
R/R DLBCL 
Currently approved dosing regimen per Monjuvi® USPI 
Drug 
Route 
Dose 
Dosing Schedule1 
Tafasitamab 
i.v. 
12 mg/kg 
Cycle 1: Days 1, 4, 8, 15, and 22 
Cycle 2 to 3: Days 1, 8, 15, and 22 
Cycle 4 and beyond: Days 1 and 15 
LEN 
Oral (capsule) 
25 mg 
Cycle 1–12: 25 mg on Days 1-21 of each cycle 
Administer LEN for a maximum of 12 cycles and then 
continue tafasitamab as monotherapy until progression 
or unacceptable toxicity 
Abbreviations: DLBCL=diffuse large B-cell lymphoma; i.v.=intravenous; LEN=lenalidomide; R/R=relapsed/refractory; 
USPI=United States Prescribing Information. 
1Each treatment cycle is 28 days. 
3.1.2 Study Treatment 
As tafasitamab 
 
 tafasitamab 
 
 in R/R DLBCL patients. 
 

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3.2 Non-Clinical Background Information 
Tafasitamab is an Fc-modified mAb targeting CD19, a crucial component of B-cell receptor 
signaling. CD19 is expressed throughout normal B-cell development until terminal plasma cell 
differentiation and is also present on the surface of malignant hematopoietic cell. Tafasitamab 
possesses significantly increased tumor cytotoxicity when compared with the parental, 
non-engineered, murine 4G7 CD19 antibody. The increased binding of tafasitamab to Fc gamma 
receptors (FcγR), due to the engineered mutations, significantly enhances in vitro 
antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated 
phagocytosis (ADCP), and its direct cytotoxic effects (apoptosis) on the tumor cells compared 
with the non-engineered parental murine antibody (Lazar et al., 2006). 
Non-clinical studies with tafasitamab were designed to support human clinical trials with 
tafasitamab for the treatment of CD19 positive hematologic malignancies, such as chronic 
lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL) and NHL. 
Non-clinical studies evaluating the PK, pharmacodynamics and toxicity of tafasitamab were 
performed in cynomolgus monkeys. Overall, the findings in five preclinical studies were limited 
to the expected pharmacological effects of tafasitamab, with no reports of unanticipated toxicity. 
More specifically, in the pivotal GLP-compliant, repeat-dose toxicity study, i.v. one-hour infusion 
of tafasitamab into sexually mature male and female cynomolgus monkeys at doses of 0, 10, 30, 
and 100 mg/kg once a week for 13 weeks was well-tolerated up to the highest dose tested (with no 
adverse effects observed) and did not affect safety pharmacology or reproductive endpoints. No 
mortalities occurred. There were no drug-related effects on body weights, food consumption, 
clinical signs, neurobehavioral observations, blood pressure, electrocardiography, respiratory rate, 

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ophthalmology, urinalysis, coagulation, serum chemistry or cytokine analysis. Local tolerance was 
assessed following each i.v. infusion and did not reveal any adverse effects at the administration 
sites. The reduced peripheral B-cell counts as well as the histopathological changes to several 
lymphatic organs (decreased cellularity of the germinal centers in lymphoid follicles of spleen, 
mesenteric and mandibular lymph nodes) are considered exaggerated pharmacodynamic effects. 
The no observed adverse effect level (NOAEL) was determined at the highest dose tested 
(i.e., 100 mg/kg i.v. weekly [QW]) (report MOR208P008). 
Following i.v. administration in cynomolgus monkey at dose levels from 0.3-100 mg/kg, 
tafasitamab exhibited a typical 2-compartment profile. Tafasitamab showed consistent PK 
parameters across studies and study groups (volume of distribution at steady state [Vss] of 
52.6-124.3 mL/kg; clearance [CL] of 4.31-7.37 mL/day/kg; mean terminal elimination half-life of 
7.7-14.2 days). Dose linearity was observed between 2-100 mg/kg. 
3.3 Clinical Background 
3.3.1 Tafasitamab Clinical Development 
The first-in-human trial with tafasitamab was a phase 1 dose escalation trial in patients with 
R/R CLL (XmAB5574-01, [NCT1161511]). Tafasitamab was administered i.v. as monotherapy 
in doses ranging from 0.3 mg/kg to 12 mg/kg for a total of up to seven 28-day cycles. Due to the 
acceptable safety profile, the 12 mg/kg dose (highest administered dose level) cohort was 
expanded to a total of 16 patients and was used for further development. 
The Sponsor initiated a phase 2a, open-label, multicenter trial of single-agent tafasitamab in 
patients with R/R NHL (MOR208C201 [NCT1685008, EudraCT No. 2012-002659-41]; Jurczak 
et al., 2018). In the DLBCL subtype, objective responses were observed in 9 (26%) of 35 patients 
(2 CR, 7 PR). 
Based on the unmet medical need of aggressive lymphoma, further development of tafasitamab 
focused on clinical trials in R/R DLBCL and more recently in patients with newly diagnosed 
DLBCL as follows: 
• 
A phase 2 trial (MOR208C203) in patients with R/R DLBCL (L-MIND) 
• 
A randomized phase 2/3 trial (MOR208C204) in patients with R/R DLBCL (B-MIND; of 
tafasitamab + bendamustine followed by tafasitamab until progression versus 
RTX + bendamustine followed by RTX until progression) 
• 
A phase 1b trial (MOR208C107) in patients with newly diagnosed DLBCL (First-MIND) 
• 
A phase 3 trial (MOR208C310) in patients with newly diagnosed DLBCL (frontMIND) 
Results from the pivotal clinical trial MOR208C203 (L-MIND) are described in the following. For 
additional information on all other trials, please refer to the current investigator's brochure (IB). 

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3.3.2 Results From L-MIND [Primary Analysis (NOV 2018) and Data Cut-Off 
OCT 2020] 
L-MIND is an ongoing, pivotal phase 2, single-arm, open-label, multicenter trial designed to 
evaluate the efficacy and safety of tafasitamab plus LEN in patients with R/R DLBCL 
(NCT02399085; EudraCT No. 2014-004688-19). Based on the efficacy and safety data from 
L-MIND, tafasitamab was granted accelerated FDA approval in combination with LEN for the 
treatment of R/R DLBCL. 
Treatment consisted of LEN and tafasitamab (12 mg/kg) administered in 28-day cycles at specified 
dose intervals, until disease progression, unacceptable toxicity, or discontinuation for any other 
reason, whichever was first. See Table 4 for treatment regimen. 
The primary endpoint of the trial is objective response rate (ORR) per independent review 
committee (IRC) based on response criteria per the guidelines of the International Working Group 
(Cheson et al., 2007), further defined as the proportion of patients with CR or PR as best response. 
The primary analysis has been completed (efficacy cut-off date of NOV 2018), and the primary 
data were recently published (Salles et al., 2020). 
On 30 OCT 2020, an update to the efficacy analysis was performed (FAS, N = 80, assessed by 
Independent Radiology/Clinical Review Committee. At the time of this data cut-off, the time from 
last patient enrolled until data cut-off was approximately 3 years (35 months), presenting with a 
longer follow up across the cohorts. 
Of the 80 patients treated in the trial (excluding 1 patient who received tafasitamab only), 
34 patients entered tafasitamab monotherapy after discontinuing LEN. The best objective response 
was CR for 32/80 (40.0%) patients and PR 14/80 (17.5%). Based on these data, the IRC-assessed 
best ORR was 57.5% (95% confidence interval [CI]: 45.9, 68.5). Thirteen patients (16.3%) had 
SD as their best objective response. Thirteen patients (16.3%) had PD as their best objective 
response. Eight (10.0%) patients were not evaluable, as no valid post-baseline radiological 
examination for response assessment was available. 
An overview of updated analysis for clinical efficacy from trial L-MIND, as of cut-off date 
OCT 2020 is shown in Table 6, based on the FAS (N = 80 patients), assessed by Independent 
Radiology/Independent Review Committee (IRC). 

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Table 6: Updated Efficacy Analysis Results in L-MIND (Cut-Off Date OCT 2020) 
Response 
Tafasitamab plus LEN 
N = 80 
Best overall response rate, n (%) 
(95% CI) 
CR rate 
PR rate 
SD 
PD 
Not evaluable 
46 (57.5%) 
(45.9%–68.5%) 
40% 
17.5% 
16.3% 
16.3% 
10% 
Duration of response 
Median (95% CI, months)1 
 
43.9 (26.1, NR) 
Abbreviations: LEN=lenalidomide. 
1Kaplan-Meier estimates. 
Overall, the efficacy results from L-MIND demonstrate that the combination of tafasitamab plus 
LEN provides clinical benefit for patients with R/R DLBCL. In addition, the outcomes suggest a 
synergistic activity of the combination in R/R DLBCL patient's ineligible for stem cell transplant, 
who have limited treatment options and a poor prognosis. 
3.3.3 Safety Profile of Tafasitamab Plus LEN From L-MIND (Cut-Off Date OCT 2020) 
In the L-MIND trial, 81 patients were treated with tafasitamab in combination therapy with 
lenalidomide. In Table 7, TEAEs considered related to tafasitamab reported in ≥ 3% of patients 
are presented, sorted by System Organ Class (SOC) and incidences (number of patients [%]). 

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Table 7: Adverse Drug Reactions Observed in L-MIND (Tafasitamab – Lenalidomide 
Combination Therapy in Patients With DLBCL) in ≥ 3.0% Patientsb 
Adverse Reaction Related to Tafasitamab 
Incidencea 
Total N=81 (%) 
     System Organ Class 
Preferred Term 
Any Grade 
     Blood and lymphatic system disorders 
Neutropenia 
30 (37.0%) 
Anaemia 
13 (16.0%) 
Thrombocytopenia 
10 (12.3%) 
Leukopenia 
6 (7.4%) 
Febrile neutropenia 
5 (6.2%) 
Lymphopenia 
3 (3.7%) 
     Gastrointestinal disorders 
Nausea 
6 (7.4%) 
Constipation 
6 (7.4%) 
Vomiting 
5 (6.2%) 
Diarrhoea 
4 (4.9%) 
     General disorders and administration site conditions 
Pyrexia 
10 (12.3%) 
Asthenia 
7 (8.6%) 
Fatigue 
7 (8.6%) 
     Infections and infestations 
Pneumonia 
6 (7.4%) 
Bronchitis 
5 (6.2%) 
Respiratory tract infection 
4 (4.9%) 
Sepsisc 
3 (3.7%) 
     Investigations 
Alanine aminotransferase increased 
3 (3.7%) 
C-reactive protein increased 
3 (3.7%) 
     Respiratory, thoracic and mediastinal disorders 
Cough 
6 (7.4%) 
     Metabolism and nutrition disorders 
Hypomagnesaemia 
3 (3.7%) 
     Injury, poisoning and procedural complications 
Infusion related reaction 
5 (6.2%) 
     Immune system disorders 
Hypogammaglobulinaemia 
3 (3.7%) 
N=number of patients 
aIncidence: number and percentage of patients 
bData cut-off OCT 2020 
cIncludes the following MedDRA Preferred Terms: sepsis, streptococcal sepsis, neutropenic sepsis 

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3.3.4 Clinical Pharmacokinetics of Tafasitamab 
For more detailed non-clinical pharmacology, PK and toxicology results of tafasitamab, please 
refer to the current version of the IB. 
3.4 Justification for Dose 
To evaluate 
 
 
• 
• 
The tafasitamab administration 
 
 
 
 to limit potential AEs 
occurring shortly after treatment initiation (e.g. IRRs or tumor lysis syndrome [TLS]). 

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3.5 Benefit/Risk Assessment 
The risk assessment of tafasitamab and LEN is based on the data from nonclinical studies as well 
as on clinical experience from completed and ongoing clinical trials. Tafasitamab monotherapy 
was well tolerated in R/R B-cell lymphomas (BCLs) (Jurczak et al., 2018). Similarly, tafasitamab 
plus LEN showed a manageable safety profile in the L-MIND trial in R/R DLBCL (Salles 
et al., 2020) and received FDA approval in the US on 31 JUL 2020. 
Furthermore, tafasitamab (Minjuvi®) was granted conditional approval in R/R DLBCL in Europe 
on 26 AUG 2021, and thereafter in other countries. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of tafasitamab is available in the current version of the IB. 
3.5.1 Risk Assessment 
As per Monjuvi® (2021) USPI, tafasitamab is approved for use at a dose of 12 mg/kg. 
 
. Based on the clinical experience of tafasitamab in combination with 
LEN from L-MIND, the most common side effects (≥ 20%) of tafasitamab plus LEN were 
neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, 
respiratory tract infection, and decreased appetite. Serious adverse events (SAEs) were reported in 
≥ 6% of patients, and included infections including pneumonia and febrile neutropenia. 
Management of AEs due to the tafasitamab plus LEN combination is detailed in Section 7.3. 
3.5.2 Benefit Assessment 

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The combination of tafasitamab plus LEN provides clinical benefit for patients with R/R DLBCL 
as demonstrated in the L-MIND trial. Based on the clinical efficacy data as of data cut-off of 
30 OCT 2020, for patients who had their DLBCL diagnosis confirmed by central pathology, 
combining tafasitamab plus LEN, showed an ORR of 53.5% (95% CI: 41.3; 65.5) with a CR rate 
of 35.2% (95% CI: 24.2; 47.5) and a median DoR of 43.9 months (95% CI: 15.0; no response 
[NR]). Compared with monotherapy of tafasitamab and LEN, an ORR of > 50% is considered 
highly clinically meaningful in the relapse-refractory setting of DLBCL not eligible to high dose 
chemotherapy and ASCT. Furthermore, the safety data from the L-MIND trial indicates that the 
addition of tafasitamab to LEN adds little additional toxicity, based on the characterized safety 
profile of LEN administered as monotherapy. 
3.5.3 Overall Benefit Risk Conclusion 

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4 OBJECTIVES, ENDPOINTS AND ESTIMANDS 
4.1 Objectives and Endpoints 
The following study objectives and corresponding endpoints are listed in Table 8 below. 
Table 8: Objectives and Corresponding Endpoints 
Objectives 
Endpoints 
Primary 
• To evaluate the safety and tolerability of 
tafasitamab administered 
 
 in 
combination with lenalidomide in R/R DLBCL 
patients 
• To determine a recommended dose for 
tafasitamab 
 in 
combination with lenalidomide in R/R DLBCL 
patients 
Incidence and severity of TEAEs  
Secondary 
To evaluate the pharmacokinetic profile of 
tafasitamab after 
 in combination 
with lenalidomide 
Tafasitamab serum concentrations after 3 (Ctrough and Cmax) 
and 12 (Ctrough) treatment cycles 
To assess anti-tumor activity of tafasitamab after 
 in combination with 
lenalidomide 
• Best Objective Response Rate (ORR) by investigator 
assessment up to treatment Cycle 12 based on 
Cheson et al. (2007) 
• Duration of Response (DoR) by investigator assessment 
based on Cheson et al. (2007) 
• Progression-Free Survival by investigator assessment 
based on Cheson et al. (2007) 
To assess the incidence of anti-drug antibodies to 
tafasitamab 
Number and percentage of patients developing 
anti-tafasitamab antibodies up to treatment Cycle 12 
Abbreviations: Cmax=maximum concentration; 
; Ctrough=minimum concentration; DLBCL=diffuse 
large B-cell lymphoma; LEN=lenalidomide; 
 
 
; NA=not applicable; 
 
; 
ORR=objective response rate; PK=pharmacokinetic; 
 
 
 
 
 
 
 
 
R/R=relapsed/refractory; TEAEs=treatment-emergent adverse events. 
4.1.1 Primary Estimand 
Rationale for estimand: The primary objective of the study is to evaluate the safety and 
tolerability 
 of tafasitamab in combination with LEN. 
 
 
 

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The estimand is described by the following attributes: 
Population: All R/R DLBCL patients who receive at least 
 
 
Endpoint: Incidence and severity of TEAEs. 
TEAEs are defined as all AEs which start or worsen after the first dose of study treatment until 
90 days after the last dose of the study treatment. 
Treatment condition: Treatment consisting of tafasitamab and LEN combination will be 
administered until disease progression, unacceptable toxicity, or discontinuation for any other 
reason, whichever comes first. LEN can be given for up to 12 cycles in total, after which patients 
can continue with tafasitamab as monotherapy until progression or unacceptable toxicity. 
Intercurrent events: 
• TEAE data will be collected regardless of dose modifications, study treatment interruptions or 
non-adherence to study treatment, and included in the analysis (treatment policy strategy). 
• TEAE data will be collected, regardless of whether patients take permitted concomitant 
medications or not and included in the analysis (treatment policy strategy). 
• No further TEAE data past the start date of prohibited concomitant medication will be analyzed 
(while on treatment strategy). For a list of prohibited concomitant medication, refer to 
Section 7.9. 
• No further TEAE data past withdrawal of consent will be collected (while on treatment strategy). 
• In case of discontinuation from study treatment due to unacceptable toxicity, disease 
progression or any other reason, TEAE data will be collected until 90 days after the last dose of 
the study treatment and included in the analysis (while on treatment strategy). 
Population-level summary: cumulative incidence and severity of TEAEs in the population as 
defined in the estimand attribute above until the last patient on study completes the 90-day safety 
follow-up visit. 
4.1.2 Supplemental Estimand 
Rationale for estimand: For safety signal detection, all collected TEAE data are relevant 
 
. The estimand is described by the following attributes: 
Population: All R/R DLBCL patients who receive at least one dose of any component of the study 
treatment (tafasitamab or LEN or tafasitamab plus LEN). 
Endpoint: Same as primary estimand. 
Treatment condition: Same as primary estimand. 
Intercurrent events: Same as primary estimand. 
Population-level summary: Same as primary estimand. 

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5 STUDY DESIGN 
5.1 Overall Design 
MOR208C115 (MINDway) is an open-label, multi-center, phase 1b/2 study of tafasitamab 
combined with LEN to evaluate the safety and PK 
 in 
adult patients with R/R DLBCL. 
Patients will receive LEN in combination with tafasitamab in 28-day cycles. 
 
 
Tafasitamab will be administered as intravenous infusion according to the following dosing 
schedule: 
• 
• 
• 
• 
LEN (25 mg) will be administered for a maximum of 12 cycles or until disease progression, 
unacceptable toxicity, withdrawal, death or lost to follow up, whichever comes first. After cycle 
12 or LEN discontinuation, patients will continue with tafasitamab monotherapy 
 
 until disease progression, unacceptable toxicity, withdrawal, death or lost to follow 
up, whichever comes first. 
 
 
 
 
 
 
 
. If a patient 
discontinues the study for reasons other than safety before the completion of the predefined safety 
observation window (5 weeks) as per Section 8.4, the patient may be replaced. 
 

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A patient is considered to have started the study and entered the screening period when they have 
signed the informed consent form. 
 
 
 
. This safety window will also be maintained 
 
 
Patient is considered enrolled in the study if they received at least one dose of any study treatment 
(tafasitamab or LEN). 
The end of the study is reached for an individual patient if any of the following applies: withdrawal, 
lost to follow up, death or completion of the end of study (EOS)/90-Day Safety Follow-up visit 
after treatment discontinuation. Regardless of the reason for treatment discontinuation on study 
(with the exception of withdrawal of consent, death or lost to follow up) all patients must complete 
a Safety Follow-up visit 90 days after the last dose of study treatment, see Section 2. 
The end of the study is reached when all patients still on study treatment have been followed for 
at least 3 years, or when the final patient on study has completed their last visit, whichever comes 
first. 
Patients who are receiving ongoing treatment at the end of study may continue treatment with 
either of the options below upon assessment of a clinical benefit of continued treatment by the 
investigator and in accordance with the local regulatory guidance: 
• 
commercially available tafasitamab for the approved dose regimen locally; or 
• 
participation in the tafasitamab extension study if above option is not available 
Upon study closure, Incyte will notify the applicable regulatory agencies in accordance with local 
requirements. 
No overall survival follow-up after EOT will be performed in the study. 
5.2 Data and Safety Monitoring Committee 
A data and safety monitoring committee (DSMC), consisting of Sponsor representatives and 
investigators, will continuously monitor the study and can recommend to stop enrollment at any 
time based on emerging safety data and pre-defined stopping rules. In addition, pre-defined DSMC 
meetings will take place when 6 patients have completed the 5-week safety observation period 
(35 days from C1D1 onwards) 
 respectively. 
Details of specific responsibilities, composition, meeting formats and frequency of the DSMC are 
outlined in the Data Safety Monitoring Committee Charter. 
A recommendation 
 
 
 
 
 
The DSMC recommendations will be guided by pre-defined safety criteria that apply to the safety 
observation window of 35 days (from Cycle 1 Day 1 to Cycle 2 Day 7). 

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Pre-defined safety criteria (stopping rules): 
• 
• 
• 
The pre-defined safety events are the following according to CTCAE version 5: 
• 
Grade 4 or higher non-hematologic AE 
• 
Grade 4 or higher neutropenia lasting > 7 days, despite standard of care treatments 
(i.e. G-CSF, others as needed) 
• 
Grade 4 or higher anemia 
• 
Grade 3 or higher neutropenia with associated fever (> 38.3 °C) lasting > 7 days, despite 
standard of care treatments (i.e. anti-infectives, G-CSF, others as needed) 
• 
Grade 3 or higher IRR 
• 
Grade 3 or higher TLS 
• 
Grade 3 or higher thrombocytopenia with clinically significant bleeding 
• 
CRS Grade 2 or higher 
Events that are clearly attributed to the underlying disease or LEN alone will be discussed at the 
DSMC and a decision will be made whether these events should be considered as a pre-defined 
safety event. 
If the safety results 
 
 
 
 in approximately 45 patients in total. 

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6 STUDY POPULATION 
The study will enroll approximately 51 patients with histologically confirmed diagnosis of 
R/R DLBCL based on the local pathology report. 
All patients must meet below listed eligibility criteria to be enrolled in the study. Prospective 
approvals of deviations to eligibility criteria, also known as protocol waivers or exemptions, are 
not permitted. 
6.1 Inclusion Criteria 
Patients are eligible to be included in the study only if all the following criteria apply: 
1. Capable of giving signed informed consent as described in Appendix 2: Regulatory, 
Ethical, and Trial Oversight Considerations which includes compliance with the 
requirements and restrictions listed in the informed consent form (ICF) and in this 
protocol. 
2. Patient must be at least 18 years of age and of  legal age (whichever is higher) in the 
jurisdiction in which the study is taking place at the time of signing the informed consent. 
3. One of the following histologically confirmed diagnoses: 
• DLBCL not otherwise specified (NOS) 
• T cell/histiocyte-rich large B-cell lymphoma (THRLBCL) 
• Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive 
DLBCL) 
• Grade 3b follicular lymphoma 
• Composite lymphoma with a DLBCL component with a subsequent DLBCL 
relapse, according to the Revised European American Lymphoma/World 
Health Organization (REAL/WHO) classification 
Additionally, patients with the evidence of histological transformation to DLBCL 
from an earlier diagnosis of low-grade lymphoma (i.e., an indolent pathology such 
as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) 
into DLBCL with a subsequent DLBCL relapse are also eligible. 
4. Tumor tissue for retrospective central pathology review must be provided as an adjunct 
to participation in this study. If archival formalin fixed paraffin embedded tumor tissue 
acquired ≤3 years prior to screening is not available, a fresh tumor tissue sample from 
the patient should be obtained. Archival formalin fixed paraffin embedded tumor tissue 
acquired >3 years prior to screening is acceptable only in cases where a fresh tumor 
biopsy cannot be collected due to a safety risk e.g. due to co-morbidity, or inaccessible 
tumor site. 

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5. Patients must have: 
a. Relapsed and/or refractory disease as defined in Appendix 3: Study Specific 
Definitions 
b. At least one bidimensionally measurable disease site. The lesion must have a 
greatest transverse diameter of ≥ 1.5 cm and greatest perpendicular diameter of 
≥ 1.0 cm at baseline. The lesion must be positive on positron emission 
tomography (PET) scan for definition (see Juweid et al., 2007) 
c. Received at least one, but no more than three previous systemic regimens for 
the treatment of DLBCL and one therapy line must have included a cluster of 
differentiation-20 (CD20)-targeted therapy (e.g., rituximab [RTX]) 
d. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 
6. Patients that are not eligible to undergo intensive salvage therapy including autologous 
stem cell transplantation (ASCT). The reason for a patient's ineligibility must meet one 
of the criteria described below and documented in the patient's source data: 
a. Inadequate performance status (Karnofsky performance status ≤ 80%; see 
Appendix 5: Karnofsky Performance Status Scale) 
b. Disease not responsive to salvage chemotherapy. Responsiveness is defined as 
a tumor demonstrating either complete response (CR) or partial response (PR) 
to salvage chemotherapy 
c. Inadequate major organ function (any of the below): 
i. symptomatic congestive heart failure 
ii. lung function-forced vital capacity (FVC), forced expiratory volume in 
1 second (FEV-1), and corrected diffusion capacity of the lung for 
carbon monoxide (DLCO) ≤ 60% 
iii. liver function-total serum bilirubin and transaminases > 2 x upper limit 
of normal (ULN) 
d. History or evidence of significant co-morbid medical or psychiatric illness 
which would significantly compromise the patient's clinical care and chances 
of survival 
e. Inability to collect adequate stem cell graft (e.g. < 1-2 x 106 CD34+ cells free 
of tumor contamination/kg recipient body weight) 
7. Patients must meet the following laboratory criteria at screening: 
a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (unless secondary to bone 
marrow involvement by DLBCL as demonstrated by recent bone marrow 
aspiration and bone marrow biopsy) 
b. Platelet count ≥ 75 × 109/L (unless secondary to bone marrow involvement by 
DLBCL as demonstrated by recent bone marrow aspiration and bone marrow 
biopsy) 
c. Total serum bilirubin ≤ 2.5 × ULN unless secondary to Gilbert's syndrome or 
documented liver involvement by lymphoma. Patients with Gilbert's syndrome 
or documented liver involvement by lymphoma may be included if their total 
bilirubin is ≤ 5 × ULN (see exclusion criterion 6g) 

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d. Alanine transaminase (ALT), aspartate transaminase (AST) and alkaline 
phosphatase (ALP) ≤ 3 × ULN or < 5 × ULN in cases of documented liver 
involvement 
e. Serum creatinine CL must be ≥ 60 mL/minute either measured or calculated 
using a standard Cockcroft and Gault formula (see Appendix 6: 
Cockcroft-Gault Formula) 
8. Patients who received previous CD19 targeted therapy (other than tafasitamab) must 
have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior 
CD19 targeted therapy 
9. Patients with primary refractory disease (see Appendix 3: Study Specific Definitions) 
who received at least one, but no more than three previous systemic regimens 
(including a CD20 targeted therapy) for the treatment of DLBCL are eligible 
6.2 Exclusion Criteria 
Patients are excluded from the study if any of the following criteria apply: 
1. General provisions: 
a. Patients who are legally institutionalized, or patients under judicial protection 
b. Concurrent enrollment in another interventional clinical study 
2. Patients who have: 
a. Any other histological type of lymphoma including primary mediastinal 
(thymic) large B-cell (PMBL) or Burkitt lymphoma 
b. Known "double/triple hit" genetics (high grade B-cell lymphoma) 
characterized by simultaneous detection of MYC with BCL2 and/or BCL6 
translocation(s) defined by fluorescence in situ hybridization. MYC, BCL2, 
BCL6 testing prior to study enrollment is not required 
3. Patients who have: 
a. Not discontinued (within 14 days prior to Day 1 dosing): CD20 targeted 
therapy, chemotherapy, radiotherapy, investigational anticancer therapy or 
other lymphoma-specific therapy 
b. Undergone major surgery (within 4 weeks prior to Day 1 dosing) or suffered 
from significant traumatic injury 
c. Received live vaccines (within 4 weeks prior to Day 1 dosing) (see 
Appendix 7: COVID-19: Infection Prophylaxis and Vaccines) 
d. Required parenteral antimicrobial therapy for active, intercurrent infections 
(within 14 days prior to Day 1 dosing). 
4. Patients who: 
a. Have, in the opinion of the investigator, not recovered sufficiently from the 
adverse toxic effects of prior therapies 
b. Were previously treated with tafasitamab or IMiDs® (e.g., thalidomide, LEN) 
c. Have a history of hypersensitivity to compounds of similar biological or 
chemical composition to tafasitamab, IMiDs® and/or the excipients contained 
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d. Have undergone ASCT within the period ≤ 3 months prior to signing the ICF. 
Patients who have a more distant history of ASCT must exhibit full 
hematological recovery before enrollment into the study 
e. Have undergone previous allogenic stem cell transplantation 
f. Have a history of deep venous thrombosis/embolism, threatening 
thromboembolism or known thrombophilia or are at high risk for a 
thromboembolic event in the opinion of the investigator and who are not 
willing/able to take venous thromboembolism (VTE) prophylaxis during the 
entire treatment period 
g. Concurrently use other anticancer or experimental treatments 
5. History of other malignancy that could affect compliance with the protocol or 
interpretation of results. Exceptions: 
a. Patients with any malignancy appropriately treated with curative intent and 
the malignancy has been in remission without treatment for >2 years prior to 
enrollment are eligible 
b. Patients with low-grade, early-stage prostate cancer (Gleason score 6 or 
below, Stage 1 or 2) with no requirement for therapy at any time prior to study 
are eligible 
6. Patients with: 
a. Positive hepatitis B and/or C serology (see Appendix 8: Hepatitis Virus 
Serology for details) 
b. Known seropositivity for or history of active viral infection with human 
immunodeficiency virus (HIV) 
c. Central nervous system (CNS) lymphoma involvement – present or past 
medical history 
d. History or evidence of clinically significant cardiovascular, CNS and/or other 
systemic disease that would in the investigator's opinion preclude 
participation in the study or compromise the patient's ability to give informed 
consent 
e. History or evidence of rare hereditary problems of galactose intolerance, the 
Lapp lactase deficiency or glucose-galactose malabsorption 
f. Gastrointestinal (GI) abnormalities (issue with absorption) including the 
inability to take oral medication 
g. History or evidence of severe hepatic impairment (total serum 
bilirubin > 3mg/dL), jaundice unless secondary to Gilbert's syndrome or 
documented liver involvement by lymphoma (see inclusion criterion 7c) 
h. History of hypersensitivity to any of the study treatments or its excipients or 
to drugs of similar chemical class 
i. Any other medical condition which, in the investigator's opinion, makes the 
patient unsuitable for the study 

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7. Contraception provisions: 
Females: Due to the teratogenic potential of LEN, FCBP must follow the rules listed 
below (otherwise excluded): 
Applicable in all countries except the US: 
a. Not be pregnant as confirmed by a negative serum pregnancy test at screening 
and a medically supervised urine pregnancy test prior to starting study therapy 
b. Refrain from breast feeding and donating oocytes during the study and for 
3 months after the last dose of study drug or according to local guidelines for 
LEN, whichever is longer 
c. Agree to ongoing pregnancy testing during the course of the study, and after 
study treatment has ended. This includes pregnancy testing and counseling if 
a patient misses her period or if there is any abnormality in her menstrual 
bleeding and applies even if the patient practices complete sexual abstinence 
d. Commit to continued abstinence from heterosexual intercourse if it is in 
accordance with her lifestyle (which must be reviewed on a monthly basis) or 
agree to use and be able to comply with the use of highly effective 
contraception without interruption at least 4 weeks prior to start of study 
drugs, during the study treatment and for 3 months after the last dose of study 
drug, or, for LEN, according to the local guidelines, whichever is longer 
Applicable in the US: 
e. Not be pregnant as confirmed by pregnancy tests performed before treatment 
initiation, within 10–14 days and again within 24 hours of initiating treatment 
(even if true abstinence is the chosen method of birth control) 
f. Refrain from breast feeding and donating oocytes during the study and for 
3 months after the last dose of study drug, or according to US guidelines for 
LEN, whichever is longer 
g. Agree to ongoing pregnancy testing during the study (every 4 weeks in 
women with regular menstrual cycle and every two weeks in women with 
irregular menstrual cycle), and after study therapy has ended (even if true 
abstinence is the chosen method of birth control). This includes pregnancy 
testing and counseling if a patient misses her period or if there is any 
abnormality in her menstrual bleeding 
h. Not get pregnant while taking the study treatment and for at least 3 months 
after the last dose of study treatments by using at the same time 2 effective 
methods of contraception, at least one highly effective method and one 
additional effective method (see Appendix 13: Contraceptive Guidance and 
Collection of Pregnancy Information), each time engaging in sexual activity 
with a male, starting at least 4 weeks before taking the study treatment, while 
taking the study treatment, during breaks (dose interruptions) and for at least 
3 months after stopping the study treatment, or for LEN, according to the US 
guidelines, whichever is longer. True abstinence from heterosexual sexual 
intercourse is also an acceptable method of contraception. The use of 
emergency contraception is also permitted 

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8. Due to teratogenic potential of lenalidomide, male participants must follow the rules 
listed below (otherwise excluded): 
Applicable in all countries except the US: 
a. Use an effective barrier method of contraception without interruption if the 
patient is sexually active with a FCBP. Male patients should refrain from 
donating sperm during the study participation and for 3 months after the last 
dose of study treatment, or according to the local guidelines for LEN, 
whichever is longer 
Applicable in the US: 
b. Use a latex or synthetic condom each time they have sex with a FCBP. True 
abstinence from heterosexual sexual intercourse is also an acceptable method 
of contraception. The use of emergency contraception is also permitted. Male 
patients should refrain from donating sperm during the study participation 
and for 3 months after the last dose of study drug, or according to the US 
guidelines for LEN, whichever is longer 
6.3 Screen Failures 
Screen failures are defined as patients who consent to participate in the clinical study but are not 
subsequently entered into the treatment period. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure patients. This includes: 
• 
Informed consent 
• 
Inclusion/exclusion criteria 
• 
Reason for screen failure (e.g., withdrawal of informed consent, death, etc.) 
• 
Demography 
• 
AEs (only if the patient experienced an SAE between signing the ICF and date of screen 
failure) 
Patients can be re-screened at the discretion of the investigator under certain circumstances. 
Re-screening is restricted to one attempt per patient and can only be performed if one of the 
following criteria is met: 
• 
The patient has already consented and met all of the inclusion and none of the exclusion 
criteria and his or her enrollment was delayed due to an unexpected event 
• 
The patient previously failed to be eligible due to any event (e.g., planned surgery, 
laboratory test result) that has been resolved 
• 
The patient previously failed screening but has become eligible for the study based on a 
change in the inclusion and exclusion criteria as the result of a protocol amendment 
• 
The patient failed screening due to non-progressed / non-relapsed disease at the time of 
screening and is later clinically diagnosed as having progressed/relapsed 
• 
A patient should only be rescreened if there is a clear indication that the patient may be 
eligible according to the currently valid study protocol 

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The following procedures should be performed for re-screened patients: 
• 
The patient must sign and date a new ICF as part of the re-screening procedure 
• 
The eligible patient will receive a new unique identification number 
• 
A new electronic case report form (eCRF) should be completed 
• 
The patient will be documented as rescreened in the source documents and eCRF 
A rescreened patient can be enrolled, if all of the current inclusion criteria are met and none of the 
exclusion criteria are met. 
7 STUDY TREATMENT(S) 
7.1 Investigational Medicinal Products Administered 
Tafasitamab must be handled and/or prepared as described in the Drug Handling Manual, the IB 
for tafasitamab, and other safety-relevant documents (e.g., Summary of Product Characteristics 
(SmPC) for the European Medicines Agency (EMA) or the Prescribing Information (PI, US FDA) 
for LEN). Tafasitamab will be administered in combination with LEN 25 mg 
 
 as shown in Figure 2, Figure 3, and Table 9. 
Table 9: Overview of IMPs in MINDway 
IMP Name 
Tafasitamab 
LEN 
Formulation 
Vial 
Capsule 
Unit Dose Strength(s)/Dosage 
Level(s) 
200 mg 
25 mg 
10 mg 
5 mg 
Route of Administration 
i.v. 
Oral 
Abbreviations: i.v.=intravenous; LEN=lenalidomide. 
On days when both study drugs are given together, LEN should be administered prior to 
tafasitamab. 
7.1.1 Tafasitamab (IMP) 
Tafasitamab will be centrally supplied. Tafasitamab must be stored under 2° C to 8° C in its 
original package in an appropriate storage facility accessible only to the pharmacist(s), the 
investigator, or a duly designated person. 
Tafasitamab is a lyophilizate supplied in single-use 20 mL glass vials. Each vial contains 200 mg 
of tafasitamab for reconstitution with 5 mL of water for injection (WFI). Reconstitution yields 
40 mg/mL tafasitamab in 25 mM sodium citrate, 200 mM trehalose and 0.02% weight by volume 
(w/v) polysorbate 20 at pH 6.0. Reconstituted tafasitamab will be diluted into an infusion bag of 
0.9% w/v sodium chloride solution for injection according to the description given in the Drug 
Handling Manual. The solution after reconstitution is colorless to slightly yellow and essentially 
free of foreign particles; it may contain a few white to whitish product-related particles. 
The individual tafasitamab infusion will be prepared under aseptic conditions and administered at 
the study site, according to the directions of the sponsor, which will be provided in a Drug 
Handling Manual. In general, a vial of tafasitamab must be used as soon as possible after 

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reconstitution with WFI. After dilution for infusion, administration of tafasitamab should take 
place as soon as possible. Maximum allowed storage times and conditions will be detailed in the 
Drug Handling Manual. 
Tafasitamab will be administered i.v. as per schedule of assessment and dosing scheme, 
respectively (see Section 2 and Table 5). 
Tafasitamab should NOT be administered as an i.v. push or bolus but as an i.v. infusion. 
In the first 28-day cycle (Cycle 1) tafasitamab is given on Day 1, Day 4 and Day 8 at a dose of 
12 mg/kg to mitigate the risk of IRRs and TLS. 
Body weight will be measured on Day 1 of each cycle. This baseline weight can be used to 
calculate the tafasitamab dose during the given cycle provided the weight does not deviate more 
than ±10% from baseline during the course of this cycle. Using actual body weight measured prior 
to the particular tafasitamab infusion on visits other than Day 1 of the cycle is also allowed for 
dose calculation, if this is preferred by investigators. 
In cases where the patient's body weight changes more than ± 10% from weight measured on Day 1 
of the cycle, the current weight, measured 24 hours prior to the particular tafasitamab infusion 
must be used to calculate the tafasitamab dose. 
Guidance on the infusion duration for each visit is summarized 
 Further details on 
the infusion rates are provided in the drug handling manual. If required, the investigator should 
use clinical judgement to optimize patient safety by administering the infusion more slowly. 
Additionally, further guidance on infusion rate modifications for subsequent administrations in 
case of IRRs Grade ≥3 is summarized in Table 11 below. 
Please note that general management of IRRs is described in Section 7.3.1. 

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Table 11: Infusion Rate Modifications for Tafasitamab Infusion (
) in 
Case of IRR's, Cytokine Release Syndrome (CRS) 
Infusion related reaction, 
Cytokine release syndrome 
Infusion Rate 
IRR Grade 3 and/or Grade 2 CRS 
during Cycle 1 
If IRR Grade 3 and/or Grade 2 CRS in Cycle 1 has resolved and no further 
IRR Grade ≥3 events are observed in cycle 2 and 3, the patient may receive 
tafasitamab with shorter infusion time from Cycle 4 Day 1 onward at the 
discretion of the investigator 
IRR Grade 3 and/or Grade 2 CRS 
during any other Cycle 
If IRR Grade 3 and/or Grade 2 CRS has resolved, tafasitamab 
administrations must be given at regular infusion rate i.e. approximately 
4 hours in the current and subsequent Cycle. If the patient experiences no 
further IRR Grade ≥3, they may receive the tafasitamab administration with 
short infusion time from the next but one cycle onward at the discretion of 
the investigator.  
IRR Grade 4 and/or Grade 3 CRS, 
Grade 4 CRS 
Tafasitamab administration should be permanently discontinued. 
7.1.2 Lenalidomide (IMP) 
LEN (generic) as sourced from commercially available drug suppliers will be provided centrally. 
Patients will self-administer a starting dose of 25 mg oral daily on Days 1–21 of each cycle until 
cycle 12 or discontinuation. Treatment with LEN may be modified and/or de-escalated from 25 mg 
to 5 mg based upon clinical and laboratory findings. Detailed dose modification guidelines to 
manage hematological and/or other toxicities are provided in the Section 7.3.2. 
Patients must be counselled on the reproductive risks associated with LEN, at the timepoints 
according to SoA (see Section 2). 
7.1.3 Pre-Medication for Tafasitamab Infusions 
IRRs have been reported for patients with R/R DLBCL treated with tafasitamab and there is a 
potential increased risk of IRRs with higher dose levels of tafasitamab. 
To reduce the risk of IRRs, pre-medication is mandatory for the first 4 infusions (doses) of 
tafasitamab. Pre-medication for patients who do not experience any IRRs to tafasitamab during 
the first 4 infusions (doses) will be optional for subsequent infusions at the discretion of the 
investigator. Otherwise, the pre-medication should be continued for subsequent administrations. 
It is suggested that pre-medication is administered between 30 minutes and 2 hours prior to the 
tafasitamab infusions. 
The pre-medication may include the following: 
• 
Antipyretics (e.g., acetaminophen [paracetamol] 1000 mg per dose per by [p.o.] or i.v. or 
equivalent). 
• 
Histamine H1 receptor blockers (e.g., diphenhydramine 25–50 mg per dose i.v. or 
equivalent). 
• 
Histamine H2 receptor blockers (e.g., cimetidine 300 mg p.o. (except Austria), ranitidine 
150 mg tablet p.o. or equivalent). 
• 
Glucocorticosteroids (methylprednisolone 80–120 mg per dose i.v. or equivalent - please 
refer to Appendix 9: Equivalent Doses for Corticosteroids. 

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The investigator may repeat doses of individual agents as required and use other agents, doses 
and/or formulations in accordance with institutional guidelines. Equivalence for pre-medications 
includes variations to the stated dose due to the formulations available locally. Any pre-medication 
given should be reported in the eCRF. 
7.1.4 Patient Monitoring During and After Tafasitamab Infusion 
Vital signs should be measured as outlined in Section 9.4.1. 
All supportive measures consistent with optimal patient care will be provided throughout the study 
according to institution standards. The observation of patients after the infusion is recommended, 
however, the duration and potential monitoring of vital signs should be determined by the 
investigator based on clinical judgement in accordance with local/practice guidelines of the 
institution. The Sponsor recommends that the investigators consider hospitalization on C1D15 for 
patients who experienced infusion related events during previous infusions on C1D1, C1D4 and/or 
C1D8 with 12 mg/kg tafasitamab or if otherwise clinically indicated. 
Precautions for anaphylaxis should be observed during tafasitamab administration. Emergency 
resuscitation equipment and medications should be readily available. 
Additional supportive measures should also be available and may include, but are not limited to, 
epinephrine, antihistamines, corticosteroids, i.v. fluids, vasopressors, oxygen, bronchodilators, 
diphenhydramine, and acetaminophen (paracetamol). 
In case of hospitalization of patient as a prophylactic measure in accordance with local/practice 
guidelines of the institution will not be reported as AE/SAE. 
7.2 Standard of Care 
Not applicable. 
7.3 Dose Modifications, Drug Interruptions and Discontinuation 
7.3.1 Tafasitamab Specific Dose Modifications, Drug Interruptions and Discontinuation 
Intra-patient dose reductions of tafasitamab are not permitted. Drug interruptions or 
discontinuation may occur e.g. in case of severe IRRs, Cytokine Release Syndrome (CRS), allergic 
reactions, infections, febrile neutropenia or severe hematologic toxicity. If a tafasitamab infusion 
is delayed due to toxicity for more than 2 days during treatment Cycle 1 or for more than 7 days 
during treatment Cycles 2 and 3, this infusion should be skipped and tafasitamab treatment 
continued only at the next scheduled timepoint. In case 2 consecutive tafasitamab doses are 
skipped during the first three treatment Cycles, study drugs will be discontinued, and the EOT visit 
will be performed. See Table 14 and Table 15 for additional details. 
For further details on the management of tafasitamab IRRs and CRS, please see Table 12. 
7.3.1.1 Management of Tafasitamab IRRs and Cytokine Release Syndrome (CRS) 
IRRs and CRS will be defined according to the NCI-CTCAE, version 5.0 definition of IRR and 
CRS (see Table 12). 

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Table 12: Definition of IRR and CRS NCI-CTCAE Version 5.0: IRR and CRS 
AE  
Grade 1 
Grade 2 
Grade 3 
Grade 4 
IRR 
Mild transient reaction; 
infusion interruption 
not indicated; 
intervention not 
indicated 
Therapy or infusion 
interruption indicated 
but responds promptly 
to symptomatic 
treatment 
(e.g., antihistamines, 
NSAIDs, narcotics, i.v. 
fluids); prophylactic 
medications indicated 
for ≤ 24 hours  
Prolonged (i.e. not 
rapidly responsive to 
symptomatic 
medication, brief 
interruption of infusion, 
or both); recurrence of 
symptoms following 
initial improvement; 
hospitalization indicated 
for clinical sequelae  
Life-threatening 
consequences; urgent 
intervention indicated 
CRS 
Fever with or without 
constitutional 
symptoms  
Hypotension 
responding to fluids; 
hypoxia responding to 
< 40% O21  
Hypotension managed 
with one pressor; 
hypoxia requiring 
≥ 40% O21  
Life-threatening 
consequences; urgent 
intervention indicated  
Abbreviations: CRS=cytokine release syndrome; IRR=infusion-related reaction; i.v.=intravenous; NCI-CTCAE= National Cancer 
Institute Common Terminology Criteria for Adverse Events; NSAIDs=non-steroidal anti-inflammatories. 
Please note: An acute infusion reaction may occur with an agent that causes cytokine release (e.g., monoclonal antibodies or other 
biological agents). Signs and symptoms usually develop during or shortly after drug infusion and generally resolve completely 
within 24 hours of completion of infusion. Signs/symptoms may include: allergic reaction/hypersensitivity (including drug fever), 
arthralgia (joint pain), bronchospasm, cough, dizziness, dyspnoea, fatigue (asthenia, lethargy, malaise), headache, hypertension, 
hypotension, myalgia, nausea, pruritus/itching, rash/desquamation, rigors/chills, sweating (diaphoresis), tachycardia, tumor pain 
(onset or exacerbation of tumor pain due to treatment), urticaria (hives, welts, wheals), and vomiting. 
1Applied e.g. via breathing mask. 
7.3.1.2 Interventions for Grade 2 IRRs, Grade 1 CRSs 
If a patient presents with a grade 2 infusion reaction or grade 1 CRS: 
• 
The infusion should be stopped immediately 
• 
The patient should receive appropriate treatment with an antihistamine and/or 
acetaminophen (paracetamol) or methylprednisolone (or equivalent) as clinically indicated 
• 
Once the symptoms have been resolved or IRR reduced from Grade 2 to Grade 1, according 
to investigator assessment, the infusion can be continued at an infusion rate of 50% of the 
speed so far. If, after one hour, the patient'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 patient receives further infusions of tafasitamab, then pre-medication should be given 
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7.3.1.3 Interventions for Grade 3 IRRs, Grade 2 CRSs 
If a patient presents with a grade 3 IRR or grade 2 CRS: 
• 
The infusion should be stopped immediately 
• 
The patient must receive appropriate treatment with an antihistamine and/or 
acetaminophen (paracetamol) or methylprednisolone (or equivalent) and, if necessary, 
further medications (i.e. epinephrine, bronchodilator) as clinically indicated 
• 
Only after the complete resolution of all symptoms, and after having received appropriate 
prophylactic medication(s), the infusion may be resumed at an infusion rate of 25% of the 
speed so far. If, after 1 hour, the patient'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 patient 
• 
Based on the investigator's decision the patient may receive further infusions of tafasitamab 
provided clinically appropriate precautions are undertaken. Pre-medication should be given 
before all subsequent infusions of tafasitamab throughout the study 
If precluded from further tafasitamab administrations, the patient may continue treatment with 
lenalidomide. 
7.3.1.4 Interventions for Grade 4 IRRs, Grade 3 CRSs, Grade 4 CRSs 
If a patient presents with a grade 4 infusion reaction or grade 3-4 CRS: 
• 
The infusion should be stopped immediately, and the infusion tubing should be 
disconnected from the patient 
• 
The patient must receive appropriate treatment with an antihistamine and/or 
acetaminophen (paracetamol) or methylprednisolone (or equivalent) and, if necessary, 
further medications (i.e. epinephrine, bronchodilator) as clinically indicated 
• 
The patient must not receive any further tafasitamab infusions but may continue treatment 
with LEN 
7.3.2 LEN Specific Dose Modifications, Drug Interruptions and Discontinuation 
LEN may be given only on Days 1 to 21 of each cycle up to 12 cycles in total and must not be 
administered beyond this period. 
In case of LEN-related toxicity (e.g., neutropenia), the dose of LEN may be interrupted temporarily 
and/or reduced successively level by level from the starting dose of 25 mg daily as described below 
in Table 13. 
Table 13: LEN Dose Modification Guidelines 
Starting Dose 
25 mg Daily on Days 1–21, Every 28 Days 
Dose Level – 1 
20 mg daily on Days 1–21, every 28 days 
Dose Level – 2 
15 mg daily on Days 1–21, every 28 days 
Dose Level – 3 
10 mg daily on Days 1–21, every 28 days 
Dose Level – 4 
5 mg daily on Days 1–21, every 28 days  

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Patients who cannot tolerate Dose Level – 4 are to be discontinued from LEN treatment in the 
study but should continue therapy with tafasitamab alone. 
If LEN dosing was interrupted during the previous cycle and was restarted with a one-level dose 
reduction without requiring an interruption for the remainder of the cycle, then that reduced dose 
level will be initiated on Day 1 of the new cycle. There will be no more than one dose reduction 
from one cycle to the next. Once a patient's LEN dose has been reduced, no dose re-escalation is 
permitted. 
7.3.3 General Dose Modifications, Drug Interruptions and Discontinuation due to 
Toxicity 
The next cycle of treatment may begin on the scheduled Day 1 if all of the following criteria are 
met: 
• 
ANC is ≥ 1,000/mm3 (unless neutropenia is due to infiltration of bone marrow) 
• 
Platelets (PLT) ≥ 50,000/mm3 (unless thrombocytopenia is due to infiltration of bone 
marrow, patient may have received transfusion) and absence of active bleeding 
• 
No other treatment related toxicities > Grade 2 
If, based on medical judgment, the treating physician considers a change in laboratory parameter 
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 patient should be dosed. The decision and rationale 
behind the decision should be documented in the source data. 
If any of the above conditions are not met on Day 1 of a new cycle, the patient will be monitored 
as per institutional guidelines and a new cycle will be initiated when all criteria listed above are 
met. Specific course of action for a given toxicity occurring in the course of the treatment cycle is 
described below. 
If initiation of the next planned Cycle is delayed by > 28 days for the same persistent study drug-
related toxicity, then study drugs will be discontinued, and the EOT visit will be performed. 
7.3.3.1 Hematological and Other Toxicities 
Patients will be evaluated for AEs at each visit with the NCI CTCAE v5.0 used as a guide for 
grading severity. The dose and/or administration of study drug(s) for each patient will be 
interrupted and/or modified following toxicity as described below in Table 14 and Table 15 and 
Table 13 for LEN dose reduction instructions. 

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Table 14: Hematological Toxicities 
Hematological Toxicity 
LEN1 
Tafasitamab 
Neutropenia Grade 4 
(ANC < 500/µl) with or without a 
temperature of ≥ 38.0°C/100.4°F 
Interrupt LEN. 
Withhold tafasitamab infusion. 
If neutropenia has resolved to ≤ Grade 2 
(ANC ≥ 1.000/µl) within 7 days, LEN 
should be restarted in the next cycle at the 
same dose. 
If neutropenia has not resolved to ≤ Grade 2 
within 7 days, LEN should be resumed in 
the next cycle at the next lower dose level 
(see Table 13 above). Monitor CBC at least 
QW until neutrophil count is ≥ 1,000/µl. 
If neutropenia has resolved to ≤ Grade 2, 
resume tafasitamab. 
Monitor CBC at least QW until neutrophil 
count is ≥ 1,000/µl. 
Neutropenia Grade 3 
(ANC < 1,000/µl) > 7 days 
LEN should be resumed in the next cycle at 
the next lower dose level (see Table 13 
above).  
Hold tafasitamab until resolved to ≤ Grade 2 
(ANC ≥ 1,000/µl). 
Neutropenia Grade 3 
(ANC < 1,000/µl) with a 
temperature of ≥ 38.0°C/100.4°F 
(Febrile Neutropenia) 
Interrupt LEN. 
Interrupt tafasitamab. 
If infection is resolving (< 38°C/100.4°F), 
and neutropenia has resolved to ≤ Grade 2, 
LEN should be resumed in next cycle at the 
next lower dose level (see Table 13 above). 
If infection is resolving (< 38°C/100.4°F), 
continue tafasitamab as per protocol. 
Neutropenia < Grade 3 associated 
with infection ≥ Grade 3 or fever 
(≥ 38.0°C body temperature) 
First occurrence interrupt LEN. 
If infection is resolving (< 38°C/100.4°F), 
LEN should be restarted in the next cycle at 
the same dose.  
Interrupt tafasitamab. 
If infection is resolving (< 38°C/100.4°F), 
continue tafasitamab per protocol.  
Re-occurrence: interrupt LEN. If infection is 
resolving (< 38°C/100.4°F), LEN should be 
restarted in the next cycle at the next lower 
dose level.  
 
Thrombocytopenia Grade 3-4 
(PLT< 50,000/µl) with or without 
bleeding 
Interrupt VTE prophylaxis. 
Consider platelet transfusion according to institutional guidelines. 
If thrombocytopenia has resolved to ≤ grade 1, consider change of VTE prophylaxis agent 
(e.g. change antiplatelet agent to low molecular weight heparin). 
VTE prophylaxis should be tailored to the patient's individual risk/benefit profile by taking 
into account the individual thrombotic risk and bleeding risk. 
Interrupt LEN 
Follow CBC at least every 7 days. 
If thrombocytopenia has resolved to ≤ Grade 
2 (PLT ≥ 50,000/µl), LEN should be 
resumed in the next cycle at the next lower 
dose level (see Table 13 for LEN dosing). 
Withhold tafasitamab infusion 
Follow CBC at least every 7 days. 
If thrombocytopenia has resolved to 
≤ Grade 2 (PLT ≥ 50,000/µl), restart 
tafasitamab. 
Monitor as clinically indicated. 
Anemia Grade 3-4 
(Hemoglobin <8.0 g/dL) 
Interrupt LEN 
Consider transfusion according to 
institutional guidelines 
Urgent intervention indicated as per local 
institutional guidance 
Interrupt Tafasitamab 
Consider transfusion according to 
institutional guidelines 
Urgent intervention indicated as per local 
institutional guidance 
Abbreviations: AE=adverse event; ANC=absolute neutrophil count; CBC=complete blood count; VTE=venous thromboembolism; 
LEN=lenalidomide; PLT=platelets. QW=weekly 
1If, 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 patient should be dosed. The decision and rationale behind 
the decision should be documented in the source data. 

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Table 15: Non-Hematological Toxicities 
Non-hematological toxicity 
LEN1 
Tafasitamab 
Thromboembolic events 
≥ Grade 3  
Discontinue LEN permanently. 
Continue tafasitamab infusion as per 
protocol if clinically appropriate.  
Allergic reaction or 
hypersensitivity Grade 2 
If related to LEN then interrupt/skip the dose.  
If related to tafasitamab then interrupt/skip 
the dose.  
Note: if the causality cannot be determined, and the AE may be related to LEN and/or 
tafasitamab, both drugs should be held.  
If toxicity resolves to ≤ Grade 1, restart LEN at 
the next lower dose level (see Table 13 above).  
If toxicity resolves to ≤ Grade 1, tafasitamab 
may be resumed.  
Allergic reaction or 
hypersensitivity ≥ Grade 3 
If related to LEN then discontinue permanently.  If related to tafasitamab then discontinue 
permanently. 
Note: If the causality cannot be determined and the AE may be related to LEN and/or 
tafasitamab, discontinue both drugs permanently.  
Rash Grade 2 or 3 
non-desquamating (blistering) 
If related to LEN then interrupt the dose. 
If the AE resolves to ≤ Grade 1, restart LEN at 
the same level (see Table 13 above). 
If related to tafasitamab then interrupt the 
dose. 
If toxicity resolves to ≤ Grade 1, tafasitamab 
may be resumed.  
Note: if the causality cannot be determined, and the AE may be related to LEN and/or 
tafasitamab, interrupt both drugs. 
Rash 
Desquamating (blistering) 
≥ Grade 3 
OR 
Non-desquamating Grade 4  
If related to LEN then discontinue permanently.  If related to tafasitamab then discontinue 
permanently.  
Note: If the causality cannot be determined and the AE may be related to LEN and/or 
tafasitamab, discontinue both drugs permanently.  
TFR Grade 3–42 
Interrupt LEN. 
If the AE resolves to grade ≤ 1, restart LEN and 
maintain the same dose level (see Table 13 
above). 
Continue tafasitamab infusion as per 
protocol if clinically appropriate. 
TFR Grade 1–22 
Continue LEN.  
Continue tafasitamab infusion as per 
protocol. 
Constipation ≥ Grade 3 
Interrupt LEN. 
If the AE resolves to ≤ Grade 2, restart at same 
dose level.  
Continue tafasitamab infusion as per 
protocol if clinically appropriate.  
Other non-hematologic AEs 
≥ Grade 3 
Interrupt LEN. 
If the AE resolves to ≤ Grade 2, restart at the 
same or next lower dose level per the 
investigator's discretion.  
Continue tafasitamab infusion as per 
protocol if clinically appropriate.  
Other LEN related AEs in 
patients with moderate renal 
impairment (creatinine CL 
59-30 mL/min) 
If the AE resolves to ≤ grade 2, restart at the 
same or next lower dose level per the 
investigator's discretion (see Table 13 above). 
Continue tafasitamab infusion as per 
protocol if clinically appropriate.  
Creatinine CL decreases to 
< 30 mL/min 
Interrupt LEN during the current cycle. If 
creatinine CL ≥ 30 mL/min in the next cycle, 
restart at the next lower dose level. 
Continue tafasitamab/ infusion as per 
protocol if clinically appropriate.  
Abbreviations: AE(s)=adverse event(s); LEN=lenalidomide; NCI-CTCAE=National Cancer Institute Common Terminology 
Criteria for Adverse Events; TFR=tumor flare reaction. 
1If, 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/relapse of the underlying disease, then it is at the physician's 
discretion and assessment of the individual risk/benefit ratio to determine whether the patient should be dosed. The decision and 
rationale behind the decision should be documented in the source data. 
2Tumor flare reaction is defined as constellation of signs and symptoms in direct relation to initiation of therapy. The 
symptoms/signs include tumor pain, inflammation of visible tumor, hypercalcemia, diffuse bone pain, and electrolyte disturbances 
(TFR is the only AE that will be graded using NCI-CTCAE version 3.0). 
Grade 1: Mild pain not interfering with function; Grade 2: Moderate pain; pain or analgesics interfering with function but not with 
activities of daily living.; Grade 3: Severe pain; pain or analgesics interfering with function and interfering with activities of daily 
living; Grade 4: Disabling.; Grade 5: Death. 

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7.3.3.2 Additional Information 
The most up-to-date information regarding constitution, dosing, interaction with other medicinal 
products and most frequent AEs related to the administration of LEN and tafasitamab are contained 
in the SmPC (EMA), PI (US FDA) and the current tafasitamab IB, respectively, and supplied to 
the study sites. 
7.3.3.3 Tumor Flare With LEN 
Patients in this study should be monitored for tumor flare (TFR). TFR is defined as a sudden and 
tender increase in the size of the disease bearing sites, including the lymph nodes, spleen and/or 
the liver, often accompanied by low-grade fever, non-pruritic diffuse rash and in some cases, an 
increase in the peripheral blood lymphocyte counts. TFR is an expected toxicity with LEN, 
especially in patients with a high tumor burden and may mimic disease progression. Therefore, 
careful monitoring and evaluation is important prior to discontinuing a study patient for PD in the 
initial cycles of LEN therapy. There are currently no laboratory or radiological tests to help 
distinguish TFR from PD. The distinction should be made on clinical grounds, incorporating 
observations such as associated physical findings, laboratory findings, and pace of disease before 
and after the initiation of treatment. TFR should be recorded as an AE of special interest (graded 
using the NCI-CTCAE 3.0 criteria) and not as PD. 
Treatment of TFR is at the discretion of the investigator and dependent on the severity, clinical 
situation and institutional standards. 
7.3.3.4 Tumor Lysis Syndrome (TLS) 
TLS results from the rapid breakdown of tumor cells and the release of their intracellular content 
into the bloodstream. The release of large amounts of potassium, phosphorus, and nucleic acids 
overwhelms normal homeostatic mechanisms, resulting in hyperkalemia, hyperphosphatemia, 
hyperuricemia, and secondary hypocalcemia. Elevated lactate dehydrogenase (LDH) and elevated 
AST are potential indicators for TLS. The onset of TLS is rapid, usually within 24-48 hours of 
receipt of the first dose of anticancer medication, but can also occur after the first week of 
treatment. Left untreated, TLS can lead to acute renal failure, cardiac dysrhythmia, neurologic 
complications, and seizures. 
Bulky disease, moderate renal insufficiency, a high number of circulating lymphoma cells and 
high uric acid levels (>8 mg/dL) prior to therapy, increase the likelihood of TLS. 
In patients with high risk of tumor lysis syndrome (e.g. patients with large tumor burden, elevated 
LDH, or high proliferation rate of tumor cells), TLS prophylaxis should be considered. All 
approaches to mitigate the risk of developing TLS, such as adequate hydration or hypouricemic 
agents (e.g. allopurinol or rasburicase), may be used in high risk patients as per institutional 
guidelines. Patients should be monitored closely for TLS during treatment with tafasitamab. These 
measures are described in the IB. 
7.3.3.5 Thromboembolism 
LEN increases the risk of thrombotic events in patients who are at high risk of thrombosis. High 
risk is defined, for example, as a history of a thromboembolic event and/or taking a concomitant 
medication associated with an increased risk of a thromboembolic event and/or a known 
hypercoagulable state, regardless of thromboembolic history. It is recommended that patients 

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receive adequate anticoagulation therapy according to the institutional standards and investigator's 
discretion. It should be tailored to the patient's individual risk/benefit profile by taking into account 
the individual thrombotic and bleeding risk, and the quality of compliance with VTE prophylaxis. 
Anticoagulants may include acetylsalicylic acid (e.g., aspirin) prophylaxis, low molecular weight 
heparin, warfarin or new oral anticoagulants (NOACs, e.g., dabigatran, rivaroxaban). 
7.4 Overdose 
For this study, any dose of tafasitamab greater than 120% of the assigned dosage per single 
infusion as per protocol (see Section 7.7) will be considered an overdose. 
For LEN, the overdose is defined as any dose greater than the planned dose (i.e., above 100%) for 
a particular patient as per protocol (see Section 7.7). 
The sponsor does not recommend specific treatment for an overdose. Symptomatic treatment 
including but not limited to blood product transfusions, growth factors, antibiotics, antiemetics and 
analgesics may be administered per investigator's discretion. 
In the event of an overdose, the investigator/treating physician should: 
• 
Evaluate the patient carefully with regards to an immediate measure for the patients safety 
• 
Contact the medical monitor immediately. 
• 
Determine, in consultation with the medical monitor, whether study treatment should be 
interrupted or whether the dose should be reduced. 
• 
Closely follow the patient for AEs and laboratory abnormalities and report any observed 
symptoms as AE and SAE as applicable. 
• 
Obtain a sample for PK analysis if requested by the medical monitor (determined on a 
case-by-case basis) 
• 
Document the overdose and actions taken in the source documentation (see Section 9.4.9). 
7.5 Measures to Minimize Bias: Randomization and Blinding 
Not applicable. 
7.6 Preparation/Handling/Storage/Accountability 
Each investigator is responsible for ensuring that deliveries of IMPs and other clinical study 
materials from the sponsor are completely and correctly received, recorded, handled and stored 
safely and properly in accordance with all applicable regulatory guidelines, and used in accordance 
with this clinical study protocol and related plans and guidance. Only patients enrolled in the study 
may receive study treatment and only authorized site staff may supply or administer study 
treatment. 
Authorized site staff must confirm appropriate temperature conditions have been maintained for 
all IMP received. All IMP must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with information provided on the labels of IMP with 
access limited to the investigator and authorized site staff. 

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7.7 Treatment Compliance 
Dosing modifications due to toxicity are described in Section 7.3. 
Patients will receive tafasitamab under the direct supervision of study personnel. Each 
administration volume or dose will be checked and the vial/outer package code and volume or 
dose per administration will be recorded in each patient's eCRF as well as in the source data. 
A patient will be considered compliant with the protocol if the tafasitamab dose administered is 
≥ 80% to ≤ 120% of the assigned dosage per single infusion. 
LEN is to be dispensed in 28-day cycles. Patients should return all unused or empty LEN 
bottles/blister packs to the site throughout the treatment period of the study, as instructed by the 
investigator. A patient will be considered compliant with the protocol if the LEN dose administered 
is ≥ 80% to ≤ 120% of the assigned dosage during a particular cycle. 
Drug accountability will be checked by the field monitor during site visits and at the completion 
of the study. 
7.8 Prior and Concomitant Therapy 
Prior therapy must be recorded in the eCRF as follows: 
• 
All prior immunosuppressive medications administered/taken within the past 5 years prior 
to signing the ICF 
• 
Corticosteroids for symptom control administered/taken within the three weeks prior to 
signing the ICF 
• 
All other medications and therapies (including non-drug procedures) taken 
by/administered to the patient within 30 days prior to signing the ICF 
Any concomitant therapy up to 4 weeks (medication or vaccine (including over the counter or 
prescription medicines, vitamins, and/or herbal supplements) and non-drug procedures) that the 
patient is receiving at the time of signing the ICF or receives during the study must be recorded in 
the eCRF. 
eCRF records of prior and concomitant medication include at least the dose, regimen, route of 
administration, indication, and dates of use (start, end). 
Patients may receive concomitant medications that are medically indicated as standard care for the 
treatment of symptoms, AEs, and intercurrent illnesses. Medications to treat concomitant diseases 
like diabetes, hypertension, bronchial asthma, chronic obstructive pulmonary disease (COPD) etc., 
are allowed. Patients will also receive therapy to mitigate side effects of the study medication as 
clinically indicated, as well as best supportive care (BSC) as per institutional guidelines. This may 
include, but is not limited to, antiemetics, antidiarrheals, anticholinergics, antispasmodics, 
antipyretics, antihistamines, analgesics, antibiotics, and other medications intended to treat 
symptoms. 
The Medical Monitor should be contacted if there are any questions regarding concomitant or prior 
therapy. 

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7.8.1 Recording of Prior Lines of Anti-Lymphoma Therapy 
Information should be provided on any previous DLBCL specific- therapies since the time point 
of the first diagnosis of DLBCL. The generic or the trade name of a medication may be recorded. 
To become eligible for the MOR208C115 study the patients must have received at least one, but 
no more than three previous systemic therapy lines for the treatment of DLBCL, and at least one 
therapy line must have included a CD20 targeted therapy (e.g., RTX). 
Planned consolidation of responding patients, i.e. by radiotherapy or second line regimens with or 
without ASCT, is regarded as one therapy line. Changing to a different chemotherapy regimen is 
regarded as a separate line of therapy, unless the change was caused by toxicity of the employed 
regimen. 
Radiotherapy of the involved site (limited field radiotherapy) or radiation pre-planned to occur at 
the conclusion of systemic cytotoxic therapy will not be considered a separate prior line of therapy. 
The administration of a mAb alone with a curative/therapeutic intent (e.g., RTX monotherapy) 
counts as a separate line of therapy. On the other hand, the addition of a mAb to chemotherapy or 
mAb maintenance treatment subsequent to chemotherapy/chemoimmunotherapy regimen is 
considered one treatment therapy line, provided that the mAb was part of the initial treatment plan. 
As for the ASCT, the induction, consolidation, stem cell collection, preparative regimen including 
transplantation, and maintenance will be considered a single line of therapy. 
7.8.2 Growth Factors 
Growth factors may be prescribed during the treatment and follow-up periods at the investigator's 
discretion, according to institutional standards. Growth factors or platelet, transfusions should not 
be administered during the screening period solely for the purpose of improving a patient's blood 
values in order to meet eligibility criteria. 
7.8.3 Anticancer Therapies 
Patients should not have received a CD20 targeted therapy, chemotherapy, radiotherapy, 
investigational anticancer therapy or other lymphoma specific- therapy within 14 days prior to 
Cycle 1 day 1 of the study. In addition, no radiotherapy (including limited field radiotherapy) is 
permitted after the baseline PET/computed tomography (CT) scan for initial disease assessment 
has been performed. Other than the study drugs, patients should not receive any other DLBCL 
specific- therapy during the study treatment period. The patient should not receive any 
investigational agent other than tafasitamab and LEN during the treatment period of the study. 
After disease progression has been recorded, additional antineoplastic therapies are permitted at 
the discretion of the investigator and in accordance with the local guidelines and should be 
recorded in the eCRF. 
7.8.4 Systemic Glucocorticosteroids 
The use of systemic glucocorticosteroids is generally discouraged unless as part of pre-medication 
as described in Section 7.1.3 because their potential anti-lymphoma activity in patients with 
DLBCL may confound interpretation of antitumor effects mediated by study treatment 
(tafasitamab and LEN). 

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Additionally, systemic corticosteroids is allowed in doses up to 20 mg/day prednisone or 
equivalent (i.e. equipotent corticosteroid) are permitted, provided the dosing is stable (not 
increased within the last month), but only for the treatment of non-neoplastic comorbid indications 
(e.g., rheumatoid arthritis). 
7.8.4.1 Screening 
Patients may potentially receive systemic glucocorticosteroids in doses above 20 mg/day 
(prednisone or equivalent) to manage severe DLBCL manifestations (e.g., compressive disease, 
rapidly progressing symptomatic adenopathy) during Screening as per institutional standards. For 
these patients the glucocorticosteroids treatment needs to be tapered to a total daily dosage of 20 
mg or less of prednisone or its equivalent prior to study treatment(s) administration on Cycle 1, 
Day 1. 
7.8.4.2 Cycle 1 Through EOT Visit 
Systemic glucocorticosteroids in doses above 20 mg/day (prednisone or equivalent) are not 
allowed during Cycle 1 through EOT visit, with the exceptions of pre-medication, CRS treatment 
at any time. Additionally, systemic doses above 20 mg/day (prednisone or equivalent; please refer 
to Appendix 9: Equivalent Doses for Corticosteroids) will be allowed for antiemetic prophylaxis 
for up to 24 hours. 
In the event a patient experiences an exacerbation of a chronic non-neoplastic condition such as 
COPD, bronchial asthma or rheumatoid arthritis, peak doses above 20 mg/day (prednisone or 
equivalent) may be allowed for a limited period of time; the glucocorticosteroid dosage and the 
allowable treatment period will be determined by the investigator on a case-by-case basis 
following agreement with the medical monitor of the study. The specified systemic 
glucocorticosteroid use at a daily dose above 20 mg, if short in duration, is not likely to confound 
the treatment effect and efficacy analysis. 
Similarly, patients who develop severe or life-threatening conditions that may be alleviated by 
systemic glucocorticosteroid therapy (e.g., adrenal insufficiency) are permitted to receive such 
drugs and are not required to discontinue study participation. 
The investigator should aim to discuss the systemic usage of glucocorticosteroids in doses above 
20 mg/day (prednisone or equivalent) with the medical monitor of the study prior to the 
implementation. 
7.8.4.3 Other Provisions on Glucocorticosteroids 
Single dose, topical, intranasal, inhaled eye drops or local injections (e.g., intra-articular) 
containing corticosteroids are permitted during study participation. 
Immunosuppressive therapies other than systemic glucocorticosteroids as described are not 
permitted. 
7.8.5 Concomitant Therapies That May Increase the Risk of Thrombosis 
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen 
containing therapies, should be used with caution after making a careful benefit-risk assessment 
in patients receiving LEN. 

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7.9 Prohibited Medication/Therapy 
No radiotherapy is permitted after the screening PET/CT scan for initial disease assessment has 
been performed. 
The use of concurrent antineoplastic therapies other than study drugs, including, but not limited 
to, chemotherapies, hormonal therapy, immunotherapy, biological response modifiers, mAbs with 
or without conjugation, radioisotopic therapies, stem cell transplant and targeted small molecules 
are not permitted during the entire treatment period of this study. 
The patient may not receive any investigational agent other than tafasitamab and LEN during the 
treatment period of the study. 
After disease progression/relapse has been observed, additional anti-lymphoma therapies are 
permitted at the discretion of the investigator and in accordance with the local treatment guidelines. 
These therapies should be recorded in the eCRF as next anti-lymphoma treatments. 
Live vaccines must not be administered to patients during the treatment and up-to 90 days after 
the last dose of the study drug in this study. Killed, inactivated vaccines, such as an injectable 
annual influenza vaccine, are permitted. Investigators should follow institutional guidelines 
concerning infection chemoprophylaxis for patients regarded to be at high risk for infection. See 
Appendix 7: COVID-19: Infection Prophylaxis and Vaccines. 
7.10 Rescue Medication 
Not applicable. 
7.11 Restrictions 
Note: LEN is structurally related to thalidomide. Thalidomide is a known human teratogenic 
substance that causes severe life-threatening birth defects. If LEN is taken during pregnancy, a 
teratogenic effect can be expected. Therefore, LEN is contraindicated during pregnancy. In FCBP 
LEN is contraindicated unless the conditions for pregnancy prevention are complied with 
Appendix 13: Contraceptive Guidance and Collection of Pregnancy Information. 
Patients should refrain from donating blood during the course of study and for 3 months after the 
last dose of study treatment. 
7.11.1 Restrictions Applicable in All Countries Except US 
• 
All men and all women of childbearing potential should undergo counselling on the need 
to avoid pregnancy. 
• 
Patients should be capable of complying with the requirements of safe use of LEN 
• 
Patients must be provided with appropriate patient educational brochure and patient card 

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The following restrictions apply while the patient is receiving study treatments and for the 
specified times before and after: 
• 
FCBP should use reliable methods of contraception at least 4 weeks prior to start of study 
treatments until 3 months after discontinuing study treatments. Acceptable methods of 
contraception include true abstinence, implant, tubal ligation, levonorgestrel releasing 
intrauterine 
system, 
medroxyprogesterone 
acetate 
depot, 
ovulation 
inhibitory 
progesterone-only pills (i.e., desogestrel) and vasectomized partner (vasectomy must have 
been confirmed by two negative semen analyses). All these methods of contraception 
should be used in combination with the use of a condom by their male sexual partner for 
intercourse 
Note: implants and levonorgestrel-releasing intrauterine systems are associated with an 
increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic 
antibiotics should be considered particularly in patients with neutropenia. 
• 
True abstinence is part of the preferred and usual lifestyle of the patient. Periodic 
abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration 
of abstinence for the duration of exposure to the investigational product, and withdrawal 
are not acceptable methods of contraception. If FCBP wish to become pregnant they should 
be advised to arrange for the freezing of oocytes prior to the start of study treatment 
• 
Male patients should avoid unprotected sex with a FCBP during treatment with the study 
treatments and for a washout period of 3 months. Patients should refrain from donating 
sperm from the start of dosing until 3 months after discontinuing study treatments. If male 
patients wish to father children, they should be advised to arrange for freezing of sperm 
samples prior to the start of study treatment 
7.11.2 Restrictions Applicable in US 
• 
All men, and all women of childbearing potential should undergo pregnancy and risk 
interview and counselling on the need to avoid pregnancy, including contraception 
requirements (females), barrier contraception requirements (males), true abstinence and 
emergency contraception 
• 
Patients should be capable of complying with the requirements of safe use of LEN 
• 
Patients must be provided with an appropriate patient educational brochure and a patient 
card. The following restrictions apply while the patient is receiving study treatments, and 
for the specified times before and after: 
o FCBP should use at the same time 2 effective methods of contraception (at least 
one highly effective method and one effective method, (see below for definition) 
each time when engaging in sexual activity with a male, starting at least 4 weeks 
before taking the study treatment, while taking the study treatment, during breaks 
(dose interruptions), and for at least 3 months after stopping the study treatment. 
True abstinence (see below for definition) from heterosexual sexual intercourse is 
also an acceptable method of contraception. The use of emergency contraception is 
also permitted. If females of child-bearing potential wish to become pregnant they 
should be advised to arrange for freezing oocytes prior to the start of study treatment 

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o Male patients should use latex or synthetic condom each time they have sex with 
an FCBP while taking the study treatment, during breaks (dose interruptions), and 
for at least three months after stopping the study treatment. True abstinence (see 
definition below) from heterosexual sexual intercourse is also an acceptable method 
of contraception. The use of emergency contraception is permitted 
Highly effective birth control methods: Intrauterine device, hormonal methods (birth control 
pills, hormonal patches, injections, vaginal rings, or implants), tubal ligation, partner's vasectomy. 
True abstinence: true abstinence is part of the preferred and usual lifestyle of the patient. Periodic 
abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of 
abstinence for the duration of exposure to the investigational product, and withdrawal are not 
acceptable methods of contraception. 
Additional effective birth control methods: male latex or synthetic condom, diaphragm, cervical 
cap. 
Unacceptable methods of birth control: progesterone-only "mini-pills", intrauterine device 
Progesterone T, female condoms, natural family planning (rhythm method) or breastfeeding, 
fertility awareness, withdrawal, and cervical shield (A cervical shield should not be confused with 
a cervical cap, which is an effective method of contraception). 
7.12 Treatment After the End of the Study 
If the study is terminated early by the Sponsor for reasons other than safety, alternative methods 
of drug supply may be considered for patients that are benefitting from treatment, in accordance 
with local regulatory guidance. 
The Sponsor does not have any plans to provide study treatment to patients after the end of the 
study. 
End of Study: The end of the study is reached when all patients still on study treatment have been 
followed for at least 3 years, or when the final patient on study has completed their last visit, 
whichever comes first. 
Patients who are receiving ongoing treatment at the end of study may continue treatment with 
either of the options below upon assessment of a clinical benefit of continued treatment by the 
investigator and in accordance with the local regulatory guidance: 
• commercially available tafasitamab for the approved dose regimen locally; or 
• participation in the tafasitamab extension study if above option is not available 
End of study visit for a patient: An end of study visit for a patient is defined as the visit taking 
place when the patient has completed 90-day safety follow up after the last tafasitamab dose given. 

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8 PATIENT DISCONTINUATION 
8.1 Discontinuation From the Study 
A patient may withdraw from participation in the study at any time at his/her own request or may 
be removed at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. If such premature discontinuation occurs, the investigator should 
determine the primary reason for a patient´s premature discontinuation from the study and record 
the information in the eCRF. If the reason for premature discontinuation is an adverse event, 
monitoring should continue until the outcome is evident, unless the patient has withdrawn his/her 
consent to study participation. 
If the patient withdraws consent, the sponsor may retain and continue to use any data collected 
before such a withdrawal of consent. 
If a patient 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 and eCRF. 
See SoA (Section 2) for data to be collected at the time of study discontinuation and follow-up and 
for any further evaluations that need to be completed. 
8.2 Discontinuation of Study Treatment 
Study treatment must be discontinued for a patient under the following circumstances: 
• 
Pregnancy or expressed intend to become pregnant 
• 
Disease progression 
• 
Withdrawal of consent 
• 
Use of prohibited treatment, including participation in another interventional study and/or 
initiation of new anti-cancer treatment (see Section 7.9 for details) 
• 
Unacceptable toxicity or TEAE, as determined by the investigator 
• 
Protocol Deviation that may impact the benefit/risk assessment for the individual patient 
following discussion with the Medical Monitor 
• 
Occurrence of new diseases that could influence the treatment efficacy, for which the study 
medications are contraindicated or that are treated with a medication that is not permitted 
as a concomitant medication 
• 
Any other medical condition that may jeopardize the patient's safety if he or she continues 
on study treatment 
The investigator is encouraged to keep a patient experiencing clinical benefit on study treatment 
per investigator discretion unless significant toxicity puts the patient at risk or repeated cases of 
routine noncompliance put the study outcomes at risk. 
An End of Treatment visit must be performed within 14 days after decision on treatment 
discontinuation. See the SoA (Section 2) for data to be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that need to be completed. 
Patients who are withdrawn for any reason may not re-enter this clinical study at any time. 

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8.3 Lost to Follow-Up 
A patient will be considered lost to follow-up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site. 
The following actions must be taken if a patient fails to return to the site for a required study 
visit: 
• 
The site must attempt to contact the patient and reschedule the missed visit as soon as 
possible and counsel the patient on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the patient wishes to and/or should continue in the 
study 
• 
Before a patient is deemed lost to follow up, the investigator or designee must make every 
effort to regain contact with the patient (at least 3 attempts should be made). These contact 
attempts should be documented in the patient's medical record 
• 
Should the patient continue to be unreachable, he/she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up, which will be recorded in the 
eCRF 
8.4 Replacement of Patient 
If a patient discontinues the study for reasons other than safety before the completion of the 
predefined safety observation window (35 days from C1D1), this patient may be replaced. 
9 STUDY ASSESSMENTS AND PROCEDURES 
Study procedures and their timing are summarized in Section 2. 
Adherence to the study design requirements, including those specified in the SoA (see Section 2), 
is essential and required for study conduct. 
Protocol waivers or exemptions are not allowed, except where necessary to eliminate an immediate 
hazard to study patients. 
9.1 Demographic and Baseline Characteristics 
Demographic variables to be recorded include year of birth/ age, gender, and race/ ethnicity. 
Relevant medical history and current medical conditions data includes data until signature of the 
ICF. The assessment of the lymphoma should include disease staging. In order to reflect the 
patient's status at the time of screening, the standard Ann Arbor staging system used for DLBCL 
reflecting the number of sites of involvement and their relation to the diaphragm, the existence of 
B-symptoms, and the presence of extranodal disease, will be documented (see Appendix 10: 
International Prognostic Index and Ann Arbor Staging Classification). Additionally, the disease 
risk assessment as per International Prognostic Index (IPI) (see Appendix 10: International 
Prognostic Index and Ann Arbor Staging Classification) and patient status as per ECOG 
performance status criteria (see Appendix 11: ECOG Performance Status Scale) will be recorded. 

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9.2 Physical Examinations 
Physical examination will be performed by the investigator or a qualified designee according to 
the SoA (see Section 2). 
Full PE must be performed according to the best standards of local medical practice but should 
include at least vital signs and palpable tumor assessments, general appearance, skin, head, eyes, 
ears, nose, throat including Waldeyer lymphatic structures, lungs, breasts and axillae, 
cardiovascular system, back and spine, abdomen (if applicable including spleen size below the 
costal margin), extremities, infusion site, lymph nodes, and neurological examination. Limited 
physical examination will be guided by the individual patient's status and will include body 
systems associated with symptoms and/or the underlying DLBCL disease (lymph node status, 
liver, spleen). Limited physical examinations may be focused on tumor response assessment 
(e.g., lymph node status, liver, spleen) and AEs per investigator discretion. 
9.3 Efficacy Assessments 
Efficacy will be evaluated in terms of ORR, DoR and PFS. The ORR is defined as the proportion 
of patients with a best overall response of CR or PR (ORR = CR + PR) based on local 
radiological + clinical evaluations up until disease progression or end of treatment, whichever is 
earlier. 
Disease response assessments will be made according to the revised response criteria based on the 
guidelines of the IWG reported by Cheson et al. (2007) (see Appendix 4: International Working 
Group Resource Criteria for Malignant Lymphoma. All response assessments made by the local 
radiology + clinical review will be considered for the efficacy analysis. 
9.3.1 Radiographic Imaging Assessment 
Initial disease and disease response assessments will be made by positron emission tomography 
PET CT (CT should be done with IV contrast) or PET-MRI at the time points indicated in the SoA 
(see Section 2). Additional radiographic assessments may be performed by the investigator during 
the course of the study, if deemed necessary. 
If progression/relapse is suspected on the basis of clinical symptoms, PET-CT or PET-MRI should 
be performed to confirm disease progression. 
Tumor measurements and disease assessment (local) will be performed as indicated in Section 2 
by CT. The CT portion of PET/CT will be acceptable in place of CT for tumor measurement and 
disease assessment, only when the CT portion is of adequate diagnostic-quality, and using adequate 
intravenous contrast. 
Magnetic resonance imaging (MRI) may be used in lieu of CT, and PET-MRI in lieu of PET-CT 
for patients with contraindications to the administration of contrast agents, or due to other medical 
reasons, at the same time points as CT, or in addition to CT, at the discretion of the investigator 
(in this case, MRI may be performed as/when appropriate). The method used at baseline should be 
used throughout the study unless otherwise medically indicated. 
If available and of acceptable quality, previously performed PET-CT or PET-MRI examinations, 
in accordance with the standard of care, that were done up to four weeks prior to the date of 
informed consent may be used for a patient's baseline radiology assessment. Additional PET-CT 

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or PET-MRI or CT or MRI examinations may be performed by the investigator in the course of 
the study, if deemed necessary (e.g., to confirm the occurrence of a CR or to make important 
treatment-related decisions). Whenever feasible, in such cases the investigator should seek prior 
approval of the sponsor for the additional imaging. 
If the patient discontinues from treatment, a PET-CT or PET -MRI scan is only required at the 
EOT Visit if it was not performed in the cycle prior to the end of treatment or if disease progression 
was not already radiologically confirmed. CT may be performed in lieu of PET-CT if the patient 
discontinues from treatment within Cycle 1 
The same scan modality should be used for all assessments, and all patients are required to have 
scans of the neck/chest/abdomen/pelvis. 
If it is impossible for the patient to have their PET examination in fasted state, adequate procedures 
should be in place to measure and control blood glucose level. 
9.3.2 Bone Marrow Assessment 
Histological examination of the bone marrow should be performed locally at the protocol specified 
time-points as indicated in the SoA (see Section 2). 
At the screening visit, a unilateral or bilateral bone marrow aspirate and a biopsy should be 
obtained to assess bone marrow involvement. Results from a bone marrow examination done 
within the 4 weeks prior to the date of informed consent will be acceptable if the patient's disease 
has been stable since then. 
The achievement of CR in the course of study must be confirmed locally, by clinical and radiologic 
evaluation along with bone marrow confirmation. The latter applies only in case the bone marrow 
was involved by lymphoma before study entry. If bone marrow was not involved by lymphoma 
before commencing the study treatment, then bone marrow confirmation biopsy is not required. 
The repeated bone marrow examination is also not required for patients in whom bone marrow has 
already been cleared of the infiltrate at previous evaluation, i.e. their previous response was CR. 
9.4 Safety Assessments 
9.4.1 Vital Signs 
Vital signs will be measured at the time points described in the SoA (see Section 2). 
They will include temperature, systolic and diastolic blood pressure, pulse and respiratory rate. 
Vital signs are to be obtained pre-tafasitamab infusion, and then at least 3 times during the infusion, 
and as clinically indicated. 
Vital signs will be measured immediately prior to infusion, 15 ± 5, 30 ± 10, and then every 
60 ± 15 minutes during infusion and at end of infusion (± 20 min). The actual time of vital sign 
measurements should be accurately documented. If the infusion is interrupted and/or subsequently 
restarted, vital signs should be assessed every 60 ± 15 minutes after the first hour. The frequency 
or the length of the monitoring period may be adapted if clinically indicated, for example if in the 
opinion of the investigator the vital sign results, at the time of event onset, are clinically significant. 
In such a case the patient's vital sign measurements should continue to be recorded until they have 
returned to normal or pre-infusion levels and an AE recorded. 

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All supportive measures consistent with optimal patient care will be provided throughout the study 
according to institutional standards. The observation of patients after the infusion is recommended, 
however, the duration and potential monitoring of vital signs should be determined by the 
investigator based on clinical judgement in accordance with local/practice guidelines of the 
institution. The Sponsor recommends that the investigators consider hospitalization on C1D15 for 
patients who experienced infusion related events during previous infusions on C1D1, C1D4 and/or 
C1D8 with 12 mg/kg tafasitamab or if otherwise clinically indicated. 
In case of hospitalization of patient as a prophylactic measure in accordance with local/practice 
guidelines of the institution will not be reported as AE/SAE. 
If possible, before vital signs are measured, the patient should be resting for at least 5 minutes. The 
same position should be used each time vital signs are measured for a given patient, and blood 
pressure should be measured from the arm contralateral to the site of study drug administration. 
Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the 
patient in a quiet setting without distractions (e.g., television, cell phones). 
Three readings of blood pressure and pulse will be taken. The first reading should be rejected. The 
second and third readings should be averaged to give the measurement to be recorded in the eCRF 
Body temperature should be measured according to normal hospital practice. 
Any clinically significant changes occurring during the study should be recorded in the AE section 
of the eCRF. 
Blood pressure and pulse measurements will be assessed with a completely automated device. 
Manual techniques will be used only if an automated device is not available. 
9.4.2 Electrocardiograms (ECGs) 
Standard local 12-lead resting ECGs will be obtained at the various time points described in the 
SoA (see Section 2). Ideally, ECGs will be recorded after the patient has rested in a supine position 
for at least 5 minutes. Heart rate, PR, QRS, RR and QT intervals will be recorded. 
The investigator will evaluate the clinical significance of each ECG value outside the reference 
ranges, according to the nature and degree of the observed abnormality. Any new abnormal values 
or those deteriorating from baseline considered to be clinically significant should be reported as 
AEs. 
If clinically significant abnormalities are observed or artefacts are present that result in an inability 
to adequately interpret the results, the ECG will be repeated. 
9.4.3 Pregnancy 
Details of all pregnancies in female patients and female partners of male patients will be collected 
after the start of study treatment and until 3 months after the last dose of study treatment. 
If a pregnancy is reported/ detected, the investigator should inform the sponsor within 24 hours of 
learning of the pregnancy and should follow the procedures outlined in Appendix 13: 
Contraceptive Guidance and Collection of Pregnancy Information. Every infant has to be followed 
up for up to 3 months after delivery. 

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Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs. 
9.4.3.1 Pregnancy Testing 
A pregnancy test will be performed for FCBP at various time points (in accordance with 
lenalidomide SmPC/USPI), either by urine pregnancy test or beta-human chorionic gonadotropin 
(β-HCG) test of a serum sample as specified in the SoA (see Section 2). The pregnancy test assay 
should have a minimum sensitivity of 25 IU/mL. 
Applicable in all countries except US: FCBP must have two negative pregnancy tests prior to 
starting the study treatment, even if true abstinence is the chosen method of birth control. The first 
pregnancy test must be performed during screening and the second pregnancy test must be 
performed within the 24 hours prior to the start of study treatment. The patient must not receive 
study treatment until the investigator or designee has verified that the results of these pregnancy 
tests are negative. Pregnancy testing and counseling should be performed if a patient misses her 
period or if there is any abnormality in her menstrual bleeding. Lenalidomide treatment must be 
discontinued during this evaluation. 
Applicable in US: FCBP must have two negative pregnancy tests prior to starting study treatment, 
even if true abstinence is the chosen method of birth control. The first pregnancy test must be 
performed within 10-14 days before study treatment initiation, the second pregnancy test must be 
performed within 24 hours prior to the start of study treatment. The patient must not receive study 
treatment until the investigator or designee has verified that the results of these pregnancy tests are 
negative. See Appendix 13: Contraceptive Guidance and Collection of Pregnancy Information for 
more information. Pregnancy testing and counseling should be performed if a patient misses her 
period or if there is any abnormality in her menstrual bleeding. Lenalidomide treatment must be 
discontinued during this evaluation. 
9.4.4 Viral Serology 
Patients will be examined locally according to the schedule in Section 2 for viral hepatitis B and 
hepatitis C. 
Hepatitis B biomarkers include hepatitis B surface antigen (HBsAg), total anti-hepatitis B core 
antibody (HBcAb) and anti-hepatitis B surface antibody (anti-HBsAb). Patients with a positive 
test for anti-HBc can only be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is 
not detected. In these patients only, HBV DNA should be assessed at various subsequent visits 
as outlined in Section 2. 
In the context of exclusion criteria, seropositive for or active viral infection with HBV means: 
• 
HBsAg positive 
• 
HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable HBV DNA 
Note: Patients who are HBsAg negative, anti-HBc positive and HBV DNA negative are eligible. 
Note: Patients who exhibit the classical vaccination profile of anti-HBs positive, anti-HBc 
negative, and HBsAg negative are eligible. 

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If HBV DNA becomes detectable during treatment, patients should be prophylactically treated and 
followed-up for potential hepatitis B reactivation. If the HBV-DNA assay is positive, then patients 
can only stay in the study if they are assessed by a physician experienced in the treatment of 
hepatitis B and pre-emptive treatment is initiated, if deemed appropriate, and/or according to local 
practice/guidelines. 
Hepatitis C serology is to be done at screening only. Hepatitis C biomarkers include 
anti-hepatitis C virus (HCV) antibody. For patients who are positive for anti-HCV antibody, 
HCV-ribonucleic acid (RNA) should be measured. A positive Hepatitis C test is defined as a 
positive test for HCV antibodies and a positive test for HCV RNA. 
9.4.5 Clinical Safety Laboratory Assessments 
All protocol-required laboratory assessments, as defined in Table 16 must be conducted in 
accordance with the SoA (see Section 2). 
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. 
Additional tests may be performed at any time during the study as determined necessary by the 
investigator or required by local regulations. 
Laboratory results are required for determining patient eligibility for study enrollment and as a 
prerequisite prior to study drug administration. Samples will be collected and evaluated in the local 
laboratory (can be done on the day before study drug administration). The investigator or designee 
must review laboratory results before dosing so that the administration of the IMP may be adjusted 
or paused if necessary. 
The investigator must document this review and record any clinically significant changes 
occurring during the study in the AE section of the CRF. The laboratory reports must be filed with 
the source documents. Clinically significant abnormal laboratory findings are those which are not 
associated with the underlying disease, unless judged by the investigator to be more severe than 
expected for the patient's condition. 
All abnormal laboratory test values considered clinically significant during participation in the 
study (until 90 days after the last dose of study treatment) should be repeated until the values return 
to normal or baseline or are no longer considered clinically significant by the investigator or 
medical monitor. 
During screening, it is permitted to repeat the local laboratory assessment of serum chemistry and 
hematology parameters due to the variability of the parameters and their dependence on multitude 
of factors (e.g., hydration, muscle mass). This is, provided no safety concerns arise and that such 
laboratory results might have been caused by a transient, medically plausible event, which resolved 
spontaneously or as result of a medical intervention in the meantime (e.g., dehydration, imaging 
procedure with a contrast, pre-phase treatment). This procedure and the rationale behind it must 
be explicitly documented in source data. Such repeated assessment of the concerned parameters 
will not be counted as "re- screening" for that patient. 
The laboratory results including sampling time/date will be kept in the patient's source 
documentation and reported in the eCRF. All blood samples will be processed and handled 
according to standard laboratory procedures. 

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Table 16: Local Laboratory Assessments 
Laboratory Test 
Parameter 
Urinalysis 
Appearance, color, urine bilirubin, glucose, hemoglobin, ketones, pH, protein, 
specific gravity, urobilinogen. 
Microscopy will only be performed if clinically indicated 
Pregnancy tests in FCBP 
Refer to Section 9.4.3.1 
Hematology 
WBC with differential count (lymphocytes, monocytes, neutrophils, band 
neutrophils*, eosinophils, basophils), hematocrit, hemoglobin, mean corpuscular 
volume, mean corpuscular hemoglobin concentration, platelet count, RBC count, 
erythrocyte sedimentation rate 
*Band neutrophils may be performed optionally. 
Serum chemistry 
ALT, total albumin, ALP, amylase, AST, bicarbonate, bilirubin (total), urea or 
blood urea nitrogen, total calcium, chloride, creatinine, creatine kinase, GGT, 
glucose, LDH, lipase, phosphate, potassium, protein (total), sodium, uric acid, 
magnesium, β2-microglobulin, C-reactive protein, HbA1c in patients with 
diabetes mellitus II, TSH 
Coagulation  
aPTT or PTT, 
PT and /or INR (In accordance with the local institutional practice. Ideally both 
PT and INR should be provided). 
Hepatitis serology/virology 
Refer to Section 9.4.4 
Abbreviations: ALT=alanine aminotransferase; ALP=alanine phosphatase; AST=aspartate aminotransferase; FCBP=female of 
childbearing potential; GGT=gamma-glutamyl transferase; HbA1c=glycated hemoglobin; LDH= lactate dehydrogenase; RBC=red 
blood cell; WBC=white blood cells, TSH=Thyroid stimulating hormone 
9.4.6 Diagnostic Lymphoma Biopsy and Central Pathology Review 
For each participating patient suitable and sufficient archival tumor tissue material must be 
provided (see Section 6.1 on inclusion criteria). Surgically acquired tissue samples are preferred, 
but core biopsies are permitted. Bone marrow biopsies are not adequate for this purpose and should 
be performed only for disease staging. 
If archival formalin fixed paraffin embedded tumor tissue acquired ≤ 3 years prior to screening is 
not available, a fresh tumor tissue sample from the patient should be obtained. If a fresh tumor 
biopsy poses any risk to patient safety e.g. due to co-morbidity, age, or inaccessible tumor site, an 
earlier tumor tissue may be acceptable upon consultation with the medical monitor. 
The local pathology report indicating DLBCL diagnosis will determine a patient's eligibility for 
study enrollment. 
Central pathology review is mandatory, but retrospective in nature and not intended to determine 
a patient's eligibility. Tissue samples (or archival paraffin blocks, as stated above) should be 
submitted within 30 days of patient enrollment in the study. Patients can be enrolled prior to 
submission of tissue sample(s). 
If the DLBCL diagnosis of the local pathologist cannot be confirmed by the central pathologist, 
and a patient's treatment has already commenced, they may remain in the study at the discretion 
of the treating physician. 

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Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 
positive lymphoma confirmed on a biopsy (as per local institutional guidelines), taken since 
completing the prior CD19 targeted therapy. 
The local pathology report indicating DLBCL diagnosis and CD19 positivity will determine a 
patient's eligibility for study enrollment. In this patient group, a sample of this most recent biopsy 
should be provided for central pathology confirmation of both DLBCL diagnosis and CD19 
expression. Only the most recent biopsy needs to be provided, it is not necessary to provide tissue 
taken at different stages of disease. 
9.4.7 AEs, SAEs and AESI 
The definitions of an AE or SAE can be found in Appendix 12: AEs: Definitions and Procedures 
for Recording, Evaluating, Follow-Up, and Reporting. 
AEs of Special Interest (AESIs) are defined in Section 9.4.7.4. 
The patient (or, when appropriate, a caregiver, surrogate) informs the investigator about any AEs. 
The investigator is responsible for detecting, documenting, recording, and following up on events 
that meet the definition of an AE, AESI or SAE. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the patient is the preferred method to inquire about 
AE occurrences. 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the procedures 
for completing and transmitting SAE and AESI reports are provided in Appendix 12: AEs: 
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting. 
9.4.7.1 Time Period and Frequency for Collecting AE, SAE and AESIs Information 
All AEs, SAEs and AESIs will be collected and recorded in eCRF from the signing of the ICF 
until the end of study visit. 
If the investigator learns of any SAE/AESI, including a death, at any time after a patient has 
completed the study, and he/she considers the event to be reasonably related to the study treatment 
or study participation, the investigator must promptly notify the sponsor. 
Medical occurrences that begin before obtaining informed consent will be recorded on the Medical 
History/Current Medical Conditions section of the eCRF not the AE section. 
All SAEs and AESIs will be reported to the sponsor or designee within 24 hours, as indicated in 
Appendix 12: AEs: Definitions and Procedures for Recording, Evaluating, Follow-Up, and 
Reporting. The investigator will submit any updated SAE and AESI data to the sponsor within 
24 hours of it being available. 

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9.4.7.2 Follow-Up of AEs, SAEs and AESIs 
After the initial AE/SAE report, the investigator is required to proactively follow up on each event 
at subsequent patient visits/contacts. During patient's participation in the study all events will be 
followed until resolution, stabilization, the event is otherwise explained, or the patient is lost to 
follow-up (as defined in Section 8.3). After End of Study visit only SAEs and AESIs will be 
followed. Further information on follow-up procedures is given in Appendix 12: AEs: Definitions 
and Procedures for Recording, Evaluating, Follow-Up, and Reporting. 
9.4.7.3 Regulatory Reporting Requirements for SAEs 
• 
Prompt notification by the investigator to the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of patients and the safety of a 
study treatment under clinical investigation are met 
• 
The sponsor will comply with regulatory requirements relating to safety reporting to the 
regulatory authorities, Institutional Review Boards (IRB)/Independent Ethics Committees 
(IEC), and investigators 
• 
The sponsor must prepare safety reports for suspected unexpected serious adverse reactions 
(SUSARs) according to applicable regulatory requirements and sponsor policy, and will 
provide to investigators, as applicable 
• 
An investigator who receives an investigator safety report describing a SAE or other 
specific safety information (e.g., 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 and unless such reporting to IRB/IEC is performed by the sponsor 
9.4.7.4 AESIs 
AESIs for this study are: 
• 
TLS 
• 
IRRs and allergic reactions to study treatment ≥ Grade 3 
• 
CRS 
• 
Second primary malignancies 
• 
Hepatitis B reactivation 
• 
Progressive multifocal leukoencephalopathy (PML) 
• 
TFR 
9.4.8 B-Symptoms, ECOG Performance Status 
B-symptoms and ECOG performance status will be assessed at the time points indicated in the 
SoA (see Section 2). Refer to Appendix 10: International Prognostic Index and Ann Arbor Staging 
Classification and Appendix 11: ECOG Performance Status Scale for details. 

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9.4.9 Reporting of Treatment Errors, Misuse or Abuse 
Study treatment errors and uses outside of what is foreseen in the protocol, including misuse or 
abuse, will be recorded in the dose administration eCRF. 
The investigator should report symptoms associated with overdose as AE, and within 24 hours of 
awareness if symptoms meet the definition of an SAE (for definition of overdose refer to 
Section 7.4, definition of SAE refer to Appendix 12: AEs: Definitions and Procedures for 
Recording, Evaluating, Follow-Up, and Reporting). 
The investigator should inform the sponsor within 24 hours of awareness of misuse and abuse and 
should follow the procedures for reporting of SAEs/AESIs as outlined in Appendix 12: AEs: 
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting. 
A medication error is an unintended failure in the drug treatment process that leads to, or has the 
potential to lead to, harm to the patient. Misuse refers to situations where the medicinal product is 
intentionally and inappropriately used not in accordance with the authorized product information. 
Abuse refers to persistent or sporadic, intentional excessive use of medicinal products which is 
accompanied by harmful physical or psychological effects. 
Study medication errors and uses outside as directed in the protocol, including misuse or abuse, 
will be recorded as protocol deviations. Any symptoms or signs associated with medication error, 
misuse or abuse should be reported as AEs in accordance with Section 9.4.7. 
9.5 Pharmacokinetics and Immunogenicity 
Blood samples for PK and Immunogenicity (tafasitamab ADAs) will be collected on the visits and 
time-points specified in the SoA (see Section 2). 
The details of blood sample handling and shipment instructions will be provided in a separate 
laboratory manual. 
Actual dates and times of PK and ADA blood sampling will be recorded in the eCRF. 

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10 STATISTICAL CONSIDERATIONS 
Tabulations of summary statistics, graphical presentations, and statistical analyses will be 
performed using SAS® software version 9.3 or higher. 
Continuous, quantitative variable summaries will include the number of patients (N) (with 
non-missing values/valid cases), mean, standard deviation, minimum, 25th quartile, median, 
75th quartile and maximum, except for PK metrics, where additional statistics may be used. 
Categorical, qualitative variable summaries will include the frequency and percentage of 
patients/entries in the particular category. 
Definition of baseline value: the last pre-administration observation will be used as the baseline 
value for calculating post-administration changes from baseline. 
All data obtained via the eCRF and entered into the database will be provided in separate data 
listings showing individual patient's values. A SAP detailing the statistical analyses will be 
finalized prior to first patient first visit. 
The planning and reporting of statistical analysis will be carried out as described in the sponsor's 
SOPs governing clinical study. 
The sponsor and/or designated contract research organization (CRO) will analyze the data. Any 
data analysis carried out independently by the investigator should be submitted to the sponsor 
before publication or presentation. It is planned that the data from participating centers in this 
protocol will be combined, so that an adequate number of patients will be available for analysis. 
10.1 Sample Size Determination 
As this is a Phase 1b/2 study, Primary, Secondary 
 endpoints will be analyzed 
using descriptive statistics. No formal statistical tests will be performed. 
Primary completion analysis and final analysis are planned to be performed. Details will be 
provided in the SAP. 

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10.2 Populations for Analyses 
Patients who were screened but never started study treatment will be listed. Screening failures will 
not be included in any of the summary tables (except of the patient disposition table). 
10.2.1 Analysis Set for the Primary Estimand (PAS) 
The PAS includes all patients who receive at least one 
 
, and had at least one post-baseline safety assessment. 
A valid safety assessment includes death. A "no AE" record is also considered as a valid safety 
assessment. 
10.2.2 Enrolled Patients 
The Enrolled patient population consists of all patients who received at least one dose of any study 
treatment (tafasitamab or LEN). 
10.2.3 Full Analysis Set (FAS) 
The FAS includes all patients who received at least one dose of tafasitamab and one dose of LEN. 
This means that both study drugs must have been administered at least once. The FAS will be the 
primary population for the analysis of efficacy and baseline characteristics. 
A listing showing the patients who have been excluded from the efficacy analysis will be provided. 
10.2.4 Safety Set (SAF) 
The SAF includes all patients who received at least one dose of tafasitamab or LEN and had at 
least one post-baseline safety assessment. 
A valid safety assessment includes death. A "no AE" record is also considered as a valid safety 
assessment. 
Analyses using the SAF will be based on the treatment study drug actually received. 
10.2.5 PK Analysis Set (PKAS) 
The PKAS will include all patients who received at least one dose of tafasitamab and have at least 
one quantifiable serum tafasitamab concentration. 
10.2.6 Immunogenicity Analysis Set (IAS) 
The IAS includes all patients who have at least one valid anti-tafasitamab antibody assessment. 
10.2.7 Per Protocol Set (PPS) 
Patients included in FAS without any important protocol deviation that would influence efficacy 
endpoints. 
All protocol deviations or conditions leading to exclusion from the PPS will be detailed in the data 
handling plan and SAP. Sensitivity analyses for efficacy endpoints may be performed using PPS. 
PAS is used to estimate the PAS and SAF is used to estimate the supplemental estimand for the 
primary objective. 

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10.3 Statistical Analyses 
A SAP detailing the statistical analyses will be finalized prior to first patient first visit. Details of 
the analyses to be performed on data from this study will be provided in a separate SAP. All 
analyses will be presented 
) and whenever 
applicable, overall. 
Any deviations from the statistical analysis outlined in this protocol will be described, and reasons 
for the deviations listed, in the clinical study report. 
Missing values will not be substituted by estimated values, but treated as missing in the statistical 
evaluation. All data from all patients dosed in the clinical study will be included in all listings, 
plots, summary tables, and statistical analyses where appropriate. 
If a patient discontinues the study for reasons other than safety before the completion of the 
predefined safety observation window, this patient may be replaced. 
In the event of a significant volume of missing data, sensitivity analyses for the efficacy 
 
 endpoints may be performed using the principle of multiple imputation. 
This section is a summary of the planned statistical analyses of the most important endpoints 
including primary and secondary endpoints. 
10.3.1 Analysis Time Points 
The following analyses are pre-planned: An internal DSMC, consisting of Sponsor representatives 
and investigators, will continuously monitor the study and can recommend to stop enrollment at 
any time based on emerging safety data. In addition, pre-defined DSMC meetings will take place 
when 
 
 
Patient profiles and Listings of AEs will be provided in case a DSMC Safety Data Review is 
performed. 
10.3.1.1 Primary Analysis 
Primary analysis will be performed when all patients have either reached C3D28 or discontinued 
the study prior to C3D28. 
Primary and Secondary Objectives will be analyzed at the time of primary analysis completion. 
Details will be provided in the SAP. 
10.3.1.2 Final Analysis 
The final analysis of the study will occur approximately 3 years after the last patient was enrolled. 
At the time of Final Analysis, analyses performed during Primary Analysis will be repeated using 
updated data in addition to the performance of Secondary 
 objectives. 
Additional analyses for safety or efficacy endpoints may be performed if needed or if requested 
by authorities. 

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10.3.2 Efficacy Analyses 
Disease response assessments will be made according to the revised response criteria based on the 
guidelines of the IWG reported by Cheson et al. (2007) (see Appendix 4: International Working 
Group Resource Criteria for Malignant Lymphoma). 
10.3.2.1 Best ORR Until EOS by Investigator Assessment (Secondary Endpoint) 
The best ORR by investigator assessment is defined as the proportion of patients with CR or PR 
based on the best response achieved until the end of study. The best ORR along with 95% exact 
CI (using Clopper-Pearson exact method) will be presented. The number and percentage of 
patients with CR or PR will be presented. 
10.3.2.2 Duration of Response (DoR) by Investigator Assessment (Secondary Endpoint) 
DoR is defined as the time interval between the initial time point of tumor response (CR or PR 
whichever status is recorded first) and the first date that recurrence of progressive disease is 
documented. Response duration by the local assessment (investigator) will be tabulated with 
descriptive statistics. 
Disease progression is defined as the first occurrence of progressive disease according to the 
revised response criteria (Cheson et al., 2007) as assessed by the investigator. 
10.3.2.3 Progression-Free Survival by Investigator Assessment (Secondary Endpoint) 
PFS is defined as the time from the date of randomization to the date of the first radiologically 
documented disease progression or death due to any cause. If a patient has not progressed or died 
at the analysis cut-off date or when he/she receives further anti-neoplastic therapy, PFS will be 
censored on the date of the last adequate tumor evaluation before the earlier of the cut-off date or 
start of the further antineoplastic therapy date. 
Kaplan Meier plots will be used to estimate the distribution of PFS. The PFS probabilities and the 
associate 95% CI will be summarized. 
10.3.3 Safety Analyses (Primary Endpoint) 
The primary objective of this study is to evaluate the safety and tolerability of 
 
tafasitamab i.v. 
 combined with LEN in patients with R/R DLBCL. 
As this is a Phase 1b/2 study, no formal hypothesis testing will be performed. 
To assess safety and tolerability, the incidence and severity of hematological and non-
hematological AEs including clinically significant laboratory abnormalities will be determined. 
AEs will be categorized with regards to seriousness, intensity, toxicity, study treatment 
relationship, outcome and action taken. AE reports will be graded according to National Cancer 
Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 5.0. 
All Safety Analyses will be presented by 
 
. 

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10.3.4 Patient Disposition 
An overview table will be provided for all patients and will include the number of patients enrolled, 
the number of patients in each analysis population set, the number of completers and the number 
of withdrawals and the reasons for withdrawal. Compliance parameters for drug administration 
will be tabulated. 
Demographic information will be summarized using descriptive statistics or counts and 
percentages. 
General medical histories and DLBCL-specific medical histories will be summarized by counts 
and percentages using appropriate classification codes. Concomitant medications will be recorded 
and tabulated with counts/percentages showing the number of medications/percentages used in 
each medication class. 
10.3.5 Additional Secondary Endpoint Analyses 
10.3.5.1 Pharmacokinetic Analysis 
Tafasitamab serum concentrations will be summarized using descriptive statistics. Mean 
concentrations (on original and on log-linear scale) will be visualized in figures. 
In addition, tafasitamab PK data will be used for population PK analysis. Details of the intended 
population PK analysis will be described in a separate analysis plan and results of the analysis will 
be described in a separate population PK report. 
10.3.5.2 Immunogenicity Analysis 
The absolute number and percentage of patients, who develop anti-tafasitamab antibodies, and the 
results of anti-tafasitamab antibody titer determinations of confirmed positive samples will be 
tabulated. 

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10.3.7 Additional Safety Analysis 
10.3.7.1 AEs 
All AEs which start or worsen on or after the first dose of study treatment until 90 days after the 
last dose of the study treatment, i.e. of end of the study, will be considered as a TEAE. AEs that 
start during the study (and did not worsen after the first dose of study treatment) but before the 
time of the first dose of study treatment (e.g. screening period) will be classified as a non-TEAE 
and will be included in AEs listings, but will not be summarized. 
TEAEs will be coded according to MedDRA System Organ Class (SOC) and preferred terms 
classifications. Incidence and frequency of all AEs will be summarized by SOC, preferred term, 
relationship to treatment, severity and seriousness. 
An AE summary table will be presented showing the number of events, number of patients and 
the percentage of patients in each arm and overall having: 
• 
All TEAEs 
• 
TEAEs by maximum severity 
• 
SAEs 
• 
Drug-related TEAEs 
• 
Drug-related TEAEs in each severity/toxicity grading 
• 
TEAEs that led to treatment discontinuation 
• 
IRRs by grade 
AEs of Special Interests in this study are defined in Section 9.4.7.4. 
The sponsor will describe AESIs, in addition to those reported as SAEs. AESI tabulations will be 
analogous to the tabulation of TEAEs. 
The sponsor will describe other significant AEs as appropriate, e.g., laboratory abnormalities that 
qualify as AEs (other than those meeting the definition for serious) and any events that led to an 
intervention (including premature discontinuation of IMP, increase of dose interval, or significant 
additional concomitant therapy), in addition to those reported as SAEs. 
In addition to the investigator's evaluation of normal or abnormal, the sponsor will internally 
evaluate each clinical laboratory result, vital sign result, and ECG result for whether it reflects a 
new abnormality, and for numeric data, whether it reflects a significant worsening from baseline 
or an outlying result or extreme value. These terms are defined for clinical laboratory results, vital 
sign results, and ECG results as follows: 
• 
A new abnormality will be any abnormal post baseline result for a patient whose baseline 
was within normal limits 
• 
A significant worsening will be any numeric clinical laboratory result, vital sign result, or 
ECG interval measurement that represents a change from baseline by ≥ 25% of the baseline 
value, in the direction away from normal (i.e., in the direction that is clinically significant) 
• 
An outlying result for any numeric laboratory result, vital sign result, or ECG interval 
measurement will be any post-administration change from baseline that meets either of the 
following criteria: 
<25th Percentile - 1.5 * (interquartile range) OR 
>75th Percentile + 1.5 * (interquartile range) 

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• 
An extreme value for any numeric laboratory result, vital sign result, or ECG interval 
measurement will be any post-administration change from baseline that meets either of the 
following criteria: 
<25th Percentile - 3 * (interquartile range) OR 
>75th Percentile + 3 * (interquartile range) 
Patients who demonstrate new abnormal results will be noted in data listings. All results showing 
a significant worsening will be noted in data listings. Outlying results or extreme values will be 
identified and reviewed in the context of the patient's other abnormal results. 
10.3.7.2 Clinical Laboratory Evaluation 
The analysis of local laboratory parameters for each treatment arm will be presented, separated 
into blood parameters (e.g., hematology, serum chemistry, coagulation, serology for hepatitis B 
and C) urine parameters (e.g., urinalysis) and serum pregnancy test. 
All data collected in the course of the study will be listed. 
The following analyses will be performed, where appropriate, for measurements of hematology 
and blood chemistry tests: 
• 
Standard descriptive statistics for values measured at baseline and post-baseline visits 
including changes from baseline 
• 
For selected laboratory parameter, shifts in assessments from baseline to worst-post 
baseline value 
• 
Number (and percentage) of patients with clinically significant changes for selected tests 
Each abnormal value measured in the local laboratory will be flagged to show whether it is a value 
below or above the reference range for the given local laboratory. For the assessment of laboratory 
variables, the investigator will need to judge their clinical significance. 
The assessment of the clinical significance of central laboratory variables will be tabulated by time 
point for each clinical laboratory value using frequency tabulations. 
Clinical laboratory values with available NCI-CTCAE grades may be presented with additional 
frequency and shift tables based on these grades. 
Laboratory values that are outside the reference range will also be flagged in the data listings, 
along with the corresponding reference ranges. 
The analyses will be performed on PAS and SAF. Further details will be specified in the SAP. 
10.3.7.3 Vital Signs 
Descriptive summaries of actual values and changes from baseline will be calculated for vital 
signs. These summaries will be presented for the SAF at all time points. Each abnormal value will 
be flagged to show whether it is a value below or above the normal limit. 

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10.3.7.4 ECGs 
Summary ECG assessment (categories: 'normal'; 'abnormal, clinically significant'; 'abnormal, not 
clinically significant') will be tabulated by time point using frequency tabulations. 
Each result of the 12-lead ECG (PR, QRS, RR and QT interval values) will be flagged to show 
whether it is a value below or above the normal limit. 
Summary statistics for all time points will be displayed for QT and both QTc correction methods. 
The Bazett's correction method for QTc will be applied as follows: 
QT interval corrected for heart rate according to Bazett: (QTcB) = QT/ √RR 
QT interval corrected for heart rate according to Fridericia: (QTcF) = QT/ ∛RR 
Where relative rate (RR) = 60/heart rate. 
Also, the number and percentage of patients with QTc values above the normal limit (> 450 ms, 
> 480 ms, > 500 ms) and the number and percentage of patients who experienced a change ≥ 30 ms 
or a change ≥ 60 ms will be presented by time point. 

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10.3.8 Estimands 
Table 17: The Estimand Summary 
Objective 
Analysis 
Population Set 
Variable/ 
Endpoint 
Treatment Condition 
of Interest 
Handling of IEs 
Population-Level 
Summary 
Estimation 
Primary objective: 
evaluate the safety 
and tolerability of 
 
 of 
tafasitamab in 
combination with 
LEN 
PAS  
Incidence 
and severity 
of TEAEs 
Treatment consisting 
of tafasitamab and 
LEN combination will 
be administered until 
disease progression, 
unacceptable toxicity, 
or discontinuation for 
any other reason, 
whichever comes first. 
LEN can be given for 
up to 12 cycles in 
total, after which 
patients can continue 
with tafasitamab as 
monotherapy until 
progression or 
unacceptable toxicity 
1. Dose modifications, 
study treatment 
interruptions or non-
adherence to study 
treatment: treatment policy 
strategy 
2. Permitted concomitant 
medications: treatment 
policy strategy 
3. Prohibited concomitant 
medication: while on 
treatment strategy 
4. Withdrawal of consent: 
while on treatment strategy 
5. Study discontinuation: 
while on treatment strategy  
Cumulative 
incidence and 
severity of TEAEs 
in the population 
at risk until the 
last patient on 
study completes 
the 90-day safety 
follow-up visit 
Categorical variable 
summaries including the 
frequency and percentage 
of patients/entries in the 
particular category 
Abbreviations: IE=intercurrent events; LEN=lenalidomide; PAS=primary estimand; TEAEs=treatment-emergent adverse events. 

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11 REFERENCES 
Carbone PP, Kaplan HS, Musshoff K, et al. Report of the Committee on Hodgkin's Disease Staging 
Classification. Cancer Res. 1971;31(11):1860-1. 
Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J 
Clin Oncol. 2007;25(5):579-86. 
Coiffier B, Lepage E, Briere J, et al. CHOP Chemotherapy plus RITUXIMAB compared with 
CHOP alone in elderly patients with diffuse large-B-cell Lymphoma. N Engl J Med. 
2002;346(4):235-42. 
Coiffier B, Thieblemont C, Van Den Neste E, et al. Long-term outcome of patients in the LNH-
98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP 
chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte. 
Blood. 2010;116(12):2040-5. 
Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: 
results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-8. 
Flowers CR, Sinha R, Vose JM. Improving outcomes for patients with diffuse large B-cell 
lymphoma. CA Cancer J Clin. 2010;60(6):393-408. 
Gisselbrecht C, Glass B, Mounier N, et al. Salvage regimens with autologous transplantation for 
relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010;20:28(27):4184-90. 
Jurczak W, Zinzani PL, Gaidano G, et al. Phase IIa study of the CD19 antibody MOR208 in 
patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Annal Oncol. 2018;29:1266-
72. 
Juweid ME, Stroobants S, Hoekstra OS, et al. Imaging Subcommittee of International 
Harmonization Project in Lymphoma. Use of positron emission tomography for response 
assessment of lymphoma: consensus of the Imaging Subcommittee of International Harmonization 
Project in Lymphoma. J Clin Oncol. 2007; 25:571-78 
Karnofsky and Burchena. The Clinical Evaluation of Chemotherapeutic Agents in Cancer. In: 
MacLeod CM (ed). Evaluation of Chemotherapeutic Agents. (1949) New York: Columbia 
University Press; 1949: 196. 
Lazar GA, Dang Wei, Karki S, et al. Engineered antibody Fc variants with enhanced effector 
function. Proc Natl Acad Sci USA. 2006;103(11):4005-10. 
Lenz G, Wright G, Dave SS, et al. Stromal gene signatures in large-B-cell lymphomas. N Engl J 
Med. 2008;359(22):2313-23. 
Lister TA, Crowther D, Sutcliffe SB, et al. Report of a committee convened to discuss the 
evaluation and staging of patients with Hodgkin's disease: Cotswolds Meeting. J Clin Oncol. 
1989;7(11):1630-6. 
Minjuvi® (tafasitamab) [summary of product characteristics]. Incyte Biosciences Distribution 
B.V.; April 2024. 

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Monjuvi® (tafasitamab) [prescribing information]. Morphosys US Inc and Incyte Corporation; 
June 2021. 
Salles G, Duell J, González Barca E, et al. Tafasitamab plus lenalidomide in relapsed or refractory 
diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. 
Lancet Oncol. 2020;(7):978-88. 
Schmitz R, Wright GW, Huang DW, et al. Genetics and pathogenesis of diffuse large B-cell 
lymphoma. N Engl J Med. 2018;378(15):1396-1407. 
Tilly H, Gomes da Silva M, Vitolo U, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO 
Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;Suppl 
5:v116-25. 
Vaidya R and Witzig TE. Prognostic factors for diffuse large B-cell lymphoma in the R(X)CHOP 
era. Ann Oncol. 2014;25(11):2124-33. 

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12 APPENDICES 
12.1 Appendix 1: List of Abbreviations and Definitions of Terms 
5PS 
5-point scale 
ADA 
Anti-drug antibody  
ADCC 
Antibody-dependent cell-mediated cytotoxicity 
ADCP 
Antibody-dependent cell-mediated phagocytosis 
AE 
Adverse event  
AESI 
Adverse event of special interest  
ALL 
Acute lymphoblastic leukemia  
ALP 
Alkaline phosphatase 
ALT 
Alanine transaminase 
ANC 
Absolute neutrophil count  
Anti-HBc 
Hepatitis B core antibody 
Anti-HCV 
Anti-hepatitis C virus  
aPTT 
activated Partial thromboplastin time 
ASCT 
Autologous stem cell transplantation 
AST 
Aspartate transaminase 
AUC 
Area under the curve 
β-HCG 
Beta-human chorionic gonadotropin  
BCL 
B-cell lymphoma 
BSC 
Best supportive care 
C1D1 
Cycle 1 Day 1 
CBC 
Complete blood count 
CD 
Cluster of differentiation 
CI 
Confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences  
CL 
Clearance 
CLL 
Chronic lymphocytic leukemia  
Cmax 
Maximum concentration 
CNS 
Central nervous system 
COPD 
Chronic obstructive pulmonary disease  
COVID-19 
Disease caused by SARS-CoV-2 (coronavirus) 
CR 
Complete response 
CRO 
Contract research organization 
CRS  
Cytokine release syndrome 
CT 
Computed tomography 

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Ctrough 
Minimum concentration 
CSR 
Clinical study report 
dL 
Deciliter 
DLBCL 
Diffuse large B-cell lymphoma 
DLCO 
Diffusing capacity of the lungs for carbon monoxide  
DNA 
Deoxyribonucleic acid 
DoR 
Duration of response 
DSMC 
Data and Safety Monitoring Committee 
EBV 
Epstein-Barr virus  
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic case report form 
EMA 
European Medicines Agency 
EOS 
End of study 
EOT 
End of treatment 
EU 
European Union 
EU CTR 
EU clinical trial regulation 
FAS 
Full analysis set 
FCBP 
Female of childbearing potential 
FDA 
Food and Drug Administration 
FDG 
Fluorodeoxyglucose 
FEV-1 
Forced expiratory volume in 1 second  
FSH 
Follicle stimulating hormone 
FVC 
Forced vital capacity 
µg/mL  
Micrograms per milliliter  
GCP 
Good clinical practice 
G-CSF 
Granulocyte colony-stimulating factor  
GGT 
Gamma-glutamyl transferase  
GI 
Gastrointestinal 
HbA1c 
Glycated hemoglobin 
HBcAb 
Hepatitis B core antibody 
HBsAb 
Hepatitis B surface antibody  
HBsAg 
Hepatitis B surface antigen 
HBV 
Hepatitis B virus 
HCV 
Hepatitis C virus 
HIV 
Human immunodeficiency virus 

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HRT 
Hormonal replacement therapy  
IAS 
Immunogenicity analysis set 
IB 
Investigator's brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization 
IEC 
Independent Ethics Committee 
Ig 
Immunoglobulin 
IgA 
Immunoglobulin A 
IHC 
Immunohistochemistry 
IMP 
Investigational medicinal product 
INR 
International normalized ratio 
IPI 
International prognostic index 
IRB 
Institutional Review Board  
IRC 
Independent Review Committee 
IRR 
Infusion related reaction 
i.v. 
Intravenous(ly) 
KG 
Kilogram  
µl 
Microliter  
LDH 
Lactate dehydrogenase  
Ldi 
Longest transverse diameter 
LEN 
Lenalidomide 
mAb 
Monoclonal antibody 
mg 
Milligram  
mL 
Milliliter  
mL/h 
Milliliter per hour 
mm 
Millimeter  
 
 
MRI 
Magnetic resonance imaging 
NCI-CTCAE 5.0 National Cancer Institute-Common Terminology Criteria for Adverse Events, 
version 5.0  
NHL 
Non-Hodgkin lymphoma 
 
 
NOACs 
New oral anticoagulants 
NOAEL 
No observed adverse effect level  
NR 
No response  
ORR 
Objective response rate 
PAS 
Primary estimand 
PD 
Progressive disease 

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PET 
Positron emission tomography 
PI 
Prescribing information 
PK 
Pharmacokinetics  
PKAS 
Pharmacokinetic analysis set 
PLM 
Progressive multifocal leukoencephalopathy 
PLT 
Platelets 
PMBL 
Primary mediastinal large B-cell lymphoma 
p.o. 
By mouth 
POP-PK 
Population-PK 
PPD 
Cross product of the Ldi and perpendicular diameter 
PPS 
Per protocol set 
PR 
Partial response 
PT 
Prothrombin time 
PTT 
Partial thromboplastin time 
QTcB 
QT interval corrected for heart rate according to Bazett 
QTcF 
QT interval corrected for heart rate according to Fridericia 
QTLs 
Quality tolerance limits  
RBCs 
Red blood cells 
REAL 
Revised European American Lymphoma (Classification) 
RNA 
Ribonucleic acid 
R/R 
Relapsed or refractory  
RTX 
Rituximab 
SAE 
Serious adverse event 
SAF 
Safety set  
SAP 
Statistical analysis plan 
SD 
Stable disease 
SDi 
Shortest axis perpendicular to the LDi 
SLL 
Small lymphocytic lymphoma 
SmPC 
Summary of product characteristics 
SoA 
Schedule of assessments  
SOC 
System organ class 
SPD 
Sum of the product of the perpendicular diameters for multiple lesions 
SUSAR 
Suspected unexpected serious adverse reactions 
TB 
Tuberculosis  
TFR 
Tumor flare reaction 
THRLBCL 
T cell/histiocyte-rich large B-cell lymphoma  

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TLS 
Tumor lysis syndrome  
ULN 
Upper limit of normal 
US 
United States 
USPI 
United States prescribing information 
VTE 
Venous thromboembolism 
 
 
 
 
QW 
Weekly 
TEAE(s) 
Treatment emergent adverse event(s) 
Vss 
Volume of distribution at steady state  
WFI 
Water for injection 
WHO 
World Health Organization  
w/v 
Weight by volume 

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12.2 Appendix 2: Regulatory, Ethical, and Trial Oversight Considerations 
12.2.1 Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
• 
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
(CIOMS) International Ethical Guidelines 
• 
Applicable International Council for Harmonization (ICH) Good Clinical Practice (GCP) 
Guidelines 
• 
Applicable laws and regulations 
The protocol, protocol amendments, ICF, IB, and other relevant documents (e.g., advertisements) 
must be submitted to an IRB/IEC and reviewed and approved by the Health Authority and IRB/IEC 
before the study is initiated. 
Substantial amendments to the protocol will require Health Authority and IRB/IEC approval 
before implementation of changes made to the study design, except for changes necessary to 
eliminate an immediate hazard to study patients. 
Depending upon the local regulation the investigator will be responsible for the following: 
• 
Providing written summaries of the status of the study to the IRB/IEC (directly or through 
the sponsor) in accordance with local regulations and the requirements, policies, and 
procedures established by the IRB/IEC 
• 
Notifying the IRB/IEC (directly or through the sponsor) 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 the protocol 
and other procedures specific to the study, requirements of ICH guidelines, the IRB/IEC, 
and all other applicable local regulations 
• 
Notify the sponsor immediately of an event which might constitute a Serious Breach of the 
protocol or applicable regulations. A 'Serious Breach' means a breach likely to affect to a 
significant degree the safety and rights of a subject or the reliability and robustness of the 
data generated in the clinical trial. Contacts for reporting can be found in the Investigator 
Site File. 
12.2.2 Informed Consent Process 
The investigator or his/her representative will explain the nature of the study to the patient and 
answer all questions regarding the study. 
Patients must be informed that their participation is voluntary. Patients will be required to sign a 
statement of informed consent that meets the requirements of local regulations, ICH guidelines, 
the IRB/IEC, and study center as applicable. 
The medical record must include a statement that written informed consent was obtained before 
conducting any study-specific procedures and the date the written consent was obtained. The 
authorized person obtaining the informed consent must also sign the ICF. 
Patients must be re-consented to the most current version of the ICF(s) during their participation 
in the study. 

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A copy of the ICF(s) must be provided to the patient. 
12.2.3 Data Protection 
Personal data will be protected in accordance with applicable laws and regulations. The sponsor 
has implemented appropriate technical and organizational measures to protect information and 
personal data processed against unauthorised or unlawful access, disclosure, dissemination, 
alteration, or destruction or accidental loss. These measures include for example pseudonymization 
of patient data, access being restricted to authorized persons and controlled using a unique 
username and a confidential password, encryption of the data during transfers, requirement that 
premises used for the storage and processing of personal data to be arranged in such a way as to 
prevent unauthorized access, secure archiving. 
Patients will be assigned a unique identifier via the IRT system. The investigator will maintain a 
confidential patient identification code list in the investigator's study file, on which the investigator 
documents the names of all patients enrolled in the trial with their unique patient number. The 
investigator's study file, including the patient identification code list, will be retained at the clinical 
site according to local regulations; the patient identification code list will be destroyed at the end 
of the retention period. In order to maintain patient privacy, all eCRFs, study records and 
communications will identify the patient by the assigned patient number. Any patient records or 
datasets that are transferred to the sponsor will contain the identifier only , i.e. data is 
'pseudonymized'; patient names or any information which would make the patient identifiable will 
not be transferred. 
The use of pseudonymized data and the encryption of the data during transfers limits the risk of 
personal data security breaches. Should a personal data security breach occur, a process exists in 
the Data Protection Policy adopted by the sponsor to assess the facts and take mitigation actions 
as appropriate. 
The patient must be informed that his/her personal study-related data will be used by the sponsor 
in accordance with local data protection law. The level of disclosure must also be explained to the 
patient. 
The patient must be informed that his/her medical records may be examined by authorized 
personnel appointed by the sponsor, by Quality Assurance auditors, by appropriate IRB/IEC 
members, and by inspectors from regulatory authorities. 
12.2.4 Publication Policy 
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 
study only in their entirety and not as individual site data. In this case, a coordinating investigator 
will be designated. 
Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 

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12.2.5 Dissemination of Clinical Study Data 
The key design elements of this protocol will be posted in a publicly accessible database such as 
clinicaltrials.gov and/or the EU Clinical Trials Register. In addition, upon trial completion and 
finalization of the trial report the results of this study will be either submitted for publication and/or 
posted in a publicly accessible database of clinical trial results. 
12.2.6 Data Quality Assurance 
All patient data trial will be recorded on the eCRF by the trained personnel while specifying 
reasons for missing data (if any) transmitted to the sponsor or designee electronically. The 
investigator is responsible for verifying that data entries are accurate and correct by signing the 
CRF. The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
Quality tolerance limits (QTLs) will be predefined to identify systematic issues that can impact 
patient safety and/or reliability of study results. These predefined parameters will be monitored 
during the study, and important deviations from the QTLs and remedial actions taken will be 
summarized in the CSR. 
The sponsor or designee is responsible for the monitoring and data management of this study 
including quality checking of the data. Monitoring details describing strategy, methods, 
responsibilities, and requirements, and monitoring techniques (central, remote, or on-site 
monitoring) are provided in the monitoring plan. Data management details are provided in the Data 
Management Plan. 
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator in accordance with local regulations. No records may be destroyed 
during the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. 
12.2.7 Source Documents 
Source documents provide evidence for the existence of the patient and substantiate the integrity 
of the data collected. Source documents are filed at the investigator's site. 
Data entered in the eCRF that are transcribed from source documents must be consistent with the 
source documents or the discrepancies must be explained. Current medical records must be 
available. The investigator may need to request previous medical records or transfer records from 
other institutions outside the clinical study site. 
Definition of what constitutes source data can be found in the Investigator Source Data Agreement. 
Study monitors will 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 patients 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. 

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12.2.8 Study and Site Closure 
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 sponsor reserves the right to close a study site or terminate the study at any time for any reason 
at the sole discretion of the sponsor. 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 or no recruitment of patients by the investigator 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any CROs used in the study of the 
reason for termination or suspension, as specified by the applicable regulatory requirements. The 
investigator shall promptly inform the patient and should assure appropriate therapy and/or 
follow-up. 

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12.3 Appendix 3: Study Specific Definitions 
For the purposes of this protocol, primary refractory disease is defined as a disease progressing 
in the course of the first line treatment as per International Working Group response criteria 
(Cheson et al., 2007), and/or, showing a response of less than a PR to first-line treatment or disease 
recurrence/progression within < 6 months from the completion of first-line therapy. 
Disease refractory to last treatment is defined as having had less than a PR to the most recently 
administered systemic therapy. 
Relapsed/progressive/recurrent disease reflects the appearance of any new lesions or increase 
by ≥50% of previously involved sites from nadir according to the International Working Group 
response criteria (Cheson et al., 2007), after the most recent systemic therapy. 
First act of recruitment (EU): For purposes of EU clinical trial regulation (536/2014) the first 
act of recruitment of a potential patient is defined as the date of initiation of the first site. 
Start of study: A patient is considered to have started the study and entered the screening period 
when they have signed the informed consent form. 
End of Treatment: The end of treatment is defined as the date when the patient has received last 
tafasitamab dose. An end of treatment visit will be performed within 14 days after decision on 
treatment discontinuation. 
End of Study: The end of the study is reached when all patients still on study treatment have been 
followed for at least 3 years, or when the final patient on study has completed their last visit, 
whichever comes first. 
Patients who are receiving ongoing treatment at the end of study may continue treatment with 
either of the options below upon assessment of a clinical benefit of continued treatment by the 
investigator and in accordance with the local regulatory guidance: 
• commercially available tafasitamab for the approved dose regimen locally; or 
• participation in the tafasitamab extension study if above option is not available 
End of study visit for a patient: An end of study visit for a patient is defined as when the patient 
has completed 90 day safety follow up after the last tafasitamab dose given. 

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12.4 Appendix 4: International Working Group Resource Criteria for 
Malignant Lymphoma 
Response Criteria 
The response criteria in this study are those defined in the table below. All are based on the 
International Working Group Response Criteria (Cheson et al., 2007). 
Response 
Definition 
Nodal masses 
Spleen, liver 
Bone marrow 
CR 
Disappearance of 
all evidence of 
disease 
a) FDG-avid or PET 
positive prior to therapy; 
mass of any size 
permitted if PET 
negative 
b) Variable FDG-avid or 
PET negative; regression 
to normal size on CT 
Not palpable, 
nodules disappeared 
Infiltrate cleared on 
repeat biopsy; if 
indeterminate by 
morphology, 
immunohisto-
chemistry should be 
negative 
PR 
Regression of 
measurable disease 
and no new sites 
≥ 50% decrease in SPD of 
up to 6 largest dominant 
masses; no increase in size 
on CT 
a) FDG-avid or PET 
positive prior to therapy; 
one or more PET 
positive at previously 
involved site 
b) Variable FDG-avid or 
PET negative; regression 
on CT 
≥ 50% decrease in 
SPD of nodules 
(for single nodule in 
greatest transverse 
diameter); no 
increase in size of 
liver or spleen 
Irrelevant if positive 
prior to therapy; cell 
type should be 
specified 
SD 
Failure to attain 
CR/PR but criteria 
for progressive 
disease not met 
a) FDG-avid or PET 
positive prior to therapy; 
PET positive at prior 
sites of disease and no 
new sites on CT or PET 
b) Variable FDG-avid or 
PET negative; no change 
in size of previous 
lesions on CT 
 
 
Relapsed 
disease or 
progressiv
e disease 
Any new lesion or 
increase by ≥ 50% 
of previously 
involved sites from 
nadir 
Appearance of a new 
lesion(s) > 1.5 cm in any 
axis, ≥ 50% increase in SPD 
of more than one node, or 
≥ 50% increase in longest 
diameter of a previously 
identified node > 1 cm in 
short axis 
Lesions PET positive if 
FDG-avid lymphoma or 
PET positive prior to 
therapy 
> 50% increase from 
nadir in the SPD of 
any previous lesions 
New or recurrent 
involvement 
Abbreviations: CR=complete response; CT=computed tomography; FDG=[18F]fluorodeoxyglucose; PET=positron emission 
tomography; PR=partial response; SD=stable disease; SPD=sum of the product of the diameters.  

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12.5 Appendix 5: Karnofsky Performance Status Scale 
Source: Karnofsky and Burchena, 1949. 
F 
Normal no complaints; no evidence 
of disease. 
Able to carry on normal activity and to work; F 
Able to carry on normal activity; 
no special care needed. 
minor signs or symptoms of disease. 
F 
Normal activity with effort; some 
signs or symptoms of disease. 
-
!Cares for self: unable to carry on 
normal activity or to do active work. 
Unable to work; able to live at home and care F 
Requires occasional assistance, but is 
for most personal needs; varying amount of 
able to care for most of his personal 
assistance needed. 
!needs. 
F 
Requires considerable assistance and 
frequent medical care. 
F 
Disabled; requires special care and 
assistance. 
F 
Severely disabled; hospital admission 
is indicated although death not 
Unable to care for self: requires equivalent of 
imminent. 
r 
institutional or hospital care; disease may be 
Very sick; hospital admission 
progressing rapidly. 
necessary; active supportive 
treatment necessary. 
Moribund; fatal processes 
progressing rapidly. 
jO!I)cad 

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12.6 Appendix 6: Cockcroft-Gault Formula 
 
 
 
This formula presumes weight to be measured in kilograms and creatinine to be measured in 
mg/dL. 
 
When serum creatinine is measured in µmol/L: 
 
 
Where Constant is 1.23 for men and 1.04 for women. 
 
C 
_ (140 - Age) x Mass (in kilograms) x [0.85 if Female] 
e Cr -
72 x Serum Creatinine ( in mg/ dL) 
C 
_ (140 - Age) x Mass (in kilograms) x Constant 
e Cr -
Serum Creatinine ( in µmol/L) 

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12.7 Appendix 7: COVID-19: Infection Prophylaxis and Vaccines 
Live vaccines must not be administered to patients during the treatment and up-to 90 days after 
the last dose of the study drug in this study. Killed, inactivated vaccines, such as an injectable 
annual influenza vaccine, are permitted. Investigators should follow institutional guidelines 
concerning infection chemoprophylaxis for patients regarded to be at high risk for infection. 
Whenever possible, relapsed/refractory patients who will be treated with immunosuppressive 
therapy including tafasitamab-containing regimens should start vaccination against COVID-19 as 
soon as possible, at least first dose, ideally approximately 2 weeks prior to study treatment start. 
Based on current safety/benefit considerations and in the absence of data or guidance to the 
contrary, we recommend that all patients with lymphoma should receive a COVID-19 vaccine 
(unless explicitly contraindicated), accepting that this might not achieve full protection due to the 
impaired humoral and/or cellular immunity. 
For patients who are already on tafasitamab-
 
, the advantages and 
disadvantages of delaying vaccination to allow immune recovery or interrupting therapy requires 
careful consideration on a case-by-case basis. The recommendation would be to vaccinate these 
patients despite the fact that may be unable to generate a fully protective immune response to a 
COVID-19 vaccine. 

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12.8 Appendix 8: Hepatitis Virus Serology 
Patients will be examined according to the SoA for viral hepatitis B and C serology. Hepatitis B 
biomarkers include hepatitis B surface antigen (HBsAg), total anti-hepatitis B core antibody 
(anti-HBc) and anti-hepatitis B surface antibody (anti-HBsAb). Patients with a positive test for 
anti-HBc can only be included if HBV DNA is not detected. In these patients only, HBV DNA 
should be assessed at various subsequent visits as outlined in the SoA. 
In the context of exclusion criteria, seropositive for or active viral infection with HBV means: 
• 
HBV surface antigen positive 
• 
HBV surface antigen negative, HBV surface antibody positive and/or HBV core antibody 
positive and detectable viral DNA. Note: Patients who are HBV surface antigen negative 
and viral DNA negative are eligible 
• 
Patients who exhibit the classical vaccination profile of HBV surface antibody positive, 
HBV core antibody negative, and HBV surface antigen negative are eligible 
If HBV-DNA becomes detectable during treatment, patients should be prophylactically treated and 
followed-up for potential hepatitis B reactivation as per local medical practice or institutional 
guidelines for CD20 antibodies such as RTX. If the HBV-DNA assay is positive, then patients can 
only stay in the study if they are assessed by a physician experienced in the treatment of hepatitis 
B and pre-emptive treatment is initiated, if deemed appropriate, and/or according to local 
practice/guidelines. 
Hepatitis C serology is to be done at screening only. Hepatitis C biomarkers include anti-HCV 
antibody. For patients who are positive for anti-HCV antibody, HCV-RNA should be measured. 
A positive Hepatitis C test is defined as a positive test for HCV antibodies and a positive test for 
HCV RNA. 

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12.9 Appendix 9: Equivalent Doses for Corticosteroids 
Name (INN)  
Example 
Equivalent doses for 
80 – 100 – 120 mg methylprednisolone 
Potency 
Hydrocortisone  
Hydrocortone® 
400 – 500 – 600 mg 
1 
Prednisone  
Decortin® 
100 – 125 – 150 mg 
4 
Prednisolone  
Decortin® H 
100 – 125 – 150 mg 
4 
Methylprednisolone  
Urbason® 
80 – 100 – 120 mg 
5 
Dexamethasone  
Fortecortin® 
14 – 16 – 20 mg 
30 
Abbreviations: INN=international nonproprietary name. 

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12.10 
Appendix 10: International Prognostic Index and Ann Arbor Staging 
Classification 
International Prognostic Index Patients > 60 years 
Risk Factors 
Ann Arbor Stage III or IV 
Age > 60 years 
Elevated LDH 
ECOG performance status 2 
Extranodal involvement 2 
IPI Risk Group 
Number of IPI Risk Factors 
Low 
0 or 1 
Low-intermediate 
2 
High-intermediate 
3 
High 
4 or 5 
Abbreviations: ECOG=Eastern Cooperative Oncology Group; IPI=International Prognostic Index; LDH=lactate dehydrogenase. 
Age-Adjusted International Prognostic Index Patients ≤ 60 years  
Risk Factors 
Ann Arbor Stage III or IV 
Elevated LDH 
ECOG performance status  2 
IPI Risk Group 
Number of aaIPI Risk Factors 
Low 
0 
Low-intermediate 
1 
High-intermediate 
2 
High 
3 
Abbreviations: aaIPI=age-adjusted International Prognostic Index; ECOG=Eastern Cooperative Oncology Group; 
IPI=International Prognostic Index; LDH=lactate dehydrogenase. 
Ann Arbor Staging Classification for Hodgkin and Non-Hodgkin's Lymphoma 
Stage I 
Involvement of a single lymph node region (I) or of a single extralymphatic organ or site 
(IE).a 
Stage II 
Involvement of two or more lymph node regions or lymphatic structures on the same side of 
the diaphragm alone (II) or with involvement of limited, contiguous extralymphatic organ or 
tissue (IIE). 
Stage III 
Involvement of lymph node regions on both sides of the diaphragm (III) which may include 
the spleen (IIIS) or limited, contiguous extralymphatic organ or site (IIIE), or both (IIIES). 
Stage IV 
Diffuse or disseminated foci of involvement of one or more extralymphatic organs or tissues, 
with or without associated lymphatic involvement. 
aThe designation "E" generally refers to extranodal contiguous extension (i.e., proximal or contiguous extranodal disease) that 
can be encompassed within an irradiation field appropriate for nodal disease of the same anatomic extent. A single extralymphatic 
site as the only site of disease should be classified as IE, rather than Stage IV. 

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All cases are subclassified to indicate the absence (A) or presence (B) of the systemic ("B") 
symptoms of significant unexplained fever (> 38°C; > 100.4°F), night sweats, or unexplained 
weight loss exceeding 10% of body weight during the 6 months prior to diagnosis. 
Clinical stage refers to the extent of disease determined by diagnostic tests following a single 
diagnostic biopsy. If a second biopsy of any kind is obtained, even if negative, the term pathologic 
stage is used. 
Adapted from Carbone et al., 1971 and Lister et al., 1989. 

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12.11 
Appendix 11: ECOG Performance Status Scale 
Grade 
Description 
0 
Fully active, able to carry on all pre-disease performance without restriction  
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or 
sedentary nature, e.g., light housework or office work  
2 
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about 
> 50% of waking hours  
3 
Capable of only limited self-care, confined to a bed or chair > 50% of waking hours  
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair  
5 
Dead 

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12.12 
Appendix 12: AEs: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting 
12.12.1 
Definition of AE 
AE Definition 
• An AE is any untoward medical occurrence in a patient or clinical study patient, temporally 
associated with the use of study treatment, whether or not considered related to the study 
treatment 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the 
use of study treatment 
Events meeting the AE Definition  
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other 
safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those 
that worsen from baseline, considered clinically significant in the medical and scientific 
judgment of the investigator (i.e., not related to progression of underlying disease) 
• Exacerbation of a chronic or intermittent pre-existing condition including either an increase 
in frequency and/or intensity of the condition 
• New conditions detected or diagnosed after informed consent even though these may have 
been present before the start of the study 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or 
a concomitant medication. Overdose per se will not be reported as an AE/SAE unless it is an 
intentional overdose taken with possible suicidal/self-harming intent. Such overdoses should 
be reported regardless of sequelae 
Events NOT Meeting the AE Definition  
• Any clinically significant abnormal laboratory findings or other abnormal safety assessments 
which are associated with the underlying disease, unless judged by the investigator to be more 
severe than expected for the patient's condition 
• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the patient's condition 
• Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that leads to 
the procedure is the AE 
• Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital) 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen 
Abbreviations: AE=adverse event; ECG=electrocardiogram. 

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12.12.2 
Definition of SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious criteria 
are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
An SAE 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 event in which the patient 
was at risk of death at the time of the event. It does not refer to an event, which hypothetically 
might have caused death, if it were more severe. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the patient has been detained (usually 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 of a pre-existing condition that did not worsen from 
baseline cannot be considered an SAE because such an event would not constitute an AE. 
d. Results in persistent 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 
(e.g., sprained ankle) which may temporarily interfere with or prevent everyday life functions 
but do not constitute a substantial disruption 
e. Is a congenital anomaly/birth defect 
f. Other situations: 
• Medical or scientific judgment should be exercised in deciding whether SAE reporting is 
appropriate in other situations such as important medical events that may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may 
require medical or surgical intervention to prevent one of the other outcomes listed in the 
above definition. These events should usually be considered serious 
Examples of such events include invasive or malignant cancers, intensive treatment in an 
emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that 
do not result in hospitalization, or development of drug dependency or drug abuse. 
Abbreviations: AE=adverse event; SAE=serious adverse event. 

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12.12.3 
Recording and Follow-Up of AE and/or SAE  
AE and SAE Recording 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (e.g., hospital progress notes, laboratory reports, and diagnostics reports) 
related to the event 
• The investigator will then record all relevant AE/SAE information in the eCRF 
• It is not acceptable for the investigator to send photocopies of the patient's medical records to 
the sponsor in lieu of completion of the sponsor/AE/SAE CRF page 
• There may be instances when copies of medical records for certain cases are requested by the 
sponsor. In this case, all patient identifiers, except for the patient number, will be redacted on 
the copies of the medical records before submission to the sponsor 
• 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. 
Assessment of Intensity 
The investigator will assess the intensity for each AE and SAE reported during the study and 
assign it to one of the following categories: 
• Mild: An event that is easily tolerated by the patient, causing minimal discomfort and not 
interfering with everyday activities 
• Moderate: An event that causes sufficiently discomfort and interferes with normal everyday 
activities 
• Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with a SAE. Severe is a category utilized for rating the intensity of an 
event; and both AEs and SAEs can be assessed as severe 
An event is defined as 'serious' when it meets at least 1 of the predefined criteria as described 
in the definition of an SAE, NOT when it is rated as severe. 
Assessment of Severity (toxicity grade) 
The toxicity grade of AEs will be graded according to the NCI-CTCAE version 5 of 
27 NOV 2017 using the following definitions: 
• Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
• Grade 2: Moderate; minimal; local or non-invasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for 
groceries or clothes, using the telephone, managing money, etc.) 
• 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 intervention indicated 
• Grade 5: Death related to AE 

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Assessment of Causality 
• The investigator is obligated to assess the relationship between study treatment and each 
occurrence of each AE/SAE 
• A "reasonable possibility" of a relationship conveys that there are 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 relationship 
• Alternative causes, such as underlying 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 
• The investigator will also consult the IB and/or SmPC/ PI, for marketed products, in his/her 
assessment 
• 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 
• There may be situations in which an SAE has occurred, and the investigator has minimal 
information to include in the initial report to the sponsor. However, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to the sponsor 
• The investigator may change his/her opinion of causality in light of follow-up information, 
and update the CRF documentation accordingly. For SAEs, a follow-up report with the 
updated causality assessment should be sent 
• The causality assessment is one of the criteria used when determining regulatory reporting 
requirements 
Follow-up of AEs and SAEs 
• 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/AESI as fully as possible. This may 
include additional laboratory tests or investigations, histopathological examinations, or 
consultation with other health care professionals 
• If a patient dies during participation in the study or during a recognized follow-up period, the 
investigator will provide the sponsor with a copy of any post-mortem findings including 
histopathology 
• New or updated information will be recorded in the originally completed eCRF 
• The investigator will submit any updated SAE/AESI data to the sponsor within 24 hours of 
receipt of the information 
Abbreviations: AE=adverse event; AESI=adverse event of special interest; ECG=electrocardiogram; 
eCRF=electronic case report form; IB=Investigator's Brochure NCI-CTCAE; National Cancer Institute-
Common Terminology Criteria for Adverse Events; SAE=serious adverse event; SmPC=Summary of Product 
Characteristics; PI=Product Information. 

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12.12.4 
Reporting of SAEs/AESIs 
SAE Reporting to the Sponsor via an Electronic Data Collection Tool 
• The primary mechanism for reporting an SAE/AESI to the sponsor will be the eCRF 
• If the electronic system is unavailable for more than 24 hours, then the site will use the paper 
SAE/AESI data collection tool (see below) 
• The site will enter the SAE/AESI data into the electronic system as soon as they become 
available 
• After the study is completed at a given site, the electronic data collection tool will be taken 
off-line to prevent the entry of new data or changes to existing data 
• If a site receives a report of a new SAE/AESI from a study patient or receives updated data 
on a previously reported SAE/AESI after the electronic data collection tool has been taken 
off-line, then the site can report this information on a paper SAE/ AESI form (see below) 
• Contacts for SAE/AESI reporting can be found in the Investigator Site File 
SAE Reporting to Sponsor via Paper Reporting Form 
• The SAE/AESI paper Reporting Form should be transmitted by email or facsimile 
• Contacts for SAE/AESI reporting can be found in the Investigator Site File 
Abbreviations: AESI=adverse event of special interest; SAE=serious adverse event; eCRF=electronic case 
report form. 

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12.13 
Appendix 13: Contraceptive Guidance and Collection of Pregnancy 
Information 
12.13.1 
Definitions 
12.13.1.1 Female of Childbearing Potential (FCBP) 
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile (see below). 
If fertility is unclear (e.g., amenorrhea in adolescents or athletes) and a menstrual cycle cannot be 
confirmed before first dose of investigational medicinal product (IMP), additional evaluation 
should be considered. 
12.13.1.2 Female in the Following Categories Are Not Considered FCBP 
• 
Premenopausal with 1 of the following: 
o Documented hysterectomy 
o Documented bilateral salpingectomy 
o Documented bilateral oophorectomy 
• 
Postmenopausal 
o A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause 
o A high follicle stimulating hormone (FSH) level in the postmenopausal range may 
be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormonal replacement therapy (HRT). However, in the absence of 
12 months of amenorrhea, a single FSH measurement is insufficient 
o Females on HRT and whose menopausal status is in doubt will be required to use one 
of the non-hormonal 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 individuals with permanent infertility due to an alternate medical cause other than the above, 
(e.g., Mullerian agenesis, androgen insensitivity. Genetic abnormality like Turner syndrome), 
investigator discretion should be applied to determining study entry. 
Note: Documentation can come from the site personnel's: review of the subject's medical records, 
medical examination and/or investigation, or medical history interview. 

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12.13.2 
Contraception Guidance 
12.13.2.1 Male Patients 
Male patients with female partners of childbearing potential are eligible to participate if they agree 
to ONE of the following during the protocol-defined time frame Section 6.1 on inclusion criteria 
• 
Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle 
(abstinent on a long term and persistent basis) and agree to remain abstinent 
• 
Agree to use a male condom plus partner use of a contraceptive method with a failure rate 
of < 1% per year as described in Table 13-1 when having penile-vaginal intercourse with 
a woman of childbearing potential who is not currently pregnant 
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 during the time period 
indicated in Section 6.1 on inclusion criteria 
Refrain from donating sperm during the same time period. 
12.13.2.2 Female Patients 
Female patients of childbearing potential are eligible to participate if they agree to use a highly 
effective method of contraception consistently and correctly as described in the Table 13-1 below. 
Contraception guidance is to be followed during the time frame in Section 6.1 on inclusion criteria. 
Refrain from donating eggs during the same time period. 
Table 13-1: Highly Effective Contraceptive Methods 
Highly Effective Contraceptive Methods That Are User Dependenta 
Failure rate of < 1% per year when used consistently and correctly.  
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulationb 
• 
Oral 
• 
Intravaginal 
• 
Transdermal  
Progestogen only hormonal contraception associated with inhibition of ovulation 
• 
Oral 
• 
Injectable  
Highly Effective Methods That Are User Independenta  
Implantable progestogen only hormonal contraception associated with inhibition of ovulationb 
• 
Intrauterine device 
• 
Intrauterine hormone-releasing system 
• 
Bilateral tubal occlusion 
Vasectomized partner 
A vasectomized partner is a highly effective contraception method provided that the partner is the sole male 
sexual partner of the FCBP and the absence of sperm has been confirmed. If not, an additional highly effective 
method of contraception should be used.  

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Sexual abstinence 
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 study and the preferred and usual lifestyle of 
the patient.  
NOTES: 
a) Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent 
with local regulations regarding the use of contraceptive methods for patients participating in clinical study. 
b) Hormonal contraception may be susceptible to interaction with the study treatment, which may reduce the 
efficacy of the contraceptive method. In this case, two highly effective methods of contraception should be 
utilized during the treatment period and for 90 days after the last dose of study treatment  
Abbreviations: FCBP=female of childbearing potential. 
Pregnancy testing will be performed as outlined in the SoA (see Section 2). 
12.13.3 
Collection of Pregnancy Information 
12.13.3.1 Male Patients With Partners Who Become Pregnant 
The investigator will attempt to collect pregnancy information on any male patient's female partner 
who becomes pregnant while the male patient is in this study. This applies only to male patients 
who receive study treatment. 
After obtaining the necessary signed informed consent from the pregnant female partner directly, 
the investigator will record pregnancy information on the appropriate form and submit it to the 
sponsor within 24 hours of learning of the partner's pregnancy. The female partner will also be 
followed to determine the outcome of the pregnancy. Information on the status of the mother and 
child will be forwarded to the sponsor. Generally, the follow-up will be no longer than the time 
period described in Section 9.4.3 following the estimated delivery date. Any termination of the 
pregnancy will be reported regardless of fetal status (presence or absence of anomalies) or 
indication for the procedure. 
12.13.3.2 Female Patients Who Become Pregnant 
The investigator will collect pregnancy information on any female patient who becomes pregnant 
while participating in this study. Information will be recorded on the appropriate form and 
submitted to the sponsor within 24 hours of learning of a patient's pregnancy. The patient will be 
followed to determine the outcome of the pregnancy. The investigator will collect follow-up 
information on the patient and the neonate, and the information will be forwarded to the sponsor. 
Generally, follow-up will not be required for longer than the time period described in Section 9.4.3 
beyond the estimated delivery date. Any termination of pregnancy will be reported, regardless of 
fetal status (presence or absence of anomalies) or indication for the procedure. 
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or 
elective termination of a pregnancy will be reported as an AE or SAE. A spontaneous abortion is 
always considered to be an SAE and will be reported as such. Any post-study pregnancy related 
SAE considered reasonably related to the study treatment by the investigator will be reported to 
the sponsor as described in Section 9.4.3. While the investigator is not obligated to actively seek 
this information in former study patients, he or she may learn of an SAE through spontaneous 
reporting. 

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12.14 
Appendix 14: 
 

Signature Page for VV-CLIN-027648 v2.0
Signature Page for VV-CLIN-027648 v2.0
Approval Task
Approver
, Oncology Targeted Therapeutics
11-Apr-2024 20:06:57 GMT+0000
Approval Task
Approver
 Clinical Research Scientist
11-Apr-2024 21:02:20 GMT+0000
Approval Task
Approver
 Senior Clinical Trial Head
12-Apr-2024 04:55:54 GMT+0000
Approval Task
Approver
 Biostatistics
12-Apr-2024 08:24:04 GMT+0000