A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Phase: PHASE3
Conditions: Follicular Lymphoma, Marginal Zone Lymphoma
Sponsor: Incyte Corporation

Official Title: 
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 
Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab 
Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in 
Addition to Rituximab in Patients with Relapsed/Refractory (R/R) 
Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma 
NCT Number: 
NCT04680052 
Document Date: 
Clinical Study Protocol (Amendment 7): 18 APR 2023 

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Clinical Study Protocol 
TITLE PAGE 
INCMOR 0208-301 
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter 
Study to Evaluate the Efficacy and Safety of Tafasitamab Plus 
Lenalidomide in Addition to Rituximab Versus Lenalidomide in 
Addition to Rituximab in Patients With Relapsed/Refractory (R/R) 
Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma 
Product: 
Tafasitamab (INCMOR00208) 
IND Number: 
152,839 
EudraCT Number: 
2020-004407-13 
EU CT Number: 
2023-504684-16-00 
MorphoSys Reference Protocol Number: 
MOR208C311 
Phase of Study: 
3 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, Delaware 19803 
Original Protocol: 
08 OCT 2020 
Amendment 1: 
25 NOV 2020 
Amendment 2: 
16 DEC 2020 
Amendment 2-EU: 
01 MAR 2021 
Amendment 2-EU2: 
24 MAR 2021 
Amendment 3: 
04 MAR 2021 
Amendment 4: 
30 JUL 2021 
Amendment 5: 
22 OCT 2021 
Amendment 6: 
15 JUN 2022 
Amendment 7: 
18 APR 2023 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki (Brazil 2013) and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and 
applicable laws and country-specific regulations, including WMO (Medical Research Involving Human Participants 
Act) and Clinical Trials Regulation (EU) No. 536/2014, in which the study is being conducted. 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without prior 
written consent. 

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INVESTIGATOR'S AGREEMENT 
I have read the INCMOR 0208-301 Protocol Amendment 7 (dated 18 APR 2023) and agree to 
conduct the study as outlined.  I agree to maintain the confidentiality of all information received 
or developed in connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 

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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ................................................................................................2 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ........................................................................................................10 
1. 
PROTOCOL SUMMARY ..........................................................................................15 
2. 
INTRODUCTION ......................................................................................................25 
2.1. 
Background .................................................................................................................25 
2.1.1. 
Indolent Non-Hodgkin Lymphoma ............................................................................25 
2.1.2. 
Follicular Lymphoma .................................................................................................25 
2.1.3. 
Marginal Zone Lymphoma .........................................................................................25 
2.1.4. 
Treatment Algorithm for Indolent Non-Hodgkin Lymphoma ....................................26 
2.1.4.1. 
First-Line Therapy ......................................................................................................26 
2.1.4.2. 
Treatment of Relapsed/Refractory Disease ................................................................26 
2.1.4.3. 
Lenalidomide Plus Rituximab (R2) in Relapsed/Refractory Follicular 
Lymphoma and Marginal Zone Lymphoma ...............................................................27 
2.1.4.4. 
Tafasitamab .................................................................................................................28 
2.1.4.5. 
Tafasitamab Monotherapy in Non-Hodgkin Lymphomas ..........................................28 
2.1.4.6. 
Combination Therapy With Tafasitamab and Lenalidomide in Non-Hodgkin 
Lymphomas ................................................................................................................28 
2.1.4.7. 
Combination Therapy With Tafasitamab + Lenalidomide + Rituximab + 
CHOP Chemotherapy in Previously Untreated Diffuse Large B-Cell 
Lymphoma ..................................................................................................................30 
2.2. 
Study Rationale ...........................................................................................................30 
2.2.1. 
Role of the Micro-Environment ..................................................................................30 
2.2.2. 
Role of Tafasitamab ....................................................................................................31 
2.2.3. 
Scientific Rationale for Study Design ........................................................................31 
2.2.4. 
Justification for Dose ..................................................................................................32 
2.2.4.1. 
Tafasitamab .................................................................................................................32 
2.2.4.2. 
Lenalidomide and Rituximab .....................................................................................32 
2.3. 
Benefit/Risk Assessment ............................................................................................32 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................34 
4. 
STUDY DESIGN .......................................................................................................36 
4.1. 
Overall Design ............................................................................................................36 

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4.2. 
Overall Study Duration ...............................................................................................37 
4.3. 
Study Termination ......................................................................................................37 
5. 
STUDY POPULATION .............................................................................................37 
5.1. 
Inclusion Criteria ........................................................................................................37 
5.2. 
Exclusion Criteria .......................................................................................................41 
5.3. 
Lifestyle Considerations .............................................................................................42 
5.4. 
Screen Failures ............................................................................................................42 
5.5. 
Replacement of Participants .......................................................................................43 
5.6. 
Independent Data Monitoring Committee ..................................................................43 
6. 
STUDY TREATMENT ..............................................................................................44 
6.1. 
Study Treatments Administered .................................................................................44 
6.2. 
Preparation, Handling, and Accountability ................................................................46 
6.2.1. 
Tafasitamab/Placebo Preparation ...............................................................................46 
6.2.2. 
Handling and Accountability of Study Treatment ......................................................46 
6.2.3. 
Unblinded Site Staff, Handling, and Accountability ..................................................46 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................47 
6.4. 
Study Treatment Compliance .....................................................................................48 
6.5. 
Dose Modifications .....................................................................................................49 
6.5.1. 
Tafasitamab/Placebo Dose Modifications ..................................................................49 
6.5.2. 
Criteria and Procedures for Dose Interruptions and Adjustments of 
Tafasitamab/Placebo ...................................................................................................49 
6.5.2.1. 
Management of Tafasitamab/Placebo Infusion-Related Reactions and 
Cytokine Release Syndrome .......................................................................................49 
6.5.2.2. 
Interventions for Infusion-Related Reactions and Cytokine Release 
Syndrome ....................................................................................................................50 
6.5.3. 
Criteria and Procedures for Dose Interruptions or Adjustments of 
Lenalidomide ..............................................................................................................52 
6.5.4. 
Criteria and Procedures for Dose Interruptions or Adjustments of Rituximab ..........52 
6.5.5. 
Toxicity Management Guidelines for Hematological Toxicities ...............................52 
6.5.6. 
Toxicity Management Guidelines for Non-Hematological Toxicities .......................55 
6.5.6.1. 
Tumor Lysis Syndrome Prophylaxis ..........................................................................57 
6.5.6.2. 
Hypogammaglobulinemia ...........................................................................................58 
6.6. 
Concomitant Medications and Procedures .................................................................58 
6.6.1. 
Participant Monitoring During Tafasitamab or Placebo Infusion ..............................58 

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6.6.2. 
Lenalidomide Counseling ...........................................................................................58 
6.6.3. 
Prior and Concomitant Therapies ...............................................................................58 
6.6.4. 
Prophylaxis of Hepatitis B Reactivation .....................................................................59 
6.6.5. 
Anti-Infection Prophylaxis .........................................................................................59 
6.6.6. 
Premedication for Tafasitamab or Placebo Infusions/Infusion-Related 
Reaction Prophylaxis ..................................................................................................59 
6.6.7. 
Prophylaxis of Venous Thromboembolism ................................................................59 
6.6.8. 
Use of Growth Factors ................................................................................................60 
6.6.9. 
Use of Specific Medications Concomitantly With Lenalidomide ..............................60 
6.6.9.1. 
Digoxin .......................................................................................................................60 
6.6.9.2. 
Concomitant Therapies That May Increase the Risk of Thrombosis .........................60 
6.6.9.3. 
Warfarin ......................................................................................................................60 
6.6.10. 
Prohibited Medications and Procedures .....................................................................60 
6.6.10.1. 
Anticancer Therapies ..................................................................................................60 
6.6.10.2. 
Live Vaccines .............................................................................................................61 
6.7. 
Treatment After the End of the Study .........................................................................61 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
WITHDRAWAL FROM STUDY TREATMENT ....................................................61 
7.1. 
Discontinuation of Study Treatment ...........................................................................61 
7.1.1. 
Reasons for Discontinuation of Study Treatment .......................................................61 
7.1.1.1. 
Unacceptable Toxicity ................................................................................................61 
7.1.1.2. 
Disease Progression ....................................................................................................61 
7.1.1.3. 
Lack of Efficacy .........................................................................................................62 
7.1.1.4. 
Consent Withdrawal ...................................................................................................62 
7.1.1.5. 
Investigator Decision ..................................................................................................62 
7.1.1.6. 
Pregnancy ...................................................................................................................62 
7.1.1.7. 
Study Termination ......................................................................................................62 
7.1.2. 
Discontinuation Procedures ........................................................................................62 
7.2. 
Participant Withdrawal From the Study .....................................................................63 
7.3. 
Lost to Follow-Up.......................................................................................................63 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................64 
8.1. 
Administrative and General Procedures .....................................................................64 
8.1.1. 
Informed Consent Process ..........................................................................................64 

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8.1.2. 
Screening Procedures ..................................................................................................65 
8.1.3. 
Interactive Response Technology Procedure ..............................................................65 
8.1.4. 
Demography and Medical History ..............................................................................66 
8.1.4.1. 
Demographics and General Medical History .............................................................66 
8.1.4.2. 
Disease Characteristics, Treatment History, and Pathology .......................................66 
8.2. 
Efficacy Assessments .................................................................................................67 
8.2.1. 
Health Economics .......................................................................................................67 
8.2.2. 
Bone Marrow Biopsy and Aspirate Samples ..............................................................67 
8.2.2.1. 
Bone Marrow Biopsy Sample Collection ...................................................................67 
8.2.2.2. 
Bone Marrow Aspirate Sample Collection .................................................................67 
8.2.3. 
Minimal Residual Disease and Mutational Analyses in Peripheral Blood .................68 
8.2.4. 
Radiographic and Metabolic Imaging Assessments ...................................................68 
8.2.5. 
Quality-of-Life Assessments ......................................................................................69 
8.3. 
Safety Assessments .....................................................................................................69 
8.3.1. 
Adverse Events ...........................................................................................................70 
8.3.2. 
Physical Examinations and Eastern Cooperative Oncology Group 
Performance Status .....................................................................................................70 
8.3.3. 
Vital Signs ..................................................................................................................71 
8.3.4. 
Electrocardiograms, Echocardiograms, and/or Cardiac MUGA Scans ......................71 
8.3.5. 
Laboratory Assessments .............................................................................................71 
8.3.5.1. 
Central Laboratory Testing for Safety ........................................................................72 
8.3.5.2. 
Pregnancy Testing ......................................................................................................73 
 
 .....................................................................................74 
8.3.5.4. 
Hepatitis Virus Serology .............................................................................................74 
8.3.5.5. 
Human Immunodeficiency Virus Serology ................................................................74 
 
 ....................................................................................75 
 
 ............................................................................................75 
 
 ....................................................75 
 
 .........................................................................75 
 
 ....................................................75 
 
...................................................75 
 
 ......................................................................................76 
 
 ............................................................................................................76 

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 ..................................76 
8.7. 
Unscheduled Visits .....................................................................................................76 
8.8. 
End of Treatment and/or Early Treatment Discontinuation .......................................77 
8.9. 
Follow-Up ...................................................................................................................77 
8.9.1. 
Safety Follow-Up ........................................................................................................77 
8.9.2. 
Efficacy Follow-Up ....................................................................................................77 
8.9.3. 
Survival Follow-Up/Completion of Study ..................................................................77 
8.9.4. 
End of Study ...............................................................................................................78 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................78 
9.1. 
Definition of Adverse Event .......................................................................................78 
9.2. 
Definition of Serious Adverse Event ..........................................................................79 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........80 
9.4. 
Reporting of Serious Adverse Events .........................................................................83 
9.5. 
Events of Clinical Interest ..........................................................................................84 
9.5.1. 
Adverse Events of Special Interest by eCRF ..............................................................84 
9.5.2. 
Adverse Events of Special Interest by Category and Preferred Term ........................84 
9.6. 
Emergency Unblinding of Treatment Assignment .....................................................85 
9.7. 
Pregnancy ...................................................................................................................85 
9.8. 
Warnings and Precautions ..........................................................................................86 
9.9. 
Product Complaints ....................................................................................................86 
9.10. 
Treatment of Overdose ...............................................................................................86 
10. 
STATISTICS ..............................................................................................................87 
10.1. 
Sample Size Determination ........................................................................................87 
10.2. 
Population for Analysis ..............................................................................................88 
10.3. 
Level of Significance ..................................................................................................88 
10.4. 
Statistical Analyses .....................................................................................................89 
10.4.1. 
Efficacy Analyses .......................................................................................................89 
10.4.1.1. 
Primary Analysis for Progression-Free Survival in the Follicular Lymphoma 
Population ...................................................................................................................89 
10.4.1.2. 
Analyses of Key Secondary Efficacy Endpoints ........................................................91 
 
 .......................................92 
10.4.1.4. 
Analyses of Other Secondary Efficacy Endpoints ......................................................92 

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 .................................................................................94 
10.4.1.6. 
Sensitivity Analysis of Efficacy Endpoints ................................................................96 
10.4.2. 
Safety Analyses ..........................................................................................................96 
 
 ........................................................................................97 
 
 ...................................................................................................97 
10.5. 
Interim Analysis ..........................................................................................................97 
10.6. 
Independent Data Monitoring Committee ..................................................................98 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................99 
11.1. 
Investigator Responsibilities .......................................................................................99 
11.1.1. 
Identification of the Coordinating Principal Investigator .........................................100 
11.2. 
Data Management .....................................................................................................100 
11.3. 
Data Quality Assurance ............................................................................................102 
11.4. 
Data Privacy and Confidentiality of Study Records .................................................102 
11.5. 
Financial Disclosure .................................................................................................103 
11.6. 
Publication Policy .....................................................................................................103 
11.7. 
Study and Site Closure..............................................................................................104 
12. 
REFERENCES .........................................................................................................105 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS .............................................................................109 
APPENDIX B. DOSE ADJUSTMENT FOR LENALIDOMIDE............................................111 
APPENDIX C. CALCULATION OF CREATININE CLEARANCE USING THE 
COCKCROFT-GAULT FORMULA .......................................................................113 
APPENDIX D. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS .....................................................................................114 
APPENDIX E. ANN ARBOR STAGING ................................................................................115 
APPENDIX F. FOLLICULAR LYMPHOMA INTERNATIONAL PROGNOSTIC 
INDEX-1 ...................................................................................................................116 
APPENDIX G. THE GROUPE POUR L'ETUDE DE LYMPHOME FOLLICULAIRE 
CRITERIA ................................................................................................................117 
APPENDIX H. LUGANO RESPONSE CRITERIA FOR MALIGNANT 
LYMPHOMA ...........................................................................................................118 
APPENDIX I. MANAGEMENT OF POTENTIAL HY'S LAW CASES ...............................122 
APPENDIX J. PROTOCOL AMENDMENT SUMMARY OF CHANGES ...........................126 
 

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LIST OF TABLES 
Table 1: 
Primary and Major/Key Secondary Objectives and Endpoints ..................................15 
Table 2: 
Key Study Design Elements .......................................................................................16 
Table 3: 
Schedule of Activities .................................................................................................20 
Table 4: 
Schedule of Laboratory Assessments .........................................................................23 
Table 5: 
Objectives and Endpoints ...........................................................................................34 
Table 6: 
Inclusionary Laboratory Values .................................................................................40 
Table 7: 
Study Treatment Information .....................................................................................45 
Table 8: 
Definition of Infusion-Related Reactions and Cytokine Release Syndrome ..............50 
Table 9: 
Toxicity Management Guidelines for Hematological Toxicities ...............................53 
Table 10: Toxicity Management Guidelines for Non-Hematological Toxicities .......................56 
Table 11: Required Laboratory Analytes ....................................................................................73 
Table 12: Sample Size Assumptions...........................................................................................87 
Table 13: Analysis Population ....................................................................................................88 
Table 14: Evaluation and Censoring of Progression-Free Survival for Primary Analysis .........90 
Table 15: Guidelines for Decisions – Progression-Free Survival ...............................................98 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schema .................................................................................................19 
 

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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
2D-ECHO 
2-dimensional echocardiogram 
ADCC 
antibody-dependent cell-mediated cytotoxicity 
ADCP 
antibody-dependent cell-mediated phagocytosis 
ADR 
adverse drug reaction 
AE 
adverse event 
AESI 
adverse event of special interest  
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
anti-HCV 
hepatitis C virus antibody 
aPTT 
activated partial thromboplastin time 
AST 
aspartate aminotransferase 
AUC 
area under the curve 
AUCinf 
area under the single-dose plasma or serum concentration-time curve 
extrapolated to time of infinity 
BCL 
B-cell lymphoma 
BG 
bendamustine + obinutuzumab 
BM 
bone marrow  
BR 
bendamustine + rituximab 
C1D1 
Cycle 1 Day 1 
 
 
CBC 
complete blood count 
CFR 
Code of Federal Regulations 
CHOP 
cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone 
CLL 
chronic lymphocytic leukemia 
Cmax 
maximum concentration 
 
 
CMH 
Cochran-Mantel-Haenszel 
CNS 
central nervous system 
CPK 
creatine phosphokinase 
CR 
complete response   
CRO 
contract research organization  
CRP 
C-reactive protein 
CRS 
cytokine release syndrome  
CSR 
Clinical Study Report 

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Abbreviations and 
Special Terms 
Definition 
CT 
computed tomography  
CTCAE 
Common Terminology Criteria for Adverse Events 
CVP 
cyclophosphamide, vincristine, prednisone/prednisolone 
 
 
DLBCL 
diffuse large B-cell lymphoma 
DNA 
deoxyribonucleic acid 
DoR 
duration of response 
ECG 
electrocardiogram 
ECI 
event of clinical interest  
ECOG 
Eastern Cooperative Oncology Group  
eCRF 
electronic case report form 
EDC 
electronic data capture 
EDTA 
ethylenediaminetetraacetic acid 
EMA 
European Medicines Agency 
EORTC 
European Organisation for Research and Treatment of Cancer 
EOT 
end of treatment 
ESMO 
European Society for Medical Oncology 
EZH2 
enhancer of zeste homolog 2 
FACS 
fluorescence-activated cell sorting 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FDG 
fluorodeoxyglucose 
 
 
FL 
follicular lymphoma  
FLIPI 
Follicular Lymphoma International Prognostic Index 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
G-CSF 
granulocyte colony-stimulating factor 
GDPR 
General Data Protection Regulation 
GELF 
Groupe d'Etude des Lymphomes Folliculaires 
GGT 
gamma-glutamyl transferase 
HBcAb 
hepatitis B core antibody 
HBsAb 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 

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Abbreviations and 
Special Terms 
Definition 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
human immunodeficiency virus 
HR 
hazard ratio 
 
 
IB 
Investigator's Brochure 
ICF 
informed consent form  
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IDMC 
independent data monitoring committee 
IEC 
independent ethics committee 
IgA 
immunoglobulin A 
IgG 
immunoglobulin G 
IgM 
immunoglobulin M 
IMP 
investigational medicinal product 
 
 
INV 
investigator  
IRB 
institutional review board 
IRC 
independent review committee 
IRR 
infusion-related reaction  
IRT 
interactive response technology 
IV 
intravenous 
J-GCP 
Japanese Good Clinical Practice 
JPI 
Japanese package insert  
LiHep 
lithium heparin 
LVEF 
left-ventricular ejection fraction 
mAb 
monoclonal antibody  
MCL 
mantle cell lymphoma 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOA 
mechanism of action 
MRD 
minimal residual disease  
MRI 
magnetic resonance imaging 
MUGA 
multigated acquisition 
MZL 
marginal zone lymphoma 
NA 
not applicable 
NCCN 
National Comprehensive Cancer Network 
NCI 
National Cancer Institute 

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Abbreviations and 
Special Terms 
Definition 
NE 
not evaluable 
NHL 
non-Hodgkin lymphoma 
NK 
natural killer 
NKCC 
natural killer cell count 
NR 
not reached 
ORR 
overall response rate   
OS 
overall survival 
PCR 
polymerase chain reaction  
PD 
progressive disease 
PET 
positron emission tomography  
PFS 
progression-free survival  
 
 
PHL 
potential Hy's law 
PI3K 
phosphatidylinositol 3-kinase 
PK 
pharmacokinetics 
 
 
PMDA 
Pharmaceuticals and Medical Devices Agency 
PML 
progressive multifocal leukoencephalopathy 
POD24 
progression of disease within 24 months after initial diagnosis 
PP 
per protocol 
PPS 
per protocol set 
PR 
partial response  
PT 
prothrombin time 
QD 
once daily 
QoL 
quality of life 
R2 
rituximab + lenalidomide (Revlimid®) 
R-CHOP 
rituximab, cyclophosphamide, doxorubicin, vincristine, and 
prednisone/prednisolone 
R2-CHOP 
rituximab, lenalidomide, cyclophosphamide, doxorubicin, vincristine, and 
prednisone/prednisolone 
RNA  
ribonucleic acid 
R/R 
relapsed/refractory 
RSI 
Reference Safety Information 
SAE 
serious adverse event 
SAF 
safety analysis set 
SAP 
Statistical Analysis Plan 

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Abbreviations and 
Special Terms 
Definition 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SD 
stable disease  
SLL 
small lymphocytic lymphoma 
SmPC 
Summary of Product Characteristics  
SoA 
schedule of activities 
SOC 
system organ class 
SOP 
standard operating procedure 
SPM 
second primary malignancy 
Study drugs 
Study drugs are defined as tafasitamab/matching placebo, lenalidomide, and 
rituximab; tafasitamab, lenalidomide, and rituximab are regarded as IMPs 
(see Table 7 for the exceptions). 
Study treatment 
Study treatment is defined as tafasitamab plus lenalidomide in addition to 
rituximab (Treatment Group A [TGA]) or tafasitamab placebo plus 
lenalidomide in addition to rituximab (Treatment Group B [TGB]). 
SUSAR 
suspected unexpected serious adverse reaction 
 
 
TEAE 
treatment-emergent adverse event 
TGA 
Treatment Group A 
TGB 
Treatment Group B 
TLS 
tumor lysis syndrome 
TSH 
thyroid-stimulating hormone 
TT 
thrombin time 
 
  
ULN 
upper limit of normal 
USPI 
United States prescribing information 
VHP 
Voluntary Harmonisation Procedure 
VTE 
venous thromboembolism 
WBC 
white blood cell 
WFI 
water for injection 
WHO 
World Health Organization 
WOCBP 
woman of childbearing potential  

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1. 
PROTOCOL SUMMARY 
This Phase 3 double-blind, placebo-controlled, randomized study is designed to investigate 
whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical 
benefit compared with lenalidomide as an add-on to rituximab alone in patients with R/R FL 
Grade 1 to 3a or R/R MZL. 
Protocol Title: 
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the 
Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus 
Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular 
Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma 
Protocol Number:  INCMOR 0208-301 
Objectives and Endpoints: 
Table 1 presents the primary and major/key secondary objectives and endpoints. 
Table 1: 
Primary and Major/Key Secondary Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To compare the efficacy of tafasitamab and 
lenalidomide in addition to rituximab to the 
efficacy of placebo and lenalidomide in addition 
to rituximab in terms of PFS in participants with 
R/R FL. 
PFS by INV assessment in the FL population, 
using the Lugano 2014 criteria (Cheson et al 2014).  
PFS is defined as the time from randomization to 
first documented disease progression, or death 
from any cause, whichever occurs first. 
Key Secondary 
To compare the efficacy of tafasitamab and 
lenalidomide in addition to rituximab versus 
placebo and lenalidomide in addition to rituximab 
in terms of PFS in the overall population (FL and 
MZL).  
PFS by INV assessment in the overall population 
(FL and MZL populations). 
To compare the efficacy of tafasitamab and 
lenalidomide in addition to rituximab versus 
placebo and lenalidomide in addition to rituximab 
in terms of PET-CR rate in FDG-avid FL 
participants  and OS in the FL population. 
• PET-CR rate by INV in the FDG-avid FL 
population, defined as a complete metabolic 
response at any time after start of treatment. 
• OS in the FL population.  
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 

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Table 2: 
Key Study Design Elements 
Study Phase 
Phase 3 
Clinical Indication 
Participants with an investigator-assessed diagnosis of R/R FL Grade 1, 2, or 
3a or R/R MZL who have been previously treated with at least 1 anti-CD20 
antibody containing therapy (eg, rituximab, obinutuzumab, or other). 
Population 
Male and female participants at least 18 years of age who have histologically 
confirmed Grade 1, 2 or 3a FL or histologically confirmed nodal MZL, splenic 
MZL, or extranodal MZL. 
• Must have been previously treated with at least 1 prior systemic anti-CD20 
immunotherapy or chemo-immunotherapy.  This includes treatments such 
as rituximab monotherapy or chemotherapy plus immunotherapy with 
rituximab or obinutuzumab, with or without maintenance. 
• Must have documented relapsed, refractory, or PD after treatment with 
systemic therapy: 
− Relapsed lymphoma:  relapsed after initial response of CR or PR 
≥ 6 months after prior therapy. 
− Refractory lymphoma:  achieved less than PR to the last treatment or 
achieved a CR or PR that lasted less than 6 months. 
− Progressive lymphoma:  PD after initial response of SD to prior 
therapy. 
Number of 
Participants 
A total number of 174 PFS events in the FL population are required to detect a 
HR of 0.65 with 80% power for the primary analysis, using a 2-sided log-rank 
test at an alpha level of 5% and a 1:1 randomization ratio between the 
2 treatment groups.  A total of 528 participants with R/R FL need to be 
randomized 1:1 with stratification (264 participants per treatment group), 
assuming a median PFS of 27.8 months for lenalidomide in addition to 
rituximab, 21 months of enrollment, 12 months of follow-up for PFS and 
15% of dropouts. 
A minimum of 60 and up to 90 additional participants with R/R MZL will be 
randomized at a 1:1 ratio to 1 of the 2 treatment groups.  The number of 
participants with MZL is based on an expected enrollment proportion of FL 
and MZL participants. 
Approximately 275 centers globally (Europe, Asia Pacific, North America) 
will be participating in this study. 

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Table 2: 
Key Study Design Elements (Continued) 
Study Design 
This Phase 3, multicenter, randomized, double-blind, placebo-controlled study 
is designed to evaluate the efficacy and safety of tafasitamab and lenalidomide 
in addition to rituximab versus placebo and lenalidomide in addition to 
rituximab in participants with R/R FL or MZL. 
Approximately 618 participants will be randomized, including approximately 
528 participants with FL and 60 to 90 participants with MZL.  Participants will 
be randomized 1:1 to 1 of 2 treatment groups. 
An IDMC will review the safety data after the first 60 participants 
(approximately 30 in each treatment group) have completed 2 cycles of study 
treatment to monitor and evaluate the safety of the combination treatment. 
An interim analysis for futility will be performed at approximately 
20% information rate (35 PFS events approximately) in the FL population (an 
HR of ≥ 1.05 will be considered as a nonbinding futility boundary).  An IDMC 
will be involved in reviewing the interim analysis and provide their 
recommendation as defined in the IDMC charter. 
FL and MZL participants will be randomized separately, based on different 
stratification factors.  The 3 stratification factors for participants with FL 
include POD24 (progression of disease within 24 months after initial 
diagnosis; yes vs no), refractoriness to prior anti-CD20 mAb therapy (yes vs 
no), and the number of prior lines of therapy (< 2 vs ≥ 2).  The 1 stratification 
factor for participants with MZL is the number of prior lines of therapy 
(< 2 vs ≥ 2). 
The primary analysis will be run when 174 PFS events are observed in the FL 
population.  The timing of the analysis is independent of the recruitment target 
in the MZL population.  The overall population analysis may be run 
concomitantly to the MZL population analysis. 
Recruitment will be stopped when the required 528 participants with FL for 
the primary analysis and at least 60 participants with MZL have been 
randomized.  The maximum number of randomized participants with MZL is 
90. 
An IRC will review PET and CT/MRI images to determine ORR, PFS, and 
DoR according to Lugano response criteria in the FL and overall populations.  
Details regarding the IRC constitution and procedures will be provided in a 
separate IRC charter. 
Estimated Duration 
of Study 
Participation 
The study duration for an individual participant is divided into the screening 
period (up to 28 days), treatment period (up to twelve 28-day cycles), and 
follow-up period (up to 60 months after EOT).  The total duration may be up 
to approximately 6 years per participant. 

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Table 2: 
Key Study Design Elements (Continued) 
IDMC 
An IDMC will monitor data to ensure the safety of the participants enrolled in 
this study, and evaluate the efficacy of study treatment at a prespecified 
interim analysis for futility. 
Details regarding IDMC constitution, responsibilities, authorities, and 
procedures will be provided in a separate IDMC charter.  
Coordinating 
Principal 
Investigator 
 
University of British Columbia 
Vancouver, Canada 
Treatment Groups and Duration: 
Treatment Group A: 
• Tafasitamab (12 mg/kg IV), 28-day cycle 
− Cycles 1 to 3:  Days 1, 8, 15, and 22 
− Cycles 4 to 12:  Days 1 and 15 
• Rituximab (including biosimilars; 375 mg/m2 IV), 28-day cycle 
− Cycle 1:  Days 1, 8, 15, and 22 
− Cycles 2 to 5:  Day 1 
• Lenalidomide (including generics; 20 mg PO once daily), 28-day cycle  
− Cycles 1 to 12:  Days 1 to 21 
Treatment Group B: 
• Tafasitamab placebo (0.9% saline solution) IV, 28-day cycle 
− Cycles 1 to 3:  Days 1, 8, 15, and 22 
− Cycles 4 to 12:  Days 1 and 15 
• Rituximab (including biosimilars; 375 mg/m2 IV), 28-day cycle 
− Cycle 1:  Days 1, 8, 15, and 22 
− Cycles 2 to 5:  Day 1 
• Lenalidomide (including generics; 20 mg PO once daily), 28-day cycle 
− Cycles 1 to 12:  Days 1 to 21 
Note for both treatment groups: 
• Tafasitamab/placebo 
− Every effort should be made to administer on Days 1, 8, 15, and 22 of 
Cycles 1 to 3 and then Days 1 and 15 for Cycles 4 to 12.  If delays in infusion 
occur, the subsequent infusion date should not be changed (eg, if the 
tafasitamab/placebo infusion scheduled for C2D1 is delayed to C2D4 or later, this 
infusion should be skipped and the next infusion should be C2D8). 

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• Lenalidomide: 
− For participants with moderate renal insufficiency (creatinine 
clearance ≥ 30 mL/min to < 60 mL/min), the starting dose of lenalidomide must 
be reduced to 10 mg QD on the same schedule.  The dose of lenalidomide may be 
increased to 15 mg QD on Days 1 to 21 of each cycle if no Grade 3/4 
lenalidomide-related toxicities occur after 2 cycles. 
− Lenalidomide should be taken at approximately the same time every day. 
• Rituximab: 
− Rituximab infusion should be administered at approximately 30 minutes after 
tafasitamab/placebo infusion but no less than 15 minutes after the 
tafasitamab/placebo infusion is completed (see Section 6.1); to avoid skipping a 
dose, rituximab infusion is allowable the next day. 
The treatment period for each participant starts with first intake of study treatment at C1D1.  All 
subsequent treatment days and assessments are calculated from C1D1.  The timing of subsequent 
treatment days and assessments should not change and should remain on schedule, regardless of 
interruptions in study drug administration. 
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.  Figure 1 presents the study design, and Table 3 and Table 4 
present the schedule of activities and laboratory assessments, respectively. 
See Section 6 for additional information on tafasitamab/placebo, lenalidomide, and rituximab 
administration. 
Figure 1: 
Study Design Schema 
 
*Randomization will apply separately for FL versus MZL populations. 

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Table 3: 
Schedule of Activities 
Activities 
Screening 
Period 
Treatment Period 
EOT 
(± 2 days) 
Follow-Up Period 
Notes 
Up to 
Day −1 C1D1 
Cycle 1 
(± 1 daya) 
Cycles 2 and 3  
(± 1 daya) 
≥ Cycle 4 
(± 2 daysa) 
Safety 
Follow-Up 
Efficacy 
Follow-Up 
Survival 
Follow-Up 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
15 
90 Days 
From EOT  
(± 7 days) 
 
Every 12 Weeks 
From EOT  
(± 4 weeks) 
Administrative and general procedures (see Section 8.1) 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demography and 
medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lenalidomide 
counseling 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
 
Anticancer therapies 
and procedures 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
IRT registration 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Treatment administration (see Section 6.1) 
 
Tafasitamab/placebo 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Up to 12 cycles. 
Lenalidomide 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
 
Up to 12 cycles, Day 1 to 
Day 21. 
Rituximab 
 
X 
X 
X 
X 
X 
 
 
 
X 
 
 
 
 
 
Up to 5 cycles. 
Safety assessments (see Section 8.3) 
Concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Physical examination 
X* 
X 
 
 
 
X 
 
 
 
X 
 
X* 
 
 
 
*Comprehensive 
examination at screening 
and EOT; targeted for all 
other visits. 
B-symptoms 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
 
ECOG performance 
status  
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Body weight 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
 

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Table 3: 
Schedule of Activities (Continued) 
Activities 
Screening 
Period 
Treatment Period 
EOT 
(± 2 days) 
Follow-Up Period 
Notes 
Up to 
Day −1 C1D1 
Cycle 1 
(± 1 daya) 
Cycles 2 and 3  
(± 1 daya) 
≥ Cycle 4 
(± 2 daysa) 
Safety 
Follow-Up 
Efficacy 
Follow-Up 
Survival 
Follow-Up 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
15 
90 Days 
From EOT  
(± 7 days) 
 
Every 12 Weeks 
From EOT  
(± 4 weeks) 
Safety assessments (continued; see Section 8.3) 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Repeat as clinically 
indicated after screening. 
2D-ECHO or MUGA 
scan  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Efficacy assessments (see Section 8.2) 
Bone marrow core 
biopsy/bone marrow 
aspirate* (local) 
X 
X*,† 
X‡ 
 
 
 
*If a biopsy is not 
clinically feasible. an 
aspirate should be 
collected. 
†At the time of radiologic 
CR only if bone marrow is 
involved at screening.  
‡Only if bone marrow is 
involved at screening and 
morphologic CR is not 
seen on treatment.  
Bone marrow aspirate 
for central MRD 
assessment 
X 
X* 
 
X 
 
 
 
*At the time of radiologic 
CR only if bone marrow is 
involved at screening. 
PET scan 
X 
 
 
 
 
 
 
 
 
X* 
 
X*,† 
 
X*,† 
 
*Only to confirm 
radiologic CR in FDG-avid 
participants. 
†Repeat only if no prior 
on-treatment PET was 
performed. 
CT/MRI 
X 
Year 1:  every 12 weeks (3 mo, ± 2 wk) 
Years 2-3:  every 16 weeks (4 mo, ± 2 wk) 
Years 4-6:  every 24 weeks (6 mo, ± 3 wk) 
X 
 
X* 
 
*Only if EOT is not due to 
disease progression. 

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Table 3: 
Schedule of Activities (Continued) 
Activities 
Screening 
Period 
Treatment Period 
EOT 
(± 2 days) 
Follow-Up Period 
Notes 
Up to 
Day −1 C1D1 
Cycle 1 
(± 1 daya) 
Cycles 2 and 3  
(± 1 daya) 
≥ Cycle 4 
(± 2 daysa) 
Safety 
Follow-Up 
Efficacy 
Follow-Up 
Survival 
Follow-Up 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
15 
90 Days 
From EOT  
(± 7 days) 
 
Every 12 Weeks 
From EOT  
(± 4 weeks) 
Efficacy assessments (continued; see Section 8.2) 
Response assessment 
 
Year 1:  every 12 weeks (3 mo, ± 2 wk) 
Years 2-3:  every 16 weeks (4 mo, ± 2 wk) 
Years 4-6:  every 24 weeks (6 mo, ± 3 wk) 
X 
 
X* 
X† 
Survival status 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Quality-of-life assessments (see Section 8.2.5) 
EORTC QLQ-C30 
questionnaire 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X* 
 
*During efficacy 
follow-up, questionnaires 
must be completed at the 
same time as response 
assessment (see above).  
EQ-5D-5L 
questionnaire 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X* 
 
FACT-Lym 
questionnaire 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X* 
 
a Additional visit windows will be provided in referenced sections, as appropriate. 

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Table 4: 
Schedule of Laboratory Assessments 
Activities 
Screening 
Treatment Period 
EOT 
Follow-Up Period 
Notes 
Up to 
Day −1 
C1D1 
Cycle 1 
(± 1 Day) 
Cycles 2 and 3  
(± 1 Day) 
≥ Cycle 4 
(± 2 Days) 
Safety 
Follow-Up 
Efficacy 
Follow-Up 
Survival 
Follow-Up 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
15 
90 Days 
From EOT  
(±7 days) 
 
Every 
12 Weeks 
From EOT 
(± 4 weeks) 
Laboratory assessments (see Section 8.3.5) 
Hematology 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
 
 
 
Clinical chemistry 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
 
 
 
Coagulation 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
 
C-reactive protein 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
 
Urinalysis 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Repeat if clinically 
indicated after screening. 
Creatinine clearance 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
See Appendix C. 
Hepatitis virus and 
HIV serology 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IgG, IgA, and IgM 
X 
 
 
 
 
X* 
 
 
 
X* 
 
X 
 
 
 
*Cycle 2 and every 2 cycles 
thereafter. 
TSH 
X 
 
 
 
 
X* 
 
 
 
X* 
 
X 
 
 
 
Pregnancy testing  
X* 
X* 
X 
X 
X 
X 
 
X† 
 
X† 
 
X‡ 
X‡ 
 
 
*Serum at screening and 
Day 1 before first dose. 
†Repeat monthly or 
biweekly on treatment; see 
Section 8.3.5.2. 
‡Repeat monthly between 
EOT and safety follow-up. 

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Table 4: 
Schedule of Laboratory Assessments (Continued) 
Activities 
Screening 
Treatment Period 
EOT 
Follow-Up Period 
Notes 
Up to 
Day −1 
C1D1 
Cycle 1 
(± 1 Day) 
Cycles 2 and 3  
(± 1 Day) 
≥ Cycle 4 
(± 2 Days) 
Safety 
Follow-Up 
Efficacy 
Follow-Up 
Survival 
Follow-Up 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
8 
Day 
15 
Day 
22 
Day 
1 
Day 
15 
90 Days 
From EOT  
(±7 days) 
 
Every 
12 Weeks 
From EOT 
(± 4 weeks) 
 

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2. 
INTRODUCTION 
2.1. 
Background 
2.1.1. 
Indolent Non-Hodgkin Lymphoma 
Indolent NHL comprise approximately one-third of malignant lymphomas.  Follicular lymphoma 
and MZL are the most common indolent NHL subtypes and account for approximately 20% to 
25% and 7% of adult NHL cases, respectively (Swerdlow et al 2016).  Both subtypes are 
considered incurable as patients usually respond to initial therapy but typically relapse over time.  
Current treatment outcomes have significantly improved over recent years with the inclusion of 
anti-CD20 immunotherapy (rituximab or obinutuzumab) to chemotherapy backbones such as 
bendamustine, CHOP, or CVP, often followed by anti-CD20 antibody maintenance therapy for 
2 years (Monga et al 2019, NCCN 2020, O'Nions and Townsend 2019). 
The incidence rate for FL ranges from 2.1/100,000 in France to 4.3/100,000 in the United States 
and from 0.5/100,000 in Australia to 2.6/100,000 in the United Kingdom for the MZL subtype. 
2.1.2. 
Follicular Lymphoma 
Follicular lymphoma is characterized by an indolent clinical course, a typical cell morphology, 
and the presence of a chromosomal translocation, t(14;18)(q32;q21) or variant in 85% of patients 
(Relander et al 2010), which can result in the overexpression of the BCL-2 protein, a member of 
a family of proteins that block apoptosis.  The neoplastic lymphocytes in FL express pan-B-cell 
antigens CD19, CD20, CD22, and CD79a, as well as markers of the germinal center (including 
CD10 and BCL-6). 
Histologically, the follicular form of NHL is composed mainly of centrocytes with an admixture 
of centroblasts.  Follicular lymphoma is generally subdivided into 3 grades (Freedman 2014), 
which are based on the number of large transformed cells in 10 malignant follicles viewed at 
high power (Martinez et al 2007).  Grade 3 is further divided into 2 subgroups, 3a and 3b; with 
3b considered more aggressive (Hans et al 2003). 
Patients with FL usually present with painless diffuse lymphadenopathy.  Approximately 10% of 
patients present with B-symptoms (fever, drenching night sweats, loss of 10% of body weight in 
6 months).  The disease usually is widespread at presentation, with the involvement of multiple 
lymph node-bearing sites, liver, and spleen. 
2.1.3. 
Marginal Zone Lymphoma 
Marginal zone lymphoma is a heterogeneous indolent lymphoma type, further subclassified into 
extranodal MZL, splenic MZL, and nodal MZL (Swerdlow et al 2016). 
Clinical presentation of patients with MZL is often characterized by an indolent clinical course, a 
slow growing lymphadenopathy, organomegaly, and cytopenia (Pileri et al 2004, Dos Santos 
et al 2017).  Systemic B symptoms and spontaneous TLS are uncommon.  However, the clinical 
presentation of these patients varies depending on the subtype, such as extranodal, nodal, or 
splenic MZL. 

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2.1.4. 
Treatment Algorithm for Indolent Non-Hodgkin Lymphoma 
Both FL and MZL demonstrate a variable clinical course, with options for management ranging 
from active surveillance for asymptomatic patients to chemo-immunotherapy, immunotherapy, 
or treatment with targeted agents for those with symptomatic disease. 
2.1.4.1. 
First-Line Therapy 
Treatment guidelines in both the United States and Europe recommend chemo-immunotherapy 
with anti-CD20 antibodies (rituximab or obinutuzumab) and chemotherapy such as CHOP or 
CVP, often followed by anti-CD20 antibody maintenance therapy for 2 years (Dreyling 
et al 2016, NCCN 2020, O'Nions and Townsend 2019).  In the GALLIUM study 
(NCT01332968), addition of obinutuzumab to chemotherapy (bendamustine, CHOP, or CVP) 
resulted in an HR for progression, relapse, or death of 0.66 (95% CI:  0.51, 0.85; p = 0.001) and 
a superior 3-year PFS rate of 80.0% versus 73.3%, compared with rituximab plus chemotherapy 
(Marcus et al 2017). 
In patients with localized MZL, initial treatment depends on specific subtype and usually 
involves antibiotics, surgery, or radiotherapy (Zucca et al 2020, NCCN 2020).  In patients with 
advanced stage MZL, both the NCCN and the European guidelines (ESMO) recommend 
chemo-immunotherapy in the first-line setting similar to those recommended for the treatment of 
FL patients. 
2.1.4.2. 
Treatment of Relapsed/Refractory Disease 
Despite initial response to the first-line therapy, unfortunately most patients with FL experience 
relapse.  Of these, approximately 20% progress within 24 months of initial diagnosis (POD24).  
This group of patients has a poor prognosis with a markedly impaired OS compared with those 
who do not progress within 24 months after initial diagnosis (5-year OS:  50% vs 90%, 
respectively; Casulo et al 2015). 
There is no standard treatment approach for patients with relapsed indolent NHLs such as FL or 
MZL, and these patients are treated similarly despite being distinct entities (Dreyling et al 2016, 
NCCN 2020, Zucca et al 2020).  Treatment choice is usually based on DoR to prior therapies, 
types of prior therapies, and patient comorbidities.  Treatment options include radiation, 
rituximab monotherapy, anti-CD20–containing chemo-regimens such as BR or BG, R-CHOP, or 
R-CVP.  In addition, the PI3K inhibitors idelalisib, copanlisib, and duvelisib are recommended 
in R/R patients after 2 prior therapies (NCCN 2020).  However, despite improvements in 
treatment options for R/R FL and MZL, there is a high medical need for additional treatment 
options with improved outcomes and better safety profiles. 
The EMA and FDA recently approved obinutuzumab in combination with bendamustine (BG), 
followed by obinutuzumab (G) maintenance for the treatment of patients with FL who did not 
respond or who progressed during or up to 6 months after treatment with rituximab or a 
rituximab-containing regimen (NCT01059630; GADOLIN study).  After a median follow-up 
time of 21.9 months in the obinutuzumab plus bendamustine group and 20.3 months in the 
bendamustine monotherapy group, PFS was significantly longer with BG (median not reached 
[95% CI:  22.5 months, not estimable]) than with bendamustine monotherapy (14.9 months 
[95% CI:  12.8, 16.6]; HR, 0.55 [95% CI:  0.40, 0.74]; p = 0.0001; Sehn et al 2016). 

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On 18 JUN 2020, the FDA granted accelerated approval to the EZH2 inhibitor tazemetostat for 
adult patients with R/R FL whose tumors are positive for an EZH2 mutation and who have 
received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no 
satisfactory alternative treatment options. 
2.1.4.3. 
Lenalidomide Plus Rituximab (R2) in Relapsed/Refractory Follicular 
Lymphoma and Marginal Zone Lymphoma 
It was demonstrated that immunomodulation with lenalidomide plus rituximab is a promising 
novel treatment approach for patients with indolent lymphoma.  The positive outcome of the 
AUGMENT Phase 3 study comparing rituximab plus lenalidomide versus rituximab plus 
placebo in patients with relapsed and/or refractory FL or MZL who were considered appropriate 
for rituximab monotherapy has led to FDA approval (Revlimid 2019).  This treatment received 
EU approval for the treatment of patients with previously treated FL (European Commission 2019). 
• In the AUGMENT study (NCT01938001), a superiority in PFS by investigator was 
demonstrated in favor of the R2 arm with a reduced risk of progression by 49% (HR, 
0.51 [0.38 to 0.69], and median PFS of 25.3 months in R2 arm [21.2 to NE] vs 
14.3 [12.4 to 17.7] in the placebo arm), and an increase in median PFS by more than 
2 years compared with rituximab monotherapy (39.4 months [95% CI, 22.9 months to 
not reached] vs 14.1 months [95% CI, 11.4 to 16.7 months]).  However, the 
probability to remain free of progression at 2 years was 58% (95% CI:  49%, 65%) 
following R2 treatment, leaving room for further improvement of the clinical 
outcome.  Adverse events were more common in the lenalidomide plus rituximab 
group compared with the rituximab plus placebo group, largely due to higher rates of 
Grade 3/4 neutropenia, which was successfully managed through dose modifications 
and growth factors (Leonard et al 2019). 
• The ongoing Phase 3b study MAGNIFY (NCT01996865) compares the efficacy and 
safety of 12 cycles of the lenalidomide plus rituximab combination for induction with 
later randomization to lenalidomide plus rituximab vs rituximab maintenance in 
patients with R/R indolent lymphoma (FL, MCL, or MZL; NCT01996865).  Interim 
results of the R2 induction phase were recently presented with a median PFS of 
36.0 months (95% CI:  26.5, not estimable [Sharman et al 2019]). 
• In the RELEVANCE study (NCT01650701), efficacy results were recently reported 
to be similar with the rituximab plus lenalidomide combination compared to the 
current standard of care, rituximab plus chemotherapy combination, in patients with 
previously untreated advanced FL.  Grade 3/4 neutropenia and febrile 
neutropenia/infection rates were less common in the rituximab plus lenalidomide 
group than in the rituximab plus chemotherapy group, demonstrating again the 
importance of an immunomodulatory treatment approach (RELEVANCE study; 
Morschhauser et al 2018). 

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2.1.4.4. 
Tafasitamab 
Tafasitamab (INCMOR00208; MOR00208/MOR208/XmAb5574/tafasitamab-cxix) is an 
Fc-enhanced, humanized mAb against the pan B-cell antigen CD19 and is produced by 
recombinant DNA technology in Chinese hamster ovary cells.  CD19 is a co-receptor of the 
B-cell receptor, plays a key role in B-cell development and proliferation, and is expressed 
ubiquitously on most B cells in the B-cell maturation line, including pro-B cells.  It serves as a 
broader target compared with CD20. 
The Fc-modification led to increased binding affinity for Fc receptors on effector cells, 
particularly on NK cells, thereby increasing NK-cell–mediated effector functions on tumor cell 
lines in vitro with enhanced ADCC, ADCP, and direct cytotoxic effects (apoptosis; Horton 
et al 2008).  Antibody-dependent cell-mediated phagocytosis and direct cytotoxic effects 
(apoptosis) was also increased.  In preclinical studies, antitumor activity was increased versus 
respective monotherapy treatments when tafasitamab was combined with rituximab and different 
chemotherapeutic and nonchemotherapeutic drugs including lenalidomide (data on file).  For the 
combination with rituximab or lenalidomide, increased activity was observed on NHL cell lines 
with respect to ADCC and inhibition of tumor cell proliferation.  These data suggest a rationale 
and a potential clinical benefit of the tafasitamab add-on strategy to rituximab plus lenalidomide 
in patients with R/R FL and R/R MZL. 
Tafasitamab is currently approved in the United States (Monjuvi®) and the European Union and 
other countries (Minjuvi®) in combination with lenalidomide, followed by tafasitamab 
monotherapy, for the treatment of adult patients with R/R DLBCL who are not eligible for 
autologous stem cell transplantation. 
2.1.4.5. 
Tafasitamab Monotherapy in Non-Hodgkin Lymphomas 
Monotherapy with tafasitamab has shown promising clinical activity and acceptable toxicity in a 
Phase 1 study in R/R CLL/SLL (NCT01161511; Woyach et al 2014) and a Phase 2a study in 
R/R NHL (NCT01685008).  Treatment with tafasitamab in NHL achieved a 29% ORR in 
patients with FL (n = 34) and 33% ORR in patients with MZL (n = 9), with some responses 
(n = 4) ongoing for more than 4 years (Jurczak et al 2018, Jurczak et al 2019).  Median DoR was 
24 months (95% CI:  2.6, NE) in R/R FL patients and was not reached in R/R MZL patients.  
Median PFS was 8.8 months (95% CI:  5.4, 20.5) in FL patients and 3.5 months (95% CI:  2.0, 
NR) in the MZL patients.  Tafasitamab as single agent is well-tolerated, and its primary side 
effects consist of those induced by B-cell depletion.  Neutropenia ≥ Grade 3 was observed in 
5.9% of FL and 9.1% of MZL patients, respectively (Jurczak et al 2018, Jurczak et al 2019). 
2.1.4.6. 
Combination Therapy With Tafasitamab and Lenalidomide in Non-Hodgkin 
Lymphomas 
In the single-arm, Phase 2 study in participants with R/R DLBCL (NCT02399085; L-MIND), 
among 80 participants evaluable for efficacy, the combination of tafasitamab plus lenalidomide 
achieved an ORR of 57.5% (46 of 80 participants), a CR rate of 40.0% (32 of 80 participants), 
and a median DoR of 34.6 months (95% CI:  26.1, NR).  This combination treatment has 
received breakthrough therapy designation by the FDA and was recently approved (BLA 
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The safety data from this study indicate that tafasitamab in combination with lenalidomide is 
well tolerated in the population of patients with R/R DLBCL.  The majority of events were 
CTCAE Grade 1 (840 of 1639 events) or Grade 2 (489 of 1639 events) and mild in intensity 
(1027 of 1639 events).  The most frequently reported hematological TEAEs were neutropenia in 
41 participants (50.6%), anemia in 30 participants (37%), thrombocytopenia in 25 participants 
(30.9%), leukopenia in 12 participants (14.8%), and febrile neutropenia in 10 participants (12.3%).  
Events of neutropenia were manageable with dose reduction/modification and treatment with 
G-CSF. 
The most frequently reported nonhematological TEAEs were coded under the SOC infections 
and infestations (59 participants [72.8%]).  The majority were Grade 1 or Grade 2 and mild in 
intensity.  The most frequently reported TEAEs within this SOC were under the category urinary 
tract infection (as defined per customized MedDRA query), experienced by 18.5% of participants.  
Thirty participants (37.0%) experienced an event under the category rash, 10 participants (12.3%) 
experienced an event under the category infective pneumonia, and 4 participants (4.9%) 
experienced an event under the category sepsis.  In total, 9 participants (11.1%) experienced 
AESIs during the study including tumor flare and dermatitis allergic (3 participants [3.7%] each), 
basal cell carcinoma (second primary malignancy; 2 participants [2.5%]), and myelodysplastic 
syndrome (1 participant [1.2%]).  The AESIs of basal cell carcinoma (1 event; Grade 2), 
myelodysplastic syndrome (Grade 4), and tumor flare (1 event; Grade 3) were serious; all other 
AESIs were nonserious.  No participants experienced Grade ≥ 3 infusion-related reaction, tumor 
lysis syndrome, or cytokine release syndrome.  No participants reported overdose during the 
study.  Only 5 participants experienced an infusion-related reaction; all were Grade 1 in severity.  
In total, 42 participants (51.9%) experienced 78 serious TEAEs during the study.  The most 
frequently reported serious TEAEs were coded under the SOC infections and infestations 
(21 participants [25.9%]).  The most frequently reported Grade ≥ 3 serious TEAEs were 
pneumonia (7 participants [8.6%]) and febrile neutropenia (5 participants [6.2%]). 
Eight participants (9.9%) died while on treatment, of which 3 (3.7%) were due to AEs (sudden 
death, cerebrovascular accident, respiratory failure); none of these deaths were considered 
related to study treatment.  The remaining 5 deaths were due to disease progression. 
The incidence of TEAEs leading to discontinuation of both or only one of the study drugs was 
24.7% (20 participants), with neutropenia being the most common reason (3 out of 20 participants 
[15.0%]).  Ten participants (12.3%) discontinued both study drugs due to TEAEs.  In total, 
79 participants (98.8%) experienced a TEAE during the combination treatment phase (% of 
participants with a TEAE before discontinuation of lenalidomide + 7 days) compared with 
37 participants (72.5%) after discontinuation of lenalidomide + 7 days.  Thus, a notably reduced 
incidence and severity of TEAEs after cessation of lenalidomide was observed. 
Review of laboratory values, vital signs, ECGs, and other safety parameters did not indicate any 
clinically meaningful safety findings for either the combination treatment or tafasitamab. 
Refer to the IB for any additional information or findings. 

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2.1.4.7. 
Combination Therapy With Tafasitamab + Lenalidomide + Rituximab + CHOP 
Chemotherapy in Previously Untreated Diffuse Large B-Cell Lymphoma 
The Phase 1b study MOR208C107 (First-MIND, NCT04134936) in participants with newly 
diagnosed DLBCL evaluates the safety and preliminary efficacy of tafasitamab or tafasitamab 
plus lenalidomide in addition to R-CHOP and has the primary objective to assess the safety of 
these combination treatments.  Between DEC 2019 and AUG 2020, 66 participants were 
randomized into the study:  33 participants received tafasitamab + R-CHOP (Arm A), and 
33 participants received tafasitamab + lenalidomide in addition to R-CHOP (Arm B).  
Recruitment is complete. 
Preliminary data based on a data cutoff date of 09 DEC 2020 demonstrated that no new safety 
signals were identified in either study arm compared to data from patients with DLBCL treated 
with R-CHOP or R2-CHOP.  The addition of tafasitamab to R-CHOP or R2-CHOP did not add 
clinically relevant side effects. 
Overall, TEAEs were more frequently observed in Arm B (tafasitamab + lenalidomide + R-CHOP) 
versus Arm A (tafasitamab + R-CHOP).  The most frequent events by system organ class were 
blood and lymphatic system disorders, experienced by 28 participants (84.8%) in Arm A and 
29 participants (87.9%) in Arm B.  Grade ≥ 3 TEAEs in Arm B were driven by a higher 
incidence of neutropenia (66.7% vs 54.5%) and thrombocytopenia (30.3% vs 12.1%).  Grade ≥ 3 
febrile neutropenia occurred in 6 participants (18.2%) in Arm A and 4 participants (12.1%) in 
Arm B.  Grade ≥ 3 infections were reported in 6 participants (18.2%) in both treatment arms.  
Serious TEAEs were experienced by 31 participants (47.0%):  14 (42.4%) in Arm A and 
17 (51.5%) in Arm B.  Infusion-related reactions occurred in 1 participant (3.0%) in Arm A.  
There were 2 deaths reported in Arm A and 1 death in Arm B, which were considered unrelated 
to study treatment by the investigator. 
These safety results are in line with previously published results of a cross-trial comparison of 
randomized studies comparing lenalidomide + R-CHOP versus R-CHOP:  ROBUST Phase 3 
(NCT02285062) and ECOG-ACRIN1412 Phase 2 (NCT01856192).  Therefore, no new safety 
signals were identified in either arm compared with published data from patients treated with 
either R-CHOP or R2-CHOP. 
Based on these data and despite the more frequent hematologic TEAEs in Arm B, the 
preliminary data suggest that the combination of tafasitamab + lenalidomide + rituximab in 
addition to CHOP chemotherapy appears to be a tolerable and manageable regimen. 
2.2. 
Study Rationale 
2.2.1. 
Role of the Micro-Environment 
The rationale for this non-chemotherapy, immunomodulatory treatment with rituximab and 
lenalidomide is based on the observation that the microenvironment and the interaction of the 
lymphoma with the microenvironment play an important role in the progression and resistance to 
treatment in FL, pointing to the importance of the impaired host immune response in the 
pathogenesis of this disease (Dave et al 2004, Federico et al 2009, Gribben 2010, Ramsay 
et al 2009, Solal-Céligny et al 2004).  Preclinically, lenalidomide restored the response of 
tumor-infiltrating lymphocytes (Ramsay et al 2009) and increased NKCC and function in 

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peripheral blood and NK cell lines (Wu et al 2008).  Adding lenalidomide to rituximab enhanced 
ADCC, monocyte-mediated killing (ADCP), immune synapse formation, and direct cytotoxicity 
against FL cells (Lagrue et al 2015, Leonard et al 2019, Ramsay et al 2009, Wu et al 2008). 
2.2.2. 
Role of Tafasitamab 
Despite progressive improvements in the availability of treatment options for patients with 
R/R FL and R/R MZL, there is a need to develop additional treatment options that may further 
improve outcomes in terms of PFS and OS, and with better tolerability profiles. 
With increasing use of anti-CD20 antibodies and heterogeneity of intensity of CD20 surface 
expression, resistance to anti-CD20–based therapies is an increasing clinical concern.  Indeed, 
CD20 C-terminal deletion mutations associated with loss of CD20 expression in NHL patients 
with disease progression after rituximab therapy was described as one of the resistance 
mechanisms.  Moreover, the heterogeneity of CD20 expression indicates that subclones 
expressing lower CD20 levels are present in CD20-positive lymphoma cells and that surviving 
clones may cause resistance or relapse after rituximab therapy (Smith 2003, Terui et al 2009). 
CD19 is a co-receptor of the B-cell receptor, plays a key role in B-cell development and 
proliferation, and is expressed ubiquitously on most B cells in the B-cell maturation line, 
including pro-B cells.  It serves as an alternative target to CD20.  CD19 is the earliest and most 
broadly expressed B-cell marker and is highly expressed on tumor cells of most patients with 
BCL. 
2.2.3. 
Scientific Rationale for Study Design 
The current study is an integral part of the tafasitamab development program in the FL/MZL 
indication.  The safety profile of the tested regimen (tafasitamab + lenalidomide + rituximab) 
will be assessed taking into consideration also clinical data generated for this combination in 
studies in DLBCL participants.  This clinical study's safety monitoring plan is justified and 
adequate from a safety standpoint in view of the following: 
• The design of the safety plan permits ongoing monitoring and comparison of the 
safety outcomes in participants exposed to tafasitamab in addition to lenalidomide 
with rituximab versus in participants exposed to lenalidomide in addition to rituximab 
regimen only. 
• The safety monitoring is secured by an unblinded IDMC. 
• A safety data collection at time of the EOT permits the evaluation of late appearing 
adverse effects that may emerge or progress after the administration of study 
treatment. 
• The measures used to assess safety are well-defined and reliable, and the proposed 
safety analyses are adequate to assess the effects of the administration of tafasitamab 
in addition to well know combination of lenalidomide and rituximab, as well as to 
assess safety of adding rituximab to already known combination of tafasitamab with 
lenalidomide (L-MIND). 

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2.2.4. 
Justification for Dose 
2.2.4.1. 
Tafasitamab 
Dose selection of tafasitamab for this clinical study is based on preclinical data and the 
results from 3 clinical studies (ie, clinical study XmAb5574-01, MOR208C201, and 
MOR208C203/L-MIND), which used tafasitamab at a 12 mg/kg dose.  This dose is the same as 
approved by the FDA and EMA for tafasitamab in combination with lenalidomide for the 
treatment of R/R DLBCL. 
Initial results on safety, tolerability, and PK were generated in a Phase 1 dose-escalation study in 
R/R CLL/SLL participants (XmAb5574-01).  In this study, the maximum tolerated dose was not 
reached, and the recommended dose for further studies was defined at the highest dose tested 
(ie, 12 mg/kg with an initially weekly regimen; Clinical Study Report XmAb5574-01).  
Afterwards, this dose level was tested in 2 clinical studies in R/R NHL/DLBCL participants 
either as monotherapy (clinical study MOR208C201) or in combination with lenalidomide 
(clinical study MOR208C203/L-MIND).  Based on a detailed exposure-safety assessment across 
these 2 studies, no trends for increasing TEAEs with increasing exposure were observed (ie, Cmax 
and AUC).  Thus, tafasitamab showed a manageable safety profile independent of the individual 
tafasitamab exposure observed. 
In contrast, an exposure-response assessment for efficacy showed a direct relationship between 
tafasitamab monotherapy and clinical efficacy with higher exposure to tafasitamab resulting in 
increased ORRs and prolonged median PFS (XmAb5574-01 and MOR208C201).  In 
combination with lenalidomide (MOR208C203/L-MIND), tafasitamab exhibited a flat 
exposure-response relationship, whereas ORRs increased almost 2-folds compared with 
tafasitamab in monotherapy (XmAb5574-01 and MOR208C201; Report MOR208L035). 
According to these results, 12 mg/kg tafasitamab with initially weekly administrations is 
considered an appropriate regimen with a beneficial risk/benefit ratio for the intended patient 
population. 
2.2.4.2. 
Lenalidomide and Rituximab 
Lenalidomide 20 mg/day and rituximab 375 mg/m2 dosing in the study is following the same 
treatment regimen as defined in the registration Phase 3 study AUGMENT (Leonard et al 2019).  
This study was the basis for FDA approval in the United States for the treatment of adult patients 
with previously treated FL or MZL (Revlimid 2019) and in the European Union for the treatment 
of adult patients with previously treated FL (Grade 1-3a). 
2.3. 
Benefit/Risk Assessment 
In this study, all eligible participants will be treated with the combination therapy lenalidomide 
and rituximab.  In addition, participants will receive tafasitamab in TGA (experimental arm) to 
potentially prolong PFS and potentially improve the response rates.  Participants in TGB will 
receive placebo instead of tafasitamab. 
The risk assessment of tafasitamab is based on the data from nonclinical studies as well as on 
clinical experience from completed and ongoing clinical studies.  Tafasitamab single agent was 
well-tolerated in indolent NHL patients (Jurczak et al 2018). 

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Clinical data on the combination treatment of tafasitamab + lenalidomide + rituximab in addition 
to CHOP chemotherapy in participants with previously untreated DLBCL demonstrated that no 
new safety signals were identified and that this combination therapy is tolerable and manageable. 
The risks and most common side effects of tafasitamab and lenalidomide in addition to rituximab 
are IRRs, transient neutropenia, thrombocytopenia, anemia, diarrhea, pyrexia, and asthenia.  
Treatment-related serious AEs consist mainly of infections or neutropenic fever. 
Together, the potential risks identified with tafasitamab and lenalidomide in addition to 
rituximab alongside with the measures in place to minimize risk to participants participating in 
this study are justified by the anticipated benefits that may be achieved by the add-on treatment 
in participants with R/R FL and MZL. 
Because the combination of tafasitamab plus lenalidomide in addition to rituximab will be 
evaluated for the first time in a clinical study, an IDMC will evaluate the safety data from the 
first 60 randomized participants following the completion of at least the first 2 study treatment 
cycles (8 weeks) and provide recommendation whether the combination treatments are safe. 
In conclusion, the potential risks identified with tafasitamab and lenalidomide as well as those 
with rituximab alongside with the measures in place to minimize risk to participants participating 
in this study are justified by the anticipated benefits that may be achieved by the add-on 
treatment in participants with R/R FL or R/R MZL. 
The sponsor hypothesizes that the addition of tafasitamab to rituximab plus lenalidomide will not 
significantly alter the overall safety and tolerability profile and will improve time-to-event 
outcomes, response rates, and depth of response in participants with R/R FL or R/R MZL.  
Therefore, this prospective, randomized, double-blind, placebo-controlled Phase 3 study is 
designed to determine the efficacy and safety of tafasitamab as an add-on strategy to the 
immunomodulatory lenalidomide plus rituximab combination in this participant population. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of study treatment may be found in the IB for tafasitamab and in the SmPC, the 
JPI, and the USPI for both lenalidomide and rituximab (IB, MabThera® 2020, Revlimid 2020, 
Rituxan® 2020).  The IB for tafasitamab and the SmPC (for European sites), JPI (for Japanese 
sites), and USPI (for US sites) for both lenalidomide and rituximab will be supplied to the 
clinical sites. 

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3. 
OBJECTIVES AND ENDPOINTS 
Table 5 presents the objectives and endpoints. 
Table 5: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To compare the efficacy of tafasitamab and 
lenalidomide in addition to rituximab to the efficacy of 
placebo and lenalidomide in addition to rituximab in 
terms of PFS in participants with R/R FL. 
PFS by INV assessment in the FL population, using the 
Lugano 2014 criteria (Cheson et al 2014).  PFS is 
defined as the time from randomization to first 
documented disease progression, or death from any 
cause, whichever occurs first. 
Secondary 
Key Secondary Endpoints 
To compare the efficacy of tafasitamab and 
lenalidomide in addition to rituximab versus placebo 
and lenalidomide in addition to rituximab in terms of 
PFS in the overall population (FL and MZL). 
PFS by INV assessment in the overall population (FL 
and MZL populations). 
To compare the efficacy of tafasitamab and 
lenalidomide in addition to rituximab versus placebo 
and lenalidomide in addition to rituximab in terms of 
PET-CR rate in FDG-avid FL participants and OS in 
the FL population. 
• PET-CR rate by INV in the FDG-avid FL 
population, defined as a complete metabolic 
response at any time after start of treatment. 
• OS in the FL population. 
Other Secondary Endpoints 
To compare the efficacy of tafasitamab and 
lenalidomide in addition to rituximab versus placebo 
and lenalidomide in addition to rituximab. 
• PET-CR rate by INV in the FDG-avid overall 
population. 
• MRD-negativity rate (at thresholds of 10−4 and 10−5) 
at EOT in the FL and the overall populations. 
• ORR by INV in the FL and overall populations. 
• DoR by INV in the FL and overall populations. 
• OS in the overall population. 
To compare the efficacy between treatment groups 
based on IRC assessment. 
• PFS by IRC in the FL and overall populations. 
• ORR by IRC in the FL and overall populations. 
• DoR by IRC in the FL and overall populations. 
To evaluate QoL of tafasitamab and lenalidomide in 
addition to rituximab versus placebo and lenalidomide 
in addition to rituximab in the FL and overall 
population. 
QoL as measured by the EORTC QLQ-C30, the 
EQ-5D-5L, and FACT-Lym tools in the FL and overall 
populations. 
To compare the safety of tafasitamab and lenalidomide 
in addition to rituximab versus placebo and 
lenalidomide in addition to rituximab in the FL and 
overall population. 
Safety based on the incidence and severity of TEAEs 
in the FL and overall population. 

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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 

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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This study is a 1:1 randomized, double-blind, placebo-controlled, parallel group, multicenter, 
Phase 3 clinical study to compare the efficacy and safety of tafasitamab and lenalidomide in 
addition to rituximab versus placebo and lenalidomide in addition to rituximab in participants 
with R/R FL and R/R MZL.  The overall study design is described in Figure 1.  The study 
consists of the screening period (≤ 28 days), treatment period (up to twelve 28-day cycles), and a 
five-year follow-up period. 
The overall recruitment will be considered complete once 528 participants with FL for the 
primary analysis and at least 60 participants with MZL are randomized.  The recruitment of 
participants with MZL will be limited to a maximum of 90 participants.  Total enrollment will be 
approximately 618 participants.  Participants will be randomized at a 1:1 ratio to 1 of the 2 
treatment groups (see Section 6).  Participants with FL and MZL will be randomized separately 
using different stratification factors.  Stratified randomization will be performed using an IRT.  
Participants with FL will be stratified at the time of randomization for the following factors: 
• POD24 (disease progression within 24 months after initial diagnosis):  yes versus no 
• Refractoriness to prior anti-CD20 mAb therapy:  yes versus no  (Note:  Refractory to 
anti-CD20 mAb is defined as not achieving a response of CR or PR to a prior regimen 
containing anti-CD20 mAb, or disease progression occurring during treatment with, 
or relapse within 6 months after last dose of anti-CD20 mAb.) 
• The number of prior lines of therapy:  < 2 vs ≥ 2 
Participants with MZL will be stratified at the time of randomization for the following factor: 
• The number of prior lines of therapy:  < 2 versus ≥ 2 
Safety data will be reviewed by an IDMC, which will be convened periodically throughout this 
study as defined in the IDMC charter.  The first safety review meeting of IDMC will be held 
after the first 60 participants (approximately 30 in each treatment group) have completed 
2 cycles of study treatment to monitor and evaluate the safety of the combination treatment.  
Details on periodic safety review meetings are included in the IDMC charter. 
An interim analysis for futility will be performed at approximately 20% information rate (35 PFS 
events approximately) in the FL population.  An IDMC will be involved in reviewing the interim 
analysis and provide their recommendation as defined in the IDMC charter. 
An IRC will review PET and CT/MRI images to determine ORR, PFS, and DoR according to the 
Lugano response criteria (Cheson et al 2014) in the FL and overall populations.  
The study will employ safety monitoring activities that will comprise standard evaluation of 
AE/SAE/AESI reports (preferred term, incidence, toxicity grade, causality), performance status, 
physical examinations, and laboratory data assessed on an ongoing basis by the sponsor's 
responsible safety physicians and/or other nominated personnel to provide support in the review 
of safety data.  Such events will be graded using the NCI CTCAE, v5.0 or higher.  Laboratory 
safety assessments will include routine monitoring of hematology and blood chemistry and tests 
of immunologic parameters. 

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4.2. 
Overall Study Duration 
The total study duration from first-patient-first-visit to last-patient-last-visit is expected to be 
approximately 8 years. 
The study duration for an individual patient is divided into the screening period (up to 28 days), 
treatment period (up to 12 months), and follow-up period (up to 60 months after EOT, either 
completion of the last treatment cycle or treatment discontinuation). The total duration is up to 
approximately 6 years per participant. 
4.3. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator/head of study site (Japan) is to notify the 
IRB/IEC of the study's completion or early termination in writing, send a copy of the notification 
to the sponsor or sponsor's designee, and retain 1 copy for the site study regulatory file. 
The sponsor may terminate the study electively, if required by regulatory decision, or upon 
advice of the IDMC.  The IDMC may recommend termination of the study if warranted, as 
described in the IDMC Charter.  If the study is terminated prematurely, the sponsor will notify 
the investigators/head of study site (Japan), the IRBs, and regulatory bodies of the decision and 
reason for termination of the study.  For Japan, the decision from the sponsor will be via the head 
of the study site(s) who will notify the investigators and the IRBs of the decision and reason for 
termination of the study. 
The study may also be terminated by the local health authority, IRB, or IEC. 
5. 
STUDY POPULATION 
Deviations from eligibility criteria are not allowed because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or participant safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential.  Prospective approval of 
Protocol deviations to recruitment and enrollment criteria, also known as Protocol waivers or 
exemptions, are not permitted. 
At the sponsor's discretion, the sponsor may decide to use recruitment tools and vendors to 
support the enrollment activities.  Additionally, sites will complete participant enrollment forms 
for all participants being considered for this study.  Completed enrollment forms will be 
submitted to the sponsor along with completely redacted (pseudonymized) supportive 
documentation (eg, laboratory reports, pathology reports, imaging reports, and a brief summary 
of the participant's disease-specific medical history) that is necessary to confirm eligibility. The 
PI will be ultimately responsible for ensuring participants meet eligibility criteria.  
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Age ≥ 18 years at the time of signing the ICF. 
2. Ability to comprehend and willingness to sign a written ICF for the study. 

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3. Histologically confirmed Grade 1, 2, or 3a FL or histologically confirmed nodal MZL, 
splenic MZL, or extranodal MZL as assessed locally (Swerdlow et al 2016);
 
 
 
NOTE:  Participants with gastric MZL and evidence of Helicobacter pylori must have a 
documented nonresponse to antibiotic therapy prior to randomization. 
4. Willingness to avoid pregnancy or fathering children based on the criteria below. 
a. Male participants with reproductive potential must agree to take appropriate 
precautions to avoid fathering children (with at least 99% certainty) from screening 
through 180 days (6 months) after the last dose of study treatment, even if they have 
undergone a successful vasectomy, and must refrain from donating sperm during this 
period.  Permitted methods that are at least 99% effective in preventing pregnancy 
(see Appendix A) should be communicated to the participants and their understanding 
confirmed. 
b. WOCBP participants: 
− Must commit either to abstain continuously from heterosexual sexual intercourse 
or agree to take appropriate precautions to avoid pregnancy (by using 2 different 
methods of birth control:  one with at least 99% certainty and an additional 
effective [barrier] method) starting at least 4 weeks before taking the study 
treatment, while taking the study treatment, during breaks (dose interruptions), 
and for at least 180 days (6 months) after stopping the study treatment.  Permitted 
methods that are at least 99% effective in preventing pregnancy and the permitted 
additional effective (barrier) methods (see Appendix A) should be communicated 
to the participants and their understanding confirmed. 
Note:  Because of the increased risk of venous thromboembolism, combined oral 
contraceptive pills are not recommended.  If a participant is currently using 
combined oral contraception, the participant should switch to one of the effective 
methods listed in Appendix A.  The risk of venous thromboembolism continues 
for 4 to 6 weeks after discontinuing combined oral contraception. 
− Must have a negative serum pregnancy test at screening (within 10-14 days of the 
first study drug treatment) and before the first dose on Day 1 (within 24 hours of 
initiating treatment with lenalidomide). 
− Agree to ongoing pregnancy testing during the course of the study; weekly during 
the first month of study drug treatment, then monthly thereafter for women with 
regular menstrual cycles or every 2 weeks for women with irregular menstrual 
cycles (even if true abstinence is the chosen method of birth control) up to and 
including the EOT visit. 
− Must refrain from breastfeeding and donating oocytes during the course of study 
and for 180 days (6 months) after the last dose of study treatment. 

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c. A woman not considered to be of childbearing potential as defined in Appendix A is 
eligible. 
Note:  The participants should be informed about the option of donation and 
cryopreservation of germ cells before the study if applicable. 
5. All participants must: 
a. Have an understanding that lenalidomide could have a potential teratogenic risk. 
b. Abstain from donating blood while on study treatment and for 28 days after 
discontinuation of study treatment. 
c. Not share any study medications with another person. 
d. Agree to be counseled about pregnancy precautions and risk of fetal exposure. 
e. In the opinion of the investigator, be able and willing to receive adequate mandatory 
prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily 
or low-molecular-weight heparin).  Participants unable or unwilling to take any 
prophylaxis are not eligible. 
f. In the opinion of the investigator, be able to understand and comply with all 
study-related procedures, medication use, and evaluations. 
g. In the opinion of the investigator, not have a history of noncompliance or be 
considered potentially unreliable and/or uncooperative. 
6. Tumor tissue sufficient for retrospective central pathology review and correlative studies 
must be provided to participate in this study; a new biopsy must be performed if 
progression or relapse of disease is within 24 months from the initial diagnosis (POD24) 
to exclude transformed cases and potentially misdiagnosed cases.  NOTE:  A more recent 
biopsy is preferred if clinically feasible but if not, an archival specimen is acceptable 
except in cases of POD24 (refer to the Laboratory Manual). 
7. Must have been previously treated with at least 1 prior systemic anti-CD20 
immunotherapy or chemo-immunotherapy.  This includes treatments such as the 
following:  rituximab monotherapy or chemotherapy plus immunotherapy with rituximab 
or obinutuzumab, with or without maintenance.  Note:  At least 4 doses of anti-CD20 
immunotherapy must have been given in prior therapy.  Note:  Systemic therapy does not 
include, for example, local involved field radiotherapy for limited stage disease, 
HBV/HCV therapy, or H pylori eradication. 
8. Must have documented relapsed, refractory, or PD after treatment with systemic therapy 
(a participant in remission [in CR or PR] after the last prior treatment line would not be 
eligible).   
a. Relapsed lymphoma:  relapsed after initial response of CR or PR ≥ 6 months after 
prior therapy. 
b. Refractory lymphoma:  achieved less than PR to the last treatment or achieved a CR 
or PR that lasted less than 6 months. 
c. Progressive lymphoma:  PD after initial response of SD to prior therapy. 
9. Must be in need of treatment for relapsed, refractory, or PD as assessed by the 
investigator.  NOTE:  For FL only, refer to GELF criteria (see Appendix G) as a 
guidance. 

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10. Participants must have at least 1 measurable disease site.  A radiographically measurable 
lymphadenopathy is defined as at least 1 nodal lesion > 1.5 cm in longest diameter or at 
least 1 extranodal lesion > 1.0 cm in longest diameter (Cheson et al 2014).  The lesion 
must be confirmed to be measurable by CT, MRI, or PET-CT, at the latest at the time of 
randomization. 
Note:  Participants with PET-negative lesions that are measurable by CT or MRI are 
eligible and followed up with CT or MRI only as described in Section 8.2.4. 
11. ECOG performance status of 0 to 2. 
12. Participants with laboratory values at screening defined in Table 6. 
Table 6: 
Inclusionary Laboratory Values 
Laboratory Parameter 
Inclusion Criterion 
Hematology (hematological laboratory values should be considered in the absence of growth 
factors or transfusions) 
a 
Platelets 
≥ 75 × 109/L (unless secondary to BM involvement as 
demonstrated by BM biopsy). 
b 
ANC 
≥ 1.5 × 109/L (unless secondary to BM involvement as 
demonstrated by BM biopsy). 
c 
Hemoglobin  
≥ 8.0 g/dL (unless secondary to BM involvement as 
demonstrated by BM biopsy). 
Hepatic 
d 
ALT 
≤ 3 × ULN or < 5 × ULN in cases of documented liver 
involvement. 
e 
AST 
≤ 3 × ULN or < 5 × ULN in cases of documented liver 
involvement. 
f 
Total serum bilirubin 
≤ 1.5 × ULN unless secondary to Gilbert's syndrome or 
documented liver involvement by lymphoma.  Participants 
with Gilbert's syndrome or documented liver involvement 
by lymphoma may be included if their total bilirubin is 
≤ 5 × ULN. 
g 
Alkaline phosphatase 
≤ 3 × ULN or < 5 × ULN in cases of documented liver 
involvement. 
Renal 
h 
Serum creatinine clearance 
≥ 30 mL/min either measured or calculated using a 
standard Cockcroft and Gault formula (Cockcroft and 
Gault 1976). 

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5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Women who are pregnant or breastfeeding.  For Japan, women who are breastfeeding and 
wish to enroll must discontinue breastfeeding at least 90 days before receiving study 
drug/treatment.  They must also refrain from breastfeeding during the course of study and 
for 90 days after the last dose of study treatment. 
2. History of or current histology other than FL and MZL or clinical evidence of 
transformed lymphoma by INV assessment. 
3. History of radiation therapy to ≥ 25% of the BM for other diseases. 
4. History of prior nonhematologic malignancy except for the following: 
a. Malignancy treated with curative intent and with no evidence of active disease for 
more than 2 years before screening. 
b. Adequately treated lentigo maligna melanoma without current evidence of disease or 
adequately controlled nonmelanomatous skin cancer. 
c. Adequately treated carcinoma in situ without current evidence of disease. 
5. Congestive heart failure (left ventricular ejection fraction of < 50%, assessed by 
2D-echocardiography or MUGA scan. 
6. Participants with: 
a. Known positive test result for HCV (with anti-HCV serology testing) and a positive 
test for HCV RNA. 
Note:  Participants with positive serology must have been tested for HCV RNA and 
are eligible only in the case of negative HCV RNA. 
b. Known positive test result for chronic HBV infection (defined by HBsAg positivity). 
Note:  Participants with occult or prior HBV infection (defined as negative HBsAg 
and positive total HBcAb) may be included if HBV DNA was undetectable, provided 
that they are willing to undergo monthly ongoing DNA testing.  Antiviral prophylaxis 
may be administered as per institutional guidelines.  Participants who have protective 
titers of HBsAb (HBsAb positive, HBcAb negative, and HBsAg negative) after 
vaccination or previously cured hepatitis B are eligible. 
c. Seropositivity for or history of active viral infection with human immunodeficiency 
virus (HIV). 
7. Active systemic infection (including SARS-CoV-2–positive test). 
8. Participants in a severely immunocompromised state. 
9. Known CNS lymphoma involvement. 
10. Uncontrolled concurrent illness. 
11. 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 participant's ability to give informed consent. 
12. Life expectancy < 6 months. 

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13. History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase 
deficiency, or glucose-galactose malabsorption. 
14. Major surgery (excluding lymph node biopsy) within 28 days prior to signing the ICF 
unless the participant is recovered at the time of signing the ICF. 
15. Any systemic antilymphoma and/or investigational therapy within 28 days prior to the 
start of Cycle 1. 
16. Administration of a live vaccine within 28 days prior to the start of study treatment 
(Cycle 1 Day 1). 
17. Prior use of lenalidomide in combination with rituximab. 
18. History of hypersensitivity to compounds of similar biological or chemical composition 
to tafasitamab, immunomodulatory drugs, rituximab, other mAbs, and/or the excipients 
contained in the study drug formulations. 
19. Any condition that would, in the investigator's judgment, interfere with full participation 
in the study, including administration of study treatment and attending required study 
visits; pose a significant risk to the participant; or interfere with interpretation of study 
data. 
5.3. 
Lifestyle Considerations 
No restrictions are required. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently randomly assigned to study treatment. 
A participant can be rescreened at the discretion of the investigator under certain circumstances.  
Rescreening is restricted to 1 attempt per participant and can only be performed if 1 of the 
following criteria is met: 
• The participant has already consented and met all of the inclusion and none of the 
exclusion criteria, and randomization was delayed due to an unexpected change in the 
participant's personal situation (eg, family issues). 
• The participant previously failed to be eligible due to any event (eg, planned surgery, 
laboratory test result) that has been resolved. 
Note:  A participant should only be rescreened if there is a clear indication that the participant 
may be eligible according to the currently valid study Protocol. 
If previous screening activities were discontinued and enrollment did not occur, the following 
procedures should be implemented: 
• The eligible participant will receive a new participant number via the IRT. 
• A new eCRF will be completed. 
• The participant will be documented as rescreened in the source documents. 
• A new ICF will be signed as per Section 8.1.1. 
A rescreened participant can be randomized if all of the inclusion criteria and none of the 
exclusion criteria are met and all assessments have been performed as per Table 3 and Table 4. 

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5.5. 
Replacement of Participants 
No participants will be replaced at any time during this study. 
5.6. 
Independent Data Monitoring Committee 
An IDMC will monitor data to ensure the safety of the participants enrolled in this study, and 
evaluate the efficacy of the treatment.  The IDMC will consist of an independent group of 
clinical and statistical experts who are not involved in the management of the current study. 
The IDMC will have access to unblinded aggregated interim data to make recommendations, 
suggest clinical study Protocol changes, or terminate the study.  An unblinded, 
study-independent group from the CRO will support the IDMC activities.  All other study 
personnel will have access to blinded safety and efficacy data only. 
The IDMC safety review will focus on deaths, treatment discontinuations, SAEs, events 
≥ Grade 3, and AESIs.  The details of the analyses will be defined in the IDMC charter. 
The details regarding IDMC constitution, responsibilities, authorities, and procedures and the 
process by which the IDMC will make recommendations and decisions are provided in the 
IDMC charter.  The charter also defines and documents the content of the safety summaries and 
general procedures (including communications). 
The IDMC will meet on the following schedule: 
• After the first 60 randomized participants (approximately 30 in each treatment group) 
complete at least the first 2 study treatment cycles (8 weeks).  The IDMC will review 
the safety data to monitor and evaluate the safety of the combination treatment and 
provide recommendation on whether the combination treatments are safe. 
• Following the first meeting, the IDMC will meet approximately every 6 months. 
• An interim analysis for nonbinding futility is planned at approximately 20% 
information rate (approximately 35 PFS events) in the FL population.  The interim 
analyses for futility will be conducted by an external unblinded statistician and will 
be reviewed by the IDMC; the IDMC will use the guidelines provided in Section 10.5 
for recommendation of either continuation or early termination of the study at the 
interim analysis. 
• In addition, both the sponsor and the IDMC can request ad-hoc meetings for any 
reasons. 
All AEs meeting SAE/AESI criteria will be reviewed by the sponsor's responsible safety 
physician on an ongoing basis and in a blinded manner to identify safety concerns.  The IDMC 
will be informed of SUSARs according to expedited reporting rules, and about any potential 
safety signals. 
Following each meeting, the IDMC will recommend to the sponsor whether the study should 
continue according to the Protocol or may suggest changes to the Protocol based on the outcome 
of data review.  The sponsor will make the final decision for continuation or discontinuation of 
the study on the basis of the IDMC's recommendation. 

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6. 
STUDY TREATMENT 
6.1. 
Study Treatments Administered 
A treatment cycle is defined as 28 calendar days and includes treatment with 
tafasitamab/placebo, lenalidomide, and rituximab.  The treatment period for each participant 
starts with the first administration of study treatment on Cycle 1, Day 1 (C1D1).  Study drugs are 
tafasitamab/placebo, lenalidomide, and rituximab.  Tafasitamab, lenalidomide, and rituximab are 
considered IMPs (see Table 7).  
Tafasitamab (12 mg/kg IV) or placebo (0.9% saline solution IV) 
• Administered Cycles 1 to 3 on Days 1, 8, 15, and 22, and Cycles 4 to 12 on Days 1 and 
15.   
• Tafasitamab will be supplied by the sponsor to an unblinded pharmacy.  The placebo will 
be locally sourced and delivered to an unblinded pharmacy.  In case of changes in body 
weight, tafasitamab dosing should be based on the participant's weight as assessed at the 
most recent treatment cycle. 
Rituximab (including biosimilars; 375 mg/m2 IV) 
• Administered Cycle 1 on Days 1, 8, 15, and 22, and Cycles 2 to 5 on Day 1.   
• Rituximab should be administered approximately 30 minutes after the 
tafasitamab/placebo infusion is completed but no less than 15 minutes.  Sites have the 
option for the sponsor to provide rituximab via the IRT.  Rituximab may also be 
obtained by the sites, where applicable.  For logistical reasons, rituximab may be 
administered on the day after the tafasitamab infusion, or administration may be split 
over 2 consecutive days, according to local practice and the institution's standard of care. 
Lenalidomide (including generics) (20 mg PO QD*) 
• Administered Cycles 1 to 12 on Days 1 to 21 at approximately the same time every day.  
Lenalidomide will be provided by the sponsor to the sites.   
• *For participants with moderate renal insufficiency (creatinine clearance ≥ 30 mL/min to 
< 60 mL/min), the starting dose of lenalidomide must be reduced to of 10 mg daily using 
the same schedule. The dose of lenalidomide may be increased to 15 mg QD on Days 1 
to 21 of each cycle if no Grade 3/4 lenalidomide-related toxicities occur after 2 cycles.  
Table 7 presents the study treatment information. 

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Table 7: 
Study Treatment Information 
 
Study Treatment 1 
Study Treatment 2 
Study Treatment 3 
Study treatment name: 
Tafasitamab 
Lenalidomide 
Rituximab 
Mechanism of action: 
Fc-enhanced, humanized mAb against the pan 
B-cell antigen CD19 
Activates and increases number of T cells and 
NK cells, inhibits proinflammatory cytokines 
by monocytes, inhibits cell proliferation, and 
induces inhibition of tumor growth. 
Direct effects:  complement-mediated 
cytotoxicity and ADCC. 
Dosage formulation: 
Powder for concentrate for solution for 
infusion 
Capsules for oral administration 
Solution for infusion 
Unit dose strength(s)/ 
dosage level(s): 
200 mg in glass vials  
Various strengths (refer to the Pharmacy 
Manual) 
Rituximab (originator or biosimilar) will be 
prescribed and administered according to 
institutional guidelines. 
Administration 
instructions: 
Administered as an IV infusion at a dose of 
12 mg/kg. 
First infusion:  70 mL/h for the first 
30 minutes and increased to 125 mL/h; total 
infusion duration approximately 2.5 hours. 
Subsequent infusions:  125 mL/h over 
approximately 2-hours. 
Tafasitamab is NOT to be administered as an 
IV push or bolus.a 
Dispensed at the beginning of each cycle. 
Participants will self-administer lenalidomide 
at a starting dose of 20 mg PO QD.  
 
Participants with renal impairment will have a 
starting dose of 10 mg PO QD. 
Administered as an IV infusion at the dose of 
375 mg/m2 
Rituximab will be administered under the 
direct supervision of clinical study site 
personnel. 
Rituximab will be administered until Cycle 5. 
Sites should follow product insert instructions 
for administration adjustments due to toxicity. 
Packaging and labeling: 
Supplied by sponsor in single-use 20 mL 
glass vials. 
Each vial will be labeled as required per 
country requirement. 
Lenalidomide (including generic drugs) from 
a commercial source. 
Each container will be labeled as required per 
country requirement. 
Commercial source 
Storage: 
Vials must be stored at 2°C to 8°C in the 
original package accessible only to the 
unblinded clinical study site pharmacy 
personnel. 
As per the label. 
As per the label. 
Status of treatment in 
participating countries: 
Investigational 
Investigational 
Considered non-IMP in Japan 
Investigational 
Considered non-IMP in Canada, Australia, 
South Korea, Taiwan, and Turkey  
a The infusion rate escalation schedules in this Protocol and the Pharmacy Manual are recommendations.  If required, the investigator should use clinical judgment to optimize 
participant safety by administering the infusion more slowly. 

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6.2. 
Preparation, Handling, and Accountability 
6.2.1. 
Tafasitamab/Placebo Preparation 
Reconstitution of tafasitamab vials will yield 40 mg/mL tafasitamab in 25 mM sodium citrate, 
200 mM trehalose, and 0.02% (w/v) polysorbate 20 at pH 6.0.  Each product vial is intended to 
deliver 200 mg of tafasitamab in 5 mL of reconstituted solution.  The solution is colorless to 
slightly yellow and should be free of foreign particles; the solution may contain a few whitish 
product-related particles. 
For administration, reconstituted tafasitamab will be diluted into a commercially available 
infusion container with 0.9% (w/v) sodium chloride for injection to achieve a diluted tafasitamab 
solution concentration between 2 and 8 mg/mL.  Infusion container volumes should be 250 mL; 
however, participants weighing less than 42 kg or above 160 kg will require a different size 
infusion bag to ensure the concentration of tafasitamab is between 2 and 8 mg/mL.  Refer to the 
Pharmacy Manual for guidance. 
Tafasitamab infusion bag preparation should be prepared using an aseptic technique and 
administered at the clinical study site according to direction from the sponsor.  Details for 
tafasitamab reconstitution, preparation, and infusion are included in the Pharmacy Manual. 
Participants randomized to the placebo arm will receive 0.9% saline for infusion.  Refer to the 
Pharmacy Manual for guidance. 
Materials and methods for blinding the infusion bags and infusion lines are outlined in the 
Pharmacy Manual and in the Blinding Procedure document. 
6.2.2. 
Handling and Accountability of Study Treatment 
In the below section, the term "investigator" also represents the investigational drug storage 
manager for Japan as applicable. 
Each investigator is responsible for ensuring that deliveries of study drugs 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. 
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatments received and any discrepancies are reported and 
resolved before use of the study treatment. 
Only participants enrolled in the study may receive study treatment, and only authorized site 
staff may supply or administer study treatment.  All study treatment must be stored in a secure, 
environmentally controlled, and monitored (manual or automated) area in accordance with the 
labeled storage conditions with access limited to the investigator and authorized site staff. 
6.2.3. 
Unblinded Site Staff, Handling, and Accountability 
While the investigator (or designee) has ultimate responsibility for study treatment 
accountability, reconciliation, and record maintenance (ie, receipt, reconciliation, and final 
disposition records), during the conduct of the study in order to maintain the study blind, an 

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unblinded team consisting of an unblinded pharmacist and an unblinded nurse/medically 
qualified individual to oversee the infusion administration.  Blinding materials (eg, Myonex 
infusion bag covers and infusion line covers) are provided by the sponsor.  Refer to the Blinding 
Procedures document for additional details. 
Inventory and accountability records must be maintained by the unblinded pharmacist and only 
accessible by unblinded study staff members.  The documents must be consistently updated by 
the unblinded study staff and be readily available for inspection by the unblinded study monitor 
and open to inspection at any time by any applicable regulatory authority.  The unblinded 
pharmacist must maintain records that document: 
• Delivery of study drugs to the study site. 
• Inventory of study drugs at the site. 
• Participant use of the study drugs, including lot numbers and/or vial numbers, and 
vial counts from each supply dispensed. 
• Inventory or documentation for destruction of used vials/infusion materials. 
• Return of study drugs to the unblinded pharmacist by participants (lenalidomide). 
The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the participants were provided the 
specified study drug.  These records should include dates, quantities, and any available batch or 
serial numbers or unique code numbers assigned to the investigational product and study 
participants. 
Completed accountability records will be archived by the site.  The unblinded pharmacist will be 
expected to collect and retain all used, unused, and partially used containers of study drugs until 
verified by the study monitor, unless otherwise agreed to by the sponsor based on institutional 
procedures.  At the conclusion of the study, the unblinded pharmacist will oversee shipment of 
any remaining study drug back to the sponsor or its designee for destruction according to 
institutional procedures.  If local procedures mandate on-site destruction of the investigational 
supply, the site should (where local procedures allow) maintain the investigational supply until 
the unblinded study monitor inspects the accountability records in order to evaluate compliance 
and accuracy of accountability by the investigative site.  At sites where the study drug is 
destroyed before unblinded monitor inspection, the unblinded monitors will rely on 
documentation of destruction per the institutional procedure. 
Study drug/treatment will be dispensed at the study visits summarized in the SoA (see Table 3). 
Returned study drug/treatment must not be redispensed to the participants. 
Further guidance and information for the final disposition of unused study treatments are 
provided in the Pharmacy Manual. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
Stratified randomization will be done through IRT using the stratification factors described 
below.  Stratified randomization will be performed separately for participants with FL and MZL. 

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Participants with FL will be stratified at the time of randomization for the following factors: 
• POD24 (yes vs no) 
• Refractoriness to prior anti-CD20 mAb therapy (yes vs no) 
• The number of prior lines of therapy (< 2 vs ≥ 2). 
Participants with MZL will be stratified at the time of randomization for the following factor: 
• The number of prior lines of therapy (< 2 vs ≥ 2). 
Further details of procedures regarding participant randomization and treatment assignment is 
provided in the Suvoda IRT Site User Manual. 
Block size and block permutation algorithms are specified in a separate Randomization Plan.  
Blinded treatment will be used to reduce potential bias during data collection and evaluation of 
clinical endpoints.  Details of tafasitamab/placebo treatment blinding will be outlined in the 
Pharmacy Manual.  This is a double-blind study; therefore, participants, investigators, and the 
study team members will remain blinded to treatment assignment.  The investigator will not be 
provided with randomization codes. 
Data that may potentially unblind the treatment assignment (ie, study treatment concentrations) 
will be handled with special care to ensure that the integrity of the blind is maintained, and the 
potential for bias is minimized.  This will include making special provisions such as segregating 
the data in question from view by the investigators, clinical team, or others as appropriate until 
the time of database lock and/or unblinding. 
Participants, investigators, and the study team members will remain blinded to treatment 
assignment until the time of the primary analysis.  Unblinding procedures and the control of the 
unblinded data are described in the IDMC charter.  Examples of personnel who may be 
unblinded during the study are as follows: 
• The IDMC and the biostatistician and statistical programmers from an independent 
statistical support group who are responsible for preparing interim tables, listings, and 
graphs for IDMC review. 
 
 
• The sponsor's safety team in order to fulfill regulatory reporting requirements for 
SUSARs. 
• In case of an urgent safety concern, the clinical study site personnel and the sponsor 
may be unblinded if treatment assignment information is needed to determine further 
actions to address the urgent safety concern (eg, life-threatening event, medication 
error such as an accidental overdose). 
6.4. 
Study Treatment Compliance 
Compliance with study treatment administration will be calculated by the sponsor based on study 
drug accountability and infusion records documented by the site staff and monitored by the 
sponsor/designee. 

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Participants should receive tafasitamab/placebo under direct supervision of clinical study site 
unblinded personnel.  Each administration volume will be checked, and the vial code and volume 
per administration will be recorded in each participant's eCRF as well as in the source data.  
Unblinded data for tafasitamab will be captured in a separate eCRF database via the IRT system 
and will be monitored by an unblinded CRA.  Refer to the Pharmacy Manual and Suvoda IRT 
Site User Manual for details. 
The dosing of tafasitamab or placebo will be considered appropriate if the dose administered is 
≥ 80% to ≤ 120% of the assigned dose per single infusion.  Overdose treatment is described in 
Section 9.10. 
Lenalidomide will be dispensed on Day 1 of each new treatment cycle.  Participants will return 
all unused or empty lenalidomide blister packs to the clinical study site throughout the treatment 
period as instructed by the investigator, and keep a record of lenalidomide doses taken at home, 
which will be reviewed by clinical study site personnel on an ongoing basis.  The clinical site 
personnel will document the amount of study drug received from and returned to the sponsor and 
dispensed to participants in accordance with local regulatory requirements.  Throughout the 
course of the study, drug accountability records must be maintained.  A participant will be 
considered compliant with the Protocol if the lenalidomide dose administered is ≥ 80% to 100% 
of the assigned dosage.  Overdose treatment is described in Section 9.10. 
6.5. 
Dose Modifications 
6.5.1. 
Tafasitamab/Placebo Dose Modifications 
Dose reductions of tafasitamab/placebo are not permitted.  Drug interruptions or discontinuation 
may occur in the case of severe IRRs, allergic reactions, infections, febrile neutropenia, or severe 
hematologic toxicity.  Delaying the administration of tafasitamab/placebo is permitted for no 
more than 2 days.  If the delay lasts more than 2 days, administration of tafasitamab/placebo 
must be skipped completely, and the next scheduled dose will be administered (eg, if an infusion 
is skipped on Day 8, the next dose will be administered on Day 15). 
6.5.2. 
Criteria and Procedures for Dose Interruptions and Adjustments of 
Tafasitamab/Placebo 
6.5.2.1. 
Management of Tafasitamab/Placebo Infusion-Related Reactions and Cytokine 
Release Syndrome 
Infusion-related reactions will be defined according to the NCI CTCAE v5.0 definition of IRR 
and CRS (see Table 8). 

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Table 8: 
Definition of Infusion-Related Reactions and Cytokine Release Syndrome 
Adverse Event 
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 
(eg, antihistamines, 
NSAIDs, narcotics, 
IV fluids); 
prophylactic 
medications indicated 
for ≤ 24 hours  
Prolonged (ie, 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% O2a 
Hypotension managed 
with one pressor; 
hypoxia requiring 
≥ 40% O2a 
Life-threatening 
consequences; 
urgent intervention 
indicated  
NSAIDs = nonsteroidal anti-inflammatories. 
a Applied, for example, via breathing mask. 
Source:  NCI CTCAE v5.0 (2017). 
Note:  An acute IRR may occur with an agent that causes cytokine release (eg, mAbs 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 of 
an acute IRR may include (but are not limited to) the following:  allergic 
reaction/hypersensitivity (including drug fever), arthralgia (joint pain), bronchospasm, cough, 
dizziness, dyspnea, 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. 
6.5.2.2. 
Interventions for Infusion-Related Reactions and Cytokine Release Syndrome 
6.5.2.2.1. Grade 2 Infusion-Related Reactions, Grade 1 Cytokine Release Syndrome 
The following should occur if a participant presents with a Grade 2 IRR or Grade 1 CRS: 
• The infusion should be stopped immediately. 
• The participant 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 reduced to Grade 1 (IRR) according to 
investigator assessment, the infusion can be continued at 50% of the last infusion rate.  
If, after 1 hour, the participant's symptoms do not return and vital signs are stable, the 
infusion rate may be increased every 30 minutes, as tolerated, to the baseline rate. 
If a participant who developed a Grade 2 IRR or Grade 1 CRS receives further infusions of 
tafasitamab/placebo, then premedication should be given before all subsequent infusions of 
tafasitamab/placebo throughout the study. 

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If a participant develops an additional episode, that is, a recurrent Grade 2 IRR or Grade 1 CRS, 
then the participant may receive further tafasitamab/placebo based on the investigator's decision, 
provided clinically appropriate precautions are undertaken.  Premedication must be given before 
all subsequent infusions of tafasitamab/placebo. 
If precluded from further tafasitamab/placebo administrations, the participant may continue 
treatment with rituximab and/or lenalidomide. 
6.5.2.2.2. Grade 3 Infusion-Related Reactions, Grade 2 Cytokine Release Syndrome 
The following should occur if a participant presents with a Grade 3 IRR or Grade 2 CRS: 
• The infusion should be stopped immediately. 
• Appropriate treatment with an antihistamine and/or acetaminophen (paracetamol) or 
methylprednisolone (or equivalent) and, if necessary, further medications 
(ie, epinephrine, bronchodilator). 
• Only after the complete resolution of all symptoms and after having received 
appropriate prophylactic medication(s) as described above, the infusion may be 
resumed at 25% of the last infusion rate.  If, after approximately 1 hour, the 
participant's symptoms do not return and vital signs are stable, the infusion rate may 
be increased every 30 minutes to a maximum of 50% of the baseline rate. 
• If, after the resumption of the infusion, symptoms return (irrespective of grade), the 
infusion must be stopped immediately, and the infusion tubing disconnected from the 
participant. 
Based on the investigator's decision, the participant may receive further tafasitamab/placebo 
provided clinically appropriate precautions are undertaken.  If a participant who developed a 
Grade 3 IRR or Grade 2 CRS receives further infusions, then premedication will be given before 
all subsequent infusions of tafasitamab/placebo throughout the study. 
If a participant develops another Grade 3 IRR or Grade 2 CRS, then the participant will be 
permanently discontinued from further tafasitamab/placebo administrations.  If 
tafasitamab/placebo is discontinued, the participant may still continue to receive treatment with 
rituximab and lenalidomide. 
6.5.2.2.3. Grade 4 Infusion-Related Reactions, Grade 3 to 4 Cytokine Release Syndrome 
The following must occur if a participant presents with a Grade 4 infusion reaction or Grade 3 to 
4 CRS: 
• The infusion must be stopped immediately, and the infusion tubing disconnected from 
the participant. 
• Appropriate treatment with an antihistamine and/or acetaminophen (paracetamol) or 
methylprednisolone (or equivalent) and, if necessary, further medications 
(ie, epinephrine, bronchodilator). 
• The participant will be permanently discontinued from further tafasitamab/placebo 
administrations. 

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If tafasitamab/placebo is discontinued, the participant may continue treatment with rituximab and 
lenalidomide. 
6.5.3. 
Criteria and Procedures for Dose Interruptions or Adjustments of Lenalidomide 
Lenalidomide dose adjustments will be performed according to the label as described in 
Appendix B and in Section 6.5.5. 
6.5.4. 
Criteria and Procedures for Dose Interruptions or Adjustments of Rituximab 
Dose modifications of rituximab are not mandated unless clinically indicated as per the SmPC, 
the USPI, and applicable institutional guidelines (MabThera 2020, Rituxan 2020). 
6.5.5. 
Toxicity Management Guidelines for Hematological Toxicities 
In case of hematologic toxicities, tafasitamab/placebo, lenalidomide and/or rituximab treatment 
may need to be interrupted or discontinued according to the toxicity management guidelines 
provided in Table 9. 
Delaying the tafasitamab/placebo dose or the rituximab dose is permitted for no more than 
2 days (≤ 2 days).  If a tafasitamab/placebo or rituximab infusion is delayed for 3 or more days 
(≥ 3 days), then this infusion should be skipped and tafasitamab/placebo or rituximab treatment 
continued only at the next scheduled timepoint.  Investigators may choose to follow their 
institution's standard of care for delayed dosing due to toxicity for lenalidomide and rituximab.  
This is acceptable and should be noted in the participant's medical record. 
Dose reductions of tafasitamab/placebo or rituximab are not permitted.  See Table 9 and 
Appendix A for guidance on dose adjustments for lenalidomide. 

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Table 9: 
Toxicity Management Guidelines for Hematological Toxicities 
Adverse Eventa 
Tafasitamab/Placebo 
Lenalidomide 
Rituximab 
Thrombocytopenia 
Grade 3 (platelets 
< 50-25 G/L) 
with or without 
bleeding 
• Interrupt tafasitamab/ 
placebo. 
• Follow CBC at least every 
7 days. 
• If thrombocytopenia has 
resolved to ≤ Grade 2 
(platelets ≥ 50 G/L), 
restart tafasitamab/ 
placebo at the same dose. 
• Monitor as clinically 
indicated. 
• Interrupt lenalidomide. 
• Follow CBC at least 
every 7 days. 
• If thrombocytopenia has 
resolved to ≤ Grade 2 
(platelets ≥ 50 G/L), 
restart lenalidomide at 
the next lower dose level 
(see Appendix B). 
• Monitor as clinically 
indicated 
• Interrupt rituximab. 
• Follow CBC at least 
every 7 days. 
• If thrombocytopenia has 
resolved to ≤ Grade 2 
(platelets ≥ 50 G/L), 
restart rituximab at the 
same dose. 
• Monitor as clinically 
indicated. 
Thrombocytopenia 
Grade 4 (platelets 
< 25 G/L) 
• Interrupt tafasitamab/ 
placebo. 
• Follow CBC at least every 
7 days. 
• If thrombocytopenia has 
resolved to ≤ Grade 2 
(platelets ≥ 50 G/L), 
restart tafasitamab/ 
placebo at the same dose. 
• Monitor as clinically 
indicated. 
• Interrupt lenalidomide 
• Follow CBC at least 
every 7 days. 
• If thrombocytopenia has 
resolved to ≤ Grade 2 
(platelets ≥ 50 G/L), 
restart lenalidomide at 
the next lower dose level 
(see Appendix B). 
• Monitor as clinically 
indicated 
• Interrupt rituximab. 
• Follow CBC at least 
every 7 days. 
• If thrombocytopenia has 
resolved to ≤ Grade 2 
(platelets ≥ 50 G/L), 
restart rituximab at the 
same dose. 
• Monitor as clinically 
indicated. 
Thrombocytopenia 
Grade 3-4 
• Interrupt VTE prophylaxis. 
• Consider platelet transfusion. 
• Consider change of VTE prophylaxis agent (eg, 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. 
Neutropenia Grade 3 
(ANC < 1.0 G/L) 
sustained < 7 days 
• Interrupt tafasitamab/ 
placebo. 
• Follow CBC at least every 
7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial prophylaxis 
as per local guidelines. 
• If neutropenia has resolved 
to ≤ Grade 2 (ANC 
≥ 1.0 G/L), restart 
tafasitamab/placebo at the 
same dose. 
• Monitor as clinically 
indicated. 
• Interrupt lenalidomide. 
• Follow CBC at least 
every 7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial 
prophylaxis as per local 
guidelines. 
• If neutropenia has 
resolved to ≤ Grade 2 
(ANC ≥ 1.0 G/L), restart 
lenalidomide at the same 
dose. 
• Monitor as clinically 
indicated. 
• Interrupt rituximab. 
• Follow CBC at least 
every 7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial 
prophylaxis as per local 
guidelines. 
• If neutropenia has 
resolved to ≤ Grade 2 
(ANC ≥ 1.0 G/L), restart 
rituximab at the same 
dose. 
• Monitor as clinically 
indicated. 

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Table 9: 
Toxicity Management Guidelines for Hematological Toxicities (Continued) 
Adverse Eventa 
Tafasitamab/Placebo 
Lenalidomide 
Rituximab 
Neutropenia Grade 3 
(ANC < 1.0 G/L) 
with a temperature of 
≥ 38.5°C/ 101.3°F 
(febrile neutropenia) 
• Interrupt tafasitamab/ 
placebo. 
• Follow CBC at least every 
7 days. 
• Use growth factors (eg, 
G-CSF) and antimicrobial 
prophylaxis as per local 
guidelines. 
• If fever is resolving 
(< 38.0°C/100.4°F) and 
neutropenia has resolved 
to ≤ Grade 2 (ANC 
≥ 1.0 G/L), restart 
tafasitamab/placebo at the 
same dose. 
• Monitor as clinically 
indicated. 
• Interrupt lenalidomide. 
• Follow CBC at least 
every 7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial 
prophylaxis as per local 
guidelines. 
• If fever is resolving 
(< 38.0°C/100.4°F) and 
neutropenia has resolved 
to ≤ Grade 2 (ANC 
≥ 1.0 G/L), restart 
lenalidomide at the next 
lower dose level (see 
Appendix B). 
• Monitor as clinically 
indicated. 
• Interrupt rituximab. 
• Follow CBC at least 
every 7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial 
prophylaxis as per local 
guidelines. 
• If fever is resolving 
(< 38.0°C/100.4°F) and 
neutropenia has resolved 
to ≤ Grade 2 (ANC 
≥ 1.0 G/L), restart 
rituximab at the same 
dose. 
• Monitor as clinically 
indicated. 
Neutropenia Grade 4 
(ANC < 0.5 G/L) 
with or without a 
temperature of 
≥ 38.5°C/ 101.3°F 
• Interrupt tafasitamab/ 
placebo. 
• Follow CBC at least every 
7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial prophylaxis 
as per local guidelines. 
• If neutropenia has resolved 
to ≤ Grade 2 (ANC 
≥ 1.0 G/L), restart 
tafasitamab/placebo at the 
same dose. 
• Monitor as clinically 
indicated. 
• Interrupt lenalidomide. 
• Follow CBC at least 
every 7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial 
prophylaxis as per local 
guidelines. 
• If neutropenia has 
resolved to ≤ Grade 2 
(ANC ≥ 1.0 G/L), restart 
lenalidomide at the next 
lower dose level (see 
Appendix B). 
• Monitor as clinically 
indicated. 
• Interrupt rituximab. 
• Follow CBC at least 
every 7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial 
prophylaxis as per local 
guidelines. 
• If neutropenia has 
resolved to ≤ Grade 2 
(ANC ≥ 1.0 G/L), restart 
rituximab at the same 
dose. 
• Monitor as clinically 
indicated. 

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Table 9: 
Toxicity Management Guidelines for Hematological Toxicities (Continued) 
Adverse Eventa 
Tafasitamab/Placebo 
Lenalidomide 
Rituximab 
Neutropenia 
Grade 3-4 sustained 
≥ 7 days 
• Interrupt tafasitamab/ 
placebo. 
• Follow CBC at least every 
7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial prophylaxis 
as per local guidelines. 
• If neutropenia has resolved 
to ≤ Grade 2 (ANC 
≥ 1.0 G/L), restart 
tafasitamab/placebo at the 
same dose. 
• Monitor as clinically 
indicated. 
• Interrupt lenalidomide. 
• Follow CBC at least 
every 7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial 
prophylaxis as per local 
guidelines. 
• If neutropenia has 
resolved to ≤ Grade 2 
(ANC ≥ 1.0 G/L), restart 
lenalidomide at the next 
lower dose level (see 
Appendix B). 
• Monitor as clinically 
indicated. 
• Interrupt rituximab. 
• Follow CBC at least 
every 7 days. 
• Use growth factors 
(eg, G-CSF) and 
anti-microbial 
prophylaxis as per local 
guidelines. 
• If neutropenia has 
resolved to ≤ Grade 2 
(ANC ≥ 1.0 G/L), restart 
rituximab at the same 
dose. 
• Monitor as clinically 
indicated. 
a If, based on medical judgment, the treating physician considers a laboratory parameter change or AE not to be a study drug 
related toxicity, but to represent a natural fluctuation in or progression of the underlying disease, then it is at the physician's 
discretion and assessment of the individual risk/benefit ratio to determine whether the participant should be dosed.  The 
decision and rationale behind the decision should be documented in the source data. 
6.5.6. 
Toxicity Management Guidelines for Non-Hematological Toxicities 
The guidelines for toxicity management in the presence of non-hematological toxicities are 
described in Table 10. 

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Table 10: 
Toxicity Management Guidelines for Non-Hematological Toxicities 
Adverse Eventa 
Tafasitamab/Placebo 
Lenalidomide 
Rituximab 
Thromboembolic 
event ≥ Grade 3 
• Continue tafasitamab/ 
placebo infusion as per 
Protocol if clinically 
appropriate. 
• Discontinue lenalidomide 
permanently. 
• Continue rituximab 
infusion as per Protocol 
if clinically appropriate. 
Allergic or 
hypersensitivity 
reaction Grade 2 
• If related to 
tafasitamab/placebo, 
interrupt/skip the dose. 
• If toxicity resolves to 
≤ Grade 1, tafasitamab/ 
placebo may be resumed. 
• If a tafasitamab/placebo 
infusion is delayed for 
3 or more days, then this 
infusion should be 
skipped and tafasitamab/ 
placebo treatment 
continued only at the 
next scheduled 
timepoint. 
• If related to lenalidomide, 
interrupt/skip the dose. 
• If toxicity resolves to 
≤ Grade 1, restart 
lenalidomide at the next 
lower dose level (see 
Appendix B). 
• If related to rituximab, 
interrupt/skip the dose. 
• If toxicity resolves to 
≤ Grade 1, rituximab 
may be resumed 
• If a rituximab infusion is 
delayed for 3 or more 
days, then this infusion 
should be skipped and 
rituximab treatment 
continued only at the 
next scheduled 
timepoint.  
Allergic or 
hypersensitivity 
reaction ≥ Grade 3 
• If related to 
tafasitamab/placebo, 
discontinue 
tafasitamab/placebo 
permanently. 
• If related to lenalidomide, 
discontinue lenalidomide 
permanently. 
• If related to rituximab, 
discontinue rituximab 
permanently. 
Note:  If the causality cannot be determined and the AE may be related to 
tafasitamab/placebo and/or lenalidomide and/or rituximab, discontinue all study drugs 
permanently. 
Rash Grade 2 or 3 
non-desquamating 
(blistering) 
• If related to 
tafasitamab/placebo then 
interrupt the dose. 
• If toxicity resolves to 
≤ Grade 1, tafasitamab/ 
placebo may be resumed. 
• If a tafasitamab/placebo 
infusion is delayed for 
3 or more days, then this 
infusion should be 
skipped and tafasitamab/ 
placebo treatment 
continued only at the 
next scheduled 
timepoint. 
• If related to lenalidomide, 
then interrupt the dose. 
• If the AE resolves to 
≤ Grade 1, restart 
lenalidomide at the same 
level (see Appendix B). 
• If related to rituximab, 
then interrupt the dose. 
• If toxicity resolves to 
≤ Grade 1, rituximab 
may be resumed. 
• If a rituximab infusion is 
delayed for 3 or more 
days, then this infusion 
should be skipped and 
rituximab treatment 
continued only at the 
next scheduled 
timepoint. 

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Table 10: 
Toxicity Management Guidelines for Non-Hematological Toxicities 
(Continued) 
Adverse Eventa 
Tafasitamab/Placebo 
Lenalidomide 
Rituximab 
Rash 
Desquamating 
(blistering) 
≥ Grade 3 
OR 
Non-desquamating 
Grade 4 
 If related to tafasitamab/ 
placebo, discontinue 
tafasitamab/placebo 
permanently. 
 If related to lenalidomide, 
discontinue lenalidomide 
permanently. 
 If related to rituximab, 
discontinue rituximab 
permanently. 
Note:  If the causality cannot be determined and the AE may be related to 
tafasitamab/placebo and/or lenalidomide and/or rituximab, discontinue all study drugs 
permanently. 
Tumor flare 
reactionb Grade 1-2 
 Continue tafasitamab/ 
placebo as per Protocol if 
clinically appropriate. 
 Continue lenalidomide as 
per Protocol. 
 Continue rituximab as 
per Protocol if clinically 
appropriate. 
Tumor flare 
reactionb ≥ Grade 3 
 Continue tafasitamab/ 
placebo as per Protocol if 
clinically appropriate. 
 Interrupt lenalidomide. 
 If the AE resolves to 
≤ Grade 1, restart 
lenalidomide and maintain 
the same dose level (see 
Appendix B). 
 Continue rituximab as 
per Protocol if clinically 
appropriate. 
Constipation 
≥ Grade 3 
 Continue tafasitamab/ 
placebo as per Protocol if 
clinically appropriate. 
 Interrupt lenalidomide. 
 If the AE resolves to 
≤ Grade 2, restart 
lenalidomide and maintain 
the same dose level (see 
Appendix B). 
 Continue rituximab as 
per Protocol if clinically 
appropriate. 
Other 
non-hematologic 
AEs ≥ Grade 3 
 Continue tafasitamab/ 
placebo as per Protocol if 
clinically appropriate. 
 Interrupt lenalidomide. 
 If the AE resolves to 
≤ Grade 2, restart 
lenalidomide and maintain 
the same dose level (see 
Appendix B). 
 Continue rituximab as 
per Protocol if clinically 
appropriate. 
a If, based on medical judgment, the treating physician considers a laboratory parameter change or AE not to be a study drug 
related toxicity, but to represent a natural fluctuation in or progression of the underlying disease, then it is at the physician's 
discretion and assessment of the individual risk/benefit ratio to determine whether the participant should be dosed.  The 
decision and rationale behind the decision should be documented in the source data. 
b Tumor 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 (tumor flare reaction is the only AE that will be graded using NCI CTCAE v3.0). 
6.5.6.1. 
Tumor Lysis Syndrome Prophylaxis 
Participants should hydrate well (orally) during the first week of the first cycle, or for a longer 
period if clinically indicated.  Hydration levels should be adjusted according to age and clinical 
status of the participant. 
In addition, participants may receive TLS prophylaxis (allopurinol, rasburicase, or equivalent) as 
per institutional guidelines. 
If clinically indicated, participants should continue with TLS prophylaxis measures by keeping 
hydrated and taking the TLS prophylaxis as instructed. 

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6.5.6.2. 
Hypogammaglobulinemia 
Hypogammaglobulinemia induced by B-cell depletion is a potential on-target toxicity of the 
anti-CD19 mAb tafasitamab. 
In this study, immunoglobulin levels (IgG, IgA, and IgM) are measured at screening and 
subsequently every 2 cycles starting from Cycle 2 until EOT.  Study participants experiencing 
hypogammaglobulinemia should be managed according to local guidelines. 
6.6. 
Concomitant Medications and Procedures 
6.6.1. 
Participant Monitoring During Tafasitamab or Placebo Infusion 
Vital signs should be measured as outlined in Table 3 and Section 8.3.3.  All supportive 
measures consistent with optimal participant care will be provided throughout the study 
according to institutional standards. 
Precautions for anaphylaxis should be observed during tafasitamab or placebo administration.  
Emergency resuscitation equipment and medications must be readily available.  Additional 
supportive measures should also be available and may include but are not limited to epinephrine, 
antihistamines, corticosteroids, IV fluids, vasopressors, oxygen, bronchodilators, 
diphenhydramine, and acetaminophen (paracetamol). 
Vital signs are to be obtained before tafasitamab/placebo infusion and then at least 3 times 
during the infusion (oxygen saturation is not required during the infusion) and as clinically 
indicated.  Participants should continue to be monitored for at least 30 minutes after completion 
of the tafasitamab/placebo infusion.  The frequency or the length of the monitoring period may 
be adapted if clinically indicated. 
6.6.2. 
Lenalidomide Counseling 
Lenalidomide may cause fetal harm when administered to a pregnant woman.  Male participants 
of reproductive potential and participants who are WOCBP may be treated with lenalidomide 
provided adequate precautions are taken to avoid pregnancy as described in Section 5.1. 
Participants will be counseled on lenalidomide's potential risk of teratogenicity at the beginning 
of each treatment cycle.  Additional pregnancy testing and counseling must be performed if a 
female participant misses her menstruation period or if there is any abnormality in menstrual 
bleeding. 
The investigator will ensure that all participants of reproductive/childbearing potential are able to 
understand the reason for complying with the special conditions of the pregnancy prevention risk 
management plan and will also ensure written acknowledgement of participants to adhere to this 
plan (see Section 5.1). 
6.6.3. 
Prior and Concomitant Therapies 
Details of prior, concomitant, or procedural medication or therapy will be captured in the eCRF. 
Any prior, concomitant, or procedural medications or therapy (including over-the-counter or 
prescription medicines, vitamins, vaccines, and/or herbal supplements) given to or taken by the 
participant up to 4 weeks prior to enrollment and up to 90 days after the last dose of study 

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treatment or until the participant begins a new anticancer therapy will be recorded in the eCRF.  
The sponsor will encode all therapy and medication according to the WHO Drug Dictionary.  
Any addition, deletion, or change in the dose of these medications will also be recorded.  
Concomitant medications administered after 90 days after the last dose of study treatment should 
be recorded for SAEs as defined in Section 9.4. 
Corticosteroids administered/taken within 3 weeks before ICF signature will be recorded in the 
eCRF.  Participants may continue the medications they were receiving at time of screening.  
Participants may receive concomitant medications that are medically indicated as standard of 
care for the treatment of symptoms and intercurrent illnesses such as diabetes, hypertension, 
bronchial asthma, or chronic obstructive pulmonary disease.  Participants may also receive 
therapy to mitigate side effects of the study treatment as clinically indicated, as well as best 
supportive care as per institutional guidelines.  All concomitant medications should be recorded 
in the eCRF. 
6.6.4. 
Prophylaxis of Hepatitis B Reactivation 
Participants in countries where prophylactic antiviral medications for hepatitis B reactivation are 
the standard of care may be treated prophylactically.  Participants with occult HBV infection, 
defined as negative HBsAg and positive total HBcAb and negative HBV DNA, are eligible and 
must undergo ongoing DNA testing (irrespective of prophylactic treatment) as described in 
Table 4. 
6.6.5. 
Anti-Infection Prophylaxis 
Anti-infectious prophylaxis including prophylaxis of opportunistic infections can be given as per 
institutional guidelines. 
6.6.6. 
Premedication for Tafasitamab or Placebo Infusions/Infusion-Related Reaction 
Prophylaxis 
Tafasitamab or placebo infusions are to be administered to participants after premedication with 
oral acetaminophen (eg, 650-1000 mg), an antihistamine such as diphenhydramine hydrochloride 
(eg, 50-100 mg), and glucocorticosteroids (eg, 100 mg IV prednisone or prednisolone or 
equivalent).  The premedication should be administered approximately 30 to 60 minutes prior to 
starting each infusion. 
Premedication is mandatory for the first cycle.  For participants who do not experience ≥ Grade 2 
IRRs or ≥ Grade 1 CRS to tafasitamab or placebo during the first cycle, premedication will be 
optional for subsequent antibody infusions at the discretion of the investigator. 
6.6.7. 
Prophylaxis of Venous Thromboembolism 
Prophylaxis of VTE is mandatory for all participants due to increased risk of thrombosis in 
participants treated with lenalidomide without prophylaxis (Revlimid [lenalidomide] SmPC 
[2020]).  Suggested prophylaxis treatment includes either aspirin (70-325 mg PO daily) or low 
molecular weight heparin.  Participants with a history of VTE or thrombophilia may participate 
if they are willing to be on full anticoagulation during the treatment.  The choice of VTE 
prophylaxis agent is at the investigator's discretion and should be tailored to the participant's 

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individual risk/benefit profile by taking into account the individual thrombotic risk, bleeding 
risk, and quality of compliance with the VTE prophylaxis. 
6.6.8. 
Use of Growth Factors 
The use of G-CSF or pegylated G-CSF is optional and should be administered as per institutional 
guidelines. 
6.6.9. 
Use of Specific Medications Concomitantly With Lenalidomide 
The following measurements and precautions should be considered for study participants who 
receive the following medications concomitantly with lenalidomide. 
6.6.9.1. 
Digoxin 
When digoxin was coadministered with multiple doses of lenalidomide (10 mg/day), the digoxin 
Cmax and AUCinf were increased by 14%. 
Consider periodic monitoring of digoxin plasma levels as per investigator's clinical judgment and 
based on standard clinical practice in participants receiving this medication during administration 
of lenalidomide. 
6.6.9.2. 
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 benefit/risk assessment 
in study participants who receive lenalidomide. 
6.6.9.3. 
Warfarin 
Coadministration of multiple doses of lenalidomide (10 mg/day) with a single dose of warfarin 
(25 mg) had no effect on the PK of lenalidomide or R- and S-warfarin.  Expected changes in 
laboratory assessments of prothrombin time and international normalized ratio were observed 
after warfarin administration, but these changes were not affected by concomitant lenalidomide 
administration.  It is not known whether there is an interaction between dexamethasone and 
warfarin. 
Close monitoring of the coagulation parameters should be conducted as described in Table 4. 
6.6.10. 
Prohibited Medications and Procedures 
6.6.10.1. Anticancer Therapies 
No radiotherapy (including limited field radiotherapy) is permitted after the screening PET/CT 
scan for initial disease assessment has been performed. 
The use of concurrent antineoplastic therapies 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.    
Once the decision to end study treatment has been made, new anticancer treatment is permitted at 
the discretion of the investigator.  Ideally, the safety follow-up visit should be performed prior to 

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initiating new anticancer therapy. Any new anticancer treatments and the associated response 
outcomes are to be recorded in the appropriate eCRF. 
6.6.10.2. Live Vaccines 
Because of the immunosuppressive effects of the study treatment, administration of any live 
vaccine is not recommended during the treatment period and at least 6 months after the EOT.  
Thereafter, the decision to administer live vaccines is at the investigator's discretion and should 
follow local guidelines for lenalidomide in addition to rituximab (the hematological status of 
individual participant, including B-cell depletion, should be considered). 
Please note that this does not apply to COVID-19 vaccines which are nonlive vaccines. 
6.7. 
Treatment After the End of the Study  
'Subsequent care for study participants after the discontinuation of study treatment or completion 
of the study may be given per local institution standard of care.  
7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT WITHDRAWAL FROM STUDY TREATMENT 
7.1. 
Discontinuation of Study Treatment 
See Table 3 and Table 4 for data to be collected at the time of discontinuation of study treatment 
and follow-up and for any further evaluations that need to be completed. 
7.1.1. 
Reasons for Discontinuation of Study Treatment 
7.1.1.1. 
Unacceptable Toxicity 
The occurrence of unacceptable toxicity not caused by the underlying disease will require that 
the study treatment (ie, tafasitamab/placebo, lenalidomide, and rituximab) be permanently 
discontinued.  Unacceptable toxicity is defined as follows: 
• The occurrence of an AE that is related to study treatment that, in the judgment of the 
investigator or the sponsor's medical monitor, compromises the participant's ability to 
continue study-specific procedures or is considered to not be in the participant's best 
interest. 
• In case of drug delay for more than 1 month (4 weeks), the investigator will have to 
contact the sponsor's medical monitor. 
The investigator may also discontinue the treatment to a participant if further participation would 
be injurious to the participant's health or well-being, in the investigator's medical judgment. 
7.1.1.2. 
Disease Progression 
Participants who demonstrate radiologic or metabolic progression of disease as per the Lugano 
criteria will be considered as having met criteria for disease progression.  The EOT visit should 
be performed as soon as possible, and the participant should continue with the safety and 

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survival follow-up periods of the study.  Any new anticancer therapy (and associated response 
outcomes) should be captured in the eCRFs.  
7.1.1.3. 
Lack of Efficacy 
Participants who, in the treating investigator's decision, require new anticancer therapy due to 
lack of sufficient response in the absence of either radiologic or metabolic progression of disease 
per the Lugano criteria will be considered as having met criteria for lack of efficacy.  The EOT 
visit should be performed as soon as possible, and the participant should continue on with the 
safety and survival follow-up periods of the study.  Any new anticancer therapy (and associated 
response outcomes) should be captured in the eCRFs.  
7.1.1.4. 
Consent Withdrawal 
Consent withdrawn means that the participant has explicitly indicated that they do not want to be 
followed any longer; in this case no further data, except data in the public domain, may be 
solicited from or collected on the participant. 
Participants may choose to discontinue study treatment and remain in the study to be followed 
for safety, disease progression, and survival per the SoA (see Table 3). 
7.1.1.5. 
Investigator Decision 
Investigator(s) also have the right to withdraw participants from the study or from study 
treatment in the event of illness, AEs, noncompliance, or other reasons concerning the health or 
well-being of the participant. 
7.1.1.6. 
Pregnancy 
Female participants who become pregnant during clinical study participation must discontinue 
study treatment. 
7.1.1.7. 
Study Termination 
Participants must be discontinued from study treatment if the study is terminated by the sponsor 
or by the local health authority, IRB, or IEC. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study treatment, the EOT 
visit should be conducted.  Reasonable efforts should be made to have the participant return for a 
follow-up visit.  These visits are described in Table 3 and Table 4.  The last date of the last dose 
of study treatment and the reason for discontinuation of study /treatment will be recorded in the 
eCRF. 
If a participant is discontinued from study treatment: 
• The study monitor or sponsor must be notified. 
• The reason(s) for discontinuation must be documented in the participant's medical 
record and the primary reason for discontinuation must be included in the eCRF and 
in the source documents. 

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• The EOT visit should be performed and date recorded. 
• The participant enters the follow-up period. 
• The status of the participant should be updated to EOT in the IRT. 
• Participants must be followed for safety until the time of the follow-up visit or until 
study treatment–related toxicities resolve, return to baseline, or are deemed 
irreversible, whichever is longest. 
If the participant discontinues study treatment and actively withdraws consent for collection of 
follow-up data (safety follow-up or disease assessment), then no additional data collection 
should occur; however, participants will have the option of withdrawing consent for study 
treatment but continuing in the follow-up period of the study for safety/efficacy assessments. 
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at their own request or may be withdrawn 
at any time at the discretion of the investigator for safety, behavioral, compliance or 
administrative reasons.  
If a participant withdraws from the study, they may request destruction of any samples taken and 
not tested, and the investigator must document this in the site study records.  If the participant 
withdraws consent for disclosure of future information, the sponsor may retain and continue to 
use any data collected before such a withdrawal of consent. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if they repeatedly fail to return for scheduled 
visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant's last known mailing address 
or local equivalent methods).  These contact attempts should be documented in the 
participant's medical record. 
• Should the participant continue to be unreachable, they will be considered to have 
withdrawn from the study. 

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8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
• The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study. 
− Informed consent must be obtained before any study-related procedures are 
conducted, unless otherwise specified by the Protocol. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the country(ies) in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  The level of disclosure 
must also be explained to the participant. 
• The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained.  The authorized person obtaining the informed consent must 
also sign the ICF. 
• Participants must provide consent to the most current version of the ICF during their 
participation in the study. 
• A copy of the ICF(s) must be provided to the participant or the participant's legally 
authorized representative. 
A participant who is rescreened is required to sign a new ICF. 

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8.1.2. 
Screening Procedures 
The screening period of a maximum of 28 days is the interval between the date of signing of 
informed consent and the date of randomization.  The ICF must be signed before beginning any 
study-related assessments.  Standard-of-care assessments performed on the day of consent (but 
before signing the ICF) do not need to be repeated solely for the purpose of screening and may 
be used as study data, if they meet the Protocol requirements. 
Standard of care assessments that occur outside the 28-day window that are suitable for 
enrollment (ie, meet protocol requirements) but are not feasible to repeat may be used for 
determining eligibility with sponsor medical monitor approval.  
During screening, each participant who signs the ICF will be allocated a unique identification 
number.  Treatment should start within 3 days of randomization. 
All participants must satisfy all the inclusion criteria and none of the exclusion criteria listed in 
Section 5.  Signed and dated informed consent must be obtained from all participants before their 
entering the clinical study.  Additionally, sites will complete participant enrollment forms for all 
participants being considered for this study.  Completed enrollment forms will be submitted to 
the sponsor along with completely redacted (pseudonymized) supportive documentation (eg, 
laboratory reports, pathology reports, imaging reports, and a brief summary of the participant's 
disease-specific medical history) that is necessary to confirm eligibility. The PI will ultimately be 
responsible for ensuring participants meet eligibility criteria.  
See Section 5.4 and Section 5.5 for information regarding screen failures and replacement of 
participants, respectively. 
See Table 3 and Table 4 for the screening assessments to be performed. 
8.1.3. 
Interactive Response Technology Procedure 
Each participant is identified in the study by a unique participant number that is assigned by the 
IRT system when the participant is screened (ie, signs the ICF) and is retained as the primary 
identifier for the participant throughout their entire participation in the study. 
• The participant number is unique so that each participant is numbered uniquely across 
the entire study. 
• The investigator or designated study personnel will contact the IRT system and 
provide the requested identifying information for the participant to register them into 
the IRT system and assign a participant number. 
Once assigned, the participant number must not be reused for any other participant. 
All participants who fulfill all inclusion criteria and who are not barred by any of the exclusion 
criteria will be randomly assigned to one of the study treatment groups as defined in Section 6.1. 
Randomization will be done through IRT before the participant receives any study treatment.  
While all inclusion and exclusion criteria need to be reviewed again before randomization, 
laboratory results and results of assessments obtained during the screening period or on the day 
of randomization may be used for determining participant eligibility for study randomization. 

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Additionally, the IRT will be contacted at each regular study visit to update the study drug 
supply.  Additional details are provided in the IRT Manual. 
8.1.4. 
Demography and Medical History 
8.1.4.1. 
Demographics and General Medical History 
Demographic variables to be recorded will include age, gender, race, and ethnic origin. 
At the time of signing of the ICF, relevant medical history and current medical conditions should 
be recorded.  The medical history, co-morbidities, and prior medications should be documented 
in detail, including all symptoms present at screening. 
8.1.4.2. 
Disease Characteristics, Treatment History, and Pathology  
A local pathology report indicating FL/MZL diagnosis is acceptable for determining a 
participant's eligibility for receiving the first study treatment.  The participant will be enrolled in 
the study based on the local pathology report. 
For each participant, suitable and sufficient tumor tissue material must be provided.  A central 
pathologist will provide confirmation of the histological diagnosis of FL/MZL.  A fresh biopsy is 
preferred, but an archival specimen is acceptable, preferably from the time of the last relapse.  
For archival specimens, 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.  Refer to the Central Lab Manual for details. In cases where blocks 
cannot be provided, 15 unstained slides and 3 tissue curls should be provided.  When tissue curls 
cannot be provided, 25 unstained slides should be provided. 
Central pathology review is mandatory but will be retrospective; randomization is based on 
investigator assessment, and no changes will be made to treatment assignment for discordant 
results between the investigator and the central pathology laboratory.  Differences will be 
highlighted in the final data analysis only. 
Samples should be submitted within 30 days after randomization. 
Examinations leading to the diagnosis of FL/MZL should be documented in the participant's 
source documents.  This may include, for example, results of laboratory examinations, imaging 
results, or clinical symptoms related to FL/MZL.  The assessment of the lymphoma should 
include disease staging.  In order to reflect the participant's status at the time of screening, the 
standard staging systems for FL/MZL 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 E and Appendix F). 
See Table 3 and Table 4 for the list of all assessments required at screening.  For participants 
with FL, the FLIPI-1 and GELF criteria assessment will also be performed and recorded in the 
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8.2. 
Efficacy Assessments 
Efficacy assessments except OS 
 will be made according to the response criteria for 
malignant lymphoma based on the guidelines of the Lugano Classification (Cheson et al 2014; 
see Appendix H) and will be based on investigator assessment and IRC assessment. 
Participants who experience relapse or disease progression during the study will continue to be 
followed for OS, 
, all subsequent antilymphoma therapy(ies), 
 
according to the visit 
schedule until withdrawal of consent, lost to follow-up, study end, or death, whichever comes 
first. 
8.2.1. 
Health Economics 
Health economics parameters are not evaluated in this study. 
8.2.2. 
Bone Marrow Biopsy and Aspirate Samples 
Both bone marrow aspirate and biopsy samples are to be collected at timepoints when a bone 
marrow examination is indicated (see Table 3).  If biopsy collection is not feasible (see 
Section 8.2.2.1), a bone marrow aspirate will be collected.  Samples collected prior to signing the 
ICF may be used in lieu of collecting additional samples in discussion with the sponsor medical 
monitor.  Please refer to the Laboratory Manual for details on sample preparation and shipment. 
8.2.2.1. 
Bone Marrow Biopsy Sample Collection    
A bone marrow biopsy is required at screening to determine if there is marrow infiltration of the 
underlying lymphoma.  This sample will be evaluated locally unless the marrow is the only 
organ where disease is found.  
 
   
If a bone marrow biopsy cannot be obtained, a bone marrow aspirate must be collected for local 
bone marrow examination to determine disease infiltration.  If a bone marrow aspirate is taken in 
lieu of a biopsy, the sample should contain adequate volume to support MRD analysis (see 
Section 8.2.2.2). 
Bone marrow biopsies collected as part of standard of care that are suitable for determining 
eligibility may be used in lieu of collecting an additional biopsy with sponsor medical monitor 
approval.  Bone marrow aspirates must be freshly collected samples. 
If the screening bone marrow examination indicates disease infiltration in the bone marrow, a 
bone marrow biopsy is to be repeated within 4 weeks (± 2 weeks) of radiologic CR for 
evaluation of morphologic response and MRD analysis (see Section 8.2.2.2).  If CR was not 
achieved, a repeat bone marrow biopsy must be collected at EOT. 
Results from the local bone marrow examinations must be entered in the eCRF. 
8.2.2.2. 
Bone Marrow Aspirate Sample Collection 
A bone marrow aspirate must be collected at screening and EOT and sent to the central 
laboratory for MRD analysis regardless of marrow involvement status at baseline.  A portion of 

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the first draw is preferable, but the second draw can be used if there is inadequate sample volume 
from the first draw.  
An aspirate will need to be repeated and sent for central MRD analysis at the time of radiologic 
CR only if marrow is involved at screening. 
8.2.3. 
Minimal Residual Disease and Mutational Analyses in Peripheral Blood 
Peripheral blood samples will be collected for MRD and mutational analyses at the timepoints 
listed in Table 4. 
8.2.4. 
Radiographic and Metabolic Imaging Assessments 
Radiographic assessments will be performed at the timepoints indicated below and in Table 3.  
Additional radiographic assessments may be performed by the investigator during the course of 
the study if deemed clinically necessary. 
Images of the radiographic assessments will be collected and centrally stored at the sponsor's 
central radiology vendor.  The instructions are included in the Central Imaging Manual. 
All CT scans (and CT parts of a combined PET-CT, if applicable) should cover the neck, chest, 
abdomen, and pelvis and must be of diagnostic quality, with contrast agent, if allowable based on 
participant contraindications and/or supply issues.  An MRI with contrast should be performed if 
a CT scan with contrast is contraindicated as assessed by the investigator.  If both a CT with 
contrast and an MRI with contrast are contraindicated and/or not available due to supply issues, a 
CT or an MRI without contrast is acceptable as radiographic assessment methodology, but 
should be noted in the participant's chart and eCRF.  Every effort should be made to use the same 
assessment methodology for a participant throughout the study duration. 
The CT/MRI scan assessments will be used to serve as the baseline assessments for CT/MRI 
response.  The PET assessments will be used to serve as the baseline assessments for PET 
response. 
Note:  PET-CT hybrid scanners may be used only if the CT produced by the scanner is of 
diagnostic quality (ie, allows an accurate diameter measurement and, as a guidance, a slice 
thickness of 2-2.5 mm is adequate; refer to the Study Manual).  If using a hybrid machine for 
both PET and CT, the PET should be performed before the CT is performed with IV contrast, so 
as to not compromise PET results. 
If independent CT and PET-CT scanners are used, and the participant is receiving both scans on 
the same day, the PET-CT must be performed before the CT with IV contrast (unless 
contraindicated).  The CT must be of diagnostic quality (ie, allows an accurate diameter 
measurement and, as a guidance, a slice thickness of 2 to 2.5 mm is adequate; refer to the Study 
Manual).  Lesion measurements and other parameters relevant for the response assessment based 
on the Lugano classification (Cheson et al 2014; see Appendix H) will be collected in the eCRF. 
At baseline: 
• PET + CT or PET + MRI scans must be performed on all participants. 

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During the study treatment and follow-up periods: 
• Participants with negative PET scan at baseline should be followed using CT or MRI 
imaging.  Additional PET scans may be performed at the treating investigator's 
discretion but are not required. 
• Participants with a positive PET scan at baseline (FDG-avid lymphoma) who achieve 
radiologic CR during treatment should be assessed by PET scan within 4 weeks 
(± 2 weeks) of the CT/MRI scan, noting the CR to evaluate for metabolic response. 
Subsequent PET scans are not required if a confirmatory PET scan is performed 
during treatment; otherwise, a PET scan will need to be repeated at EOT. 
• CT/MRI scans are to be performed according to the following schedule: 
− Year 1:  Every 12 weeks (3 months, ± 2 weeks), including the EOT visit. 
Circumstances where scans cannot be performed at EOT (eg, due to 
hospitalization, hospice care, recent per-protocol scan, etc.) must be properly 
documented in the eCRF 
− Years 2 to 3:  Every 16 weeks (4 months, ± 2 weeks) 
− Years 4 to 6:  Every 24 weeks (6 months, ± 3 weeks) 
• For CT/MRI scans reporting PD, a PET-CT or PET-MRI scan should be performed 
within 4 weeks (± 2 weeks) for confirmation of progression. 
Response assessments using Lugano criteria (Cheson et al 2014) are to be performed each time 
lesions are assessed. 
Participants who discontinue treatment for reasons other than disease progression will enter the 
efficacy follow-up period (see Section 8.9.2). Lesions must followed using the same modality 
and schedule as was used during the treatment period until progression of disease, initiation of 
new anticancer therapy, death, or withdrawal of consent.  
8.2.5. 
Quality-of-Life Assessments 
Quality-of-life assessments using the EORTC QLQ-C30, EQ-5D-5L, and FACT-Lym tools will 
be performed at the timepoints listed in Table 3. 
8.3. 
Safety Assessments 
Planned timepoints for all safety assessments are provided in Table 3 and Table 4. 
The investigator(s) and the sponsor will review the safety data. 
Safety will be evaluated by monitoring all AEs and clinically significant abnormalities identified 
through physical examinations, vital signs, and laboratory assessments.  Such events and 
laboratory and AE toxicities will be graded according to NCI CTCAE v5.0 (or higher).  
Laboratory safety assessments will include routine monitoring of hematology and blood 
chemistry and tests of immunologic parameters. 
Adverse events, pregnancies, concomitant medications, procedures, and hospitalizations will be 
recorded from signing the ICF until 90 days after the last dose of treatment or until the start of 
new anticancer therapy, whichever occurs first.  Participants who relapse or progress and/or 

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prematurely discontinue the study treatment will continue to be followed for SPM throughout the 
study. 
Adverse events and concomitant medications terms will be coded using MedDRA and a 
validated medication dictionary. 
8.3.1. 
Adverse Events 
Adverse events that begin or worsen after informed consent should be recorded on the Adverse 
Events Form in the eCRF regardless of the assumption of a causal relationship with the study 
treatment.  Conditions that were already present at the time of informed consent should be 
recorded on the Medical History Form in the eCRF.  Adverse events (including laboratory 
abnormalities that constitute AEs) should be described using a diagnosis whenever possible 
rather than by individual underlying signs and symptoms. 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative).  The investigator and any 
qualified designees are responsible for detecting, documenting, and recording events that meet 
the definition of an AE or SAE and remain responsible for following-up on AEs that are serious, 
considered related to the study treatment/procedures, or that caused the participant to discontinue 
the study treatment.  Care will be taken not to introduce bias when detecting AEs and/or SAEs.  
Open-ended and nonleading verbal questioning of the participant, such as "How are you 
feeling?" is the preferred method to inquire about AE occurrences.  Adverse events may also be 
detected when they are volunteered by the participant during the screening process or between 
visits or through physical examinations, laboratory tests, or other assessments.  The definition, 
reporting, and recording requirements for AEs are described in Section 9. 
All SAEs will be reported to the sponsor or designee within 24 hours.  The investigator will 
submit any updated SAE data to the sponsor within 24 hours of it being available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs, nonserious AEs, and AESIs (as defined in 
Section 9.5.1), will be followed until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3). 
8.3.2. 
Physical Examinations and Eastern Cooperative Oncology Group Performance 
Status 
Physical examinations and ECOG performance status (see Appendix D) will be assessed 
according to the SoA (see Table 3). 
A comprehensive physical examination will be performed by the investigator or a qualified 
designee during the screening and at EOT.  Comprehensive physical examination should include 
at least cardiovascular, respiratory, abdominal, and neurologic assessment.  The tumor 
assessment includes the evaluation of presence and degree of enlarged lymph nodes, liver, and 
spleen assessments. 
Targeted physical examination will be guided by the individual participant's status and will 
include body systems associated with symptoms and/or the underlying FL/MZL disease (lymph 
node status, liver, spleen).  Targeted physical examinations may be focused on tumor response 
assessment (eg, lymph nodes, liver, and spleen) and AEs per investigator discretion. 

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Body weight will be measured as indicated in the SoA (see Table 3) and height measured at 
screening only. 
B-symptoms (fever, night sweat, weight loss) will be assessed at the timepoints indicated in the 
SoA (see Table 3). 
8.3.3. 
Vital Signs 
Vital signs include blood pressure, respiratory rate, pulse, and body temperature. 
Vital signs should be measured at the timepoints described in the SoA (see Table 3).  Vital signs 
should be obtained prior to the tafasitamab/placebo infusion, and then at least 3 times during the 
infusion (end of the infusion may be included as 1 of the 3 times), and/or as clinically indicated. 
It is recommended that before vital signs are measured, the participant should be resting for 
approximately 5 minutes.  If possible, vital sign assessments should be performed in the same 
manner at each timepoint.  
8.3.4. 
Electrocardiograms, Echocardiograms, and/or Cardiac MUGA Scans 
Standard 12-lead resting ECGs will be obtained at screening as described in the SoA 
(see Table 3).  Electrocardiograms will be interpreted locally. 
The investigator will evaluate the clinical significance of each ECG value outside the reference 
ranges (including QTc assessment), 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 artifacts are present that result in an 
inability to adequately interpret the results, then the ECG will be repeated. 
After study start, ECGs will be performed as clinically indicated as per local practices. 
The decision to include or exclude a participant or discontinue study treatment based on an ECG 
flagged as "Abnormal, Clinically Significant" is the responsibility of the investigator, in 
consultation with the sponsor's medical monitor as appropriate.  Clinically notable abnormalities 
that are considered clinically significant in the judgment of the investigator are to be reported as 
AEs. 
Two-dimensional echocardiogram (2D-ECHO) or cardiac MUGA scan will be obtained at 
screening to evaluate cardiac function, including assessment of LVEF. 
8.3.5. 
Laboratory Assessments 
Any abnormal laboratory findings, regardless if centrally or locally analyzed, assessed by 
investigator as clinically significant will constitute an AE, and should be reported as such and 
followed until the outcome is known.  Clinically significant abnormal laboratory findings are 
those that are not associated with the underlying disease, unless judged by the investigator to be 
more severe than expected for the participant's condition.  All laboratory tests with values 
considered clinically significantly abnormal during participation in the study or within 90 days 
after the last dose of study treatment should be repeated until the values return to normal or 
baseline or are no longer considered clinically significant by the investigator or medical monitor.  

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Differences between central laboratory and local laboratory results may occur; central laboratory 
results will supersede local laboratory results. 
Also, additional diagnostic tests may be indicated to determine a more precise diagnosis of the 
participant's condition (eg, ordering a WBC differential count to help characterize a high or low 
WBC count, or ordering a determination of RBC indices to help characterize a low hematocrit). 
8.3.5.1. 
Central Laboratory Testing for Safety 
The measurement of all safety laboratory parameters (except pregnancy testing) as indicated in 
this Protocol will be performed centrally.  Central laboratory tests will be performed according to 
Table 4.  Laboratory results are required for determining participant eligibility for study 
enrollment and will be used for the primary statistical analysis of the study results. 
During screening, it is permitted to repeat the laboratory assessment of serum chemistry and 
hematology parameters due to the variability of the parameters and their dependence on 
multitude of factors (eg, hydration, muscle mass).  This is valid 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 
(eg, dehydration, vomiting, imaging procedure with a contrast).  This procedure and the rationale 
behind it must be explicitly documented in source data.  Such repeated assessment (once only) of 
the concerned parameters will not be counted as "rescreening" for that participant. 
Laboratory samples may be taken as defined in Table 4.  Local laboratory results may be used 
for taking treatment or clinically related decisions, or for the immediate safety management of a 
study participant; in that situation, the site will be requested to send a sample to the central 
laboratory for confirmation of the result(s).  The investigator or designee should review 
laboratory results before dosing so that the administration of the study drug(s) may be adjusted 
or interrupted if necessary. 
The laboratory results will be kept in the participant's source documentation.  Any clinically 
significant discrepancies will be evaluated on a case-by-case basis.  All blood samples will be 
processed and handled according to standard laboratory procedures.  The time of blood 
collection should be documented in the source data. 
Clinical laboratory parameters assessed in this clinical study are displayed in Table 11 below. 

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Table 11: 
Required Laboratory Analytes 
Serum Chemistries 
Hematology  
Urinalysis  
ALT 
Albumin 
Alkaline phosphatase 
Amylase 
AST 
Bicarbonate/CO2 (may not be 
applicable in Japan) 
Bilirubin (total, direct, indirect) 
Calcium 
Chloride 
CPK 
Creatinine 
GGT 
Glucose 
Lactate dehydrogenase 
Phosphorous 
Potassium 
Protein (total) 
Sodium 
Blood urea nitrogen/urea 
Uric acid 
Hemoglobin 
Hematocrit 
Platelet count 
WBC count including differentials 
 
Coagulation parameters: 
aPTT 
D-dimer 
PT 
TT 
 
Immunological parameters: 
CRP 
Glucose 
Ketone 
Occult blood 
pH 
Protein 
Specific gravity 
Urobilinogen 
Note:  Additional tests may be required, as agreed upon by the investigator and sponsor, based on emerging safety data or to rule 
out a diagnosis. 
Note:  Alternative tests (ie, CO2 or CO2 Combining Power or HCO3) are also allowed as per regional standard of care. 
IgA, IgG, IgM, and TSH assessments will be conducted as indicated in Table 4. 
Urinalysis will be performed using a dipstick at screening and during study conduct as clinically 
indicated.  A quantitative assessment may be required in the event of a positive or doubtful 
dipstick result. 
8.3.5.2. 
Pregnancy Testing 
The pregnancy tests will be performed and analyzed locally at sites. 
A pregnancy test will be performed for WOCBP at various timepoints either by urine pregnancy 
test or beta-human chorionic gonadotropin (β-HCG) test of a serum sample.  The pregnancy test 
assay should have a minimum sensitivity of 25 mIU/mL. 
The pregnancy tests will be performed at the timepoints listed in Table 4; a serum test will  be 
performed at screening, before the first study drug dose, and after any positive urine test; the 
other tests will be performed on a urine sample.  Urine pregnancy tests can be replaced with 
serum tests. 
Participants who are WOCBP must have 2 negative pregnancy tests before starting study 
treatment, even if true abstinence is the chosen method of birth control as defined in Section 5.1. 
The participant must not receive study treatment until the investigator or designee has verified 
that the results of these pregnancy tests are negative. Tests will be repeated weekly during the 

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first month and then monthly thereafter in women with regular menstrual cycles or every 
2 weeks in women with irregular menstrual cycles until the safety follow-up visit.   
If a pregnancy is confirmed by a serum pregnancy test, see Section 9.7 for reporting 
requirements. 
 
 
 
 
 
 
 
8.3.5.4. 
Hepatitis Virus Serology 
Participants will be examined according to Table 4 for viral hepatitis B and C.  Hepatitis B 
biomarkers include HBsAg, total HBcAb, and HBsAb.  Participants with a positive test for 
HBcAb can only be included if HBV DNA is not detected.  In these HBcAb-positive participants 
only, HBV DNA titer should be assessed using real-time PCR at Day 1 of each cycle, and at 
EOT. 
In the context of exclusion criteria, seropositive for or active viral infection with HBV means: 
• HBsAg positive 
• HBsAg negative, HBsAb positive, and/or HBcAb positive and detectable HBV DNA 
Participants who are HBsAg-negative, HBcAb-positive and HBV DNA–negative are eligible. 
Participants who exhibit the classical vaccination profile of HBsAb-positive, HBcAb-negative, 
and HBsAg-negative are eligible. 
If HBV DNA becomes detectable during treatment, participants should be prophylactically 
treated and followed-up for potential hepatitis B reactivation as per institutional guidelines.  If 
the HBV DNA assay is positive, then participants 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.  In HBcAb-positive 
participants, HBV DNA titer is determined using real-time PCR on Day 1 of each cycle and at 
least once 1 year after the last treatment cycle.  Additional ad-hoc measurements may be 
performed as clinically indicated in consultation with the HBV specialist. 
Hepatitis C serology is to be done at screening only.  Hepatitis C biomarkers include anti-HCV.  
For participants 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.  HCV RNA by PCR is performed only if anti-HCV Ab is positive. 
8.3.5.5. 
Human Immunodeficiency Virus Serology 
Serology for HIV is to be done at screening only (optional in the United States).  HIV serology 
will include anti–HIV-1 and anti–HIV-2 antibodies, and seropositive participants will be 
excluded from the study. 

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8.7. 
Unscheduled Visits 
Clinic visits or diagnostic laboratory visits not prescribed in the Protocol may be performed at 
any time clinically indicated at the investigator's discretion.  Results of assessments performed at 
these visits should be entered as unscheduled visits in the eCRF.  The sponsor may also request 
additional visits to be performed, if needed, based on emerging safety data. 

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8.8. 
End of Treatment and/or Early Treatment Discontinuation 
The EOT visit will be performed at the time the decision is made to discontinue study treatment 
or after the participant has completed the prescribed treatment regimen (Cycle 12 Day 28).  If the 
EOT visit coincides with a regular study visit, the EOT evaluations will supersede those of that 
scheduled visit, and the data should be entered in the EOT visit in the eCRF.  The participant 
should be encouraged to return for the follow-up visits. 
See Table 3 and Table 4 for the list of assessments be performed at the EOT visit. 
8.9. 
Follow-Up 
The follow-up period is composed of 1) the safety follow-up period, 2) the efficacy follow-up, 
and 3) the survival follow-up period(s), as applicable. 
8.9.1. 
Safety Follow-Up 
The safety follow-up period is the interval between the EOT date and the safety follow-up visit, 
which should occur 90 days (± 7 days) after the EOT visit.  
Reasonable efforts should be made to have the participant return for the follow-up visit and 
report any AEs that may occur during this period. 
If a participant is scheduled to begin new anticancer therapy before the end of the 90-day safety 
follow-up period, the safety follow-up visit should be performed before new anticancer therapy 
is started. 
Once new anticancer therapy has been started, the participant will move into the survival 
follow-up period.  
8.9.2. 
Efficacy Follow-Up 
Participants who discontinue study treatment for reasons other than disease progression will 
continue to be assessed for efficacy (eg, scans performed at regular intervals) during this period.  
Participants will continue to be assessed at the intervals noted in Section 8.2.4 until disease 
progression, initiation of new anticancer therapy, lost to follow-up, withdrawal of consent, or 
death is reported.  Participants with PD confirmed will move into the survival follow-up phase 
(see Section 8.9.3). 
8.9.3. 
Survival Follow-Up/Completion of Study 
All participants will be followed for survival status every 12 weeks (± 4 weeks) until death, lost 
to follow-up, withdrawal of consent for survival follow-up, completion of the 5-year follow-up 
interval, or the end of the study. 
For participants who have entered the survival follow-up period, sites will continue to collect 
data regarding initiation of new anticancer treatment 
 
 and report OS.  For participants who do not intend to return to the 
study investigator for their ongoing care, follow-up will be maintained by telephone contact, 
patient records, and public records/databases at intervals of no longer than 12 weeks.  
Additional survival assessments may be performed outside the 12-week interval if a survival 
update is required for an interim assessment to meet safety or regulatory needs. 

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8.9.4. 
End of Study 
The end of study will occur after the last participant has completed a minimum of 5 years of 
post-treatment follow-up.  This is expected to occur approximately 8 years after the first 
participant is enrolled. 
The sponsor has the right to terminate the study at any time. 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING 
Study personnel must remain vigilant for the occurrence of AEs, particularly those that may be 
life-threatening.  Personnel who are trained in the acute management of IRRs, CRS, anaphylaxis, 
and other emergencies, and who have access to appropriate clinical supplies, should be readily 
available. 
All AEs should be treated appropriately.  Such treatment may include changes in study treatment 
including possible interruption or discontinuation, starting or stopping concomitant treatments, 
changes in the frequency or nature of assessments, hospitalization, or any other medically 
required intervention.  Once an AE is detected, it should be followed up, and an assessment 
should be made at each visit (or more frequently, if necessary) of any changes in its severity, its 
suspected relationship to tafasitamab, lenalidomide or rituximab, any of the interventions 
required to treat it, and its outcome. 
9.1. 
Definition of Adverse Event 
Adverse Event Definition 
• An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or 
not considered drug-related. 
• An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study 
treatment. 
Additional Guidance for Events Meeting the Adverse Event Definition 
• Any safety assessments (eg, ECG, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of the investigator 
(ie, not related to progression of underlying disease) are to be reported as an AE. 
• Abnormal laboratory test results are to be reported as an AE if they are considered clinically 
meaningful, induce clinical signs or symptoms, require concomitant therapy, or require changes in 
study treatment.  Whenever possible, a diagnosis (eg, anemia, thrombocytopenia) should be recorded 
in the eCRF rather than the abnormal laboratory test result (eg, low hemoglobin, platelet count 
decreased). 
• Exacerbation of a chronic or intermittent pre-existing condition/disease, including either an increase 
in the frequency and/or intensity of the condition, is to be reported as an AE. 
• New conditions detected or diagnosed after the start of study treatment administration are to be 
reported as an AE. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction are to be reported as 
an AE. 

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• Signs and/or symptoms from dosing errors of a study treatment (eg, overdose) or a concomitant 
medication are to be reported as an AE. 
• "Lack of efficacy," "disease progression," or "failure of expected pharmacological action" will 
not be reported as an AE or SAE.  Such instances will be captured in the efficacy assessments. 
• A condition that leads to a medical or surgical procedure (eg, endoscopy, appendectomy) will be 
reported as an AE if it occurs after obtaining informed consent.  If the surgery procedure will be 
collected as well.  If the condition is present before entering the study, then it should be captured as 
medical history. 
• Pre-existing diseases or conditions with expected fluctuations in signs or symptoms should be 
reported as an AE only if the investigator judges the fluctuation to have worsened more than 
expected during study participation. 
Events NOT Meeting the Adverse Event Definition 
• Any clinically significant abnormal laboratory findings or other abnormal safety assessments that are 
associated with the underlying disease, unless judged by the investigator to be more severe than 
expected for the participant'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 participant's condition or 
considered to be treatment-related by the investigator. 
• Efficacy endpoints as outlined in Section 3 will not be reported as AE/SAEs, specifically, any event 
that is related to disease progression of the cancer under study.  Unblinded aggregated efficacy 
endpoint events and safety data will be monitored to ensure the safety of the participants in the study.  
Any suspected endpoint that upon review is not progression of the cancer under study will be 
transmitted to Incyte Pharmacovigilance via the EDC system within 24 hours of determination that 
the event is not progression of the cancer under study. 
• Medical or surgical procedure (eg, endoscopy, appendectomy):  the condition that leads to the 
procedure is the AE if it occurred after signing informed consent.  If present before entering the 
study, the condition should be captured as medical history. 
• 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. 
9.2. 
Definition of Serious Adverse Event 
If an event is not an AE per the definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death due 
to progression of disease). 
A serious adverse event is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an adverse drug experience that places 
the participant, in the opinion of the initial reporter, at immediate risk of death from the adverse 
experience as it occurs.  This does not include an adverse drug experience that, had it occurred in a 
more severe form, might have caused death. 

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c.  Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (involving at least an 
overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have 
been appropriate in the physician's office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other serious criteria, 
the event is serious.  When in doubt as to whether hospitalization occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment or planned surgery (eg, stent replacement, hip surgery) is not 
considered an SAE. 
Hospitalization for medical interventions in which no unfavorable medical occurrence occurred 
(ie, elective procedures or routine medical visits) are not considered SAEs. 
d. Results in persistent or significant disability/incapacity 
• The term "disability" means a substantial disruption of a person's ability to conduct normal life 
functions.  This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental 
trauma (eg, sprained ankle), that may interfere with or prevent everyday life functions but do not 
constitute a substantial disruption. 
e.  Is a congenital anomaly/birth defect 
f.  Is an important medical event 
An important medical event is an event that may not result in death, be immediately life-threatening, or 
require hospitalization but may be considered serious when, based on appropriate medical judgment, 
the event may jeopardize the participant and may require medical or surgical intervention to prevent 
one of the outcomes listed in the above definition.  Examples of such events include new invasive or 
malignant cancers (these would include secondary malignancies arising during the study that are 
distinct from the disease[s] under study), intensive treatment in an emergency department or at home 
for allergic bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, or 
development of drug dependency or drug abuse, or suspected transmission of an infectious agent via a 
medicinal product.  Secondary malignancies should always be considered SAEs. 
For Japan, an event which may lead to disability is also considered as the important medical event.  It 
includes a case that is exposed to a risk of dysfunction to an extent that interferes with daily life when 
the adverse drug reaction occurs.  It does not include an adverse drug reaction that, had the reaction 
been more severe, may have caused disability. 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Adverse Event and Serious Adverse Event Recording 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF.  Conditions that were present at the time informed consent was 
given should be recorded on the Medical History Form in the eCRF. 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostic reports) related to the event. 
• The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records in 
lieu of completing the Adverse Event eCRF page. 

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• There may be rare instances when copies of medical records for certain cases are requested.  In this 
case, all participant identifiers, with the exception of the participant number, will be redacted by the 
site staff on the copies of the medical records before submission.  These records can be submitted to 
Incyte Pharmacovigilance by email/fax per the contact information listed in the Study Reference 
Manual or as per SAE completing guidelines. 
• The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information.  Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE.  When a clear diagnosis cannot be identified, each sign or 
symptom should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine the following: 
• The severity grade (CTCAE v5.0 Grade 1 to 5).  See below for further instructions on the assessment 
of intensity. 
• Whether there is at least a reasonable possibility that the AE is related to the study treatment:  
suspected (yes) or not suspected (no).  See below for further instructions on the assessment of 
causality. 
• The start and end dates, unless unresolved at the final safety follow-up. 
• The action taken with regard to study treatment as a result of the AE/SAE(s). 
• The event outcome (eg, not recovered/not resolved, recovered/resolved, recovering/resolving, 
recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per the SAE definition provided in Section 9.2. 
• The action taken with regard to the event.  Note:  If an AE is treated with a concomitant medication 
or nondrug therapy, this action should be recorded on the Adverse Event Form and the treatment 
should be specified on the appropriate eCRF (eg, Prior/Concomitant Medications, Procedures and 
Non-Drug Therapy). 
Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v5.0 Grades 1 through 5.  If an event is not 
classified by CTCAE, the severity of the AE will be graded according to the scale below to estimate the 
grade of severity. 
The investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories: 
• Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment 
not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate 
activities of daily living. 
• Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4:  Life-threatening consequences; urgent treatment indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study treatment and each occurrence 
of each AE/SAE.  The relationship to each study treatment/reference therapy must be assessed 
(ie, for the Incyte product[s] and for the other product[s] that are used in combination with the Incyte 
product).  If appropriate, the relationship to the combination may be assessed as well. 

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• A "reasonable possibility" of a relationship conveys that there are medical facts, evidence, and/or 
arguments to suggest a causal relationship, rather than that a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the possibility of a relationship. 
• The investigator will also consult the RSI in the IB or product information for study treatment or 
marketed products, respectively, in making his/her assessment. 
• Alternative causes, such as underlying or concurrent disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study treatment administration, will be 
considered and investigated. 
• For each AE/SAE, the investigator must document in the medical notes that he/she has reviewed the 
AE/SAE and has provided an assessment of causality. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report.  However, the causality assessment is one of the criteria 
used when determining regulatory reporting requirements.  Therefore, it is very important that 
the investigator always make an assessment of causality based on the available information 
for every event before the initial transmission of the SAE. 
− The investigator may change his/her opinion of causality in light of follow-up information and 
submit the updated causality assessment. 
Follow-Up of Adverse Events and Serious Adverse Events 
• The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor to elucidate the nature 
and/or causality of the AE or SAE as fully as possible.  This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health care 
professionals. 
• Once an AE is detected, it should be followed in the AE eCRFs until it has resolved or until it is 
judged to be permanent; assessment should be made at each visit (or more frequently if necessary) of 
any changes in severity, the suspected relationship to the study treatment, the interventions required 
to treat the event, and the outcome. 
• When the severity of an AE changes over time for a reporting period (eg, between visits), each 
change in severity will be reported as a separate AE. 
• If a participant dies during participation in the study or during a recognized follow-up period, the 
investigator will provide the sponsor with a copy of any postmortem findings, including 
histopathology, in case an autopsy was performed. 
• Updated SAE information will be recorded in the originally completed eCRF and reported to Incyte 
Pharmacovigilance (via the EDC system or via email/fax if the paper SAE form is used) until 
resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. 
• Any updated SAE data (including SAEs being downgraded to nonserious) will be submitted to Incyte 
Pharmacovigilance within 24 hours of receipt of the information. 
See Appendix I for the management of potential Hy's Law (PHL) cases. 

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9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study treatment or study procedure[s]), all 
SAEs occurring after the participant has signed the ICF through completion of the study or until 
the participant starts a new anticancer therapy (whichever occurs earlier) must be reported to the 
sponsor (or designee) within 24 hours of learning of its occurrence, unless otherwise specified 
by the Protocol.  The investigator will submit any updated SAE data to the sponsor (or designee) 
immediately, without undue delay but not later than within 24 hours of it being available.  For 
Japan, this information must also be reported immediately to the head of the study site in Japan. 
Investigators are not obligated to actively seek SAE information after the EOT visit.  If the 
investigator learns of any SAE, including a death, at any time during this period, and he/she 
considers the event to be reasonably related to the study treatment or study participation, then the 
investigator must notify the sponsor (or designee) within 24 hours of becoming aware of the 
event. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs and AESIs (as defined in Section 9.5.1) will be followed 
until resolution, stabilization, the event is otherwise explained, or the participant is lost to 
follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor regarding an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
treatment under clinical investigation are met. 
If the SAE is not documented in the RSI of the IB or product information for study treatment 
(new occurrence) or marketed products, respectively, and is thought to be related to the study 
treatment, the sponsor or its designee may urgently require further information from the 
investigator for expedited reporting to health authorities.  The sponsor or its designee may need 
to issue an Investigator Notification to inform all investigators involved in any study with the 
same drug that this SAE has been reported.  SUSARs will be collected and reported to the 
competent authorities and relevant ethics committees in accordance with Directive 2001/20/EC 
or as per national regulatory requirements in participating countries. 
The sponsor will report suspected expected deaths and life-threatening events to PMDA in Japan, 
as per local regulatory requirements, as applicable. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation.  The 
sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 
An investigator who receives an investigator safety report describing an SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 

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Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator must report within 24 hours of learning of its occurrence any SAE via the EDC 
system (primary method) or by completing the Serious Adverse Event Report Form in English (only 
if the EDC system is not available).  The contact information for Incyte Pharmacovigilance by 
email/fax is listed in the Study Reference Manual or as per the Incyte Reference Guide for 
Completing the Serious Adverse Event Report Form. 
• In circumstances where the EDC system is not accessible for reporting SAE information (initial 
and/or follow-up SAE information) to the sponsor within 24 hours, refer to the Incyte Reference 
Guide for Completing the Serious Adverse Report Form.  Once the EDC system is functional, the 
SAE report should be retrospectively added to the EDC system and follow-up should be completed 
through the EDC.  The original copy of the Serious Adverse Event Report Form and the email or 
facsimile confirmation sheet must be kept at the study site (refer to the Incyte Reference Guide for 
Completing the Serious Adverse Report Form or Study Reference Manual for details and for the 
email address or fax number). 
• Follow-up information is also recorded in the eCRF and transmitted to Incyte Pharmacovigilance via 
the EDC system.  The follow-up report should include information that was not provided previously, 
such as the outcome of the event, treatment provided, action taken with study treatment because of 
the SAE (eg, dose reduced, interrupted, or discontinued), or participant disposition (eg, continued or 
withdrew from study participation).  Each recurrence, complication, or progression of the original 
event should be reported as follow-up to that event, regardless of when it occurs. 
9.5. 
Events of Clinical Interest 
An ECI is an AE that is either serious or nonserious that must be documented in a certain manner 
for further evaluation and assessment.  
9.5.1. 
Adverse Events of Special Interest by eCRF 
Adverse events of special interest are defined as a subset of ECIs that an investigator should 
urgently communicate information about the event to the sponsor/designee for further evaluation.  
Communication can be in the form of eCRF entry, email, or phone call to the sponsor/designee. 
Adverse events of special interest for tafasitamab/placebo are TLS, IRRs and allergic reactions to 
study drug ≥ Grade 3, CRS, SPM, hepatitis B reactivation, and PML. 
Adverse events of special interest for lenalidomide are second primary malignancy. 
Adverse events of special interest will be captured in the eCRF and if any of the serious criteria 
is met, should be captured as an SAE as well.   
Adverse events of special interest should be reported as a diagnosis and should include the 
symptoms of the event as 1 event term.  For example, IRR with symptoms of hives, chills, and 
fever. 
9.5.2. 
Adverse Events of Special Interest by Category and Preferred Term 
A second method will be used to identify AESIs programmatically using standardized MedDRA 
queries, custom MedDRA queries, and/or selected preferred terms. The same high-level terms as 

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described in Section 9.5.1 will be used for this analysis; please refer the SAP for further specific 
details. 
9.6. 
Emergency Unblinding of Treatment Assignment 
In case of a medical emergency, for a participant's safety management, the procedure for 
emergency unblinding is provided in the IRT or Study Reference Manual.  This option may be 
used only if the participant's well-being requires the investigator to be aware of the participant's 
treatment assignment.  If a participant's treatment assignment is unblinded, the sponsor or its 
designee must be notified immediately by telephone. 
If an investigator, the site personnel performing assessments, or a participant is unblinded, then 
the participant must discontinue study treatment, unless there are ethical reasons to have the 
participant remain on the study treatment.  In these cases, the investigator must obtain specific 
approval from the sponsor's (or its designee's) medical monitor for the participant to continue in 
the study. 
9.7. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that the study 
treatment may have interfered with the effectiveness of a contraceptive medication or method.  
When a pregnancy has been confirmed in a participant during maternal or paternal exposure to 
study treatment, the following procedures should be followed in order to ensure safety: 
• The study treatment must be interrupted immediately (female participants only). 
• If the female participant is no longer pregnant and meets the treatment continuation 
criteria within 28 days of the scheduled start of a cycle study treatment may be 
resumed after approval has been received from the sponsor medical monitor. 
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy Form 
to Incyte Pharmacovigilance within 24 hours of learning of the pregnancy. 
Data on fetal outcome are collected for regulatory reporting and drug safety evaluation.  
Follow-up should be conducted for each pregnancy to determine outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications, by following until the first 
well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported 
by the investigator to the sponsor or its designee.  Pregnancy follow-up information should be 
recorded on the same form and should include an assessment of the possible causal relationship 
to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the first well-baby 
visit or the duration specified in local regulations, whichever is later.  Refer to the Incyte 
Reference Guide for Completing the Clinical Trial Pregnancy Form or Study Reference Manual. 
Any SAE occurring during pregnancy of a study participant must be recorded on the 
Serious Adverse Event Report Form and submitted to the sponsor or its designee. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4.  If an abnormal pregnancy outcome is reported in a 

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study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 
9.8. 
Warnings and Precautions 
Special warnings or precautions for the study drug/treatment, derived from safety information 
collected by the sponsor or its designee, are presented in the IB.  Additional safety information 
collected between IB updates will be communicated in the form of Investigator Notifications.  
Any important new safety information should be discussed with the participant during the study 
as necessary.  If new significant risks are identified, they will be added to the ICF. 
9.9. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 
The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be recorded as described in Section 9.3. 
If the investigator is asked to return the product for investigation, he/she will return a copy of the 
product complaint communication with the product. 
In Japan, complaints associated with unapproved medical devices will be reported to the sponsor 
with a Medical Device Defect Report Form, and the sponsor will report medical device defects to 
the PMDA as per local regulatory requirements. 
9.10. 
Treatment of Overdose 
The sponsor is not recommending any specific treatment of a suspected overdose of tafasitamab, 
rituximab, and/or lenalidomide.  In case an overdose of tafasitamab, rituximab, and/or 
lenalidomide happens and requires treatment, symptomatic treatment including but not limited to 
blood product transfusions, growth factors, antibiotics, antiemetics, and analgesics may be 
administered per investigator's discretion. 
For purposes of this study, overdose of tafasitamab/rituximab is defined as any 
tafasitamab/rituximab dose above 120% of the assigned dosage per single infusion as per 
Protocol. 
For lenalidomide the overdose is defined as any dose greater than the planned dose for a 
particular participant as per Protocol. 
Overdose is not an SAE unless it meets the criteria of an SAE (see Section 9.2). 
In the event of an overdose, the investigator should do the following: 
• Contact the medical monitor immediately. 

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• Closely monitor the participant for any AE/SAE and laboratory abnormalities as 
clinically appropriate. 
• Document the quantity of the excess dose as well as the duration of the overdose in 
the eCRF. 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant. 
10. 
STATISTICS 
Any data analysis carried out independently by the investigator should be submitted to the 
sponsor before any publication or presentation. 
Data from all the sites and centers will be combined in the efficacy and safety analysis. 
10.1. 
Sample Size Determination 
The primary objective of the study is to detect a statistically significant difference in PFS (INV) 
for the tafasitamab-lenalidomide combination in addition to rituximab relative to 
placebo-lenalidomide in addition to rituximab for participants with FL. 
Based on the assumptions in Table 12 below, a total number of 174 PFS events in the FL 
population are required to detect a HR of 0.65 with 80% power at the primary analysis, using a 
2-sided log-rank test at an alpha level of 5% and a 1:1 randomization ratio between the 
2 treatment groups.  Assuming a median PFS of 27.8 months for lenalidomide in addition to 
rituximab (TGB), 21 months of enrollment, 12 months of follow-up for PFS, and 15% of 
dropouts, 528 evaluable FL participants need to be randomized. 
Table 12: 
Sample Size Assumptions 
Primary endpoint 
Progression-free survival (INV) for the FL population 
Median PFS in TGA 
42.8 months 
Median PFS in TGB 
27.8 months 
Randomization ratio 
1:1 
Assumed HR 
0.65 
Alpha (2-sided) 
5% 
Power 
80% 
Enrollment duration 
21 months 
Follow-up for PFS 
(starting from last participant randomized) 
12 months 
Accrual rate 
0.1 participant/site/month 
PFS events required at primary analysis 
174 
Total participants (without dropout) 
448 
Assumed dropout rate 
15% 
Total randomized participants  
528 

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A minimum of 60 and up to 90 additional participants with MZL will be randomized at a 
1:1 ratio to one of the 2 treatment groups.  The number of MZL participants is based on an 
expected enrollment proportion of FL and MZL participants. 
A 2-stage design with 1 interim analysis for a potential futility stop will be applied.  Information 
regarding the stopping boundaries at the interim and primary analyses is provided in Section 10.4 
and Section 10.5. 
10.2. 
Population for Analysis 
A full description of the population for analysis is presented in Table 13. 
Table 13: 
Analysis Population 
Population 
Description 
All screened  
All participants who sign the ICF. 
FAS 
All randomized participants.  Treatment groups for this population are determined 
according to the treatment they have been assigned at the time of randomization. 
The FAS will be used for the summary of demographics, baseline characteristics, 
participant disposition, and analyses of all efficacy data. 
PPS 
The subset of the participants in the FAS who are compliant with the 
requirements of the clinical study Protocol.  All Protocol deviations or conditions 
leading to exclusion from the PPS will be detailed in the Protocol Deviation 
Specifications.  Sensitivity analyses of the primary endpoint may be performed 
using PPS. 
SAF 
All randomized participants who receive at least 1 dose of tafasitamab/placebo, 
lenalidomide, or rituximab.  Treatment groups for this population will be 
determined according to the actual treatment the participant received on Cycle 1 
Day 1 regardless of assigned treatment at the time of randomization. 
All safety analyses will be conducted using the SAF.   
 
  
 
 
 
10.3. 
Level of Significance 
The primary endpoint of PFS in the FL population and 3 key secondary endpoints will be tested 
with inferential statistics.  Hypothesis testing for other secondary and exploratory endpoints may 
be performed for exploratory purposes.  Estimates and p-values will be reported for illustrative 
and exploratory purpose. 
Statistical tests will use a 0.05 significance level and will be 2-sided unless otherwise noted.  
Confidence intervals, both individual and simultaneous, will be at 95% confidence level unless 
stated otherwise. 
In order to control the study-wise type I error due to the multiple testing of the primary and key 
secondary endpoints, a hierarchical order of testing will be implemented. 

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The primary endpoint analysis will serve as a gatekeeper: 
• PFS by INV in the FL population 
If the primary hypothesis is rejected, the key secondary endpoints can be tested with the 
following fixed order: 
• PFS by INV in the overall population (FL and MZL) 
• PET-CR rate by INV in the FDG-avid FL population 
• OS in the FL population 
If a null hypothesis is not rejected, the formal sequential testing will be stopped, and the p-values 
for the remaining key secondary endpoints will be reported for exploratory and illustrative 
purposes. 
The primary analysis will be performed after approximately 174 PFS events based on INV are 
observed in the FL population in the FAS.  The primary analysis is independent of the number of 
enrolled MZL participants.  Recruitment will be stopped when the required 528 FL participants 
for the primary analysis and at least 60 MZL have been randomized.  The maximum number of 
randomized MZL participants is 90.  Formal hypothesis testing will not be performed for OS at 
the time of primary analysis; however, HRs may be estimated. 
The final analysis will be performed at the end of the study as defined in Section 8.9.4.  At the 
time of final analysis, the last key secondary endpoint OS will be tested. 
Other secondary and exploratory endpoints will be tested using a 2-sided, 5% significance level 
without multiplicity adjustment.  Estimates and nominal p-values will be reported for exploratory 
purpose.  Additional follow-up analyses for safety or efficacy endpoints may be performed if 
needed or requested by regulatory authorities. 
10.4. 
Statistical Analyses 
10.4.1. 
Efficacy Analyses 
All efficacy analyses will be based on FAS. 
10.4.1.1. Primary Analysis for Progression-Free Survival in the Follicular Lymphoma 
Population 
Progression-free survival as per INV is defined as the time from the date of randomization to the 
date of first documented disease progression, as determined by disease assessment per Lugano 
2014 criteria, or death due to any cause, whichever occurs earlier. 
For a given analysis, PFS will be censored if no PFS event is observed before the cutoff date or 
on the date that a new antilymphoma therapy is started.  Censoring for PFS will follow the 
algorithm outlined in Table 14, which is based on the FDA Guidance (FDA 2015, FDA 2018). 

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Table 14: 
Evaluation and Censoring of Progression-Free Survival for Primary Analysis 
Situation 
Censoring/Event Time 
Outcome 
Censoring Reason 
No baseline tumor 
assessment 
Date of randomization 
Censored 
No baseline assessment 
No valid postbaseline 
tumor assessment 
Date of randomization 
Censored 
No postbaseline assessment 
No PFS event observed 
before cutoff 
Date of last adequate 
tumor assessment prior 
to cutoff date 
Censored 
Ongoing  
Study discontinuation 
for undocumented 
progression or other 
reason 
Date of last adequate 
tumor assessment prior 
to cutoff date 
Censored 
Study discontinuation 
Start of a new 
antilymphoma 
treatment 
Date of last adequate 
tumor assessment 
on/before start of new 
antilymphoma treatment 
Censored 
Start of new antilymphoma 
treatment 
Death or disease 
progression 
documented after 2 or 
more missing or 
nonadequate tumor 
assessments 
Date of last adequate 
tumor assessment with 
overall lesion response 
of CR, PR, or SD prior 
to PD 
Censored 
Death or PD after 2 or more 
missing assessments 
The date of last adequate tumor assessment is the date of the last tumor assessment with overall 
lesion response of CR, PR, SD.  In this case, the last tumor evaluation date at that assessment is 
used.  If a PFS event is observed after a single missing or nonadequate tumor assessment, the 
actual date of event will be used, as per Cheson et al (2014) criteria. 
The distribution of PFS as per INV will be compared between the 2 treatment groups using a 
stratified log-rank test at 2-sided 5% level of significance.  The strata information will be based 
on the data obtained from the IRT that was used for randomization. 
A stratified Cox proportional hazard model will be used to estimate the HR between TGA 
(tafasitamab-lenalidomide in addition to rituximab) versus TGB (placebo-lenalidomide in 
addition to rituximab), along with 2-sided 95% CI, using the same stratification factor as for 
randomization as mentioned in Section 4.1. 
The distribution of PFS will be estimated using the Kaplan-Meier method.  The median along 
with 2-sided 95% CIs will be presented by treatment group.  In addition, investigator-assessed 
PFS event rates at 6, 12, 18, 24, 36, and 48 months will be provided along with the 
corresponding 2-sided 95% CIs for the estimates. 
All analysis mentioned above will be performed for participants with FL in the FAS. 
If the null hypothesis is rejected at a 2-sided significance level of 5%, the primary endpoint is 
met.  The p-value obtained from stratified log-rank test for PFS in the FL population using the 

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strata information based on IRT that was used for randomization will be used for hierarchical 
testing.  
In case of discrepancies in the diagnosis between the eCRF and the IRT, the participants will be 
analyzed into the population based on eCRF diagnosis.  
If a participant was randomized into the MZL cohort but after randomization was confirmed by 
the site to have a diagnosis of FL, the eCRF-derived information for medical history will be used 
to derive the 2 missing stratification factors for the FL cohort: POD24 status (yes versus no) and 
refractoriness to prior anti-CD20 mAb therapy (please see the definition in Section 4.1). If a 
participant was randomized into the FL cohort but after randomization was confirmed by the site 
to have a diagnosis of MZL, the IRT-derived stratification factor needed for this cohort (number 
of prior lines of therapy: < 2 vs ≥ 2) will be used. 
  Additional 
sensitivity analyses will be performed as mentioned in Section 10.4.1.6. 
10.4.1.2. Analyses of Key Secondary Efficacy Endpoints 
Hierarchical testing will be implemented for the key secondary endpoints, with the primary 
endpoint PFS serving as a gatekeeper.  This hierarchical testing procedure will maintain the 
study-wise Type I error. 
10.4.1.2.1. Progression-Free Survival in the Overall Population 
Progression-free survival in the overall population (FL and MZL) will be compared and analyzed 
in the same manner as described above in Section 10.4.1.1 for the PFS in the FL population.  The 
strata information for the stratified log-rank test will be based on the randomization factor used 
for both cohorts, FL and MZL: number of prior lines of therapy (< 2 vs ≥ 2). 
The p-value obtained from the stratified log-rank test for PFS in the overall population using the 
strata information based on IRT that was used for randomization, including stratification by FL 
versus MZL, will be used for hierarchical testing. 
  Additional 
sensitivity analyses will be performed as mentioned in Section 10.4.1.6. 
10.4.1.2.2. Positron Emission Tomography–Complete Response Rate in the FDG-Avid 
Follicular Lymphoma Population 
The PET-CR rate is defined as the proportion of participants who achieved a CR as per Lugano 
classification (Cheson et al 2014) with a PET-negative result among the participants with a 
positive PET scan at baseline. Participants with a positive PET scan are defined as participants 
with a Deauville score of 4 or 5.   
Participants with no postbaseline assessment by PET or who did not achieve a PET-CR will be 
classified as "non CR-responder." 
The CR rate will be compared between the 2 treatments groups using stratified CMH test using 
the same stratification factor as for randomization as for the PFS primary analysis.  The odds 
ratio and its 95% CIs calculated from the stratified CMH test will also be presented.  The number 

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of participants classified as PET-CR responders and the respective rates as well as 95% CIs 
(using Clopper-Pearson) will be presented. 
Key secondary analysis of PET-CR will be performed for participants with FDG-avid FL in the 
FAS. 
If the null hypothesis is rejected at a 2-sided significance level of 5%, this key-secondary 
endpoint is met.  The p-value obtained from CMH test for PET-CR rate as per INV observed in 
the FDG-avid FL population using the strata information based on IRT that was used for 
randomization will be used for hierarchical testing. 
  Additional 
sensitivity analyses will be performed as mentioned in Section 10.4.1.6. 
10.4.1.2.3. Overall Survival in the Follicular Lymphoma Population 
Overall survival is defined as the time from randomization until death from any cause.  
Participants who are not reported as a death at the time of the analysis cutoff will be censored at 
the date of last known alive, regardless if a new antilymphoma therapy was started. 
All participants should be followed until death or until the end of study as specified in the 
Protocol, whichever comes first.  The follow-up data should contain the date the participant was 
last seen alive/last known alive, the date of death, and the reason of death ("disease progression," 
"adverse event," or "other"). 
Overall survival will be compared and analyzed in the same manner as described above in 
Section 10.4.1.1 for the PFS. 
Key secondary analysis of OS will be performed for participants with FL in the FAS.  The 
analysis will be performed at the time of final analysis. 
  Additional 
sensitivity analyses will be performed as mentioned in Section 10.4.1.6. 
 
 
 
 
 
 
 
 
 
 
10.4.1.4. Analyses of Other Secondary Efficacy Endpoints 
10.4.1.4.1. Positron Emission Tomography-Complete Response Rate in the Overall 
Population 
The PET-CR rate in the overall FDG-avid population (FL and MZL) will be compared and 
analyzed in the same manner as described in Section 10.4.1.2.2 for the PET-CR rate in the 
FDG-avid FL population.  The stratification factors will be those used for the PFS analysis on 

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the FL population and on the overall population, respectively (see Section 10.4.1.1 and 
Section 10.4.1.2.1). 
10.4.1.4.2. Minimal Residual Disease-Negativity Rate at End of Treatment in the Follicular 
Lymphoma and Overall Population 
The MRD-negativity rate is defined as the proportion of participants who achieved a negative 
MRD result at EOT.  Participants with no postbaseline assessment or who did not achieve a 
negative MRD result will be classified as "non MRD-negative." 
The MRD-negativity rate in the 2 treatment groups will be compared and analyzed in the same 
manner as described in Section 10.4.1.2.2 for the PET-CR rate.  The stratification factors will be 
those used for the PFS analysis on the FL population and on the overall population, respectively 
(see Section 10.4.1.1 and Section 10.4.1.2.1).  Analysis of the MRD-negativity rate at EOT will 
be performed for participants with FL and the overall population (FL and MZL) in the FAS. 
 
10.4.1.4.3. Overall Response Rate in Follicular Lymphoma and Overall Populations 
Overall response rate is defined as the proportion of participants who achieved a CR or PR as 
determined per Lugano classification (Cheson et al 2014) at any time during the study but before 
the first PD and before/at the start of a new antilymphoma treatment. 
Overall response rate will be compared and analyzed in the same manner as described above in 
Section 10.4.1.2.2 for PET-CR rate in the FDG-avid FL population.  The stratification factors 
will be those used for the PFS analysis on the FL population and on the overall population, 
respectively (see Section 10.4.1.1 and Section 10.4.1.2.1). 
10.4.1.4.4. Duration of Response in the Follicular Lymphoma and Overall Populations 
Duration of response is defined as the time from first tumor response (CR or PR as per Lugano 
classification [Cheson et al 2014]) until the time of first documented disease progression, or 
death from any cause, among participants who achieve an objective response.  Participants with a 
response but no documented disease progression or death at the time of analysis will be censored 
at the date of last adequate tumor assessments. 
Kaplan-Meier estimation of median DoR and its 95% CIs will be presented by treatment group 
for participants who achieve an objective response.  No statistical comparison will be performed 
for this analysis. 
Duration of response will be analyzed for FL and overall populations. 
10.4.1.4.5. Overall Survival in Overall Population 
Overall survival in the overall population (FL and MZL) will be compared and analyzed in the 
same manner as described in Section 10.4.1.2.3 for the OS in the FL population. The only 
difference will be that the strata information for the stratified log-rank test will be based on the 
randomization factor used for both cohorts, FL and MZL: number of prior lines of therapy (< 2 
vs ≥ 2). 

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10.4.1.4.6. Analysis of Efficacy Endpoints by Independent Review Committee  
The endpoints PFS, ORR, and DoR, as determined by IRC assessment using International 
Working Group 2014 response criteria (Cheson et al 2014), will be analyzed on the FL and 
overall populations. 
They will be analyzed the same way as described for the respective efficacy endpoints by INV 
(see Section 10.4.1.1, Section 10.4.1.4.3, and Section 10.4.1.4.4). 
10.4.1.4.7. Response Assessment Concordance 
The concordance rate represents the agreement in the best overall outcome (CR, PR, SD, PD, not 
evaluable, and not available) in response assessments between the IRC and INV assessment.  
The concordance rate is the number of concordant participants over the total number of assessed 
participants and will be calculated across all response categories. 
10.4.1.4.8. Quality of Life Questionnaires EORTC QLQ-C30, EQ-5D-5L, and FACT-Lym in 
Follicular Lymphoma and Overall Populations 
Quality of life will be assessed using the EORTC QLQ-C30, the EQ-5D-5L, and FACT-Lym 
tools.  The EORTC QLQ-C30 is composed of 5 functional scales (eg, physical function, 
emotional functioning), 3 symptom scales (eg, fatigue), a global health status, and 6 single items 
(eg, dyspnea, insomnia).  The EQ-5D-5L contains a participant reported score on a visual 
analogue scale and 5 questions on mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression.  Scoring of each scale will be calculated following the respective manuals.  
The FACT-Lym questionnaire is composed of the FACT-General (FACT-G)—a 27-item 
compilation of general questions and an additional 15 items that assess patient concerns relating 
to lymphoma:  the FACT-Lym lymphoma-specific subscale or FACT-Lym LYMS.  The 
FACT-Lym LYMS consists of common lymphoma disease and/or treatment-related symptoms 
(eg, pain, fever, swelling, night sweats, insomnia, itching, weight loss, fatigue, and loss of 
appetite). 
Descriptive statistics for each of the scores will be tabulated.  Change from baseline for each 
score will be summarized by visit for each treatment group in the FL population and overall 
population. 

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10.4.1.6. Sensitivity Analysis of Efficacy Endpoints 
The following sensitivity analysis will be performed: 
• All primary and key secondary efficacy analyses 
 
 may be performed on the PPS. 
• For time to event endpoints, the assumption of proportional hazard may be tested.  If 
the assumption is not met, a Renyi test may be performed.  Additional details will be 
provided in the SAP. 
• For time to event endpoints, unstratified log-rank test may be performed and 
unadjusted HR may be obtained using unstratified Cox PH model. 
• Stratified analyses may be performed using stratification factors from the eCRF. 
• For binary endpoints like PET-CR rate and ORR, Fisher's exact test may be 
performed. 
• For the primary and key secondary endpoint of PFS in the FL and overall 
populations, the analysis may be performed considering participants having an event 
after 2 or more missed visits as having a PFS event. 
• For the primary and key secondary endpoint of PFS in the FL and overall 
populations, the analysis will correct for potential bias in the follow-up schedules for 
disease assessment by assigning the dates for censoring and events only at scheduled 
visit dates.  It is the same as the primary analysis except that the date of progression is 
approximated as the date of the Protocol-scheduled visit immediately after the 
radiologic assessment of PD. 
• For the primary and secondary efficacy endpoints, sensitivity analyses may be 
performed to evaluate the impact of subsequent antilymphoma therapy.  For the PFS 
and DoR endpoints, sensitivity analyses may be performed per EMA guidelines to 
consider new antilymphoma treatment as an event or consider all disease progressions 
and deaths as events regardless of whether they occur after initiating new 
antilymphoma treatment. 
Any additional sensitivity analysis will be outlined in the SAP. 
10.4.2. 
Safety Analyses 
Safety analyses will be conducted for the SAF.  No formal statistical testing will be performed. 
All TEAEs, clinical laboratory measurements, vital sign measurements, and abnormal ECGs will 
be summarized by treatment group.  Quantitative safety variables and their changes from 
baseline (laboratory and vital signs) will be summarized with descriptive statistics.  Abnormal 
values outside of established ranges will be flagged and tabulated based on predefined criteria. 
Measures of exposure (eg, days of exposure, dose intensity) of tafasitamab/placebo, 
lenalidomide, and rituximab will be summarized descriptively. 

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Adverse events will be coded by the MedDRA dictionary and severity of AEs will be based on 
the NCI CTCAE v5.0 using Grades 1 through 5.  A TEAE is defined as an AE either reported for 
the first time or worsening of a pre-existing event on or after first dose of study treatment and 
within 90 days of the last administration of study treatment.  Number (%) of participants 
reporting any TEAEs, any serious TEAEs, any Grade 3 or higher TEAEs, any treatment-related 
TEAEs, any treatment-related serious TEAEs, any treatment-related Grade 3 or higher TEAEs, 
any fatal TEAEs, and any TEAEs leading to treatment interruption/delay/dose 
reduction/discontinuation will be tabulated by MedDRA system organ class and preferred term.  
Data listings will include all AEs regardless of their timing to study drug/treatment 
administration. 
The clinical laboratory data will be analyzed using summary statistics; no formal treatment group 
comparisons are planned.  In addition, distributions of key laboratory parameters may be plotted 
over time; these values will also be classified into CTCAE toxicity grades when applicable, and 
tabulated. 
Descriptive statistics and mean change from baseline will be determined for vital signs at each 
assessment time.  The abnormal values for participants exhibiting vital sign abnormalities will be 
listed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.5. 
Interim Analysis 
An interim analysis will be performed after 20% of the required PFS (INV) events 
(approximately 35 events) have been observed in participants with FL in the FAS population.  
This is expected to occur approximately 15 months after the first participant is randomized and 
approximately 338 (out of 528 total) participants with FL will have been randomized in the 
study. 

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An IDMC will be involved in reviewing the interim analysis results and provide their 
recommendation for a potential futility stop based on comparative efficacy and safety data.  The 
PFS HR will be calculated and the IDMC may recommend to stop the study if the observed HR 
of tafasitamab plus lenalidomide in addition to rituximab (TGA) over placebo plus lenalidomide 
in addition to rituximab (TGB) is ≥1.05 for participants with FL in the FAS population 
(nonbinding futility boundary; see Table 15).  Early stop for efficacy is not planned. 
The false negative rate for a futility stop with a futility boundary of HR = 1.05 is 
• Approximately 8% if the true HR is 0.65, and 
• Approximately 15% if the true HR is 0.74. 
The false positive rate for continuation of the study with a futility boundary of HR = 1.05 is 
• Approximately 62% if the true HR is 0.95. 
Table 15: 
Guidelines for Decisions – Progression-Free Survival 
 
Interim Analysis 
Projected timing 
15 months 
Projected randomized participants 
338 participants 
Number of PFS events 
35 events 
Decision outcome 
Futility Boundary 
Continue 
Estimated HR  
≥ 1.05 
< 1.05 
At the interim analysis, descriptive analyses will also be provided for other efficacy endpoints, 
including PFS by INV in the overall population (FL + MZL), PET-CR rate at EOT by INV in the 
FL and overall populations, and ORR, OS, and DoR by INV in the FL and overall populations.   
10.6. 
Independent Data Monitoring Committee 
Preplanned analyses of safety and efficacy will be provided to an IDMC as specified in the 
IDMC charter (see Section 5.6). 

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

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− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations.  
The sponsor will retain the original eCRF data and audit trail. 
• For Japan, the record retainer (delegated by the head of the study site) will retain the 
J-GCP–defined essential documentation at this site until the regulatory approval of 
the study drug(s)/treatment or at least 3 years after the discontinuation or completion 
of the study conduct, whichever is later.  If the sponsor requires retention of these 
documents for a longer period of time, the duration and method of retention will be 
decided upon through discussion between the sponsor and the study site.  It is the 
responsibility of the sponsor to inform the head of the study site as to when the 
documents no longer need to be retained. 
11.1.1. 
Identification of the Coordinating Principal Investigator 
A coordinating principal investigator will be appointed by the sponsor before the end of the 
study.  As part of their responsibilities, the coordinating principal investigator will review the 
final CSR.  Agreement with the final CSR will be documented by the dated signature of the 
coordinating principal investigator. 
11.2. 
Data Management 
Data management will be performed in a validated EDC system.  The investigator and the 
unblinded pharmacist will be provided with access to an EDC system so that an eCRF can be 
completed for each participant. 
The site will be provided with eCRF completion guidelines for instructions on data entry in the 
eCRF.  The study monitor will reference the Monitoring Plan in order to ensure that each issue 
identified is appropriately documented, reported, and resolved in a timely manner in accordance 
with the plan's requirements.  Other data outside the EDC system required in the study conduct 
of the Protocol, such as documents or results transmitted to the sponsor via a central laboratory 
or specialized technical vendors and as designated by the sponsor, will have their own data flow 
management plans, study charters, 
, as applicable. 
The sponsor (or designee) will be responsible for the following: 
• Managing the integrity of the data and the quality of the conduct of the study, such as 
ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved Protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Managing and reconciling the data generated and/or collected, including documents 
and results such as laboratory or imaging data analyzed centrally by a designated 
vendor of the sponsor. 

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The investigator will be responsible for the following: 
• Recording, or ensuring the recording of, all relevant data relating to the study in the 
eCRF. 
• Delivering, or ensuring the delivery of, all other results, documents, data, know-how, 
or formulas relating to the study to the sponsor or designee electronically and/or 
centrally (eg, laboratory data, imaging data, 
, photographs, diary data) 
or as otherwise specified in the Protocol. 
• Maintaining adequate and accurate source documents and trial records that include all 
pertinent observations on each of the site's trial participants.  Source data should be 
attributable, legible, contemporaneous, original, accurate, and complete.  Changes to 
source data should be traceable, should not obscure the original entry, and should be 
explained if necessary (eg, via an audit trail).  Source data are, in general, all 
information in original records and certified copies of original records of clinical 
findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial.  Source data are contained in source 
documents (original records or certified copies). 
• Verifying that data entries are accurate and correct by physically or electronically 
signing the eCRF. 
• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF, sent to a central vendor designated by the sponsor, or as 
described in other study and data flow manuals. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed and 
available at the investigator's site.  Examples of source documents are original 
documents, data, and records (eg, hospital records; electronic hospital records; 
clinical and office charts; laboratory notes; memoranda; participants' diaries or 
evaluation checklists; pharmacy dispensing records; recorded data from 
automated instruments; copies or transcriptions certified after verification as 
being accurate copies; microfiches; photographic negatives; microfilm or 
magnetic media; x-rays; participants' files; and e-records/records kept at the 
pharmacy, at the laboratories, and at medico-technical departments involved in 
the clinical trial). 
− Data entered in the eCRF that are transcribed from source documents must be 
consistent with the source documents or the discrepancies must be explained.  The 
investigator may need to request previous medical records or transfer records, 
depending on the study.  Current applicable medical records must be available. 
• Sending participants' data, either as unique samples, or copies, or photographs, to be 
evaluated centrally or analyzed centrally, or both, by a qualified vendor designated by 
the sponsor. 

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• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
participant records at each monitoring visit. 
− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all participants. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
11.3. 
Data Quality Assurance 
The sponsor assumes accountability for actions delegated to other individuals (eg, contract 
research organizations). The sponsor or designee is responsible for the data management of this 
study, including quality checking of the data. Further, monitoring details describing strategy, 
including definition of study-critical data items and processes (eg, risk-based initiatives in 
operations and quality such as risk management and mitigation strategies and analytical risk-
based monitoring), methods, responsibilities, and requirements, including handling of 
noncompliance issues, Protocol deviations, and monitoring techniques (eg, central, remote, or 
on-site monitoring) are provided in the monitoring plan.  
Quality tolerance limits will be predefined in the monitoring plan to identify systematic issues 
that can impact participants' safety, efficacy results and analysis, and/or reliability of study 
results. These predefined parameters will be monitored during the study and can be adjusted 
during the study upon data review. Important deviations from the quality tolerance limits and 
remedial actions taken, including reporting to IRBs/IECs and health authorities if applicable, will 
be summarized in the CSR. 
11.4. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data protection laws 
and regulations. The investigator and the sponsor or its designee are responsible for ensuring that 
personal information is handled in accordance with local data protection laws (including but not 
limited to HIPAA and GDPR) as applicable, and the sponsor operates comprehensive data 
privacy and data security programs that are applicable to this study. Appropriate notice, or notice 
and consent (as may be required by each applicable jurisdiction), for collection, use, disclosure, 

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and/or transfer (if applicable) of personal information must be obtained in accordance with local 
data protection laws. Appropriate data protection terms that comply with applicable laws will be 
included in relevant study agreements.  
To ensure confidentiality of records and protect personal data, participant names will not be 
supplied to the sponsor or its designee. Only the participant number will be recorded in the 
eCRF; if the participant's name appears on any other document (eg, laboratory report), it must be 
obliterated on the copy of the document to be supplied to the sponsor or its designee. Study 
findings stored on a computer will be stored in accordance with appropriate technical and 
organizational measures as required by local data protection laws. 
In the event of a data breach involving participant data, the sponsor or its designee will follow 
the sponsor's incident response procedures. The precise definition of a data breach varies in 
accordance with applicable law but may generally be understood as a breach of security leading 
to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, 
personal data. In accordance with its incident response procedures, the sponsor will assess the 
breach to consider its notification and remediation obligations under applicable law. 
11.5. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 CFR Part 54 – Financial Disclosure by Clinical Investigators (ie, "covered 
studies") are required to submit a completed Clinical Investigator Financial Disclosure Form that 
sufficiently details any financial interests and arrangements that apply.  For the purpose of this 
regulation, "clinical investigator" is defined as any investigator or subinvestigator who is directly 
involved in the treatment or evaluation of research participants, including the spouse and each 
dependent child of the clinical investigator or subinvestigator.  These requirements apply to both 
US and foreign clinical investigators conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Clinical Investigator Financial Disclosure Form.  During a covered clinical 
study, any changes to the financial information previously reported by a clinical investigator 
must be reported to the sponsor or its designee.  At the conclusion of the covered clinical study, 
the clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 
11.6. 
Publication Policy 
By signing the study Protocol, the investigator and their institution agree that the results of the 
study may be used by the sponsor, Incyte Corporation/Incyte Biosciences International Sàrl 
(Incyte), for the purposes of national and international registration, publication, and information 
for medical and pharmaceutical professionals.  Study results will be published in accordance 
with applicable local and national regulations.  If necessary, the authorities will be notified of the 
investigator's name, address, qualifications, and extent of involvement.  The terms regarding the 
publication of study results are contained in the agreement signed with the sponsor or its 
designee.  A signed agreement will be retained by the sponsor or its designee. 

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The results of this study may be published or presented at scientific meetings.  If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.  
This allows the sponsor to protect proprietary information and to provide comments. 
The sponsor will comply with the requirements for publication of study results.  In accordance 
with standard editorial and ethical practice, the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data.  In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.7. 
Study and Site Closure 
The sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor.  Study sites will be closed upon study 
completion.  A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
For Japan, when the trial is completed, the investigator should inform the head of the study site 
of the completion in writing and submit a written summary of the trial's outcome, and then the 
head of the study site should promptly inform the IRB and sponsor or designee of the completion 
in writing. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
• Failure of the investigator to comply with the Protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further study treatment development. 

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12. 
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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS 
Definitions 
Woman of childbearing potential (WOCBP) 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below). 
Women in the following categories are not considered WOCBP: 
• Premenarchal 
• Premenopausal female with 1 of the following: 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
Note:  Documentation can come from the site personnel's review of the participant's medical records, 
medical examination, or medical history interview. 
Postmenopausal female 
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. 
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, confirmation with 2 FSH measurements 
in the postmenopausal range is required.  Add FSH in the laboratory table at screening, as needed. 
Females on HRT and whose menopausal status is in doubt will be required to use one of the 
nonhormonal highly effective contraception methods if they wish to continue their HRT during the 
study.  Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before 
study enrollment. 
For male participants of reproductive potentiala 
The following methods during the Protocol-defined timeframe in Section 5.1 are highly effective: 
• Condom 
− Use of a male condom plus partner use of an additional contraceptive method when having 
penile-vaginal intercourse with a WOCBP who is not currently pregnant. 
• Sexual abstinenceb (sexual abstinence is not approved in Japan) 
− Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on 
a long-term and persistent basis) and agree to remain abstinent. 
The following are not acceptable methods of contraception: 
• Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus 
interruptus), spermicides only, and lactational amenorrhoea method. 
• Male condom with cap, diaphragm or sponge with spermicide. 
• Male and female condom cannot be used together. 
Note:  Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal 
intercourse or use a male condom during each episode of penile penetration. 

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For female participants who are WOCBP 
The following methods during the Protocol-defined timeframe in Section 5.1 that can achieve a failure 
rate of less than 1% per year when used consistently and correctly are considered as highly effective 
birth control methods: 
• Progestogen-only hormonal contraception associated with inhibition of ovulationc 
(progesterone-only hormonal contraception is not approved in Japan, so this bullet and its 
sub-bullets will not apply for Japan) 
− oral 
− injectable 
− implantabled 
• Intrauterine deviced 
• Intrauterine hormone-releasing systemd 
• Bilateral tubal occlusiond 
• Vasectomized partnerd,e 
• Sexual abstinence (sexual abstinence is not approved in Japan). 
Examples of additional effective (barrier) methods: 
• Male condom 
• Diaphragm 
• Cervical cap 
a If the male participant has a partner with child-bearing potential the partner should also use contraceptives. 
b In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.  The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the 
preferred and usual lifestyle of the participant. 
c Hormonal contraception may be susceptible to interaction with the IMP, which may reduce the efficacy of the 
contraception method; 2 methods of contraception should be used. 
d Contraception methods that in the context of this guidance are considered to have low user dependency. 
e Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the WOCBP study participant and that the vasectomized partner has received medical assessment of the 
surgical success. 
Source:  Clinical Trials Facilitation and Coordination Group 2014. 

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APPENDIX B. DOSE ADJUSTMENT FOR LENALIDOMIDE 
Dose Reduction Steps 
 
Other dose levels/dose regimens for lenalidomide may be considered after discussion and 
approval by the sponsor's medical monitor. 
Dose Adjustments for Toxicity 
 

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For study participants experiencing a Grade 3 or higher adverse event of renal impairment, ie, a decrease 
of the creatinine clearance to less than 30 mL/min, the following dose modification will apply: 
Renal 
impairment 
(chronic 
kidney 
disease)a 
Grade 3: 
Creatinine clearance 29-15 mL/min 
• Interrupt lenalidomide treatment. 
• Provided toxicities resolve to ≤ Grade 2, restart 
lenalidomide at the next lower dose level. 
− Restart lenalidomide at 15 mg/d (D1-21 
Q28D) if participant was on 20 mg/d 
lenalidomide before the event. 
− Restart lenalidomide at 10 mg/d (D1-21 
Q28D) if participant was on 15 mg/d 
lenalidomide before the event. 
− Restart lenalidomide at 5 mg/d (D1-21 
Q28D) if participant was on 10 mg/d 
lenalidomide before the event. 
• Monitor as clinically indicated. 
Grade 4: 
Creatinine clearance < 15 mL/min 
• Permanently discontinue lenalidomide 
treatment. 
• Monitor as clinically indicated. 
a If, based on medical judgment, the treating physician considers a laboratory parameter change or AE not to be a 
study drug related toxicity, but to represent a natural fluctuation in or progression of the underlying disease, then it 
is at the physician's discretion and assessment of the individual risk/benefit ratio to determine whether the 
participant should be dosed.  The decision and rationale behind the decision should be documented in the source 
data. 

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APPENDIX C. CALCULATION OF CREATININE CLEARANCE USING 
THE COCKCROFT-GAULT FORMULA 
 

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APPENDIX D. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS 
Grade 
Description 
0 
Fully active; able to carry on all predisease performance without restriction. 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a 
light or sedentary nature (eg, light 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 
Source:  Oken et al 1982. 

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APPENDIX E. ANN ARBOR STAGING 
Grade 
Description 
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 IVb 
Diffuse or disseminated foci of involvement of one or more extralymphatic organs or 
tissues, with or without associated lymphatic involvement 
Note:  All cases are subclassified to indicate the absence (A) or presence (B) of the systemic B symptoms of 
significant unexplained fever (> 38°C), night sweats, or unexplained weight loss exceeding 10% of body weight 
during the 6 months prior to diagnosis. 
a The designation "E" generally refers to extranodal contiguous extension (ie, 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. 
b Involvement of BM at screening will always qualify for Ann Arbor Stage IV and should be recorded as extranodal 
involvement. 
Source:  Carbone et al 1971, Lister et al 1989. 

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APPENDIX F. FOLLICULAR LYMPHOMA INTERNATIONAL 
PROGNOSTIC INDEX-1 
The Follicular Lymphoma International Prognostic Index-1 (FLIPI-1) is a prognostic scoring 
system developed as a result of a large international cooperative effort in which clinical data was 
collected from 4167 patients with FL diagnosed between 1985 and 1992 (Solal-Céligny 
et al 2004).  From this database, a prognostic index with 5 adverse factors was derived and 
validated.  The parameters include age, Ann Arbor stage, and number of nodal sites involved, 
hemoglobin levels and serum lactate dehydrogenase (LDH) levels.  Each of these adverse factors 
is assigned 1 point if positive, the points are totaled to give the final FLIPI-1 score, and 
lymphoma prognoses are based on this score. 
The index is able to separate participants with FL into 3 distinct prognostic groups with unique 
survival outcomes.  If the score is 0 to 1, the participant is considered "low risk" according to the 
FLIPI-1.  Overall survival at 10 years is estimated to be 70%.  If the score is 2, the participant is 
considered "intermediate risk" according to the FLIPI-1.  Overall survival at 10 years is 
estimated to be 50%.  If the score is ≥ 3, the participant is considered "high risk" according to the 
FLIPI-1.  Overall survival at 10 years is estimated to be 35%. 
Table A1: 
FLIPI-1 Criteria 
Parameter 
Adverse Factor 
Age 
≥ 60 years 
Ann Arbor stage 
III to IV 
Hemoglobin level 
< 12 g/dL 
Serum LDH level 
> ULN (upper limit of normal) 
Number of involved nodal sites 
> 4 
Risk Group According to FLIPI-1 Score 
Number of Factors 
Low 
0-1 
Intermediate 
2 
High 
≥ 3 

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APPENDIX G. THE GROUPE POUR L'ETUDE DE LYMPHOME 
FOLLICULAIRE CRITERIA 
GELF Criteria 
Involvement of ≥ 3 nodal sites, each with a diameter of > 3 cm 
Any nodal or extranodal tumor mass with a diameter of > 7 cm or risk of local compressive symptoms 
that may result in organ compromise 
B symptoms 
Splenomegaly 
Pleural effusions or peritoneal ascites 
Cytopenias (leukocytes < 1.0 × 109/L and/or platelets < 100 × 109/L 
Leukemia (> 5.0 × 109/L circulating malignant cells) 
Source:  GELF criteria:  A guide for the need for treatment of indolent lymphoma (Chen et al 2012, Solal-Céligny 
et al 1998). 

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APPENDIX H. LUGANO RESPONSE CRITERIA FOR MALIGNANT 
LYMPHOMA 
Target and Nontarget Lesions 
Up to 6 of the largest target nodes, nodal masses, or other lymphomatous lesions that are 
measurable in 2 diameters should be identified from different body regions representative of the 
participant's overall disease burden and include mediastinal and retroperitoneal disease, if 
involved.  At baseline, a measurable node must be > 15 mm in longest diameter (LDi).  
Measurable extranodal disease may be included in the 6 representative measured lesions.  At 
baseline, measurable extranodal lesions should be > 10 mm LDi. 
All other lesions (including nodal, extranodal, and assessable disease) should be followed as 
nonmeasured disease as nontarget lesions (eg, cutaneous, GI, bone, spleen, liver, kidneys, pleural 
or pericardial effusions, ascites, bone, BM). 
Split Lesions and Confluent Lesions 
Lesions may split or may become confluent over time.  In the case of split lesions, the individual 
product of the perpendicular diameters (PPDs) of the nodes should be summed together to 
represent the PPD of the split lesion; this PPD is added to the sum of the PPDs of the remaining 
lesions to measure response.  If subsequent growth of any or all of these discrete nodes occurs, 
the nadir of each individual node is used to determine progression.  In the case of confluent 
lesions, the PPD of the confluent mass should be compared with the sum of the PPDs of the 
individual nodes, with more than 50% increase in PPD of the confluent mass compared with the 
sum of individual nodes necessary to indicate PD.  The LDi and smallest diameter (SDi) are no 
longer needed to determine progression. 

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Response 
Imaging 
Lymph Node and Extra 
Lymphatic Sites 
Nontarget 
Lesions 
Liver and 
Spleen 
Bone Marrow 
New Lesion 
CR 
PET 
Score of 1, 2 or 3a with our 
without a residual mass on 5PS.b 
Not applicable 
Not applicable 
No evidence of FDG-avid 
disease in marrow 
None 
CT 
Target nodes/nodal masses must 
regress to ≤ 1.5 cm in LDi. 
No extra lymphatic site of disease. 
Absent 
Regress to 
normal 
Normal by morphology; if 
intermediate, IHC negative 
None 
PR 
PET 
Score 4 or 5b with reduced uptake 
compared with baseline and 
residual mass(es) of any size. 
At interim, these findings suggest 
responding disease. 
At end of treatment, these findings 
indicate residual disease. 
Not applicable 
Not applicable 
Residual uptake higher 
than uptake in normal 
marrow but reduced 
compared with baseline 
(diffuse uptake compatible 
with reactive changes from 
chemotherapy allowed).  If 
there are persistent focal 
changes in the marrow in 
the context of a nodal 
response, consideration 
should be given to further 
evaluation with MRI or 
biopsy or an interval scan. 
None 
CT 
≥ 50% decrease in SPD of up to 
6 target measurable nodes and 
extranodal sites. 
When a lesion is too small to 
measure on CT, assign 5 mm 
× 5 mm as the default value. 
When no longer visible, 0 × 0 mm. 
For a node > 5 mm × 5 mm, but 
smaller than normal, use actual 
measurement for calculation. 
Abnormal/ 
normal, 
regressed, but no 
increase 
Spleen must 
have regressed 
by > 50% in 
length beyond 
normal 
Not applicable 
None 

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Response 
Imaging 
Lymph Node and Extra 
Lymphatic Sites 
Nontarget 
Lesions 
Liver and 
Spleen 
Bone Marrow 
New Lesion 
SD 
PET 
Score 4 or 5b with no significant 
change in FDG uptake from 
baseline at interim or end of 
treatment. 
Not applicable 
Not applicable 
No change from baseline 
None 
CT 
< 50% decrease from baseline in 
SPD of up to 6 dominant, 
measurable nodes and extranodal 
sites; no criteria for PD are met. 
No increase 
consistent with 
progression 
No increase 
consistent with 
progression 
Not applicable 
None 
PD 
PET 
Score 4 or 5b with an increase in 
intensity of uptake from baseline 
and/or 
New FDG-avid foci consistent 
with lymphoma at interim or 
end-of-treatment assessment. 
Not applicable 
Not applicable 
New or recurrent 
FDG-avid foci 
New FDG-avid foci 
consistent with 
lymphoma rather than 
another etiology (eg, 
infection, 
inflammation); if 
uncertain regarding 
etiology of new lesions, 
biopsy or interval scan 
may be considered. 
CT 
An individual node/lesion must be 
abnormal with LDi > 1.5 cm and 
Increase by ≥ 50% from PPD nadir 
and 
An increase in LDi or SDi from 
nadir 
0.5 cm for lesions ≤ 2 cm 
1.0 cm for lesions > 2 cm 
In the setting of splenomegaly 
(> 13 cm), the splenic length must 
increase by > 50% of the extent of 
its prior increase beyond baseline 
(eg, a 15-cm spleen must increase 
to > 16 cm).  If no prior 
splenomegaly, must increase by at 
least 2 cm from baseline. 
New or clear 
progression of 
preexisting 
nontarget lesions 
New or 
recurrent 
splenomegaly 
New or recurrent 
involvement 
Regrowth of previously 
resolved lesions 
A new node > 1.5 cm 
in any axis 
A new extranodal site 
> 1.0 cm in any axis; if 
< 1.0 cm in any axis, its 
presence must be 
unequivocal and must 
be attributable to 
lymphoma 
Assessable disease of 
any size unequivocally 
attributable to 
lymphoma 

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5PS = 5-point scale; CT = computed tomography; FDG = fluorodeoxyglucose; IHC =immunohistochemistry; LDi = longest transverse diameter of a lesion; MRI = magnetic 
resonance imaging; PET = positron emission tomography; PPD = cross product of the LDi and perpendicular diameter; SDi = shortest axis perpendicular to the LDi; SPD = sum 
of the product of the perpendicular diameters for multiple lesions. 
a A score of 3 in many patients indicates a good prognosis with standard treatment, especially if at the time of an interim scan.  However, in trials involving PET where de-
escalation is investigated, it may be preferable to consider a score of 3 as inadequate response (to avoid undertreatment). 
Measured dominant lesions:  Up to six of the largest dominant nodes, nodal masses, and extranodal lesions selected to be clearly measurable in two diameters.  Nodes should 
preferably be from disparate regions of the body and should include, where applicable, mediastinal and retroperitoneal areas.  Non-nodal lesions include those in solid organs 
(eg, liver, spleen, kidneys, lungs), gastrointestinal involvement, cutaneous lesions, or those noted on palpation.  Non-measured lesions:  Any disease not selected as measured; 
dominant disease and truly assessable disease should be considered not measured.  These sites include any nodes, nodal masses, and extranodal sites not selected as dominant or 
measurable or that do not meet the requirements for measurability but are still considered abnormal, as well as truly assessable disease, which is any site of suspected disease that 
would be difficult to follow quantitatively with measurement, including pleural effusions, ascites, bone lesions, leptomeningeal disease, abdominal masses, and other lesions that 
cannot be confirmed and followed by imaging.  In Waldeyer's ring or in extranodal sites (eg, GI tract, liver, BM), FDG uptake may be greater than in the mediastinum with 
complete metabolic response, but should be no higher than surrounding normal physiologic uptake (eg, with marrow activation as a result of chemotherapy or myeloid growth 
factors). 
b PET 5PS: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than 
liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. 
Source:  Cheson et al 2014. 

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

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Potential Hy's Law Criteria Not Met 
If the participant has NOT had AST or ALT ≥ 3 × ULN AND total bilirubin > 2 × ULN at any 
point in the study (the elevations do not have to be at the same time or within a specified 
timeframe), irrespective of ALP, please follow the instruction below: 
• Perform follow-up on subsequent laboratory results according to the guidance 
provided in Section 8 and Section 9 of the Protocol. 
Potential Hy's Law Criteria Met 
If the participant has had AST or ALT ≥ 3 × ULN AND total bilirubin > 2 × ULN at any point in 
the study (the elevations do not have to be at the same time or within a specified timeframe), 
irrespective of ALP, please follow the instruction below: 
• Have participant interrupt study drug. 
• Notify Incyte study team without delay. 
− The investigator, or designee, should contact the medical monitor to discuss and 
agree upon an approach for the study participant's follow-up and the continuous 
review of data. 
• Monitor the participant until liver biochemistry parameters and appropriate clinical 
symptoms and signs return to normal or baseline levels, or as medically indicated. 
• Investigate the etiology of the event and perform any relevant diagnostic 
investigations as discussed with the medical monitor. 
• Enter the laboratory data into the laboratory CRF as soon as possible. 
• If at any time (in consultation with the medical monitor) the PHL case meets serious 
criteria, report it as an SAE using standard reporting procedures. 
REVIEW AND ASSESSMENT 
No later than 3 weeks after the biochemistry abnormality is initially detected and the criteria for 
PHL is met, the medical monitor, Incyte pharmacovigilance physician, and investigator will 
discuss and review available data and agree on whether there is an alternative explanation for the 
elevations in liver biochemistry other than drug-induced liver injury caused by the study drug.  
Participant matter experts will be included in the review as appropriate. 
Evaluation of Alternative Causes 
In order to gather additional clinical information to seek other possible causes of the observed 
liver test abnormalities, the following alternative etiologies should be considered, including but 
not limited to: 
• Active viral hepatitis 
• Alcoholic and autoimmune hepatitis 

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

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

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APPENDIX J. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Document 
Date 
Amendment 1 
25 NOV 2020 
Amendment 2 
16 DEC 2020 
Amendment 2-EU 
01 MAR 2021 
Amendment 2-EU2 
24 MAR 2021 
Amendment 3 
04 MAR 2021  
Amendment 4 
30 JUL 2021 
Amendment 5 
22 OCT 2021 
Amendment 6 
15 JUN 2022 
Amendment 7 
18 APR 2023 
Amendment 7 (18 APR 2023) 
Overall Rationale for the Amendment: 
The purpose of this amendment is to incorporate IRC review as a secondary objective, 
 
, and further clarify the timing of various study visits and procedures. 
1. Section 1, Protocol Summary (Table 1:  Primary and Major/Key Secondary 
Objectives and Endpoints); Section 3, Objectives and Endpoints (Table 5: 
Objectives and Endpoints); Section 10.3, Level of Significance; Section 10.4.1.2.2, 
Positron Emission Tomography–Complete Response Rate in the FDG-Avid 
Follicular Lymphoma Population; Section 10.4.1.4.1, Positron Emission 
Tomography–Complete Response Rate in the Overall Population; Section 10.4.1.4.2, 
Minimal Residual Disease–Negativity Rate at End of Treatment in the Follicular 
Lymphoma and Overall Population; Section 10.4.1.4.3, Overall Response Rate in 
Follicular Lymphoma and Overall Populations; Section 10.4.1.5.3, Transformation 
of Follicular Lymphoma Into More Aggressive State 
Description of change:  Clarified analysis of PET-CR rate and applicable populations. 
Rationale for change:  The EOT component of PET-CR rate was removed; participants 
having a PET to confirm radiologic CR are not expected to have a repeat PET at EOT.  
Text was also revised to clarify that only participants with FDG-avid disease at screening 
will be included in the PET-CR analysis. 
2. Section 1, Protocol Summary (Table 2:  Key Study Design Elements); Section 3, 
Objectives and Endpoints (Table 5:  Objectives and Endpoints); Section 4.1, Overall 
Design; Section 8.2, Efficacy Assessments; Section 10.4.1.4.6, Analysis of Efficacy 
Endpoints by Independent Review Committee; Section 10.4.1.4.7, Response 
Assessment Concordance 
Description of change:  Added IRC efficacy review as a secondary endpoint. 
Rationale for change:  Addition of a new endpoint that will be assessed at the final 
analysis. 

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3. Section 1, Protocol Summary 
Description of change:  Clarified that the lenalidomide schedule is Cycles 1 to 12, 
Days 1 to 21 in Treatment Group A. 
Rationale for change:  Clarification. 
4. Section 1, Protocol Summary; Section 6.1, Study Treatments Administered 
Description of change:  Clarified that the dose of lenalidomide must be reduced to 
10 mg daily for participants with moderate renal insufficiency. 
Rationale for change:  Clarification.  
5. Section 1, Protocol Summary (Table 3:  Schedule of Activities) 
Description of change:   
• Separated C1D1 from the rest of Cycle 1 visits as no visit window applies to C1D1. 
• Added a window to the EOT visit for participants who complete the prescribed study 
treatment regimen. 
• Clarified timing for the safety follow-up visit (90 days from EOT [± 7 days]). 
• Added columns clarifying the need for efficacy and survival follow-up and required 
assessments. 
• Clarified timing for bone marrow examination (screening and either at radiologic CR 
or EOT for participants with positive infiltration at screening). 
• Clarified timing for PET scan (screening, at time of radiologic CR in FDG-avid 
participants, or EOT). 
 
 
 
• Revised the QoL collection schedule to align with efficacy assessment timepoints 
after EOT. 
Rationale for change:  Clarification and correction to align with study design. 
6. Section 1, Protocol Summary (Table 3:  Schedule of Activities); Section 8.2.2, Bone 
Marrow Biopsy and Aspirate Samples; Section 8.2.2.1, Bone Marrow Biopsy Sample 
Collection; Section 8.2.2.2, Bone Marrow Aspirate Sample Collection 
Description of change:  Revised text to ensure proper samples are being collected at the 
proper timepoints for bone marrow examinations and MRD analysis and allow for 
standard-of-care biopsies to be used for determining eligibility in certain cases.  
Rationale for change:  To reduce the collection of unnecessary samples. 

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7. Section 1, Protocol Summary (Table 4:  Schedule of Laboratory Assessments) 
Description of change:   
• Separated C1D1 from the rest of Cycle 1 visits as no visit window applies to C1D1. 
• Added a window to the EOT visit for participants who complete the prescribed study 
treatment regimen. 
• Clarified timing for the safety follow-up visit (90 days from EOT [± 7 days]). 
• Added columns clarifying the need for efficacy and survival follow-up and required 
assessments. 
• Included monthly pregnancy testing between EOT and safety follow-up visit per 
regulatory feedback. 
• Revised collection of 6- and 12-month post-EOT sample to be an optional sample. 
• 
 
 
• Revised MRD blood sample collection timepoints (screening, C4D1, C8D1, EOT). 
Rationale for change:  Clarification of sample collection timing. 
8. Section 3, Objectives and Endpoints (Table 5:  Objectives and Endpoints); 
, 
 
Description of change:  
 
Rationale for change:  Limited sample availability. 
9. Section 5, Study Population; Section 8.1.2, Screening Procedures 
Description of change:  Included language regarding specific documents needed to 
support candidate enrollment forms and confirm that a participant's eligibility is 
determined by the PI. 
Rationale for change:  Ethics committee request regarding eligibility review. 
10. Section 5.1, Inclusion Criteria (Inclusion Criterion 10) 
Description of change:  Clarified measurable lesion requirements (ie, lesions must be 
confirmed as measurable using CT, MRI, or PET-CT). 
Rationale for change:  Investigator feedback and frequently asked questions. 
11. Section 5.6, Independent Data Monitoring Committee 
Description of change:  Clarified scope of interim analysis and removed stipulations 
regarding certain Grade 4/5 toxicities. 
Rationale for change:  Clarification and alignment with IDMC charter. 

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12. Section 6.5.7, Treatment After Initial Radiologic Evidence of Disease Progression 
Description of change:  Section removed. 
Rationale for change:  Elimination of redundancy with other protocol sections and 
alignment with current sponsor protocol template. 
13. Section 6.6.10.1, Anticancer Therapies 
Description of change:  Removed redundant text. 
Rationale for change:  Elimination of redundancy and alignment with current sponsor 
protocol template. 
14. Section 7.1, Discontinuation of Study Treatment 
Description of change:  Clarified reasons for discontinuing treatment, including that lack 
of efficacy and disease progression are considered mutually exclusive reasons for 
discontinuing treatment. 
Rationale for change:  Clarification and alignment with current sponsor protocol 
template. 
15. Section 7.2, Participant Withdrawal From the Study 
Description of change:  Clarified reasons for withdrawing from the study. 
Rationale for change:  Clarification and alignment with current sponsor protocol 
template. 
16. Section 7.3, Lost to Follow-Up 
Description of change:  Removed redundant paragraph. 
Rationale for change:  Clarification and alignment with current sponsor protocol 
template. 
17. Section 8.1.2, Screening Procedures 
Description of change:  Clarified that standard of care assessments that occur outside the 
28-day screening window may be used for determining eligibility with sponsor medical 
monitor approval. 
Rationale for change:  Flexibility for determining eligibility with respect to certain 
procedures that cannot be practically repeated. 
18. Section 8.1.4.2.1, Central Pathology Review 
Description of change:  Incorporated relevant text into Section 8.1.4.2. 
Rationale for change:  Clarification and elimination of redundancy. 

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19. Section 8.2.4, Radiographic and Metabolic Imaging Assessments 
Description of change:  Revised section to ensure proper radiologic and metabolic 
imaging will be performed at the correct timepoints: participants with FDG nonavid 
disease do not require repeat PET assessments, and participants with FDG-avid disease 
only require 1 subsequent PET scan (either at radiologic CR or at EOT).  Clarified that 
the schedule of radiologic imaging is to be followed while on treatment and in efficacy 
follow-up.   
Rationale for change:  Clarification of procedural requirements and timepoints. 
20. Section 8.3.5.4, Hepatitis Virus Serology 
Description of change:  Removed collection of HBV DNA titer after EOT. 
Rationale for change:  Removed unnecessary sample collection. 
21. Section 8.8, End of Treatment and/or Early Treatment Discontinuation 
Description of change:  Clarified that the EOT visit is to occur on Cycle 12 Day 28 if 
the participant completes the prescribed study treatment regimen or at the time the 
decision is made to discontinue study treatment. 
Rationale for change:  To remove language related to the EOT visit occurring 90 days 
after the last dose because this interval only applies to the safety follow-up visit. 
22. Section 8.9.1, Safety Follow-Up 
Description of change:  Clarified that the safety follow-up visit is to occur 90 days after 
EOT.  
Rationale for change:  Clarification of visit timings. 
23. Section 8.9.2, Efficacy Follow-up 
Description of change:  Clarified that participants who discontinue treatment for reasons 
other than disease progression will continue to have disease assessments until progression 
of disease, start of new anticancer therapy, withdrawal of consent, lost to follow-up, or 
death.  
Rationale for change:  Clarification of visit timings. 
24. Section 8.9.3, Survival Follow-up/Completion of Study 
Description of change:  Clarified the interval and window for performing survival 
follow-up assessments (every 12 weeks with a ± 4-week window) 
 
  
Rationale for change:  Clarification of visit timings. 
25. Section 8.10, Appropriateness of Measurements 
Description of change:  Removed section. 
Rationale for change:  Alignment with current sponsor protocol template. 

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26. Section 9.4, Reporting of Serious Adverse Events 
Description of change:  Clarified previous amendment language indicating that all SAEs 
occurring more than 90 days after the last dose of study treatment must be reported and 
surveillance must continue until initiation of new anticancer therapy or end of study. 
Rationale for change:  Clarification of the previous changes to reporting process. 
27. Section 9.5.1, Adverse Events of Clinical Interest by eCRF 
Description of change:  Split section to account for a second methodology that will be 
used for this analysis; AESIs will be identified by investigators in the clinical database 
but will also be accounted for programmatically (new section, Section 9.5.2). 
Rationale for change:  Program-level revision to AESI reporting process. 
28. Section 10.4.1.1, Primary Analysis for Progression-Free Survival in the Follicular 
Lymphoma Population 
Description of change:  Added discrepancy handling process related to differences in 
diagnosis and/or stratification. 
Rationale for change:  Process clarification and alignment with the SAP. 
29. Section 10.5, Interim Analysis 
Description of change:  Included OS as part of the data deliverables for the interim 
analysis. 
Rationale for change:  Revision to interim analysis deliverables. 
30. Incorporation of administrative changes.  Other regulatory guidance and 
administrative changes have been incorporated throughout the Protocol and are noted in 
the redline version of the amendment. 

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Amendment 6 (15 JUN 2022) 
Overall Rationale for the Amendment: 
The rationale for this amendment is to update protocol language in order to provide clarity to 
processes and procedures. 
1. Section 1, Protocol Summary (Table 2:  Key Study Design Elements); Section 2.3, 
Benefit/Risk Assessment; Section 4.1, Overall Design; 5.1 Inclusion Criteria; 
Section 5.2, Exclusion Criteria; Section 5.6, Independent Data Monitoring 
Committee; Section 6.1, Study Treatments Administered (Table 7:  Study 
Treatment Information); Section 6.2.1, Tafasitamab/Placebo Preparation; 
Section 6.5.1, Tafasitamab/Placebo Dose Modifications; Section 6.5.2.1, 
Management of Tafasitamab/Placebo Infusion-Related Reactions and Cytokine 
Release Syndrome; Section 6.5.2.2.2, Grade 3 Infusion-Related Reactions, Grade 2 
Cytokine Release Syndrome; Section 6.5.2.2.3, Grade 4 Infusion-Related Reactions, 
Grade 3 to 4 Cytokine Release Syndrome; Section 6.5.5, Toxicity Management 
Guidelines for Hematological Toxicities (Table 9:  Toxicity Management Guidelines 
for Hematological Toxicities); Section 6.5.6.2, Hypogammaglobulinemia; Section 
6.6.6, Premedication for Tafasitamab or Placebo Infusions/Infusion-Related 
Reaction Prophylaxis; Section 6.6.7, Prophylaxis of Venous Thromboembolism; 
Section 6.6.10.2, Live Vaccines; Section 7.1.1.4, Investigator Decision; 
Section 8.1.4.1, Demographics and General Medical History; Section 8.1.4.2, Disease 
Characteristics, Treatment History and Pathology; Section 8.2.2, Bone Marrow 
Samples; Section 8.2.3, Minimal Residual Disease Analyses; Section 8.2.4, 
Radiographic Imaging Assessment; Section 8.3.3, Vital Signs; Section 8.3.4, 
Electrocardiograms, Echocardiograms, and/or Cardiac MUGA Scans; Section 8.3.5, 
Laboratory Assessments; 
 
 Section 8.9.2, 
Efficacy Follow-Up; Section 9.5, Events of Clinical Interest; Section 9.5.1, Adverse 
Events of Special Interest; Section 11.2, Data Management 
Description of change:  Language has been updated/revised to align participant visits 
with assessment requirements and visit windows. 
Rationale for change:  The language in the original and previous versions of the 
protocol was confusing and resulted in a significant number of site errors and protocol 
deviations.  Providing clarity will reduce errors and deviations. 
2. Section 1, Protocol Summary (Table 3:  Schedule of Activities; Table 4:  Schedule of 
Laboratory Assessments) 
Description of change:  Added column for safety follow-up period and revised headers 
and notes column.  
. 
Rationale for change:  Safety follow-up column was missing in prior versions; updates 
to headers provide clarity regarding visit windows; revisions to the notes column deleted 
detail already included in the referenced sections and provided references to sections that 
were missing.  
. 

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4. Section 5, Study Population; Section 8.1.2, Screening Procedures 
Description of change:  Participant enrollment forms will be used for all participants 
being considered for this study.  Completed enrollment forms will be shared with the 
sponsor, along with completely redacted supportive documentation (eg, laboratory 
reports, pathology reports), to confirm eligibility. 
Rationale for change:  Language was included in the clinical study manual with respect 
to the enrollment form and supportive documentation; however, this guidance was not 
included in the protocol.  It is an important step in the screening process to ensure the 
eligibility of all randomized participants. 
5. Section 5.1, Inclusion Criteria 
Description of change:  The age requirement for the study population enrolled in Japan 
will be updated to indicate that participants enrolled in this study on or prior to 
31 MAR 2022 must be aged ≥ 20 years; beginning 01 APR 2022, participants may be 
aged ≥ 18 years. 
Rationale for change:  Effective 01 APR 2022, the age of adulthood in Japan changes 
from ≥ 20 years to ≥ 18 years. 
6. Section 6.2.1, Tafasitamab/Placebo Preparation; Section 6.2.3, Unblinded Site Staff, 
Handling, and Accountability; Section 6.3, Measures to Minimize Bias:  
Randomization and Blinding; Section 6.4, Study Treatment Compliance; 
Section 11.2, Data Management 
Description of change:  Language was updated and Section 6.2.3 was added to highlight 
the unblinded component of this study to include the responsible parties and details of the 
unblinded database. 
Rationale for change:  This language and section was missing from previous versions of 
the protocol. 
7. Section 6.5.5, Toxicity Management Guidelines for Hematological Toxicities 
Description of change:  Language was added to clarify dose and schedule adjustments 
for study treatment compounds. 
Rationale for change:  Clarification was needed due to numerous questions from sites. 
8. Section 6.6.10.1, Anticancer Therapies 
Description of change:  Language was added to clarify when anticancer therapies can 
start after EOT. 
Rationale for change:  Clarification was needed due to errors and questions by the sites. 

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9. Section 8.1.2, Screening Procedures 
Description of change:  Added language to allow for standard of care assessments to be 
used in screening of participant. 
Rationale for change:  To provide clarity and flexibility for use of standard of care 
assessments to be performed before obtaining ICF signature. 
10. Section 8.1.4.2.1, Central Pathology Review 
Description of change:  Section was added to outline the central pathology review plans 
for this study. 
Rationale for change:  This section was missing from previous versions of the protocol. 
11. Section 8.2.3, Minimal Residual Disease Analyses 
Description of change:  Section was added to clarify the samples needed for MRD 
analysis. 
Rationale for change:  Language was not clear in the previous versions and a new 
section was needed to provide adequate details. 
12. 
 
 
 
 
 
 
 
 
 
13. Section 8.9.4, End of Post-Treatment Follow-Up (Study Phase Completion) 
Description of change:  The section has been removed due to it being redundant with 
other sections. 
Rationale for change:  This section caused confusion with the clinical research 
associates and sites. 
14. Appendix B, Dose Adjustment for Lenalidomide 
Description of change:  Language was added to allow for other dose levels and/or dose 
regimens of lenalidomide after discussion and approval by the sponsor's medical monitor. 
Rationale for change:  The language in the protocol was more restrictive than the 
product label that allows for dose adjustments lower than 5 mg once daily. 
15. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

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Amendment 5 (22 OCT 2021) 
Overall Rationale for the Amendment: 
The rationale for this amendment is to implement updates to the background section to be in line 
with updated information in the IB, as per VHP request. 
1. Section 2.1.4.6, Combination Therapy With Tafasitamab and Lenalidomide in 
Non-Hodgkin Lymphomas 
Description of change:  The section has been updated with language from the most 
recent version of the IB. 
Rationale for change:  Request per VHP. 
2. Section 9.4, Reporting of Serious Adverse Events 
Description of change:  The statement regarding participants enrolled in Germany has 
been changed to include all sites. 
Rationale for change:  Request per VHP. 

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Amendment 4 (30 JUL 2021) 
Overall Rationale for the Amendment: 
The rationale for this amendment is to implement clarifications to address investigators' 
questions and requests, include Japanese sites in the study, and incorporate changes from 
previous local amendments. 
1. Section 1, Protocol Summary (Figure 1:  Study Design Schema) 
Description of change:  The "TGB" part has been updated to clarify that it is composed 
of tafasitamab placebo (0.9% saline solution), and the mention of 12 mg/kg has been 
removed. 
Rationale for change:  Clarification. 
2. Section 1, Protocol Summary (Table 2:  Key Study Design Elements); Section 2.1.3, 
Marginal Zone Lymphoma; Section 5.1., Inclusion Criteria (Criterion 3) 
Description of change:  Removed text indicating that extranodal MZL be of the mucosa-
associated lymphoid tissue. 
Rationale for change:  Clarification. 
3. Section 2.3, Benefit/Risk Assessment; Section 4.3, Study Termination; Section 5.1, 
Inclusion Criteria (Criterion 1); Section 5.2, Exclusion Criteria (Criterion 1); 
Section 6.1, Study Treatments Administered (Table 7:  Study Treatment 
Information); Section 8.3.5, Laboratory Assessments (Table 11:  Required 
Laboratory Analytes); Section 9.2, Definition of Serious Adverse Event; 
Appendix A, Information Regarding Effectiveness of Contraceptive Methods 
Description of change:  Updated sections to include Japanese sites in the study. 
Rationale for change:  Study sites may be located in Japan. 
4. Section 5, Study Population 
Description of change:  Added that the sponsor may decide to use recruitment tools and 
vendors to support the enrollment activities. 
Rationale for change: Clarification. 
5. Section 5.1, Inclusion Criteria (Inclusion Criteria 6, 7, and 8) 
Description of change:  Criterion 6 was clarified with respect to the fresh biopsy 
performance.  Criterion 7 was changed to indicate that at least 4 doses instead of 6 doses 
of prior anti-CD20 immunotherapy are required for eligibility in the study.  For 
Criterion 8, clarification was added to indicate that a participant in remission after the last 
prior treatment line would not be eligible. 
Rationale for change:  For Criterion 6, clarification; for Criterion 7, alignment with 
NCCN guidelines; and for Criterion 8, clarification regarding eligibility with respect to 
the participant clinical status after the last prior treatment line. 

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6. Section 5.1, Inclusion Criteria (Inclusion Criteria 9 and 9a) 
Description of change:  Split Criterion 9 and 9a into Criteria 9 and 10.  Clarified that the 
GELF criteria are referenced as guidance and apply to FL participants only and that the 
lesion must be confirmed to be measurable by CT and/or PET (PET-negative lesions that 
are measureable by CT are also eligible). 
Rationale for change:  Clarification and separation of 2 independent criteria. 
7. Section 6.1, Study Treatments Administered; Section 6.2.1, Tafasitamab/Placebo 
Preparation 
Description of change:  Guidelines were added for tafasitamab dose administration in 
case of changes in body weight and preparation of the tafasitamab/placebo solution for 
participants above 160 kg. 
Rationale for change:  Clarification. 
8. Section 6.1, Study Treatments Administered (Table 7:  Study Treatment 
Information); Section 6.2.2, Handling and Accountability of Study Treatment; 
Section 8.3.5.1, Central Laboratory Testing 
Description of change:  Clarification added that rituximab and lenalidomide are not 
considered IMPs in all countries.  As a result, the statement "Study drug shall be used 
synonymously with IMP" has been removed. 
Rationale for change:  Clarification. 
9. Section 6.6.10.1, Anticancer Therapies 
Description of change:  Sentence stating that a participant may stay in the study unless 
they participate in another clinical study was removed. 
Rationale for change:  Participants should be encouraged to complete the follow-up 
period. 
10. Section 8.1.4.2, Disease Characteristics and Treatment History:  Diagnostic 
Follicular Lymphoma/Marginal Zone Lymphoma Biopsy and Central Pathology 
Review; 
 
Description of change:  Preferred timing for the prestudy biopsy/archival sample was 
added and sections were harmonized. 
Rationale for change:  Clarification. 
11. Section 8.2.3, Radiographic Imaging Assessment 
Description of change:   The slide thickness guidance was updated to 2-2.5 mm.  Text 
was added to indicate that a CT or MRI without contrast may be acceptable if neither CT 
with contrast nor MRI with contrast can be performed and that the baseline CT/MRI and 
PET assessments are used for the respective CT/MRI and PET responses. 
Rationale for change:  Clarification of the requirements for the disease assessments. 

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12. Section 8.3.5.1, Central Laboratory Testing (Table 11:  Required Laboratory 
Analytes) 
Description of change:  Serum chemistry tests of CO2 and blood urea nitrogen were 
added and can be measured interchangeably with bicarbonate and urea, respectively. 
Rationale for change:  Clarification. 
13. Section 8.3.5.4, Hepatitis Virus Serology 
Description of change:  Updates were made to the schedule of the HBV DNA titer 
assessments for HBcAb-positive participants. 
Rationale for change:  Clarification. 
14. Section 8.3.5.5, Human Immunodeficiency Virus Serology 
Description of change:  Added that HIV serology testing is optional in the United States. 
Rationale for change:  Clarification. 
15. Section 9.1, Definition of Adverse Event; Section 9.3, Recording and Follow-Up of 
Adverse Events and/or Serious Adverse Events; 9.7, Pregnancy 
Description of change:  Clarification added that SAEs and SAE updates must be 
transmitted first to Incyte Pharmacovigilance via the EDC system. 
Rationale for change:  Clarification of the wording and harmonization between sections. 
16. Section 9.4, Reporting of Serious Adverse Events 
Description of change:  Text was added to indicate that, for Germany, all SAEs 
occurring more than 90 days after the last dose of study treatment must be reported until 
the participant receives a new anticancer therapy or end of the study, whichever occurs 
earlier. 
Rationale for change:  Clarification as requested by the German Central Ethics 
Committee. 
17. Section 9.10, Treatment of Overdose 
Description of change:  Guidelines/definitions in case of an overdose with rituximab 
were added. 
Rationale for change:  Clarification. 
18. Section 10.4.1.6, Sensitivity Analysis of Efficacy Endpoints 
Description of change:  The last 2 bullet points describing potential sensitivity analyses 
were combined and to clarify that sensitivity analyses may apply to both primary and 
secondary efficacy endpoints. 
Rationale for change:  Clarification. 
19. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

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This amendment also includes the changes from local adaptations for the European Union 
(Amendment 2-EU and Amendment 2-EU2) and United States (Amendment 3), which are 
summarized below. 
Amendment 3 (04 MAR 2021) 
Overall Rationale for the Amendment: 
The overall rationale for this amendment is to implement changes based on FDA requests. 
1. Section 1, Protocol Summary 
Description of change:  Removed "(FL)" and "(MZL)" from the protocol title. 
Rationale for change:  Harmonization with the title on the cover page. 
 
 
 
 
 
3. Section 6.6.9, Use of Specific Medications Concomitantly With Lenalidomide 
Description of change:  Added Section 6.6.9 to describe the measurements and 
precautions to be implemented in the event study participants take specific medications 
concomitantly with lenalidomide. 
Rationale for change:  Inclusion of instructions for concomitant medications due to 
potential drug-drug interactions as consistent with the labeling for lenalidomide. 
4. Section 10.4.1.6, Sensitivity Analysis of Efficacy Endpoints 
Description of change:  Added text regarding additional sensitivity analyses for the 
primary and key secondary endpoints. 
Rationale for change:  Inclusion of additional sensitivity analyses to evaluate the impact 
of subsequent antilymphoma therapy. 
5. Section 10.5, Interim Analysis 
Description of change:  Added text to specify the efficacy endpoints to be analyzed at 
the PFS futility interim analysis besides the primary endpoint. 
Rationale for change:  Clarification that descriptive analyses for other efficacy 
endpoints besides the primary endpoint will also be provided and OS will not be analyzed 
at the PFS interim futility analysis. 

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Amendment 2-EU2 (24 MAR 2021) 
Overall Rationale for the Amendment: 
The overall rationale for this amendment is to implement changes based on VHP requests. 
1. List of Abbreviations; Section 6.1, Study Treatments Administered (Table 7:  Study 
Treatment Information) 
Description of change:  Clarification that rituximab is regarded as an IMP was added. 
Rationale for change:  Rituximab is considered an IMP in the study. 

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Amendment 2-EU (01 MAR 2021) 
Overall Rationale for the Amendment: 
The overall rationale for this amendment is to implement changes based on VHP requests. 
1. Section 1, Protocol Summary 
Description of change:  Removed "(FL)" and "(MZL)" from the protocol title. 
Rationale for change:  Harmonization with the title on the cover page. 
2. Section 1, Protocol Summary (Table 1:  Primary and Major/Key Secondary 
Objectives and Endpoints; Table 2:  Key Study Design Elements; Table 3:  Schedule 
of Activities; Table 4:  Schedule of Laboratory Assessments); Section 3, Objectives 
and Endpoints (Table 5:  Objectives and Endpoints); Section 4.2, Overall Study 
Duration; Section 8.8, End of Treatment and/or Early Treatment Discontinuation; 
Section 8.9.1, Safety Follow-Up 
Description of change:  The EOT visit will be performed 90 days after the last dose of 
study treatment instead of 4 to 8 weeks after the last dose of study treatment. 
Rationale for change:  Considering the elimination half-life of tafasitamab (16.9 days), 
the EOT visit has been changed from 4 to 8 weeks to 90 days after the last dose of study 
treatment. 
 
  
 
 
. 
4. Section 1, Protocol Summary (Table 4:  Schedule of Laboratory Assessments); 
Section 5.2, Exclusion Criteria (Exclusion Criterion 6c); Section 8.3.5.5, Human 
Immunodeficiency Virus Serology 
Description of change:  Added HIV serology at screening and specified that all 
participants must be HIV-negative at baseline. 
Rationale for change:  To avoid any potential safety issue with HIV-positive 
participants, HIV serology will be performed at screening and all participants must be 
HIV-negative at baseline. 
5. Section 2.1.4.7, Combination Therapy With Tafasitamab + Lenalidomide + 
Rituximab + CHOP Chemotherapy in Previously Untreated Diffuse Large B-Cell 
Lymphoma; Section 2.3, Benefit/Risk Assessment 
Description of change:  Added Section 2.1.4.7 to summarize the safety data on the 
combined treatment of tafasitamab + lenalidomide + rituximab + CHOP in participants 
with newly diagnosed DLBCL and updated Section 2.3 to reflect these changes. 
Rationale for change:  Addition of the key safety findings from the MOR208C107 
(First-MIND) study, presenting the safety data of the combination of tafasitamab 
+ lenalidomide + rituximab + CHOP in participants with newly diagnosed DLBCL. 

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6. Section 5.1, Inclusion Criteria (Inclusion Criterion 4b); Appendix A, Information 
Regarding Effectiveness of Contraceptive Methods 
Description of change:  Clarified that WOCBP should use 2 different methods of birth 
control (one with at least 99% certainty and an additional effective [barrier] method) and 
that use of combined oral contraceptive pills is not recommended.  Also, updated the list 
of highly effective birth control methods and added the permitted examples of additional 
effective (barrier) methods. 
Rationale for change:  Alignment with the lenalidomide Pregnancy Prevention Program 
and the contraception guidelines in the Revlimid SmPC. 
7. Section 5.2, Exclusion Criteria (Exclusion Criterion 16) 
Description of change:  Added the exclusion criterion of administration of a live vaccine 
within 28 days prior to the start of the study treatment. 
Rationale for change:  Due to the immunosuppressive effects of the study treatment, 
added exclusion of participants who have been vaccinated with a live vaccine within 
4 weeks prior to the start of the study treatment. 
8. Section 5.6, Independent Data Monitoring Committee 
Description of change:  Clarified that if the IDMC identifies that a reported Grade 5 
hematological ADR is related to tafasitamab, a safety review must take place 
immediately and further enrollment into the study must be stopped. 
Rationale for change:  To extend the IDMC process and enrollment pause to include 
Grade 5 hematological ADRs that are identified by the IDMC. 
9. Section 6.5.6, Toxicity Management Guidelines for Hematological Toxicities 
(Table 9:  Toxicity Management Guidelines for Hematological Toxicities) 
Description of change:  Updated the toxicity management guidelines for febrile 
neutropenia. 
Rationale for change:  Clarification. 
10. Section 6.5.7.2, Hypogammaglobulinemia 
Description of change:  Added Section 6.5.7.2 to specify incidence data and 
management guideline for the potential on-target toxicity of hypogammaglobulinemia. 
Rationale for change:  The primary side effects related to tafasitamab monotherapy 
consist of those induced by B-cell depletion, so incidence data and management guideline 
for the on-target toxicity hypogammaglobulinemia have been included. 
11. Section 6.6.1, Participant Monitoring During Tafasitamab or Placebo Infusion 
Description of change:  Added text regarding the timing of vital sign measurements. 
Rationale for change:  Clarification of safety monitoring of participants with respect to 
vital sign assessments. 

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12. Section 6.6.3, Prior and Concomitant Therapies; Section 8.3, Safety Assessments; 
Section 8.3.5, Laboratory Assessments; Section 9.4, Reporting of Serious Adverse 
Events; Section 10.4.2, Safety Analyses 
Description of change:  Extended the timeframe for collection of details regarding all 
AEs, concomitant medications, pregnancies, procedures, hospitalizations, and abnormal 
laboratory findings from 30 days to 90 days after the last dose of study treatment and 
updated the definition of TEAE. 
Rationale for change:  Considering the elimination half-life of tafasitamab (16.9 days), 
the period for collection of details regarding AEs, concomitant medications, pregnancies, 
procedures, hospitalizations, and abnormal laboratory findings has been changed from 
30 days to 90 days after the last dose of study treatment. 
13. Section 8.9.5, End of Study 
Description of change:  Clarified the definition of "end of study." 
Rationale for change:  Clarification. 
14. Section 10.4.1.6, Sensitivity Analysis of Efficacy Endpoints 
Description of change:  Added text regarding additional sensitivity analyses for the 
primary and secondary endpoints. 
Rationale for change:  Inclusion of additional sensitivity analyses for the PFS and DoR 
endpoints to apply EMA censoring rules. 

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Amendment 2 (16 DEC 2020) 
Overall Rationale for the Amendment: 
The overall rationale for this amendment is to update the TLS sections and clarify some sections. 
1. Section 1, Protocol Summary (Table 4:  Schedule of Laboratory Assessments) 
Description of change:  Blood sampling at Cycle 4 Day 1 for B-cell, T-cell, 
 
 was removed. 
Rationale for change:  Clarification of the blood sampling schedule. 
. 
 
 
 
 
 
 
 
 
. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. Section 1, Protocol Summary (Table 4: Schedule of Laboratory Assessments); 
Section 5.1, Inclusion Criteria (Criterion 6); 
 
 
Description of change:  
 
 
  Clarification that collection of tumor tissue 
at EOT is strongly encouraged. 
Rationale for change:  Previous language regarding tumor biopsies was unclear and 
required clarification that tumor tissue collection at screening is not optional. 

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6. Section 2.1.4.1, First-Line Therapy 
Description of change:  The words "in the first line setting ones" were removed. 
Rationale for change:  Clarification of the treatment guidelines for indolent NHL in the 
United States and Europe. 
7. Sections 2.2.4.1, Tafasitamab; Section 3, Objectives and Endpoints 
(Table 5:  Objectives and Endpoints); Section 10.4.1.4.3, Overall Response Rate in 
Follicular Lymphoma and Overall Populations 
Description of change:  Best ORR was replaced with ORR. 
Rationale for change:  Editorial update to clarify wording. 
8. Section 2.3, Benefit/Risk Assessment; Section 6.5.5, Criteria and Procedures for 
Dose Interruptions or Adjustments of Rituximab; Section 12, References 
Description of change:  References to the USPI for lenalidomide and rituximab were 
added. 
Rationale for change:  References added for US sites. 
9. Section 3, Objectives and Endpoints (Table 5:  Objectives and Endpoints) 
Description of change:  Clarification regarding the thresholds for MRD assessments was 
added, 
Rationale for change:  Clarification of MRD analyses. 
. 
 
 
 
 
 
 
 
 
 
 
 
 
. 
 
 
 
 
 

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13. 
 
 
 
 
 
14. Sections 5.2, Exclusion Criteria (Criterion 7) 
Description of change:  Added clarification that the exclusion criterion of active 
systemic infection includes a SARS-CoV-2–positive test. 
Rationale for change:  Clarification. 
15. Section 6.1, Study Treatments Administered; Section 6.2.1, Tafasitamab/Placebo 
Preparation 
Description of change:  If acceptable at the site, the possibility of administering the 
rituximab infusion the day after administering tafasitamab or of splitting the infusion over 
2 consecutive days was added.  Clarification that placebo will be locally sourced and 
delivered to an unblinded pharmacy and that sites have the option to obtain rituximab 
from the sponsor through the IRT system was added. 
Rationale for change:  Incorporation of flexibility for rituximab infusion and 
clarification of the sourcing for placebo and rituximab. 
16. Section 6.5.7.1, Tumor Lysis Syndrome Prophylaxis 
Description of change:  Guidelines for the prevention of TLS were added. 
Rationale for change:  Clarification of the prophylaxis to avoid TLS. 
17. Section 8.2.2, Bone Marrow Samples and Minimal Residual Disease Assessments 
Description of change:  Clarification that BM core biopsy samples should be sent to the 
local laboratory and BM aspirate samples should be sent to the central laboratory was 
added.  Text was also added to indicate that the BM biopsy at EOT should be performed 
as clinically indicated, and to indicate that BM aspirate should be collected at time of 
radiological CR and as clinically indicated and pathology report results from the BM core 
biopsy will be entered in the eCRF. 
Rationale for change:  Clarification of the sample management for MRD assessments. 
18. Section 8.2.3, Radiographic Imaging Assessments 
Description of change:  Clarification that radiographic images will be centrally stored by 
a vendor contracted by the sponsor. 
Rationale for change:  Clarification. 

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19. Section 8.3.5.2, Pregnancy Testing 
Description of change:  Correction of typographical error to indicate that the pregnancy 
test assays should have a minimum sensitivity of 25 mIU/mL (and not 25 IU/mL) and 
clarification that urine pregnancy tests can be replaced with serum ones. 
Rationale for change:  Clarification. 
20. 
 
 
 
 
 
 
21. Section 10.4.2, Safety Analyses 
Description of change:  Clarification that abnormal ECGs will be summarized by 
treatment group. 
Rationale for change:  Clarification regarding the ECG data to be analyzed. 
22. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

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Amendment 1 (25 NOV 2020) 
Overall Rationale for the Amendment: 
The overall rationale for this amendment is to implement changes based on FDA comments and 
requests. 
1. Section 1, Protocol Summary (Table 1: Primary and Major/Key Secondary 
Objectives and Endpoints); Section 3, Objectives and Endpoints (Table 5: 
Objectives and Endpoints); Section 10.3, Level of Significance; Section 10.4.1.2.3, 
Minimal Residual Disease-Negativity Rate at End of Treatment in the Follicular 
Lymphoma Population; Section 10.4.1.4.2, Minimal Residual Disease-Negativity 
Rate at End of Treatment in the Follicular Lymphoma and Overall Population; 
 
Description of change:  The endpoint of "MRD-negativity rate at EOT in the FL 
population" was removed from the list of key secondary endpoints and demoted to a 
"regular" secondary endpoint that became "MRD-negativity rate (< 1 residual tumor cell 
per 104 normal cells) at EOT in the FL and the overall population."  Section 10.4.1.2.3 
was removed and Section 10.4.1.4.2 was updated and applied to both FL and overall 
populations.  
 
 
Rationale for change:  Confirmation that the key secondary endpoint of 
"MRD-negativity rate at EOT in the FL population" becomes a "regular" secondary 
endpoint. 
2. Section 1, Protocol Summary (Table 3:  Schedule of Activities); Section 5.2, 
Exclusion Criteria; Section 8.3.4, Electrocardiograms, Echocardiograms, and 
Cardiac MUGA Scans 
Description of change:  "History of congestive heart failure requiring the use of ongoing 
maintenance therapy for life-threatening arrhythmias" was replaced by "Congestive heart 
failure (left ventricular ejection fraction of < 50%, assessed by 2D-echocardiography or 
MUGA scan," and an assessment of the left-ventricular ejection fraction by 2D-ECHO or 
MUGA at screening was added. 
Rationale for change:  Clarification that the participants have an assessment of the 
left-ventricular ejection fraction by 2D-ECHO or MUGA at screening was added. 
3. 
 
 
 
 
 

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4. Section 6.5.2.2.1, Grade 2 Infusion-Related Reactions, Grade 1 Cytokine Release 
Syndrome 
Description of change:  A paragraph detailing the management of tafasitamab/placebo 
in the event of recurrent Grade 2 IRR or Grade 1 CRS was added. 
Rationale for change:  Guidelines for tafasitamab/placebo management in the event of 
recurrent Grade 2 IRR or Grade 1 CRS were added. 
5. Section 6.5.2.2.2, Grade 3 Infusion-Related Reactions, Grade 2 Cytokine Release 
Syndrome 
Description of change:  A paragraph stating that tafasitamab/placebo will be 
permanently discontinued in participants experiencing a recurrent Grade 3 IRR or 
Grade 2 CRS was added. 
Rationale for change:  Guidelines for tafasitamab/placebo management in case of 
recurrent Grade 3 IRR or Grade 2 CSR were provided. 
6. Section 6.5.2.2.3, Grade 4 Infusion-Related Reactions, Grade 3 to 4 Cytokine 
Release Syndrome 
Description of change:  A paragraph stating that tafasitamab/placebo will be 
permanently discontinued in participants experiencing Grade 4 IRR or Grade 3 to 4 CRS 
was added. 
Rationale for change:  Clarification that tafasitamab/placebo will be permanently 
discontinued if a participant experiences a Grade 4 IRR or Grade 3 or 4 CRS was added. 
7. Section 6.5.4, Criteria and Procedures for Dose Interruptions or Adjustments of 
Lenalidomide; Section 6.5.6, Toxicity Management Guidelines for Hematological 
Toxicities; Appendix B, Dose Adjustment for Lenalidomide 
Description of change:  A section describing the management of the study drugs 
(tafasitamab, lenalidomide, and rituximab) in the event of hematological toxicity was 
added, and the sections in Appendix B describing the management of lenalidomide in 
presence of neutropenia or thrombocytopenia were removed. 
Rationale for change:  Guidelines for the management of the 3 study drugs in case of 
hematological toxicity were provided. 
8. Section 6.5.7, Toxicity Management Guidelines for Non-Hematological Toxicities 
Description of change:  A section describing the management of study treatment in the 
event of non-hematological toxicity was added. 
Rationale for change:  Guidelines for study treatment management in the event of 
non-hematological toxicity were incorporated. 

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9. Appendix B, Dose Adjustment for Lenalidomide 
Description of change:  A section describing the management of lenalidomide in 
participants experiencing a Grade 3 or higher adverse event of renal impairment was 
added. 
Rationale for change:  Guidelines for lenalidomide management in the event of Grade 3 
or higher adverse event of renal impairment were incorporated. 
10. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

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