Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL CD19 monoclonal antibody tafasitamab lenalidomide MOR208 MOR00208
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 66
Healthy volunteers: no

Brief summary:
This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

Detailed description:

Arms:
arm 1: Tafasitamab in addition to R-CHOP arm 2: Tafasitamab plus lenalidomide in addition to R-CHOP

Interventions: intervention 1: Tafasitamab intervention 2: Tafasitamab plus lenalidomide
Intervention descriptions: intervention 1: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP intervention 2: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP

Protocol document:
Prot_000.pdf: 
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CLINICAL TRIAL PROTOCOL 
 
Brief description of Clinical 
Trial 
A Phase Ib, open-label, randomized study to assess 
safety and preliminary efficacy of Tafasitamab in 
addition to R-CHOP or Tafasitamab plus 
Lenalidomide in addition to R-CHOP in patients 
with newly diagnosed Diffuse Large B-Cell 
Lymphoma (DLBCL) – First-MIND  
 
 
Clinical Trial Phase: 
 
Product Name: 
Phase Ib 
 
Tafasitamab 
Sponsor: 
MorphoSys AG 
Sponsor's Address: 
Semmelweisstrasse 7 
D-82152 Planegg 
GERMANY 
Clinical Trial Protocol 
Number: 
MOR208C107
EudraCT No.: 
IND No.: 
2019-001268-31 
145,009 
Effective Date: 
05-FEB-2020  
Applicable countries: 
International (North America and Europe)  
Version of the Clinical  
Trial Protocol: 
Version 6.0 
 
 
Confidentiality Statement 
This confidential document is the property of the sponsor. No unpublished information in this 
document may be disclosed without prior written approval of the sponsor. 
 


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VERSION 2.0, SUMMARY OF CHANGES 
Section 
Change 
 
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VERSION 3.0, SUMMARY OF CHANGES 
Section 
Change and Rationale 
 
 
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VERSION 4.0, SUMMARY OF CHANGES  
Section  
Change and rationale 
  
 
 
 
 
 
 
 
 
 
 


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VERSION 5.0, SUMMARY OF CHANGES  
Section  
Change and rationale 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 


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VERSION 6.0, SUMMARY OF CHANGES  
Section  
Change and rationale 
  
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 


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SIGNATURES 
SPONSOR'S SIGNATURES 
 
 
 
Clinical Trial Protocol Approved/Authorised by: 
 
Signature: 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature: 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 


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COORDINATING INVESTIGATOR’S SIGNATURE 
 
I have read and understood all pages of this clinical trial protocol. I confirm that this 
protocol contains all the information required to conduct this clinical trial. I agree that I am 
responsible for the overall clinical trial conduct. 
Country Coordinating Investigator: 
 
Signature: 
 
  Date: 
 
 
 
 
(DD-MMM-YYYY) 
Printed Name: 
 
 
 
 
 
 
 
Address: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PRINCIPAL INVESTIGATOR'S SIGNATURE 
 
I have read and understood all pages of this clinical trial protocol. I agree that this protocol 
contains all the information required to conduct this clinical trial. I agree to conduct the 
clinical trial as outlined in the clinical trial protocol and to comply with all the terms and 
conditions set out therein. I confirm that I will conduct the clinical trial in accordance with 
ICH GCP guidelines and the provisions of the Declaration of Helsinki, copies of both 
documents have been given to me by the sponsor, I will also ensure that co-investigator(s) 
and other relevant members of the my staff have access to copies of this protocol, the ICH 
GCP guidelines and the Declaration of Helsinki to enable them to work in accordance with 
the provisions of these documents. 
Signature: 
 
  Date: 
 
 
 
 
(DD-MMM-YYYY) 
Printed Name: 
 
 
 
 
 
 
 
Address: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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1 SYNOPSIS 
Title of Clinical Trial 
A Phase Ib, open-label, randomized study to assess safety and 
preliminary efficacy of Tafasitamab in addition to R-CHOP 
or Tafasitamab plus Lenalidomide in addition to R-CHOP in 
patients with newly diagnosed Diffuse Large B-Cell 
Lymphoma – First-MIND    
 
Investigational 
Medicinal Products 
Tafasitamab    
Lenalidomide 
Clinical Trial Protocol 
Number 
MOR208C107 
 
IND Number 
145,009 
EudraCT Number 
2019-001268-31 
Sponsor  
Sponsor: 
Semmelweisstrasse 7 
D-82152 Planegg 
GERMANY  
 
Clinical Trial Phase 
Phase Ib    
 
Background / Rationale Diffuse large B-cell lymphoma (DLBCL) represent approximately 
40% of all non-Hodgkin lymphomas (NHLs). Median age at 
diagnosis is 64 years and the majority of patients present with 
advanced disease. DLBCL is increasingly recognized as a 
heterogeneous disorder and the existence of biologically defined 
subgroups with different cell of origin (COO) can be shown
(Flowers, 2010; Lenz, 2008; Vaidya, 2014).  
The immune-chemotherapy regimen consisting of the anti-CD20 
monoclonal antibody (mAb) rituximab plus the standard CHOP 
chemotherapy (cyclophosphamide, doxorubicin, vincristine, and 
prednisone) (R-CHOP) is the current standard of care (SoC) for 
the treatment of newly diagnosed DLBCL. Rituximab improved 
the outcome compared with CHOP alone in untreated patients with 
DLBCL, but still 30–40% of patients relapse (Habermann, 2006; 
Coiffier, 2010). Thus, the development of a more effective initial 
therapy is essential to improve long-term outcomes.  
Literature data suggests that at least a part of the untreated DLBCL 
patients exhibits low CD20 expression (16-42%; Johnson, 2009; 
Tokunaga, 2014; Choi, 2016; Boltezar, 2018). Low CD20 
expression was reported to be associated with inferior survival (5-
year event-free survival [EFS] 39.4% in CD20-low compared to 
66.5% in CD20-high group) (Choi, 2016). Particularly for those 


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patients targeting of an additional, independent antigen might be 
of value. 
The B-lymphocyte lineage specific surface antigen CD19 is the 
earliest and most broadly expressed of the selective B-cell markers 
and is highly expressed on tumor cells of most patients with B-
NHL. Due to its lineage-specific expression pattern, targeting 
CD19 has clinical utility as a therapeutic approach to NHL 
treatment (Hammer, 2012).  
Tafasitamab is an Fc-enhanced, humanised, mAb with 
significantly 
enhanced 
antibody-dependent 
cell-mediated 
cytotoxicity 
(ADCC), 
antibody-dependent 
cell-mediated 
phagocytosis (ADCP) and direct cytotoxic effects (apoptosis). The 
Fc-enhancement led to increased binding affinity for Fc receptors 
on effector cells, particularly on NK cells, thereby increasing NK-
cell mediated effector functions (ADCC) on tumor cell lines in 
vitro. In preclinical studies, anti-tumor activity was increased 
versus respective monotherapy treatments when tafasitamab was 
combined with Rituximab, different chemotherapeutic and non-
chemotherapeutic drugs including lenalidomide. These data 
suggest a rationale and a potential benefit of the tafasitamab add-
on strategy to R-CHOP independent of CD20 expression status. 
Monotherapy with tafasitamab has shown preliminary signs of 
clinical efficacy and acceptable toxicity in a phase I study in R/R 
chronic lymphocytic leukemia/small lymphocytic lymphoma 
(CLL/SLL) (NCT01161511) and a phase IIa study in R/R NHL 
(NCT01685008). In patients with relapsed-refractory (R/R) 
DLBCL, treatment with tafasitamab until progression showed 
single agent activity with 26% ORR, with some responses ongoing 
for several years (Jurczak, 2018). 
Lenalidomide belongs to a class of immunomodulating agents 
(immunomodulatory drugs [IMiDs]), which have demonstrated 
direct tumoricidal and immunomodulatory actions. Lenalidomide 
has 
both 
anti-proliferative 
and 
antiangiogenic 
activities, 
modulating the tumor cell microenvironment and stimulating the 
activity of effector cells such as cytotoxic T-cells and natural killer 
(NK) cells. Lenalidomide demonstrated manageable toxicity when 
administered as monotherapy and in combination, as well as a 
synergistic effect with rituximab, administered alone or as a part 
of an immune-chemotherapeutic regimen (see below).  
Preclinical data suggest that the combination of tafasitamab with 
lenalidomide may act synergistically by increasing NK cell-
mediated ADCC, making this a combination of interest for further 
study in patients with B-cell lymphoma. In the phase II L-MIND 


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study (NCT02399085) in patients with R/R DLBCL, the 
combination of tafasitamab with lenalidomide achieved a high 
ORR of 58%, a CR rate of 33% and a median PFS of 16 months 
(Salles, 2018) and this combination has recently received 
breakthrough therapy designation by the FDA. 
Tafasitamab as single agent is well tolerated and its primary side 
effects consist of those induced by B-cell depletion (Jurczak,
2018).  
In combination with lenalidomide, tafasitamab had little additive 
toxicity to lenalidomide. The most common treatment-emergent 
adverse events grade ≥3 (percentage of patients with AE) were 
neutropenia (36%), thrombocytopenia (12%), febrile neutropenia 
(7%), anemia (6%), pneumonia and lung infection (7%) and rashes 
(7%) (Salles, 2018).   
The safety and tolerability of tafasitamab or tafasitamab plus 
lenalidomide in addition to R-CHOP has not yet been tested in 
humans.  
This open label, prospective phase Ib study is designed to confirm 
the safety and preliminary efficacy of tafasitamab or tafasitamab
plus lenalidomide in addition to R-CHOP in patients with newly 
diagnosed DLBCL.  
Treatment Arms 
Arm A: Tafasitamab in addition to R-CHOP 
Arm B: Tafasitamab plus lenalidomide in addition to R-CHOP 
Clinical Trial Objectives Primary Objective 
To assess safety and tolerability of tafasitamab in addition to 
R-CHOP and tafasitamab plus lenalidomide in addition to R-
CHOP  
Key Secondary Objective 
To assess efficacy of  tafasitamab in addition to R-CHOP and 
tafasitamab plus lenalidomide in addition to R-CHOP 
Secondary Objectives 
1. To assess long-term safety and tolerability of  tafasitamab
in addition to R-CHOP and tafasitamab plus lenalidomide 
in addition to R-CHOP 
 


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2. To assess long-term efficacy of tafasitamab in addition to 
R-CHOP and tafasitamab plus lenalidomide in addition to 
R-CHOP 
3. To assess the pharmacokinetic profile of tafasitamab in 
each treatment arm 
4. To assess the potential immunogenicity of tafasitamab in 
each treatment arm  
Exploratory Objectives 
1. To evaluate residual disease burden by serial ctDNA
assessment 
2. To perform longitudinal analysis of NKCC in peripheral 
blood  
3. To assess the relationship between potential molecular or 
cellular markers and efficacy of tafasitamab in addition to 
R-CHOP or tafasitamab and lenalidomide in addition to R-
CHOP 
Clinical Trial Endpoints 
 
Primary Endpoint  
Incidence and severity of treatment-emergent adverse events 
(TEAEs)  
 
Key Secondary Endpoints 
1. Objective Response Rate (ORR) at the end of treatment 
 
2. Metabolic, PET-negative complete response (CR) rate at
the end of treatment 
Secondary Endpoints 
1. Incidence and severity of AEs in the follow-up period. 
 
2. i. Best Objective Response Rate (ORR) until the end of 
study  
ii. Metabolic, PET-negative complete response (CR) rate 
until the end of study  
iii. Progression-free survival (PFS) at 12 and 24 months  
iv. Event-free survival (EFS) at 12 and 24 months  
v. Time to next anti-lymphoma treatment (TTNT) 
vi. Overall survival at 12 and 24 months 
3. Tafasitamab serum concentrations (Ctrough levels and 
Cmax levels on Day 1 of each cycle)  


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4. Number and percentage of patients developing anti-
tafasitamab antibodies, and semi-quantitative titer 
assessments  
 
Exploratory Endpoints 
1. Descriptive statistics of ctDNA by visit 
2. Descriptive statistics of NKCC in peripheral blood by visit
3. The relationship of the following endpoints may be 
assessed for the following markers: 
Endpoints:  
i. 
ORR 
ii. 
PFS 
Markers:  
For the following molecular and/or cellular markers, e.g.: 
i. 
Cell of origin 
ii. 
NK-cell count in the tumor tissue 
iii. 
NK-cell gene expression signature in the tumor tissue 
iv. 
Macrophage count in the tumor tissue 
v. 
Macrophage gene expression signature in the tumor tissue
vi. 
Quantitative and semi-quantitative CD19 expression on 
tumor cells (in diagnostic biopsies and at 
progression/relapse if available) 
vii. 
Quantitative and semi-quantitative CD20 expression on 
tumor cells (in diagnostic biopsies and at 
progression/relapse if available) 
Design, Sample Size and 
Methodology 
This is a Phase Ib, open-label, randomized study of tafasitamab
given in addition to R-CHOP or tafasitamab plus lenalidomide 
given in addition to R-CHOP in patients with newly diagnosed 
Diffuse Large B-Cell Lymphoma. Each of the two arms will enroll 
approximately 30 patients (for a total of approximately 60
patients). If a patient discontinues the trial for any reason other 
than treatment related toxicity or progression/relapse of disease or 
death, this patient may be replaced. 
Safety monitoring will be performed continuously throughout the 
study. For further detail see section 6.1 and 6.3.  
Safety Committee meetings will be held to evaluate safety data and 
to monitor if stopping rules have been met. In case stopping rules 
were met, enrolment in the concerned arm will pause until the 
Safety Committee will meet. The committee will advice the 


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Sponsor on whether treatment with study drugs of ongoing patients 
and enrolment in the concerned arm should be stopped.  
In addition, an independent Data and Safety Monitoring Board 
(iDSMB) will review safety data at defined timepoints and give 
advice to the sponsor in regards to the safety of the study treatment. 
The Study consists of two phases: 
1. Safety Run-in Phase: 
Initially, 12 patients will be enrolled in each arm. In order to 
evaluate the safety in accordance with the stopping rules (section 
6.3), enrolment may be paused when 12 patients in each arm have 
been recruited and have been followed for 21 days after C1D1.  
2. Main Phase:  
If no unexpected safety signals (except for those being causally 
related to R-CHOP) are observed in either arm, enrolment will 
continue as planned to enrol additional approximately 18 patients 
in each arm in the main phase. 
Stopping rules for the Safety Run-in Phase and the Main Phase of 
the study are described in the section 6.3. 
As this is a Phase Ib study to primarily explore safety objectives, 
no formal statistical hypothesis will be considered for the sample 
size calculation of this study.  
Indication 
Newly diagnosed DLBCL 
Population 
Adult patients with newly diagnosed, previously untreated 
DLBCL  
Inclusion Criteria  
1. Age >18 years 
2. Written informed consent 
3. Previously untreated, newly diagnosed DLBCL, not 
otherwise specified (NOS)  
4. Tumor tissue for retrospective central pathology review 
and correlative studies must be provided as an adjunct to 
participation in this study.  
5. Patients must have at least one measurable disease site. The 
lesion must have a greatest transverse diameter of ≥1.5 cm 
and greatest perpendicular diameter of ≥1.0 cm at 
screening. The lesion must be confirmed to be PET-
positive at the latest at the time of randomization. 
6. Eastern 
Cooperative 
Oncology 
Group 
(ECOG) 
performance status of 0 to 2 


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7. International Prognostic Index (IPI) status of 2 to 5 
8. Appropriate candidate for R-CHOP 
9. Left ventricular ejection fraction (LVEF) of ≥50%, 
assessed by echocardiography or cardiac multi-gated 
acquisition (MUGA) scan 
10. Patient must have the following laboratory criteria at 
screening: 
a. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L 
(unless secondary to bone marrow involvement by 
DLBCL as demonstrated by recent bone marrow 
aspiration and bone marrow biopsy) 
b. Platelet count ≥ 75 x 109/L (unless secondary to 
bone marrow involvement by DLBCL as 
demonstrated by recent bone marrow aspiration 
and bone marrow biopsy) 
c. Total serum bilirubin < 1.5 × upper limit of normal 
(ULN) unless secondary to Gilbert’s syndrome or 
documented liver involvement by lymphoma. 
Patients with Gilbert’s syndrome or documented 
liver involvement by lymphoma may be included if 
their total bilirubin is ≤5 × ULN 
d. Alanine 
transaminase 
(ALT), 
aspartate 
aminotransferase (AST) and alkaline phosphatase 
(ALP) ≤3 × ULN, or <5 × ULN in cases of 
documented liver involvement 
e. Serum creatinine clearance  
(all countries except US:) must be ≥50 mL/minute 
either measured or calculated using a standard 
Cockcroft and Gault formula (Cockroft, 1976) 
(US only:) must be ≥60 mL/minute either 
measured or calculated using a standard Cockcroft 
and Gault formula (Cockroft, 1976) 
11.    Females of childbearing potential (FCBP) must: 
Applicable in all countries except US:  
a. not be pregnant as confirmed by a negative serum 
pregnancy test at screening and a medically 
supervised urine pregnancy test prior to starting 
study therapy 
b. refrain from breast feeding and donating oocyte 
during the course of study and for 3 months after 
the last dose of study drug or, for R-CHOP, 
according to the local guidelines, whichever is 
longer.   
c. agree to ongoing pregnancy testing during the 
course of the study, and after study therapy has 


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ended. This applies even if the patient applies 
complete sexual abstinence 
d. commit to continued abstinence from heterosexual 
intercourse if it is in accordance with her lifestyle 
(which must be reviewed on a monthly basis) or 
agree to use and be able to comply with the use of 
highly effective contraception without interruption
at least 4 weeks prior to start of study drugs, during 
the study treatment and for 3 months after the last 
dose of study drug or, for R-CHOP, according to
the local guidelines, whichever is longer. Please 
refer also to section 7.3.1 
Applicable in US:  
a. not be pregnant as confirmed by pregnancy tests 
performed before  treatment initiation, within 10-
14 days and again within 24 hours of initiating 
treatment (even if true abstinence is the chosen 
method of birth control).  
b. refrain from breast feeding and donating oocytes
during the course of study and for 3 months after 
the last dose of study drug or, for R-CHOP,
according to the US guidelines, whichever takes 
longer.  
c. agree to ongoing pregnancy testing during the 
course of the study (every 3 weeks in women with 
regular menstrual cycle and every 2 weeks in 
women with irregular menstrual cycle), and after 
study therapy has ended (even if true abstinence is 
the chosen method of birth control). 
d. not get pregnant while taking the study drug and for 
at least 3 months after stopping the study drug by 
using at the same time 2 effective methods of 
contraception (at least one highly effective method 
and one additional effective method, see Appendix 
G each time engaging in sexual activity with a 
male, starting at least 4 weeks before taking the 
study drug, while taking the study drug, during 
breaks (dose interruptions) and for at least 3 months 
after stopping the study drug, or, for R-CHOP; 
according to the US guidelines, whichever is 
longer. True abstinence (see Appendix G) from 
heterosexual sexual intercourse is also an 
acceptable method of contraception. The use of 
emergency contraception is also permitted.  


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12.    Male participants must: 
Applicable in all countries except US:  
Use an effective barrier method of contraception without 
interruption if the patient is sexually active with female of 
childbearing potential (FCBP). Male participants should 
refrain from donating sperm during the study participation 
and for 3 months after the last dose of study drug, or, for 
R-CHOP, according to the local guidelines, whichever is 
longer 
      Applicable in US:  
Use latex or synthetic condom each time they have sex 
with a woman of childbearing potential. True abstinence 
(see Appendix G) from heterosexual sexual intercourse is 
also an acceptable method of contraception. The use of 
emergency contraception is also permitted. Male 
participants should refrain from donating sperm during the 
study participation and for 3 months after the last dose of 
study drug or, for R-CHOP, according to the US 
guidelines, whichever is longer. 
13. In the opinion of investigator, the patient must: 
a. be able and willing to receive adequate prophylaxis 
and/or therapy for thromboembolic events, e.g. 
aspirin 70-325 mg daily or low molecular weight 
heparin. This is due to increased risk of thrombosis 
in patients treated with lenalidomide without 
prophylaxis. Patients unable or unwilling to take 
any prophylaxis are not eligible  
b. be able to understand, give written informed 
consent, and comply with all study-related 
procedures, medication use, and evaluations 
c. not have a history of noncompliance in relation to 
medical regimens or be considered potentially 
unreliable and/or uncooperative 
d. be able to understand the reason for complying with 
the special conditions of the pregnancy prevention 
risk 
management 
plan 
and 
give 
written 
acknowledgement of this. 
e.  
Exclusion Criteria 
Patient who have:   
1. Any other histological type of lymphoma according to 
WHO2016 classification of lymphoid neoplasms, e.g. 
primary mediastinal (thymic) large B-cell lymphoma


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(PMBL), known double- or triple-hit lymphoma or 
Burkitt’s lymphoma.  
2. Transformed NHL and evidence for composite lymphoma
3. History of radiation therapy to ≥25% of the bone marrow 
for other diseases or history of anthracycline therapy 
4. History of prior non-hematologic malignancy except for 
the following:  
a. Malignancy treated with curative intent and with no 
evidence of active disease present for more than 2 
years before screening 
b. Adequately treated lentigo maligna melanoma 
without current evidence of disease or adequately 
controlled non-melanomatous skin cancer.  
c. Adequately treated carcinoma in situ without 
current evidence of disease 
5. History of myocardial infarction ≤6 months, or congestive 
heart failure requiring use of ongoing maintenance therapy 
for life-threatening arrhythmias  
6. Patients with: 
a. Known positive test result for hepatitis C (hepatitis 
C virus [HCV] antibody serology testing) and a 
positive test for HCV RNA. Patients with positive 
serology must have been tested locally for HCV 
RNA and are eligible, in case of negative HCV 
RNA test results.  
b. Known positive test results for chronic HBV 
infection (defined by HBsAg positivity). Patients 
with occult or prior HBV infection (defined as 
negative HBsAg and positive total HBcAb) may be 
included if HBV DNA was undetectable (local test 
result), provided that they are willing to undergo 
ongoing DNA testing. Antiviral prophylaxis may 
be administered as per institutional guidelines.
Patients who have protective titers of hepatitis B 
surface antibody (HBsAb) after vaccination or 
prior but cured hepatitis B are eligible.  
c. Known seropositive for or history of active viral 
infection with human immunodeficiency virus 
(HIV)  
d. Known 
active 
bacterial, 
viral, 
fungal, 
mycobacterial, or other infection at screening 
e. Known CNS lymphoma involvement  
f. History or evidence of clinically significant 
cardiovascular, CNS and/or other systemic disease 
that would in the investigator opinion preclude 


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participation in the study or compromise the 
patient’s ability to give informed consent 
g. History or evidence of rare hereditary problems of 
galactose intolerance, Lapp lactase deficiency or 
glucose-galactose malabsorption  
h. Vaccination with live vaccine within 21 days prior 
to study randomization 
i. Major surgery (excluding lymph node biopsy) 
within up to 21 days prior to signing the informed 
consent form, unless the patient is recovered at the 
time of signing the informed consent form 
j. Any anti-cancer and/or investigational therapy 
within 21 days prior to the start of Cycle 1. Note: 
Steroid pre-phase is permitted 
k. Pregnancy or lactation 
l. History of hypersensitivity to any component of R-
CHOP, to lenalidomide, to compounds of similar 
biological or chemical composition as tafasitamab, 
IMiDs® and/or the excipients contained in the 
study drug formulations or R-CHOP 
m. Any contraindication concerning any individual 
components of R-CHOP 
Sample Size, Planned 
total number of Clinical 
Trial Sites and 
Locations 
 
 
A total of approximately 60 patients will be enrolled in the study. 
Initially, 12 patients in each arm will be enrolled in the safety run-
in phase. Once safety will be confirmed, additional approximately 
18 patients in each arm will be enrolled in the main phase.  
If a patient discontinues the trial for any reason other than 
treatment related toxicity or progression/relapse of disease or 
death, this patient may be replaced.  
Approximately 30-40 centers in the North America and Europe
will be participating in this trial. 
Anticipated Screening 
Failure and Drop-Out 
Rate  
Screening Failure Rate: 25% 
Drop-Out Rate: Patients who drop out before 2 years after 
randomization: 15%, thereof patients who drop-out before end of 
treatment (EOT): 10% 
Duration of the Study 
 Screening: The screening period will last for a maximum of 21
days from date of signature of ICF to date of randomization.  
 Planned  treatment: 6 cycles of 21 days.  
 Follow-up: Starts on the day of End of Treatment Visit and will 
last up to 18 months after End of Treatment Visit. Clinical 
evaluation will be performed approximately every 3 months 
until final completion of trial, CTs approximately every 6
months until final completion of trial.  


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Investigational 
Product(s) and Control 
Drug(s)  
The investigational products tafasitamab or tafasitamab plus
lenalidomide will be given in addition to standard of care i.e. R-
CHOP treatment in this study. 
Note: R-CHOP is considered the current standard of care for first-
line treatment of newly diagnosed DLBCL and serves as a 
backbone in this study. R-CHOP is considered a non-IMP and is 
not provided by the sponsor.  
Note: Rituximab or equivalent approved biosimilar anti-CD20 
will be used as per investigator´s choice. Subcutaneous 
formulation of Rituximab will not be allowed in this Phase Ib trial.
Dose, Route of 
Administration, 
Treatment Regimen 
Tafasitamab in addition to R-CHOP in patients with newly 
diagnosed DLBCL 
Treatment consists of tafasitamab in addition to R-CHOP
for six 21-day cycles  
Tafasitamab dose: 12 mg/kg body weight 
Each 21-day cycle (Cycles 1-6) will consist of a 
tafasitamab intravenous (IV) infusion on Day 1, Day 8 and 
Day 15  
R-CHOP: 
Rituximab or equivalent approved biosimilar 375mg/m2, 
IV Day 1 of every 21-day cycle 
Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle 
Doxorubicin 50mg/m2, IV Day 1 of 21-day cycle 
Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day 
cycle 
Prednisone/Prednisolone 100 mg, per oral, Day 1-5 of
every 21-day cycle 
Tafasitamab plus lenalidomide in addition to R-CHOP in 
patients with newly diagnosed DLBCL 
Treatment consists of tafasitamab plus lenalidomide in 
addition to R-CHOP for six 21-day cycles  
Tafasitamab dose: 12 mg/kg body weight 
Each 21-day cycle (cycles 1-6) will consist of a tafasitamab
IV infusion on Day 1, Day 8 and Day 15  


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Lenalidomide:  
Patients will self-administer a starting dose of 25 mg 
lenalidomide orally daily on Days 1–10 of each 21-day 
cycle.  
Dose modification in response to toxicity is allowed in 5 
mg steps to a minimum dose of 10 mg and will be specified 
in the toxicity management section of the protocol. 
R-CHOP: 
Rituximab or approved biosimilar 375mg/m2, IV Day 1 of 
every 21-day cycle 
Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle 
Doxorubicin 50mg/m2, IV Day 1 of 21-day cycle 
Vincristine 1.4 mg/m2 (max 2 mg) IV. Day 1 of 21-day 
cycle 
Prednisone/Prednisolone 100 mg, per oral, Day 1-5 of
every 21-day cycle. 
Co-Medication 
6 cycles of R-CHOP: Patients will be treated with R-CHOP 
according to the institutional guidelines. R-CHOP serves as a 
backbone treatment. 
Steroid pre-phase: In patients with urgent need for a steroid pre-
phase before initiation of therapy, the use of oral prednisone 25-
100 mg/d or equivalent over 7 days is allowed after tumor 
investigations (imaging, blood samples) for screening have been 
performed.  
Under exceptional circumstances and at the discretion of the 
investigator, the steroid pre-phase can be started prior to 
acquisition of PET. Any pre-phase steroid use must be adequately 
documented and justified in the patient’s source data. 
IRR prophylaxis for tafasitamab infusions should be administered 
in accordance with the protocol and consist of oral acetaminophen 
(e.g., 650−1000 mg), an antihistamine such as diphenhydramine 
hydrochloride (50−100 mg) and glucocorticosteroids (e.g. 100 mg 
IV prednisone or prednisolone or equivalent) 30−60 minutes prior 
to the start of the infusion (unless contraindicated). Note: the Day 
1 steroid dose being part of CHOP (100 mg prednisone or 
prednisolone or equivalent, IV or PO) can be used as further 
component of premedication prior to Tafasitamab infusion.  


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Prophylaxis of venous thromboembolism (VTE) for patients 
receiving lenalidomide: Patients in the tafasitamab plus 
lenalidomide in addition to R-CHOP arm must receive e.g. aspirin 
70-325mg daily or low molecular weight heparin. This is due to 
increased risk of thrombosis in patients treated with lenalidomide 
without prophylaxis.  
CNS prophylaxis: Central nervous system (CNS) prophylaxis with 
intrathecal chemotherapy may be given according to institutional 
practice. CNS prophylaxis with intravenous methotrexate is 
allowed only if it was pre-planned and it may be administered only 
after the last treatment cycle and after the End of Treatment tumor 
assessment by PET/CT or PET/MRI. 
Pre-planned radiotherapy: Pre-planned local radiotherapy may be 
administered to initial sites of bulky or extranodal disease 
according to institutional guidelines. Pre-planned radiotherapy 
may be administered only after the last treatment cycle and after 
the End of Treatment tumor assessment by PET/CT or PET/MRI.
Use of growth factors: The use of granulocyte colony stimulating 
factor (G-CSF) or pegylated G-CSF is mandatory for the 
prophylaxis of neutropenia and should be administered as per 
institutional guidelines.  
Prophylaxis of tumor lysis syndrome (TLS):  In patients with high 
risk of tumor lysis syndrome (e.g. patients with large tumor 
burden, elevated lactate dehydrogenase (LDH), or high 
proliferation rate of tumor cells), TLS prophylaxis should be 
considered. All approaches to mitigate the risk of developing TLS, 
such as adequate hydration or hypouricemic agents (e.g. 
allopurinol or rasburicase), may be used in high risk patients as per 
institutional guidelines. 
Supply and Preparation Tafasitamab DP is a lyophilisate supplied in single-use 20 ml 
glass vials. Each vial contains 200 mg of tafasitamab for 
reconstitution with 5 ml of water for injection (WFI). 
Reconstitution yields 40 mg/ml tafasitamab in 25 mm sodium 
citrate, 200 mm trehalose and 0.02% (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. Tafasitamab will be diluted into 
a 250 ml infusion bag containing 0.9% (w/v) sodium chloride for 
injection.  
Lenalidomide will be provided by the sponsor.  
R-CHOP is not an IMP. It will be not provided by the sponsor. 


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Note: Rituximab or an equivalent approved biosimilar will be used 
as per investigator´s choice. 
Visit Schedule and 
Assessments 
Please refer to the Schedule of Assessments (SoA)    
Efficacy Assessments 
Disease response assessments will be made according to the 
revised response criteria for malignant lymphoma based on the 
guidelines of the Lugano Classification (as reported by Cheson,
2014) and will be based on investigator assessment. Efficacy will 
be evaluated in terms of ORR, DoR, PFS, EFS, OS, TTP and 
TTNT.  
Safety Assessments 
The safety and tolerability of study treatment (tafasitamab in 
addition to R-CHOP or tafasitamab and lenalidomide in addition 
to R-CHOP) will be evaluated by means of AE reports (nature, 
severity, frequency, causality), performance status, physical 
examinations, ECG and laboratory safety evaluations.  
Laboratory and AE reports will be graded according to National 
Cancer Institute (NCI) Common Terminology Criteria for adverse 
events (CTCAE), version 5.0.  
Pharmacokinetics of 
Tafasitamab 
The pharmacokinetic profile of tafasitamab will be investigated 
during the course of the study. Tafasitamab PK samples will be 
collected as outlined in the Schedule of Assessments.  
Immunogenicity 
Assessments (anti-
tafasitamab antibodies) 
The potential immunogenicity of tafasitamab will be investigated 
during the course of the study. Anti-tafasitamab antibody samples 
will be collected as outlined in the Schedule of Assessments. 
Other Assessments 
Blood and tumor specimens for the analysis of exploratory 
biomarkers will be collected throughout the study.   
 Tumor biopsies at screening and if available at 
progression/relapse 
 Peripheral blood samples will be collected as outlined in 
the Schedule of Assessments.   
Biomarker 
Assessment(s) 
Blood and tumor specimens for the analysis of exploratory 
biomarkers will be collected throughout the study. A range of 
exploratory biomarkers are planned to be investigated during the 
course of the study including tumor CD19 and CD20 expression, 
B-, T- and NK and other cell counts in peripheral blood or tumor 
tissue. To facilitate the investigational research blood samples will 
be stored for the analysis of peripheral blood mononuclear cell 
populations (e.g. monocytes or CD4+ T-cells). 


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To assess the pharmacodynamic effect of tafasitamab, circulating 
tumor DNA (ctDNA) will be quantified serially in the peripheral 
blood as an early indicator of treatment response and to detect 
minimal residual disease (MRD). 
Gene expression profiling of diagnostic tumor biopsies will be 
used to determine the cell of origin (COO) subtype and to assess 
tumor infiltrating immune cells via their gene expression 
signature. Together, with the quantification of tumor-associated 
macrophages 
and 
tumor 
infiltrating 
NK 
cells 
by 
immunohistochemistry this will provide a deeper understanding of 
the mode of action of tafasitamab.    
Statistical Methods and 
Data Analysis  
As this is a Phase 1b study, Primary, Secondary and Exploratory 
endpoints will be analyzed using descriptive statistics. No formal 
statistical tests will be performed.  
Primary completion analyses are planned to be performed after all 
randomized patients completed their treatment phase or 
discontinued earlier. Final Analyses will be performed at the end 
of Follow-up period. Details will be provided in the Statistical 
Analysis Plan (SAP). 
Stopping Rules 
If any of the situations listed below occur, the Sponsor will pause 
enrolment in the relevant study arm. The Safety Committee and 
the iDSMB will convene ad-hoc meetings and make 
recommendations on e.g. whether to stop further enrolment and 
stop treatment of ongoing patients. The Sponsor will make the 
final decisions, taking account of these recommendations. 
1) The situations are as follows. During Safety Run-in Phase: 
if any of the events listed below (A-C)* occur in ≥4 of the 
first 12 patients in either of the two arms who have received 
at least one dose of study drug.  
2) During Main Phase: if any of the events listed below (A-
C)* occur in more than 33% of the currently randomized 
patients in either of the two arms who received at least one 
dose of study drug.  
A) a grade 4 or higher non-hematologic adverse event (in 
either of the two arms) 
B) a grade 3 or higher thrombosis/embolism suspected to 
be related to treatment with lenalidomide (only for the 
tafasitamab-lenalidomide-R-CHOP arm) 


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C) a dose reduction or delay of over 7 days of R-CHOP
(for the total across both treatment arms). 
*Any combination of events (A-C) occurring in ≥ 4 
patients during the Safety Run-in Phase or in more than 
33% of the currently randomized patients during the Main
Phase will lead to a Safety Data Review.   
 


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2 TABLES OF CONTENT 
2.1 Overall Table of Contents 
CLINICAL TRIAL PROTOCOL ........................................................................................................ 1 
VERSION 2.0, SUMMARY OF CHANGES ....................................................................................... 2 
VERSION 3.0, SUMMARY OF CHANGES ....................................................................................... 2 
VERSION 4.0, SUMMARY OF CHANGES ....................................................................................... 4 
VERSION 5.0, SUMMARY OF CHANGES ....................................................................................... 5 
VERSION 6.0, SUMMARY OF CHANGES ....................................................................................... 6 
SIGNATURES ........................................................................................................................................ 8 
SPONSOR'S SIGNATURES ................................................................................................................. 8 
COORDINATING INVESTIGATOR’S SIGNATURE ..................................................................... 9 
PRINCIPAL INVESTIGATOR'S SIGNATURE .............................................................................. 10 
1 
SYNOPSIS ..................................................................................................................................... 11 
2 
TABLES OF CONTENT ............................................................................................................. 28 
2.1 
Overall Table of Contents .................................................................................................. 28 
2.2 
List of Tables....................................................................................................................... 32 
2.3 
List of Figures ..................................................................................................................... 32 
3 
LIST OF ABBREVIATIONS ...................................................................................................... 33 
4 
BACKGROUND INFORMATION ............................................................................................ 37 
4.1 
Overview of Diffuse Large B-Cell Lymphoma ................................................................ 37 
4.2 
Current Treatment of DLBCL and Unmet Medical Need ............................................. 37 
4.3 
Lenalidomide in Hematological Malignancies ................................................................. 38 
4.4 
Overview of Tafasitamab ................................................................................................... 38 
4.4.1 
Clinical Experience with Tafasitamab ..................................................................... 40 
4.4.2 
Safety of Tafasitamab .............................................................................................. 40 
4.5 
Study Rationale .................................................................................................................. 42 
5 
CLINICAL TRIAL PURPOSE AND OBJECTIVES ............................................................... 43 
6 
CLINICAL TRIAL DESIGN ...................................................................................................... 46 
6.1 
Overall Clinical Trial Design and Investigational Plan .................................................. 46 
6.1.1 
Safety monitoring .................................................................................................... 46 
6.2 
Early Study Termination ................................................................................................... 48 
6.3 
Stopping Rules .................................................................................................................... 48 
6.4 
Clinical Trial Duration ...................................................................................................... 49 
6.4.1 
Screening period ...................................................................................................... 49 
6.4.2 
Treatment period ..................................................................................................... 49 
6.4.3 
Follow-up period ..................................................................................................... 50 
6.5 
Risks and Benefits to Patients ........................................................................................... 50 
7 
SELECTION AND WITHDRAWAL OF PATIENTS ............................................................. 51 
7.1 
Inclusion Criteria ............................................................................................................... 51 


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7.2 
Exclusion Criteria .............................................................................................................. 53 
7.3 
Restrictions ......................................................................................................................... 54 
7.3.1 
Restrictions applicable in all countries except US .................................................. 54 
7.3.2 
Restrictions applicable in US .................................................................................. 55 
7.4 
Withdrawal and Termination Criteria ............................................................................. 56 
7.4.1 
Patient Withdrawal .................................................................................................. 56 
7.4.2 
Clinical Trial or Clinical Trial Site Termination ..................................................... 57 
8 
STUDY TREATMENT ................................................................................................................ 57 
8.1 
Definition of Treatment Cycle ........................................................................................... 57 
8.2 
Investigational Medicinal Product(s) ................................................................................ 58 
8.2.1 
Tafasitamab ............................................................................................................. 58 
8.2.2 
Lenalidomide ........................................................................................................... 59 
8.3 
R-CHOP .............................................................................................................................. 59 
8.3.1 
R-CHOP administration .......................................................................................... 60 
8.4 
Treatment Compliance and Product Accountability ...................................................... 60 
8.5 
Recommended Dose Modifications, Drug Interruptions and Discontinuation 
Guidelines ............................................................................................................................ 60 
8.5.1 
Tafasitamab Dose Modifications, Drug Interruptions and Discontinuation ............ 60 
8.5.2 
Management of Tafasitamab Infusion-Related Reactions (IRRs) and Cytokine 
Release Syndrome (CRS) ........................................................................................ 60 
8.5.3 
Interventions for IRRs and CRSs ............................................................................ 61 
8.5.4 
Lenalidomide Dose Modifications, Drug Interruptions and Discontinuation ......... 62 
8.5.5 
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, 
Prednisone/Prednisolone Dose Modifications and Drug Interruptions and 
Discontinuation ....................................................................................................... 63 
8.5.6 
Criteria to Start Next Treatment Cycle (day 1 of cycle 2-6) ................................... 63 
8.5.7 
Dose Modifications, Drug Interruptions and Discontinuation in Case of Non-
Hematological Toxicity ........................................................................................... 67 
8.6 
Tafasitamab and Lenalidomide Overdose Treatment .................................................... 69 
8.7 
Concomitant and Prohibited Medication ......................................................................... 69 
8.7.1 
Prior and Concomitant Medication ......................................................................... 69 
8.7.2 
Prohibited Medication ............................................................................................. 71 
8.8 
End of Clinical Trial Treatment ....................................................................................... 72 
9 
CLINICAL TRIAL PROCEDURES .......................................................................................... 73 
9.1 
Patient Numbering ............................................................................................................. 73 
9.2 
Assigning Patients to Treatment Groups ......................................................................... 73 
9.3 
Re-Screening ....................................................................................................................... 73 
9.4 
Demographic Data/Relevant Medical History and Current Medical 
Conditions/Baseline Stage and Prognostic Classification ............................................... 74 
9.5 
Diagnostic Lymphoma Biopsy and Central Pathology Review ...................................... 74 


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9.6 
Bone marrow assessment ................................................................................................... 74 
9.7 
Radiographic Imaging Assessment ................................................................................... 75 
9.8 
Vital Signs ........................................................................................................................... 75 
9.9 
Electrocardiograms, Echocardiograms or Cardiac MUGA scans ................................. 76 
9.10 Physical Examination (PE) ................................................................................................ 77 
9.11 Body Weight Measurement ............................................................................................... 77 
9.12 B-symptoms, ECOG performance status ......................................................................... 77 
9.13 Hepatitis Virus Serology .................................................................................................... 77 
9.14 Pregnancy Testing .............................................................................................................. 78 
9.15 Local Laboratory Testing .................................................................................................. 78 
9.16 Immunogenicity (anti-tafasitamab antibodies) ................................................................ 79 
9.17 Tafasitamab Pharmacokinetic Assessments .................................................................... 79 
9.18 Other Laboratory Evaluations .......................................................................................... 79 
10 SCHEDULE OF ASSESSMENTS .............................................................................................. 80 
11 EFFICACY, PHARMACOKINETIC, SAFETY AND OTHER VARIABLES ..................... 85 
11.1 Efficacy Assessments .......................................................................................................... 85 
11.2 Safety Assessments ............................................................................................................. 85 
11.2.1 Local Safety and Hematology Laboratory Testing.................................................. 85 
11.2.2 Safety Monitoring .................................................................................................... 85 
11.2.3 Definition of Adverse Events, Serious Adverse Events and Adverse Events of 
Special Interest ........................................................................................................ 86 
11.2.4 Reporting of AEs, SAEs and AEs of Special Interest ............................................. 88 
11.2.5 Pregnancy ................................................................................................................ 88 
11.3 Other Variables .................................................................................................................. 89 
11.3.1 Biomarkers .............................................................................................................. 89 
11.4 Appropriateness of Measurements ................................................................................... 89 
12 DATA HANDLING AND QUALITY ASSURANCE ............................................................... 90 
12.1 Completing and Signing Case Report Forms .................................................................. 90 
12.2 Clinical Monitoring ............................................................................................................ 90 
12.3 Audit and Inspection .......................................................................................................... 90 
12.4 Clinical Data Management ................................................................................................ 90 
12.5 Archiving ............................................................................................................................. 90 
13 STATISTICAL METHODS AND PLANNED ANALYSIS ..................................................... 91 
13.1 General Statistical Considerations.................................................................................... 91 
13.2 Timing of Analysis .............................................................................................................. 91 
13.2.1 Safety Run-in Analysis ............................................................................................ 91 
13.2.2 Primary Completion Analysis ................................................................................. 91 
13.2.3 Final Analysis .......................................................................................................... 91 
13.3 Population for Analysis ...................................................................................................... 92 
13.3.1 Full Analysis Set (FAS) .......................................................................................... 92 


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13.3.2 Safety Set (SAF) ...................................................................................................... 92 
13.3.3 Per Protocol Set (PPS) ............................................................................................. 92 
13.3.4 Pharmacokinetic Analysis Set (PKAS) ................................................................... 92 
13.3.5 Immunogenicity Analysis Set (IAS) ....................................................................... 92 
13.4 Patient Disposition, Demographics and Baseline Characteristics.................................. 92 
13.5 Treatments (study treatment, concomitant therapies, compliance) .............................. 93 
13.5.1 Study Treatment ...................................................................................................... 93 
13.5.2 Prior and concomitant therapies .............................................................................. 93 
13.5.3 New Anti-lymphoma therapies................................................................................ 94 
13.6 Hypothesis ........................................................................................................................... 94 
13.7 Sample Size Determination................................................................................................ 94 
13.8 Procedures for Missing, Unused and Spurious Data ...................................................... 94 
13.9 Procedures for Reporting Deviations from Original Statistical Plan ............................ 94 
13.10 Primary Objective Analysis ............................................................................................... 94 
13.11 Key Secondary Objective Analysis ................................................................................... 95 
13.11.1 Objective response Rate at the end of treatment ..................................................... 95 
13.11.2 The Metabolic, PET-negative complete response rate at the end of treatment ....... 95 
13.12 Secondary Objectives Analysis.......................................................................................... 95 
13.12.1 Long-term Safety Analysis ...................................................................................... 95 
13.12.2 Efficacy endpoints ................................................................................................... 95 
13.12.3 Pharmacokinetic Analysis ....................................................................................... 96 
13.12.4 Immunogenicity Analysis ........................................................................................ 96 
13.12.5 ctDNA Analysis ...................................................................................................... 97 
13.12.6 NKCC Analysis ....................................................................................................... 97 
13.13 Exploratory Objective Analysis ........................................................................................ 97 
13.14 Safety Analysis .................................................................................................................... 97 
13.14.1 Adverse Events ........................................................................................................ 98 
13.14.2 Clinical Laboratory Evaluation ............................................................................... 99 
13.14.3 Vital Signs ............................................................................................................. 100 
13.14.4 Electrocardiograms ................................................................................................ 100 
14 SPECIAL REQUIREMENTS AND PROCEDURES ............................................................. 100 
14.1 Regulatory and Ethical Considerations ......................................................................... 100 
14.2 Investigator’s Responsibilities ......................................................................................... 100 
14.2.1 Overall Responsibilities ........................................................................................ 100 
14.2.2 Patient Informed Consent ...................................................................................... 101 
14.2.3 Direct access to Source Data/ Documents ............................................................. 101 
14.2.4 Confidentiality Regarding Clinical Trial Patients ................................................. 101 
14.2.5 Financial Disclosure .............................................................................................. 101 
14.3 Publication of trial protocol and results ......................................................................... 101 
14.4 Publication Policy ............................................................................................................. 102 


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15 REFERENCES ........................................................................................................................... 103 
16 APPENDICES ............................................................................................................................. 106 
Appendix A .................................................................................................................................. 106 
Appendix B .................................................................................................................................. 107 
Appendix C .................................................................................................................................. 108 
Appendix D .................................................................................................................................. 109 
Appendix E .................................................................................................................................. 110 
Appendix F .................................................................................................................................. 115 
Appendix G (Applicable in US only) ......................................................................................... 116 
Appendix H ................................................................................................................................. 117 
 
2.2 List of Tables 
Table 1 Definition of Infusion-Related Reaction 
Table 2 Lenalidomide Dose Modification Guidelines 
Table 3 Dose modification and drug interruptions and discontinuation in case of 
hematological toxicity 
Table 4 Dose modification and drug interruptions and discontinuation in case of non-
hematological toxicity 
2.3 List of Figures 
Figure 1 Trial Design 
Figure 2 Clinical trial periods: Screening, Treatment and Follow-up  


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3 LIST OF ABBREVIATIONS 
 
ABC 
Activated B-cell 
ADCC 
Antibody-dependent cytotoxicity 
ADCP 
Antibody-dependent Cell-mediated Phagocytosis 
ADR 
Adverse Drug Reaction 
AE 
Adverse event 
AESI 
Adverse Event of Special Interest 
AGES 
Österreichische Agentur für Gesundheit und Ernährungs-sicherheit 
GmbH, (Austrian regulatory agency) 
ALL 
Acute Lymphoblastic Leukemia 
ALP 
Alkaline phosphatase 
ALT 
Alanine amino Transferase 
ANC 
Absolute Neutrophil Count  
ANSM 
Agence nationale de sécurité du médicament et des produits de santé 
(French regulatory agency) 
aPTT 
Activated Partial Thromboplastin Time 
ASCT 
Autologous Stem Cell Transplantation 
AST 
Aspartate amino Transferase 
ATC 
Anatomical Therapeutic Chemical 
AUC28 
Area under the time-concentration curve from 0-28 days 
BEN 
Bendamustine 
β-HCG 
β-human chorionic gonadotropin  
CDC 
Complement-dependent Cytotoxicity 
CHOP 
Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone 
CI 
Confidence Interval  
Cmax 
Concentration max. 
CML 
Chronic Myeloid Leukemia 
CNS 
Central Nervous System 
CLL/SLL 
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma 
COO 
Cell of Origin 
CR 
Complete Response 
CRS 
Cytokine Release Snndrome 
CrCl 
Creatinine Clearance 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CT 
Computerised Tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
ctDNA 
Circulating Tumor DNA 
Ctrough 
Concentration trough 
DLBCL 
Diffuse Large B-cell Lymphoma 
DNA 
Deoxyribonucleic Acid 
DoR 
DP 
Duration of Response 
Drug Product 
DSUR 
Development Safety Update Report 
ECG  
Electrocardiogram 


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ECOG 
Eastern Cooperative Oncology Group  
EDV 
End-diastolic volume 
eCRF 
Electronic Case Report Form 
EFS 
Event Free Survival 
EMA 
European Medicines Agency 
EOT 
End of Treatment 
ESV 
End-systolicv volume 
EudraCT  
European Union Drug Regulating Authorities Clinical Trials 
FAMPH 
Federal Agency for Medicines and Health Products (Belgian 
regulatory agency) 
FAS 
Full Analysis Set 
Fc 
Fragment Crystallizable 
FCBP 
FDA 
Females of childbearing potential 
Food and Drug Administration 
FDG 
Fluorodeoxyglucose 
FISH 
Fluorescent In Situ Hybridization 
FU 
Follow-up 
GCB 
Germinal Centre B-cell 
GCP 
Good Clinical Practice 
G-CSF 
Granulocyte Colony Stimulating Factor 
GI 
Gastrointenstinal 
GLP 
Good Laboratory Practice 
HBV 
Hepatitis B Virus 
HBcAb 
Hepatitis Core Antibody 
HBsAb 
Hepatitis B Surface Antibody  
HBsAg 
Hepatitis B Surface Antigen 
HCL 
Hairy Cell Leukemia 
HCV 
Hepatitis C Virus 
HIV 
Human Immunodeficiency Virus  
IAS 
Immunogenicity Analysis Set 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
iDSMB 
Independent Data and Safety Monitoring Board 
IHC 
Immunohistochemistry 
IEC 
Independent Ethics Committee 
IgA 
Immunoglobulin A 
IgG 
Immunoglobulin G 
IgM 
Immunoglobulin M 
IMiD 
Immunomodulatory Drug 
IMP 
Investigational Medicinal Product 
IND 
Investigational New Drug 
INFARMED 
National Authority of Medicines and Health Products, I.P. 
(Portuguese regulatory agency) 
INR 
International Normalized Ratio 
IPI 
International Prognostic Index  
IRB 
Institutional Review Board 


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IRR 
Infusion-related reaction 
IRT 
Interactive Response Technology 
IU 
International Units 
IUD 
Intrauterine device 
IV 
Intravenous 
LDH 
Lactate Dehydrogenase 
LDi 
Longest Diameter 
LEN 
Lenalidomide 
LVEF 
Left Ventricular Ejection Fraction 
Lugano 2014 
 
Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for 
Initial Evaluation, Staging, and Response Assessment of Hodgkin 
and Non-Hodgkin Lymphoma: The Lugano Classification. J Clin 
Oncol. 2014;32(27):3059-3068. 
mAb 
Monoclonal Antibody 
MedDRA 
Medical Dictionary for Regulatory Activities 
MUGA 
Multigated Acquisition 
mg 
Milligram 
mL 
Millilitre 
MRD 
Minimal Residual Disease 
MRI 
Magnetic Resonance Imaging 
NCI 
National Cancer Institute 
ng 
Nanogram 
NHL 
Non-Hodgkin lymphoma 
NK 
Natural Killer 
NKCC 
Natural Killer Cell Count 
NOS 
Not Otherwise Specified 
NSAID 
Non-Steroidal Anti-Inflammatories 
ORR 
Objective Response Rate 
OS 
Overall Survival 
PBMC 
Peripheral Blood Mononuclear Cells 
PCR 
Polymerase Chain Reaction  
PD 
Pharmacodynamic 
PE 
Physical Examination 
PEI 
Paul-Ehrlich Institute (German regulatory agency) 
Peg-G-CSF 
Pegylated granulocyte colony-stimulating factor  
PET 
Positron Emission Tomography 
PFS 
Progression Free Survival 
PK 
Pharmacokinetics 
PKAS 
Pharmacokinetic Analysis Set 
PMBL 
Primary Mediastinal Large B-cell Lymphoma 
PML 
Progressive Multifocal Leukoencephalopathy 
PO 
Per Os 
PPD 
Perpendicular Diameters 
PPS 
Per Protocol Set 
PR 
Partial Response 
PT 
Prothrombin Time 
PTT 
Partial Thromboplastin Time 


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RBC 
Red Blood Cell 
R-CHOP 
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and 
Prednisone 
RNA 
Ribonucleic Acid 
R/R 
Relapsed/Refractory 
SAP 
Statistical Analysis Plan 
SAE 
Serious adverse event 
SAF 
Safety Set 
SD 
Standard Deviation 
SDi 
Smallest Diameter 
SCID 
Severe Combined Immuno Deficiency 
SmPC 
Summary of Product Characteristics 
SoA 
Schedule of Assessments 
SoC 
Standard of Care 
SOP 
Standard Operating Procedure 
SPD 
Sum of the Product of the Perpendicular Diameters 
SUKL 
Státní Ústav pro Kontrolu Léčiv (Czech regulatory agency) 
SUSAR 
Suspected Unexpected Serious Adverse Reaction  
SV 
Stroke Volume 
TEAE 
Treatment Emergent Adverse Event 
TLS 
Tumor Lysis Syndrome 
TTNT 
Time to Next Anti-lymphoma Treatment 
TTP 
Time to Progression 
TSH 
Thyroid Stimulating Hormone 
ULN 
Upper Limit of Normal 
VTE 
Venous Thromboembolism 
WBC 
White Blood Cell 
WHO 
World Health Organisation 
WFI 
Water for Injection 
 
 
 
 
 


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4 BACKGROUND INFORMATION 
4.1 Overview of Diffuse Large B-Cell Lymphoma 
Non-Hodgkin lymphoma (NHL) is the most common hematologic malignancy in adults. The 
majority of NHLs are of B-cell origin, with multiple different histologic subtypes (according to 
the WHO 2016 classification) that confer different clinical outcomes. Generally, NHL can be 
divided into aggressive and indolent lymphomas.  
Diffuse large B-cell lymphoma (DLBCL) is the most common NHL, representing approximately 
40% of all NHLs, and its rate of incidence continues to increase with median age at diagnosis of 
64 years. DLBCL is an aggressive B-NHL and the majority of patients present with advanced 
disease. DLBCL is increasingly recognized as a heterogeneous disorder with distinct cell of 
origin subtypes, each arising from different stage of normal B-cell development. Several studies 
have shown that the distinct COO subtypes, Germinal Centre B-cell type (GCB) and activated 
B-cell type (ABC) have unique mutational profile and also different prognostic outcomes (Lenz, 
2008; Flowers, 2010; Vaidya, 2014; Schmitz, 2018).  
4.2 Current Treatment of DLBCL and Unmet Medical Need 
The immune-chemotherapy regimen consisting of the anti-CD20 monoclonal antibody (mAb) 
rituximab (R) plus the CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) 
chemotherapy (R-CHOP) is the current standard of care (SoC) for the treatment of newly 
diagnosed DLBCL patients. Based on recent data published at ASH2018, there is no added 
benefit of 8 vs. 6 cycles of R-CHOP in previously untreated DLBCL. Thus, rituximab with 6 
cycles of CHOP-21 should be considered SoC (Sehn, 2018).  Although the addition of rituximab 
to CHOP dramatically improved outcomes compared with CHOP alone, still 30–40% DLBCL 
patients are primary refractory or relapse (Habermann, 2006; Coiffier, 2010). Although some 
patients with relapsed/refractory DLBCL can be salvaged with second line chemotherapy 
followed by consolidation with high dose chemotherapy and autologous stem cell transplantation 
(ASCT), the majority will succumb to the disease. Thus, the development of a more effective 
initial therapy is essential to improve long-term outcomes.  
Various alternative regimens have been explored in an attempt to improve the efficacy of R-
CHOP e.g. by increasing the intensity of the chemotherapy, increasing the dose of rituximab, 
adding maintenance therapy, adding targeted agents to R-CHOP or by using consolidation with 
high dose therapy and ASCT in the initial management of DLBCL. However, these approaches 
have largely been unsuccessful, including attempt at maximising dose density with R-CHOP 14 
(Pfreundschuh, 2008; Cunningham, 2013; Delarue, 2013). Recent large, randomized, phase III 
DLBCL trials including BO21005/GOYA, comparing the efficacy and safety of Obinutuzumab 
plus CHOP (G-CHOP) with R-CHOP (Vitolo, 2017), DA-EPOCH-R (Wilson, 2016), and 
REMARC, comparing lenalidomide maintenance with placebo (Thieblemont, 2016) did not 
demonstrate clinically meaningful benefit for the experimental therapies being tested, reflecting 
a continued need to improve upon SoC therapies.  


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4.3 Lenalidomide in Hematological Malignancies 
Lenalidomide belongs to a class of immunomodulating agents (immunomodulatory drugs 
[IMiDs]), which have demonstrated direct tumoricidal and immunomodulatory actions. 
Lenalidomide has both anti-proliferative and antiangiogenic activities, modulating the tumor cell 
microenvironment and stimulating the activity of effector cells such as cytotoxic T-cells and 
natural killer (NK) cells. Lenalidomide is FDA- and EMA-approved in multiple myeloma, 
mantle-cell lymphoma and in 5q- myelodysplastic syndromes.  
Lenalidomide monotherapy was investigated in patients with relapsed/refractory (R/R) DLBCL 
patients and shown to result in poor outcomes (Witzig, 2011; Czuczman, 2017).  Lenalidomide 
demonstrated manageable toxicity as single agent or in combination with rituximab in R/R 
DLBCL or in combination with R-CHOP in the so called R2-CHOP regimen in untreated 
DLBCL (see below). It is currently unknown whether the cell of origin (COO) has an impact on 
lenalidomide efficacy in frontline DLBCL therapy. 
A dose finding phase Ib trial of lenalidomide (dose levels 15, 20 and 25mg given days 1-10) in 
combination with R-CHOP given every 21 days was conducted in newly diagnosed DLBCL 
patients and showed that lenalidomide did not affect dose intensity and schedule of R-CHOP, 
was safe and associated with high (100% ORR, 77% CR) response rates (Nowakowski, 2011). 
Based on this study and another single arm phase II study with a different lenalidomide dosing 
regimen (15 mg, days 1-14 q21 days) (Vitolo, 2014), it was concluded that lenalidomide can be 
safely combined with R-CHOP in the initial treatment of patients with DLBCL. The phase III 
ROBUST trial of oral lenalidomide (15 mg, days 1-14) plus R-CHOP versus placebo plus R-
CHOP in patients with previously untreated ABC-type DLBCL did not meet its primary endpoint 
for PFS, although a positive trend favoring lenalidomide plus R-CHOP has been observed in 
advanced-stage and higher-risk patients (NCT 02285062). The most common grade 3/4 adverse 
events reported were neutropenia (60% in the lenalidomide/R-CHOP arm vs 48% in the 
placebo/R-CHOP arm), anemia (22% vs 14%), thrombocytopenia (17% vs 11%), leukopenia 
(14% vs 15%), febrile neutropenia (14% vs 9%), and lymphopenia (11% vs 8%). The safety 
profile of lenalidomide plus R-CHOP was consistent with those of the individual medicines, and 
no new safety signals were identified with the combination (Vitolo, 2019).  
 
In contrast, the results of the recent ECOG-ACRIN1412 trial, a randomized phase II trial of R-
CHOP in combination with Lenalidomide (25 mg/day on day 1-10 of each 21-day cycle) have 
shown promising efficacy in newly diagnosed DLBCL with 34% reduction in risk of progression 
or death in R2-CHOP arm compared to R-CHOP arm. Lenalidomide in addition to R-CHOP was 
well tolerated despite a higher frequency of haematological toxicity and febrile neutropenia 
compared to R-CHOP. Importantly, there was no increase in treatment-related mortality in the 
R2-CHOP arm (1%) compared to R-CHOP arm (4%) (Nowakowski, 2019).  
4.4 Overview of Tafasitamab 
Tafasitamab (synonyms: MOR00208; XmAb®5574) is an Fc-engineered mAb that binds to the 
human B-cell surface antigen CD19. Tafasitamab possesses significantly increased tumor 
cytotoxicity when compared to the tafasitamab version with a non-engineered Fc region. The 
increased binding of tafasitamab to Fc gamma receptors (FcγR), due to the engineered mutations, 
significantly enhances in vitro ADCC, antibody-dependent cell-mediated phagocytosis (ADCP), 


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and its direct cytotoxic effects (apoptosis) on the tumor cells compared with the non-engineered 
parental murine antibody. Tafasitamab has not been shown to mediate complement-dependent 
cytotoxicity (CDC). 
More specifically, in preclinical studies, tafasitamab has been shown to significantly enhance in 
vitro ADCC, ADCP, and direct cytotoxic effects (apoptosis) on CD19+ tumor cell lines spanning 
a broad range of human lymphomas and leukemias (Burkitt lymphoma, CLL, hairy cell leukemia 
[HCL], CD19+ chronic myeloid leukemia [CML], DLBCL and acute lymphoblastic leukemia 
[ALL]), expressing levels of CD19 antigen ranging from 15,000 to 105,000 molecules/cell. 
Similar effects were also noted in relation to freshly isolated patient CLL or ALL cells and are 
also expected to translate to primary NHL cells since the expression range reported for ALL and 
CLL B-cells covers the range observed for NHL B-cells (Ginaldi, 1998; Olejniczak, 2006). 
Tafasitamab has also shown superior efficacy to its non-engineered version in relation to its 
ability to induce a marked reduction in tumor growth, inhibit tumor growth rate and increase 
survival in vivo in xenograft models of human lymphoma in severe combined immunodeficiency 
(SCID) mice (Investigator’s Brochure [IB]). 
The pharmacodynamic (PD) interactions of tafasitamab in combination with two standard-of-
care drugs fludarabine and bendamustine (BEN), and one investigational drug, lenalidomide 
used in the treatment of patients with CLL and NHL, were investigated in a human intravenous 
(IV) lymphoma model in SCID mice (see IB). In this orthotopic model for disseminated B-cell 
malignancies, the median survival was superior for all of the groups receiving tafasitamab 
combination therapy (with fludarabine, BEN or lenalidomide) when compared with the groups 
receiving tafasitamab monotherapy. The lenalidomide xenograft study showed a clear 
potentiation of the efficacy benefit of tafasitamab (3 mg/kg) and lenalidomide (100/200 mg/kg) 
combination therapy compared with the respective monotherapies (1.5x increase in median 
lifespan). 
Tissue cross-reactivity studies have shown that the pattern and distribution of tafasitamab 
binding to cynomolgus monkey tissues closely parallels those of human tissues. Flow cytometry 
experiments show tafasitamab binding to human and cynomolgus monkey B-cells, but not to the 
B-cells of other common laboratory species (such as rat, mouse, rabbit and dog). Therefore, 
pharmacology studies were restricted to human and cynomolgus monkey cell-based in vitro 
systems, CD19+ human B-cell tumor xenograft models in SCID mice, and cynomolgus monkeys 
in vivo. In in vivo studies in cynomolgus monkeys, tafasitamab was shown to induce B-
lymphocyte depletion in peripheral blood, bone marrow, spleen and inguinal lymph nodes. 
Cynomolgus monkeys were also judged to be the only relevant common laboratory species for 
toxicity studies. 
The results of studies evaluating the pharmacokinetics (PK), PD and toxicity of tafasitamab in 
cynomolgus monkeys, are provided in the IB. The findings in four preclinical studies were 
limited to the expected pharmacological effects of tafasitamab, with no reports of unanticipated 
toxicity. 
The four studies, all conducted in cynomolgus monkeys included: a 26-week single 10.0 mg/kg 
dose, PK, PD and toxicity study; a 28-day single IV dose, dose-ranging (0.3, 1.0 and 3.0 mg/kg) 
PK/PD study; a 29-day, single-dose (3.0 mg/kg) study comparing tafasitamab with two other 
CD19 antibodies with different Fc regions; and an 8-week toxicity study in which tafasitamab 


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was administered IV every 2 weeks at a dose of 2.0, 10.0 or 50.0 mg/kg for 8 consecutive weeks 
with a 90-day recovery period. The aim of the latter Good Laboratory Practice (GLP)-compliant, 
multiple-dose toxicology study was to support the use of tafasitamab in human clinical studies. 
Other than the expected dose-related decreases in B-lymphocyte levels and cellularity in spleen 
tissues, there were no tafasitamab-related changes identified in ‘clinical observations’, food 
consumption, body weight, electrocardiography, ophthalmology, urinalysis, coagulation, serum 
chemistry, and gross anatomic pathology at doses up to 50.0 mg/kg. In addition, GLP-compliant 
tissue cross-reactivity studies were performed on normal tissue panels from human and 
cynomolgus monkey donors. No specific staining of structures other than the expected 
mononuclear leucocytes, lymphocytes and hematopoietic precursor cells was observed. 
4.4.1 Clinical Experience with Tafasitamab 
The clinical development program of tafasitamab comprises five MorphoSys AG-sponsored 
clinical trials so far. Monotherapy with tafasitamab has shown preliminary signs of clinical 
efficacy and acceptable toxicity in a phase I study in R/R chronic lymphocytic leukemia/small 
lymphocytic lymphoma (CLL/SLL) (NCT01161511) (XmAb®5574-01) and a phase IIa study 
in R/R NHL (NCT01685008) (MOR208C201). In this study, patients with R/R DLBCL (n=35), 
treatment with tafasitamab until progression showed single agent activity with 26% ORR, with 
some responses ongoing for longer than 12 months in 5 out of 9 responding patients (Jurczak, 
2018). Additional tafasitamab studies which are currently ongoing evaluate tafasitamab in 
different combination therapies in patients with R/R DLBCL and R/R CLL.  
Preclinical data suggest that the combination of tafasitamab with lenalidomide may act 
synergistically by increasing NK cell-mediated ADCC, making this a combination of interest for 
further study in patients with B-cell lymphoma.  
In the phase II MOR208C203 L-MIND study (NCT02399085) in patients with R/R DLBCL, the 
combination of tafasitamab with lenalidomide achieved a high ORR of 58%, a CR rate of 33% 
and a median PFS of 16 months (Salles, 2018). This combination has recently received 
breakthrough designation by the FDA. Enrolment is complete with 81 patients and updated 
results from the ongoing L-MIND study indicate a significant improvement in outcome for these 
patients who have very limited treatment options (Salles, 2018). 
The ongoing Phase II/III study MOR208C204 (B-MIND) (NCT02763319) is a randomized 
study of tafasitamab combined with bendamustine versus rituximab plus bendamustine in 
patients with R/R DLBCL who are not candidates for high-dose chemotherapy and ASCT.  
The ongoing study MOR208C205 (COSMOS) is a Phase II study of tafasitamab in combination 
with either idelalisib or venetoclax in R/R CLL/SLL patients (NCT02639910). 
4.4.2 Safety of Tafasitamab 
To date, a total of 351 patients have been dosed with tafasitamab up to the data lock point of the 
most recent DSUR report (Version 6, Dec 6th 2018).  Tafasitamab was generally well tolerated 
in clinical studies with no new safety signals being observed compared to other B-cell depleting 
antibodies. 


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Tafasitamab has a novel mechanism of action that may have the potential to add to the care of 
patients with NHL. Based on the available data from the completed clinical study of tafasitamab 
(Protocol XmAb®5574-01), the data from the ongoing MOR208C201 clinical study, nonclinical 
studies and experiments, and literature data on CD19, the sponsor believes that the potential 
benefit of tafasitamab outweighs the potential risks. It is expected that the potential risks will be 
adequately controlled by the design of this study (e.g., by the inclusion and exclusion criteria) 
and by frequent monitoring of adverse drug reactions throughout the entire study. As the clinical 
trials with tafasitamab in combination therapy (MOR208C203, MOR208C204 and 
MOR208C205) are ongoing, no complete analysis of safety data is available, yet.  
Based on the results of the phase I clinical study (XmAb®5574-01) of tafasitamab in patients 
with CLL/SLL (Woyach, 2014), and the results of the MOR208C201 (Jurczak, 2018) and 
MOR208C202 (Klisovic, 2017) studies, the anticipated possible risks associated with 
administration of tafasitamab to patients include the following AEs (incidence > 3%) assessed 
as expected for tafasitamab treatment: 
 Infusion related reactions (IRRs) 
 Febrile neutropenia 
 Neutropenia 
 Thrombocytopenia 
 Tumor lysis syndrome 
 Upper respiratory tract infections 
 Fatigue 
 Chills 
 Pyrexia 
 Nausea 
 Diarrhoea 
 Headache 
 Rash 
 Aspartate aminotransferase (AST) and alanine transaminase (ALT) increases. 
In clinical trials IRRs were the most frequently reported treatment emergent adverse events 
(TEAEs) and were all judged as related to tafasitamab. Other frequent adverse drug reactions 
(ADRs) were hematologic events with neutropenia, febrile neutropenia and thrombocytopenia. 
Fatigue, chills, pyrexia, nausea, diarrhoea, headache, elevation of liver enzymes, upper 
respiratory tract infection, rash and tumor lysis syndrome were the most frequent non-
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In MOR208C203, a clinical trial in which patients with R/R DLBCL were treated with a 
combination of tafasitamab and lenalidomide, the first patient was enrolled on 29-Mar-2016. As 
of 18-Oct-2018 157 patients have been screened, thereof 81 patients have received at least the 
first dosing. 
With data cut-off 05-Jun-2018, the most common treatment-emergent adverse events (any 
grade/grade ≥3) were neutropenia in 39/35 (48%/43%) patients, thrombocytopenia in 26/14 
(32%/17%), anemia in 25/7 (31%/9%), diarrhea in 24/1 (30%/1%), pyrexia in 18/1 (22%/1%) 
and asthenia in 16/2 (20%/2%) patients. Treatment-related serious adverse events occurred in 16 
(19.8%) patients; the majority of the events were infections or neutropenic fever. No infusion 
related reactions were reported with tafasitamab. 41 (51%) patients required dose reduction with 
lenalidomide, 58 (72%) patients were able to stay on a daily lenalidomide dose of 20 mg or 
higher. In 9 (11%) patients lenalidomide was permanently discontinued due to an adverse event.  
A detailed tafasitamab exposure-response analysis for safety with results from clinical studies 
MOR208C201 (tafasitamab monotherapy in R/R NHL (including DLBCL), n=92) and 
MOR208C203/L-MIND (tafasitamab plus lenalidomide) in R/R DLBCL, n=81) was performed. 
In both studies, all subjects were treated at the dose level of 12 mg/kg tafasitamab. The 
tafasitamab exposure metrics AUC28 (ie, area under the time-concentration curve from 0-28 
days) and Cmax (overall maximum tafasitamab concentration) were derived by simulation for 
each subject from a population PK model. The individual exposure metrics were separated into 
exposure quartiles and analyzed against TEAEs and AESIs. As a conclusion from this analysis, 
there were no obvious trends for increasing TEAEs or AESIs with increasing exposure. The 
numbers and percentages of subjects experiencing a TEAE/AESI were equally or randomly 
distributed across the 4 exposure quartiles (e.g. results for “Any TEAE of Special Interest” in 
study L-MIND: AUC28 quartile 1: 20 subjects (24.7%); quartile 2: 20 subjects (24.7%), quartile 
3: 19 subjects (23.5%); quartile 4: 19 subjects (23.5%)). 
The possible risks associated with the administration of tafasitamab are described in detail in the 
tafasitamab IB. 
4.5 Study Rationale 
Six cycles of R-CHOP is considered the current SoC therapy in previously untreated DLBCL 
(Sehn, 2018); however, a substantial number of patients relapse after R-CHOP or are primary 
refractory to R-CHOP. After a number of phase III studies were unable to demonstrate 
meaningful benefit of various experimental approaches over R-CHOP, there is a need to evaluate 
novel approaches in order to improve the activity of R-CHOP in patients with previously 
untreated DLBCL.  
Literature data suggests that at least a part of the untreated DLBCL patients exhibits low CD20 
expression (Johnson, 2009; Tokunaga, 2014; Choi, 2016; Boltezar, 2018). Low CD20 expression 
was reported to be associated with inferior survival (5-year event-free survival [EFS] 39.4% in 
CD20-low compared to 66.5% in CD20-high group) (Choi, 2016).  Particularly for those 
patients, therapeutic targeting of an additional, independent B-cell antigen might be of value. 
The B-lymphocyte lineage specific surface antigen CD19 is the earliest and most broadly 
expressed of the selective B-cell markers and is highly expressed on tumor cells of most B- NHL. 


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Due to its lineage-specific expression pattern, targeting CD19 has clinical utility as a therapeutic 
approach to NHL treatment (Hammer, 2012).  
Tafasitamab is an Fc-enhanced, humanised, anti-CD19 mAb with significantly enhanced 
antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated 
phagocytosis (ADCP) and direct cytotoxic effects (apoptosis) compared with the parental murine 
antibody. The Fc-enhancement leads to increased binding affinity for Fc receptors on effector 
cells, particularly on NK cells, thereby increasing NK-cell mediated effector functions (ADCC) 
on tumor cell lines in vitro.  
In preclinical studies, anti-tumor activity was increased versus respective monotherapy 
treatments when tafasitamab was combined with rituximab, different chemotherapeutic and non-
chemotherapeutic drugs including lenalidomide. 
A phase I clinical trial investigating tafasitamab in humans has been completed (clinical trial 
XmAb5574-01, “A Phase I Study of XmAb5574 to Evaluate the Safety, Tolerability and 
Pharmacokinetics in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia”). 
Based on data derived from dose levels between 3 and 12 mg/kg, the estimated beta half-life 
averaged at approximately 13.5 days. The highest tested dose of 12 mg/kg was recommended 
for phase II (Woyach, 2014). 
Lenalidomide belongs to a class of immunomodulating agents (immunomodulatory drugs 
[IMiDs]), which have demonstrated direct tumoricidal and immunomodulatory actions. 
Lenalidomide has both anti-proliferative and antiangiogenic activities, modulating the tumor cell 
microenvironment and stimulating the activity of effector cells such as cytotoxic T-cells and 
natural killer (NK) cells by various mechanisms. Lenalidomide increases NK cell proliferation 
and numbers in vivo, modulates expression of co-stimulatory surface receptors on NK cells and 
stabilizes the immunological synapse between NK cell and target tumor cell. Preclinical data 
suggest that the combination of tafasitamab with lenalidomide act synergistically by increasing 
NK cell-mediated ADCC. In the phase II MOR208C203 L-MIND study (NCT02399085) in 
patients with R/R DLBCL, the combination of tafasitamab with lenalidomide achieved a high 
ORR of 58%, a CR rate of 33% and a median PFS of 16 months (Salles, 2018).  
Taken together, these data suggest a potential benefit of the tafasitamab or tafasitamab plus 
Lenalidomide add-on strategy to R-CHOP in newly diagnosed DLBCL and thereby provide the 
rationale for this study. 
5 CLINICAL TRIAL PURPOSE AND OBJECTIVES 
This open label, prospective, randomized phase Ib study is designed to confirm the safety and 
preliminary efficacy of tafasitamab in addition to R-CHOP or tafasitamab plus lenalidomide in 
addition to R-CHOP in patients with newly diagnosed DLBCL. 
The primary and secondary objectives of the clinical trial are as follows: 
 
Objective  
Endpoint 
Primary  
To assess safety and tolerability of  
tafasitamab in addition to R-CHOP 
Incidence and severity of TEAEs  


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Objective  
Endpoint 
and tafasitamab plus lenalidomide 
in addition to R-CHOP  
Key 
Secondary  
To assess efficacy (based on 
Lugano 2014 criteria) of  
tafasitamab in addition to R-CHOP 
and tafasitamab plus lenalidomide 
in addition to R-CHOP  
1. Objective Response Rate 
(ORR) at the end of treatment 
 
2. Metabolic, PET-negative 
complete response (CR) rate at 
the end of treatment 
 
Secondary  
1. To assess long-term safety 
and tolerability of  
tafasitamab in addition to 
R-CHOP and tafasitamab 
plus lenalidomide in 
addition to R-CHOP  
Incidence and severity of AEs in the 
follow-up period. 
 
2. To assess long term 
efficacy (based on Lugano 
2014 criteria) of  
tafasitamab in addition to 
R-CHOP and tafasitamab 
plus lenalidomide in 
addition to R-CHOP 
i. 
Best Objective Response Rate 
(ORR) until the end of study 
 
ii. 
Metabolic, PET-negative 
complete response (CR) rate 
until the end of study 
 
iii. 
Progression-free survival (PFS) 
at 12 and 24 months  
 
iv. 
Event-free survival (EFS) at 12 
and 24 months  
 
v. 
Time to next anti-lymphoma 
treatment (TTNT) 
 
vi. 
Overall survival at 12 and 24 
months 
 
3. To assess the 
pharmacokinetic (PK) 
profile of tafasitamab in 
each treatment arm  
Tafasitamab serum concentrations 
(Ctrough levels and Cmax levels on 
Day 1 of each cycle) 
 
4. To assess the potential 
immunogenicity of 
Number and percentage of patients 
developing anti-tafasitamab antibodies, 


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Objective  
Endpoint 
tafasitamab in each 
treatment arm  
and semi-quantitative titer 
assessments.  
Exploratory 
1. To evaluate residual disease 
burden by serial ctDNA 
assessment 
Descriptive statistics of ctDNA by visit
 
2. To perform longitudinal 
analysis of NKCC in 
peripheral blood 
Descriptive statistics of NKCC in 
peripheral blood by visit 
 
3. To assess the relationship 
between 
 
potential 
molecular 
or 
 
cellular 
markers and efficacy of 
tafasitamab in addition to R-
CHOP or tafasitamab and 
lenalidomide in addition to 
R-CHOP 
  
The relationship of the following 
endpoints may be assessed for the 
following markers: 
 
Endpoints: 
i. 
ORR 
ii. 
PFS 
Markers, e.g.: 
i. 
Cell of origin 
ii. 
NK-cell count in the tumor 
tissue 
iii. 
NK-cell gene expression 
signature in the tumor tissue 
iv. 
Macrophage count in the tumor 
tissue 
v. 
Macrophage gene expression 
signature in the tumor tissue 
vi. 
Quantitative and semi-
quantitative CD19 expression 
on tumor cells (in diagnostic 
biopsies and at 
progression/relapse if 
available) 
vii. 
Quantitative and semi-
quantitative CD20 expression 
on tumor cells (in diagnostic 
biopsies and at 
progression/relapse if 
available) 
 


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6 CLINICAL TRIAL DESIGN 
6.1 Overall Clinical Trial Design and Investigational Plan 
This is a multicenter, open-label, randomized, Phase Ib trial to assess safety and preliminary 
efficacy of tafasitamab in addition to R-CHOP or tafasitamab plus lenalidomide in addition to 
R-CHOP in adult patients with newly diagnosed DLBCL. Approximately 60 patients (30 in each 
arm) will be randomized in this study. If a patient discontinues the trial for any reason other than 
treatment related toxicity, progression/relapse of disease or death, this patient may be replaced. 
6.1.1 Safety monitoring 
Safety monitoring will be performed on a continuous basis as follows:  
 
A. Sponsor Safety Review Meetings will be performed  every two weeks during the safety run-
in phase, and every four weeks during the main study phase.  Once all patients are in the follow-
up phase, the frequency of these meetings will be decreased to approximately every eight weeks. 
Overall patient safety data including AEs, laboratory values, ECG outputs as well as physical 
examination including vital signs of every patient will be part of the review. Safety monitoring 
will be conducted by representatives of the sponsor with medical and pharmacovigilance 
expertise and the medical monitors of the CRO. Individual case monitoring by Drug Safety will 
ensure steady oversight whether stopping rules are likely to be met. In case the stopping rules 
have been met, an ad-hoc meeting of the Safety Committee will be required. 
B. Safety Committee. The sponsor established a Safety Committee consisting of sponsor 
representatives with at least two representatives of the participating investigators of this clinical 
trial. This committee will meet regularly until all patients have completed treatment. During 
these meetings, safety data including e.g. AEs, laboratory values, ECG outputs as well as 
physical examination including vital signs of every patient will be reviewed. Details of specific 
responsibilities, composition, meeting formats and frequency of the Safety Committee are 
outlined in the Safety Committee Charter.   
C. In addition, an independent Data and Safety Monitoring Board (iDSMB) consisting of 
independent haematologists will be established. During its meetings, safety data including e.g. 
AEs, laboratory values, ECG outputs as well as physical examination including vital signs will 
be reviewed. The iDSMB will provide a recommendation at the end of safety run-in phase when 
all patients in both arms have finished their first treatment cycle; during the main phase after 
approximately 40 patients (20 per arm) have finished their first treatment cycle, and at the end of the 
treatment period (last patient reached C6D21 plus approximately 30 days). Details of specific 
responsibilities, composition, meeting formats and frequency of the iDSMB will be described 
separately in the iDSMB charter and will follow relevant regulatory requirements for such body. 
Furthermore, both committees as described in B. and C. will meet ad-hoc in case the stopping 
rules are met (see Section 6.3). In such situation, both committees will make their 
recommendation to the Sponsor on whether e.g. treatment with study drugs of ongoing patients 
and further enrolment in the concerned arm should be stopped. 
The trial consists of two phases, see Figure 1. 


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1. Safety Run-in Phase: 
As the addition of tafasitamab to R-CHOP and tafasitamab and lenalidomide plus R-CHOP has 
not previously been evaluated in a clinical study, a safety run-in phase with 12 patients in each 
arm will be performed. In order to evaluate the safety in accordance with the stopping rules 
(Section 6.3), enrolment may be paused when 12 patients in each arm have been recruited and 
have been followed for 21 days after C1D1. 
2. Main Phase:  
If no unexpected safety signals (except for those being causally related to R-CHOP) are observed 
in either arm, enrolment will continue as planned to enrol additional approximately 18 patients 
in each arm in the main phase. Stopping rules are described in Section 6.3.   
As this is a Phase Ib study to primarily explore safety objectives, no formal statistical hypothesis 
will be considered for the sample size calculation of this trial.  
It is expected that approximately 10% of the patients will prematurely withdraw from the trial 
prior to end of treatment. An additional approximately 5% are expected to prematurely withdraw 
between end of treatment and end of 24 months after randomization. 
 
 
 


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Figure 1: Trial design  
  
 
 
All patients are expected to receive 6 cycles of study treatment (each cycle consisting of 21 days) 
and to be followed up for 24 months (or 731 days) from the date of randomization. For more 
details see Section 6.4. 
3.  End of Study  
The end of study is defined as the timepoint when data collection will stop and the final analysis 
of the study will occur. The end of study will happen after all patients have completed their End 
of Study/Early Follow-up Termination Visit.  
6.2 Early Study Termination 
The study can be terminated at any time for any reason by the sponsor. Should this be necessary, 
the patient will be contacted by the investigator or his/her designee. The patient should be seen 
as soon as possible for an Early Study Treatment Discontinuation Visit or Early Follow-up 
Termination Visit as applicable, and the assessments outlined in the Schedule of Assessments 
(Section 10) should be performed. The investigator will be responsible for informing IRBs and/or 
ECs of the early termination of the trial. 
6.3 Stopping Rules 
If any of the situations listed below occur, the Sponsor will pause enrolment in the relevant study 
arm. The Safety Committee and the iDSMB will convene ad-hoc meetings and make 
recommendations on e.g. whether to stop further enrolment and stop treatment of ongoing 
patients. The Sponsor will make the final decisions, taking account of these recommendations. 
The situations are as follows: 
1)  During Safety Run-in Phase: if any of the events listed below (A-C)* occur in ≥4 of the 
first 12 patients in either of the two arms who have received at least one dose of study 
drug.  


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2) During Main Phase: if any of the events listed below (A-C)* occur in more than 33% of 
the currently randomized patients in either of the two arms who received at least one dose 
of study drug.  
A) a grade 4 or higher non-hematologic adverse event  (in either of the two treatment 
arms) 
B) a grade 3 or higher thrombosis/embolism suspected to be related to treatment with 
lenalidomide (only for the tafasitamab-lenalidomide-R-CHOP arm) 
C) a dose reduction or delay of over 7 days of R-CHOP  (for the total across both 
treatment arms) 
Note: Toxicity-related dose modifications of R-CHOP which are not thought to be related 
to lenalidomide and/or tafasitamab treatment will not be considered. 
* Any combination of events (A-C) occurring in  ≥ 4 patients during the Safety Run-in 
Phase or in more than 33% of the currently randomized patients during the Main Phase 
will lead to a Safety Data Review.   
6.4 Clinical Trial Duration 
From the time of providing informed consent, each patient is expected to be included in the study 
for a duration of approximately 25 months. Three periods are defined for each patient in the 
study. 
6.4.1 Screening period 
The screening period of a maximum of 21 days is the interval between the date of signing of 
informed consent and the date of randomization.  
The ICF must be signed prior to beginning any study related assessments. Standard of care 
assessments done on the day of consent (but prior to 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. 
During screening, each patient who signs the ICF will be allocated a unique identification 
number. All patients who fulfil all inclusion criteria and who are not barred by any of the 
exclusion criteria will be randomly assigned to treatment comprising tafasitamab in addition to 
R-CHOP or tafasitamab plus lenalidomide in addition to R-CHOP in a 1:1 ratio.  
Study treatment should start within 24 hours after randomization. 
6.4.2 Treatment period 
The treatment period starts with the first administration of study drug (C1D1) and consists of 6 
cycles, each 21 days. The End of Treatment Visit or Early Study Treatment Discontinuation Visit 
will be performed 6±2 weeks after End of Treatment. End of Treatment is defined as day 21 of 
the last treatment cycle the patient started. Patients who discontinue early because of 
progression/relapse of disease may have the Early Study Treatment Discontinuation Visit earlier 
at the discretion of the investigator. 
All assessments specified in Section 10 should be performed within the acceptable visit windows 
(+/- 2 days) on Day 1, Day 8 and Day 15 of each cycle (Note: C1D1 visit window: +1 day).  


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6.4.3 Follow-up period 
The Follow-up period starts at the End of Treatment or Early Study Treatment Discontinuation 
Visit; the 30-day safety follow-up visit will be included in this visit. Clinical evaluation will be 
performed every 3 months. CT scans will be performed every 6 months until final completion of 
study or until disease progression/relapse. All patients are expected to be followed up for a total 
of 18 months after the End of Treatment Visit or Early Study Treatment Discontinuation Visit. 
The End of Study Visit or Early Follow-up Termination Visit marks the completion of the study 
for an individual patient. 
The assessments outlined in the Section 10 should be performed within the acceptable visit 
windows during the follow-up period once patient has completed 6 cycles of tafasitamab in 
addition to R-CHOP (Arm A) and tafasitamab and lenalidomide in addition to R-CHOP (Arm 
B). A visit window of +/- 2 weeks is allowed throughout the follow-up.  
Figure 2: Clinical trial periods: Screening, Treatment and Follow-up 
 
6.5 Risks and Benefits to Patients 
All eligible patients will be treated with standard of care for six cycles of R-CHOP as a 
potentially curative treatment approach. In addition, patients will receive either tafasitamab (Arm 
A) or tafasitamab plus lenalidomide (Arm B) as an add-on to R-CHOP to potentially improve 
the CR rate and hence to possibly reduce the treatment failure rate. Based on the safety profile 
of tafasitamab single agent and the well manageable safety profile of the tafasitamab plus 
lenalidomide combination (as demonstrated in the L-MIND study in R/R DLBCL), it is expected 
that the overall risk-benefit is favorable without additional toxicities compared to the treatment 
with R-CHOP only.  
The predictable risks and most common side effects of tafasitamab +/- lenalidomide are infusion-
related reactions, 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 +/- lenalidomide alongside with the 
measures in place to minimize risk to patients participating in this trial are justified by the 
anticipated benefits that may be achieved by the add-on treatment in patients with newly 
diagnosed DLBCL, which constitutes a life-threatening condition.  
  


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7 SELECTION AND WITHDRAWAL OF PATIENTS 
The investigator or designee must ensure that only patients who meet all the following inclusion 
and none of the exclusion criteria are enrolled in the study. 
The patients are not allowed to participate in additional parallel investigational drug or device 
studies. 
The sponsor is not providing waivers to the clinical trial protocol as deviations might have a 
negative impact on patient safety or the scientific integrity and regulatory acceptability of the 
clinical trial. 
7.1 Inclusion Criteria 
Patients considered for participation in the clinical trial must meet all of the following criteria: 
1. Age >18 years 
2. Written informed consent 
3. Previously untreated, newly diagnosed and histologically confirmed DLBCL, NOS  
4. Tumor tissue for retrospective central pathology review and correlative studies must be 
provided as an adjunct to participation in this study.  
5. Patients must have at least one measurable disease site. The lesion must have a greatest 
transverse diameter of ≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm at 
screening. The lesion must be confirmed to be PET-positive at the latest at the time of 
randomization. 
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 
7. International Prognostic Index (IPI) status of 2 to 5 
8. Appropriate candidate for R-CHOP.  
9.  Left ventricular ejection fraction (LVEF) of ≥50%, assessed by echocardiography or 
cardiac multi-gated acquisition (MUGA) scan 
10. Patient must have the following laboratory criteria at screening: 
a. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (unless secondary to bone marrow 
involvement by DLBCL as demonstrated by recent bone marrow aspiration and 
bone marrow biopsy) 
b. Platelet count ≥ 75 x 109/L (unless secondary to bone marrow involvement by 
DLBCL as demonstrated by recent bone marrow aspiration and bone marrow 
biopsy) 
c. Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless secondary to 
Gilbert’s syndrome or documented liver involvement by lymphoma. Patients with 
Gilbert’s syndrome or documented liver involvement by lymphoma may be 
included if their total bilirubin is ≤5 × ULN 
d. Alanine transaminase (ALT), aspartate aminotransferase (AST) and alkaline 
phosphatase (ALP) ≤3 × ULN, or <5 × ULN in cases of documented liver 
involvement 
e. Serum creatinine clearance  
(all countries except US:) must be ≥ 50 mL/minute either measured or calculated 
using a standard Cockcroft and Gault formula (Cockroft, 1976) 
(US only:) must be ≥ 60 mL/minute either measured or calculated using a 
standard Cockcroft and Gault formula (Cockroft, 1976) 


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11.    Females of childbearing potential (FCBP) must: 
Applicable in all countries except US:  
a. not be pregnant as confirmed by a negative serum pregnancy test at screening and 
a medically supervised urine pregnancy test prior to starting study therapy 
b. refrain from breast feeding and donating oocyte during the course of study and 
for 3 months after the last dose of study drug or, for R-CHOP, according to the 
local guidelines, whichever is longer.  
c. agree to ongoing pregnancy testing during the course of the study, and after study 
therapy has ended. This applies even if the patient applies complete sexual 
abstinence 
d. commit to continued abstinence from heterosexual intercourse if it is in 
accordance with her lifestyle (which must be reviewed on a monthly basis) or 
agree to use and be able to comply with the use of highly effective contraception 
without interruption at least 4 weeks prior to start of study drugs, during the study 
treatment and for 3 months after the last dose of study drug, or, for R-CHOP, 
according to the local guidelines, whichever is longer. Please refer to section 7.3.1 
Applicable in US:  
a. not be pregnant as confirmed by pregnancy tests performed before  treatment 
initiation, within 10-14 days and again within 24 hours of initiating treatment 
(even if true abstinence is the chosen method of birth control).  
b. refrain from breast feeding and donating oocytes during the course of study and 
for 3 months after the last dose of study drug or, for R-CHOP, according to the 
US guidelines, whichever is longer.  
c. agree to ongoing pregnancy testing during the course of the study (every 3 weeks 
in women with regular menstrual cycle and every 2 weeks in women with 
irregular menstrual cycle), and after study therapy has ended (even if true 
abstinence is the chosen method of birth control). 
d. not get pregnant while taking the study drug and for at least 3 months after 
stopping the study drug by using at the same time 2 effective methods of 
contraception (at least one highly effective method and one additional effective 
method, see Appendix G) each time engaging in sexual activity with a male, 
starting at least 4 weeks before taking the study drug, while taking the study drug, 
during breaks (dose interruptions) and for at least 3 months after stopping the 
study drug or, for R-CHOP, according to the US guidelines, whichever is longer. 
True abstinence (see Appendix G) from heterosexual sexual intercourse is also an 
acceptable method of contraception. The use of emergency contraception is also 
permitted.  
12. Male participants must: 
Applicable in all countries except US:  
Use an effective barrier method of contraception without interruption if the patient is 
sexually active with female of childbearing potential (FCBP) . Male participants should 
refrain from donating sperm during the study participation and for 3 months after the 
last dose of study drug, or, for R-CHOP, according to the local guidelines, whichever is 
longer.  
 


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            Applicable in US:  
Use latex or synthetic condom each time they have sex with a woman of childbearing 
potential. True abstinence (see Appendix G) from heterosexual sexual intercourse is also 
an acceptable method of contraception. The use of emergency contraception is also 
permitted. Male participants should refrain from donating sperm during the study 
participation and for 3 months after the last dose of study drug, or, for R-CHOP, 
according to the US guidelines, whichever is longer. 
 
13. In the opinion of investigator, the patient must: 
a. be able and willing to receive adequate prophylaxis and/or therapy for 
thromboembolic events, e.g. aspirin 70-325 mg daily or low molecular weight 
heparin. This is due to increased risk of thrombosis in patients treated with 
lenalidomide without prophylaxis. Patients unable or unwilling to take any 
prophylaxis are not eligible  
b. be able to understand, give written informed consent, and comply with all study-
related procedures, medication use, and evaluations 
c. not have a history of noncompliance in relation to medical regimens or be 
considered potentially unreliable and/or uncooperative 
d. be able to understand the reason for complying with the special conditions of the 
pregnancy prevention risk management plan and give written acknowledgement 
of this. 
7.2 Exclusion Criteria 
Patients must be excluded from participating in this clinical trial if they meet any of the following 
criteria: 
1. Any other histological type of lymphoma according to WHO2016 classification of 
lymphoid neoplasms, e.g. primary mediastinal (thymic) large B-cell (PMBL), known 
double- or triple-hit lymphoma or Burkitt’s lymphoma.  
2. Transformed NHL and/or evidence of composite lymphoma 
3. History of radiation therapy to ≥25% of the bone marrow for other diseases or history of 
anthracycline therapy 
4. History of prior non-hematologic malignancy except for the following:  
a. Malignancy treated with curative intent and with no evidence of active disease 
present for more than 2 years before screening 
b. Adequately treated lentigo maligna melanoma without current evidence of 
disease or adequately controlled non-melanomatous skin cancer.  
c. Adequately treated carcinoma in situ without current evidence of disease.  
5. History of myocardial infarction ≤6 months, or congestive heart failure requiring use of 
ongoing maintenance therapy for life-threatening arrhythmias.  
6. Patients with: 
a. Known positive test result for hepatitis C (hepatitis C virus [HCV] antibody 
serology testing) and a positive test for HCV RNA. Patients with positive 
serology must have been tested locally for HCV RNA and are eligible, in case of 
negative HCV RNA test results.  
b. Known positive test results for chronic HBV infection (defined by HBsAg 
positivity). Patients with occult or prior HBV infection (defined as negative 


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HBsAg and positive total HBcAb) may be included if HBV DNA was 
undetectable (local test result), provided that they are willing to undergo ongoing 
DNA testing. Antiviral prophylaxis may be administered as per institutional 
guidelines. Patients who have protective titers of hepatitis B surface antibody 
(HBsAb) after vaccination or prior but cured hepatitis B are eligible.  
c. Known seropositive for or history of active viral infection with human 
immunodeficiency virus (HIV)  
d. Known active bacterial, viral, fungal, mycobacterial, or other infection at 
screening. 
e. Known CNS lymphoma involvement  
f. History or evidence of clinically significant cardiovascular, CNS and/or other 
systemic disease that would in the investigator opinion preclude participation in 
the study or compromise the patient’s ability to give informed consent 
g. History or evidence of rare hereditary problems of galactose intolerance, Lapp 
lactase deficiency or glucose-galactose malabsorption  
h. Vaccination with live vaccine within 21 days prior to study randomization  
i. Major surgery (excluding lymph node biopsy) within up to 21 days prior to 
signing the informed consent form, unless the patient is recovered at the time of 
signing the informed consent form  
j. Any anti-cancer and/or investigational therapy within 21 days prior to the start 
of Cycle 1. Note: Steroid pre-phase is permitted 
k. Pregnancy or lactation 
l. History of hypersensitivity to any component of R-CHOP, to lenalidomide, to 
compounds of similar biological or chemical composition as tafasitamab, 
IMiDs® and/or the excipients contained in the study drug formulations or R-
CHOP 
m. Any contraindication concerning any individual component of R-CHOP 
7.3 Restrictions  
Note: Lenalidomide is structurally related to thalidomide. Thalidomide is a known human 
teratogenic substance that causes severe life-threatening birth defects. If lenalidomide is taken 
during pregnancy, a teratogenic effect can be expected. Therefore, lenalidomide is 
contraindicated during pregnancy. In women of child bearing potential lenalidomide is 
contraindicated unless the conditions for pregnancy prevention are complied with. See Appendix 
H to decide whether a female is of childbearing potential.  
Patients should refrain from donating blood during the course of study and for 3 months after the 
last dose of study drug.  
7.3.1 Restrictions applicable in all countries except US  
 All men and all women of childbearing potential should undergo counselling on the need to 
avoid pregnancy. 
 Patients should be capable of complying with the requirements of safe use of lenalidomide. 
 Patients must be provided with appropriate patient educational brochure and patient card. 
The following restrictions apply while the patient is receiving study drugs and for the specified 
times before and after: 


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1. Women of child-bearing potential should use reliable methods of contraception at least 4 
weeks prior to start of study drugs until 3 months after discontinuing study drugs, or, for R-
CHOP, according to the local guidelines, whichever is longer. Acceptable methods of 
contraception include true abstinence, implant, tubal ligation, levonorgestrel-releasing 
intrauterine system, medroxyprogesterone acetate depot, ovulation inhibitory progesterone-only 
pills (i.e. desogestrel) and vasectomised partner (vasectomy must have been confirmed by two 
negative semen analysis). All these methods of contraception should be used in combination 
with the use of a condom by their male sexual partner for intercourse. 
Note: implants and levonorgestrel-releasing intrauterine systems are associated with an increased 
risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics 
should be considered particularly in patients with neutropenia. 
True abstinence is part of the preferred and usual lifestyle of the patient. Periodic abstinence 
(e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for 
the duration of exposure to the investigational product, and withdrawal are not acceptable 
methods of contraception. If females of child-bearing potential wish to become pregnant they 
should be advised to arrange for freezing oocytes prior to the start of study treatment.  
2. Male patients should avoid unprotected sex with a female of child- bearing potential during 
treatment with the study drugs and for a washout period of 3 months after last dose of study drug, 
or, for R-CHOP, according to the local guidelines, whichever is longer. Patients should refrain 
from donating sperm from the start of dosing until 3 months after discontinuing study drugs or, 
for R-CHOP, according to the local guidelines, whichever is longer. If male patients wish to 
father children they should be advised to arrange for freezing of sperm samples prior to the start 
of study treatment. 
7.3.2 Restrictions applicable in US 
 All men, and all women of childbearing potential should undergo counselling on the need 
to avoid pregnancy, including contraception requirements (females), barrier 
contraception requirements (males), true abstinence and emergency contraception.  
 Patients should be capable of complying with the requirements of safe use of 
lenalidomide. 
 Patients must be provided with an appropriate patient educational brochure and a patient 
card. 
The following restrictions apply while the patient is receiving study drugs, and for the 
specified times before and after: 
1. Females of childbearing potential should use at the same time 2 effective methods of 
contraception (at least one highly effective method and one effective method, see Appendix G) 
each time when engaging in sexual activity with a male, starting at least 4 weeks before taking 
the study drug, while taking the study drug, during breaks (dose interruptions), and for at least 3 
months after stopping the study drug or, for R-CHOP, according to the US guidelines, whichever 
is longer. True abstinence (see Appendix G) from heterosexual sexual intercourse is also an 
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The use of emergency contraception is also permitted. If females of child-bearing potential wish 
to become pregnant they should be advised to arrange for freezing oocytes prior to the start of 
study treatment. 
2. Male patients should use latex or synthetic condom each time they have sex with a female of 
childbearing potential while taking the study drug, during breaks (dose interruptions), and for at 
least three months after stopping the study drug or, for R-CHOP, according to the US guidelines, 
whichever is longer. True abstinence (see Appendix G) from heterosexual sexual intercourse is 
also an acceptable method of contraception. The use of emergency contraception is permitted.  
7.4 Withdrawal and Termination Criteria 
7.4.1 Patient Withdrawal 
For patients withdrawing for any reason from the clinical trial the Early Study Treatment 
Discontinuation or Early Follow-up Termination Visit, as applicable and as outlined in the 
Section 10 should be performed. 
An explanation should be given of why the patient is withdrawing or being withdrawn from the 
clinical trial. 
The reason for withdrawal must be noted in the Case Report Form (CRF). If the reason for 
withdrawal is a clinical AE, monitoring will continue until the outcome is evident.  The specific 
event or test result(s) must be recorded in the CRF.   
For patients who show clinical signs of progression/relapse of disease, an unscheduled 
radiological confirmation of disease progression/relapse should be performed.  
In case of radiologically confirmed disease progression/relapse, patients should undergo the 
Early Study Treatment Discontinuation Visit and continue with the follow-up period of the trial 
and may receive other anti-cancer treatments (see Section 8.7.2.1) unless they must be withdrawn 
per patient or investigator decision. 
Patient Decision 
In accordance with the Declaration of Helsinki, each patient is free to withdraw from the study 
at any time.   
Investigator Decision 
Investigator(s) also have the right to withdraw patients from the study or from study treatment 
in the event of illness, adverse events (AEs), or other reasons concerning the health or well-being 
of the patient, or in the case of lack of co-operation. 
The investigators are encouraged to keep a patient experiencing clinical benefit in the study 
unless significant toxicity puts the patient at risk or repeated cases of routine noncompliance puts 
the study outcomes at risk. 
At a minimum, all patients who discontinue study treatment, including those who refuse to return 
for a final visit, will be contacted for safety evaluations.  
If such withdrawal occurs, or if the patient fails to return for visits, the investigator must 
determine the primary reason for a patient´s premature withdrawal from the study and record the 
information on the eCRF. If the reason for withdrawal is an AE, monitoring should continue 
until the outcome is evident. The specific event or test result(s) must be recorded in the eCRF. 


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Patients who are withdrawn for any reason shall not re-enter the study at any time. 
Patient Replacement 
Patients dropping out during screening may be replaced. If a patient discontinues the trial for 
any reason other than treatment related toxicity or progression/relapse of disease or death, this 
patient may be replaced.  
7.4.2 Clinical Trial or Clinical Trial Site Termination 
The investigator and the sponsor both reserve the right to terminate the study at any time at a 
given clinical study center. The sponsor also reserves the right to terminate the entire study or 
temporarily interrupt enrolment and/or dosing of already enrolled patients for further evaluation, 
for example, if during the ongoing evaluation of the risk/benefit ratio the sponsor decides that 
the study risks outweigh its benefits. 
Should a termination of a given clinical study center or the whole study become necessary, then 
the procedures will be arranged with all involved parties. In terminating a study center, or the 
entire study, the sponsor and the investigators will ensure that adequate consideration is given to 
the protection of the patients’ interests. Institutional Review Boards (IRBs)/Independent Ethics 
Committees (IECs) and competent authorities will be notified of premature termination in 
accordance with applicable regulatory requirements. 
8 STUDY TREATMENT  
For the purpose of this protocol the following definitions apply: 
Study drug shall be used synonymously with Investigational Medicinal Product (Section 8.2). 
Study drugs are tafasitamab and lenalidomide.  
Study treatment is defined as tafasitamab in addition to R-CHOP (Arm A) or tafasitamab plus 
lenalidomide in addition to R-CHOP (Arm B). 
Study treatment consists of tafasitamab in addition to six cycles of R-CHOP (Arm A) or 
tafasitamab and lenalidomide in addition to six cycles of R-CHOP (Arm B) and will be 
administered for up to six 21-day cycles (see Figure 2). See section 8.7 for mandatory, 
recommended and prohibited concomitant therapy.  
8.1 Definition of Treatment Cycle 
A complete treatment cycle is defined as 21 calendar days during which tafasitamab in addition 
to R-CHOP (Arm A) or tafasitamab and lenalidomide in addition to R-CHOP (Arm B) will be 
administered according to the following plan. 
Arm A: Tafasitamab in addition to R-CHOP  
Study treatment consisting of tafasitamab and R-CHOP will be in 21-day cycles for 6 cycles.  
Drug 
Dose 
Dosing days (21-day cycle) 
Tafasitamab  
12 mg/kg IV 
1, 8, 15 
Rituximab  
375 mg/m2 IV 
1 
Cyclophosphamide 
750 mg/ m2 IV 
1 
Doxorubicin  
50 mg/m2 IV 
1 


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Vincristine  
1,4 mg/m2 (max 2.0 mg total) IV 
1 
Prednisone/Prednisolone 100 mg/day p.o. 
1-5 
Arm B: Tafasitamab plus lenalidomide in addition to R-CHOP  
Study treatment consisting of tafasitamab plus lenalidomide in addition to R-CHOP will be 
administered in 21-day cycles for 6 cycles.  
Drug 
Dose 
Dosing days (21-day cycle) 
Tafasitamab  
12 mg/kg IV 
1, 8, 15 
Lenalidomide* 
25 mg/day p.o. 
1 - 10 
Rituximab  
375 mg/m2 IV 
1 
Cyclophosphamide  
750 mg/ m2 IV 
1 
Doxorubicin  
50 mg/m2 IV 
1 
Vincristine  
1,4 mg/m2 (max 2.0 mg total) IV 1 
Prednisone/Prednisolone 
100 mg/day p.o. 
1-5 
IV= intravenous, p.o.= per os 
*Lenalidomide: Patients will self-administer a starting dose of 25 mg oral lenalidomide daily 
on Days 1–10 of each 21-day cycle. Dose modification due to toxicity is allowed in 5 mg steps. 
The minimum dose of lenalidomide is 10 mg on Days 1-10. Please refer to section 8.5 for the 
lenalidomide dose reduction guidelines.  
8.2 Investigational Medicinal Product(s) 
8.2.1 Tafasitamab 
8.2.1.1 Tafasitamab Supplies 
The sponsor will supply the Investigational Medicinal Product tafasitamab for this study.  
8.2.1.2 Tafasitamab Dosage form, Packaging, Storage and Preparation 
Study sites must store tafasitamab vials under refrigeration at 2° C to 8° C in its original package 
in an appropriate storage facility accessible only to the study site personnel. 
Tafasitamab drug product (DP) is a yellowish lyophilisate supplied in single-use 20 mL glass 
vials. Each vial contains 200 mg of tafasitamab for reconstitution with 5 mL water for injection 
(WFI). Reconstitution yields 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 after reconstitution is colorless to 
slightly yellow and essentially free of foreign particles; it may contain a few white to whitish 
product-related particles. 
For administration, tafasitamab will be diluted into a commercially available 250 mL infusion 
container with 0.9% (w/v) sodium chloride for injection. 
The individual tafasitamab infusion will be prepared under aseptic conditions and administered 
at the study site, according to the directions of the sponsor, which will be provided in a Drug 
Handling Manual. In general, a vial of tafasitamab must be used as soon as possible after 
reconstitution with WFI; any solution remaining in the vial has to be discarded. After dilution for 


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infusion, administration of tafasitamab should take place as soon as possible. Maximum allowed 
storage times and conditions will be detailed in the Drug Handling Manual. 
8.2.1.3 Tafasitamab Administration 
Tafasitamab will be administered IV at a dose of 12mg/kg body weight for 6 cycles. Each 21-
day cycle will consist of tafasitamab infusions on Day 1, Day 8 and Day 15, i.e. each patient will 
be treated with a maximum of 18 infusions of tafasitamab over the 6 cycles. 
Please refer to section 8.7 of the protocol for pre-medication for tafasitamab infusions.  
For the first infusion, the IV infusion rate should be 70 mL/h for the first 30 minutes and 
subsequently increased to a rate of 125 mL/h; the total infusion duration will be approximately 
2.5 hours.  
All subsequent tafasitamab infusions will be administered IV at a constant rate of approximately 
125 mL/h over an approximately 2-hour period. Tafasitamab should NOT be administered as an 
IV push or bolus. 
The infusion rate escalation schedules in this protocol and the Drug Handling Manual are 
recommendations. If required, the investigator should use clinical judgement to optimise patient 
safety by administering the infusion more slowly. 
8.2.1.4 Patient Monitoring During Tafasitamab Infusion 
Vital signs should be measured as outlined in Section 9.8. All supportive measures consistent 
with optimal patient care will be provided throughout the study according to institution 
standards. 
Precautions for anaphylaxis should be observed during tafasitamab 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). 
8.2.2 Lenalidomide 
8.2.2.1 Lenalidomide Supplies 
The Sponsor will supply the Investigational Medicinal Product lenalidomide from a commercial 
source as capsules in various dose strengths for oral administration as outlined in the Drug 
Handling Manual. 
8.2.2.2 Lenalidomide Administration 
Patients will self-administer a starting dose of 25 mg oral lenalidomide daily on Days 1–10 of 
each 21-day cycle. Lenalidomide dose may be reduced according to the guidelines described in 
section 8.5.3.  
8.3 R-CHOP 
R-CHOP is the standard of care and will be given according to institutional guidelines. R-CHOP 
is not an IMP and will not be supplied by the Sponsor.  


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8.3.1 R-CHOP administration 
Rituximab is advised to be given approximately 30 minutes after the tafasitamab infusion, 
followed by the CHOP chemotherapy which will be given approximately 30 minutes after the 
end of the rituximab infusion.  
Note: The Day 1 steroid dose being part of CHOP (100 mg prednisone or prednisolone or 
equivalent, IV or PO) can be used as further component of premedication prior to Tafasitamab 
infusion. 
8.4 Treatment Compliance and Product Accountability 
Patients will receive tafasitamab under the direct supervision of study site personnel. Each 
administration volume or dose will be checked and the vial/outer package code and volume or 
dose per administration will be recorded in each patient’s eCRF as well as in the source data. 
 
The dosing of tafasitamab will be considered appropriate if the tafasitamab dose administered is 
≥80% to ≤120% of the assigned dosage per single infusion. Overdose treatment is described in  
Section 8.6. 
Lenalidomide is to be dispensed at the initiation of each new treatment cycle for treatment from 
D1-10. Patients should return all unused or empty lenalidomide blister packs to the site 
throughout the treatment period of the study, as instructed by the investigator and keep record of 
lenalidomide intake at home, which will be reviewed by site personnel on an ongoing basis. A 
patient will be considered compliant with the protocol if the planned lenalidomide dose 
administered is ≥80% to 100% of the assigned dosage. Overdose treatment is described in  
Section 8.6. 
R-CHOP therapy (non IMP) must be documented in the eCRF. 
8.5 Recommended Dose Modifications, Drug Interruptions and 
Discontinuation Guidelines 
8.5.1 Tafasitamab Dose Modifications, Drug Interruptions and Discontinuation 
Dose reductions of tafasitamab are not permitted. Drug interruptions or discontinuation may 
occur in case of e.g. severe infusion-related reactions, allergic reactions, infections, febrile 
neutropenia or severe hematologic toxicity. Delaying the tafasitamab dosing is permitted for no 
more than 2 days (example:  If dosing was planned on Day 8 delaying that dose is allowed  up 
to day 10). Alternatively, a tafasitamab infusion may be skipped completely (e.g. on Day 8 or 
Day 15) and the next scheduled dose will be administered.  
8.5.2 Management of Tafasitamab Infusion-Related Reactions (IRRs) and Cytokine 
Release Syndrome (CRS) 
IRRs will be defined according to the NCI-CTCAE, Version 5.0 definition of IRR and cytokine 
release syndrome (Table 1). 
 
 


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Table 1 
Definition of Infusion-Related Reaction and Cytokine Release Syndrome 
NCI-CTCAE Version 5.0: Infusion-Related Reaction 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 (e.g., 
antihistamines, 
NSAIDs, narcotics, 
IV fluids); 
prophylactic 
medications 
indicated for ≤24 
hours 
Prolonged (i.e. not 
rapidly responsive to 
symptomatic 
medication, brief 
interruption of infusion, 
or both); recurrence of 
symptoms following 
initial improvement; 
hospitalization indicated 
for clinical sequelae 
Life-threatening 
consequences; 
urgent 
intervention 
indicated 
Cytokine 
release 
syndrome 
 
Fever with or 
without 
constitutional 
symptoms 
 
 
Hypotension 
responding to fluids; 
hypoxia responding 
to < 40% O2*  
 
Hypotension managed 
with one pressor; 
hypoxia requiring ≥ 40% 
O2* 
 
Life-threatening 
consequences; 
urgent 
intervention 
indicated 
 
Abbreviations: IRR=infusion-related reaction; IV=intravenous; NSAIDs=non-steroidal anti-inflammatories. 
Please note: An acute infusion reaction may occur with an agent that causes cytokine release (e.g., monoclonal 
antibodies or other biological agents). Signs and symptoms usually develop during or shortly after drug infusion 
and generally resolve completely within 24 hours of completion of infusion. Signs/symptoms may include: Allergic 
reaction/hypersensitivity (including drug fever); Arthralgia (joint pain); Bronchospasm; Cough; Dizziness; 
Dyspnoea; Fatigue (asthenia, lethargy, malaise); Headache; Hypertension; Hypotension; Myalgia ; Nausea; 
Pruritus/itching; Rash/desquamation; Rigors/chills; Sweating (diaphoresis); Tachycardia; Tumor pain (onset or 
exacerbation of tumor pain due to treatment); Urticaria (hives, welts, wheals); Vomiting 
* Applied e.g. via breathing mask 
8.5.3 Interventions for IRRs and CRSs 
Grade 2 IRRs, grade 1 CRSs  
If a patient presents with a grade 2 infusion reaction or grade 1 CRS: 
• the infusion should be stopped immediately 
• the patient should receive appropriate treatment with an antihistamine and/or acetaminophen 
(paracetamol) or methylprednisolone (or equivalent) as clinically indicated 
• once the symptoms have been resolved or reduced to Grade 1 according to investigator 
assessment, the infusion can be continued at an infusion rate of 50% of the speed so far. If, after 


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one hour, the patient’s symptoms do not return and vital signs are stable, the infusion rate may 
be increased every 30 minutes, as tolerated, to the baseline rate. 
If a patient who developed a grade 2 IRR or grade 1 CRS receives further infusions of 
tafasitamab, then premedication should be given before all subsequent infusions of tafasitamab 
throughout the study. 
Grade 3 IRRs, grade 2 CRSs 
If a patient presents with a grade 3 IRR or grade 2 CRS: 
• the infusion should be stopped immediately 
• the patient must receive appropriate treatment with an antihistamine and/or acetaminophen 
(paracetamol) or methylprednisolone (or equivalent) and, if necessary, further medications (i.e. 
epinephrine, bronchodilator) 
• 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 an infusion rate 
of 25% of the speed so far. If, after 1 hour, the patient’s symptoms do not return and vital signs 
are stable, the infusion rate may be increased to a maximum of 50% of the baseline speed. 
• if, after the resumption of the infusion, symptoms return (irrespective of grade), the infusion 
must be stopped immediately and the infusion tubing should be disconnected from the patient. 
Based on the investigator’s decision the patient may receive further tafasitamab provided 
clinically appropriate precautions were undertaken. If a patient who developed a grade 3 IRR or 
grade 2 CRS receives further infusions, then premedication should be given before all subsequent 
infusions of tafasitamab throughout the study. 
If precluded from further tafasitamab administrations, the patient may continue treatment with 
R-CHOP or lenalidomide in addition to R-CHOP.  
Grade 4 IRRs, grade 3 CRSs, grade 4 CRSs 
If a patient presents with a grade 4 infusion reaction or grade 3-4 CRS: 
• the infusion should be stopped immediately and the infusion tubing should be disconnected 
from the patient 
• the patient must receive appropriate treatment with an antihistamine and/or acetaminophen 
(paracetamol) or methylprednisolone (or equivalent) and, if necessary, further medications (i.e. 
epinephrine, bronchodilator) 
The patient must not receive any further tafasitamab infusions, but may continue treatment with 
R-CHOP or lenalidomide in addition to R-CHOP as per protocol. 
8.5.4 Lenalidomide Dose Modifications, Drug Interruptions and Discontinuation 
Lenalidomide may be given only on Day 1 to 10 of each cycle and must not be administered 
beyond this period. 
The dose of lenalidomide may be reduced successively level by level from the starting dose of 
25mg daily. This is described in below Table 2. 
 


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Table 2 
Lenalidomide Dose Modification Guidelines 
Starting dose 
25 mg daily on Days 1-10 of each 21-day cycle 
Dose Level -1 
20 mg daily on Days 1-10 of each 21-day cycle 
Dose Level -2 
15 mg daily on Days 1-10 of each 21-day cycle 
Dose Level -3 
10 mg daily on Days 1-10 of each 21-day cycle 
Guidelines for lenalidomide dose interruptions or discontinuations are described in Table 3 and 
Table 4.  
Lenalidomide may be interrupted (up to 3 days) within the 10-day dosing period and may be 
restarted within this period at the same dose or at dose level -1, but may not be extended beyond 
day 10 of this cycle. If lenalidomide dosing was interrupted during the previous cycle and was 
restarted with a one-level dose reduction without requiring an interruption for the remainder of 
the cycle, then that reduced dose level will be initiated on Day 1 of the next cycle. There will be 
no more than one dose reduction from one cycle to the next. Once a patient’s lenalidomide dose 
has been reduced, no dose re-escalation is permitted. 
Patients who cannot tolerate Dose Level -3 are to be discontinued from lenalidomide treatment 
in arm B but should continue therapy with tafasitamab plus R-CHOP for the total duration of six 
cycles, if possible.  
Additional information 
The most up-to-date information regarding constitution, dosing and most frequent AEs related 
to the administration of lenalidomide are contained in the summary of product characteristics 
(SmPC) which will be distributed to the participating sites.   
8.5.5 Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, 
Prednisone/Prednisolone Dose Modifications and Drug Interruptions and 
Discontinuation 
The toxicity management of R-CHOP will be performed at the investigator’s discretion and 
should follow local standard R-CHOP treatment guidelines. 
8.5.6 Criteria to Start Next Treatment Cycle (day 1 of cycle 2-6) 
The next cycle of treatment may begin on the scheduled Day 1 if the following criteria are met: 
• 
ANC ≥ 1,000/mm3  (unless neutropenia is due to infiltration of bone marrow) 
• 
Platelets ≥ 75 000/mm3 (unless thrombocytopenia is due to infiltration of bone marrow) 
• 
All other toxicities have resolved to ≤ Grade 2 
In case of overlapping toxicities it should be ensured that study drugs (lenalidomide, tafasitamab) 
are reduced or interrupted or discontinued (see below) before any dose reductions of R-CHOP. 
If the above mentioned criteria are not met on Day 1 of the planned new cycle, the next cycle 
should not be commenced. The patient will be evaluated again within 7 days. If the above 
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If the above mentioned criteria are still not met after 7 days delay, the next cycle should not 
commence. The patient will be evaluated again after another 7 days (or earlier). If the above 
mentioned criteria are met at any time within 7 days, the next treatment cycle may be initiated. 
For Patients in Arm B, lenalidomide should be decreased to the next lower dose level (Table 3). 
If lenalidomide was already at the lowest dose level, lenalidomide treatment should be 
permanently discontinued.  
If the above mentioned criteria are still not met after 14 days delay, the next cycle should not 
commence. The complete blood count should be repeated at a frequency deemed appropriate by 
the investigator. If the above mentioned criteria are met in Arm B, lenalidomide should be 
permanently discontinued and tafasitamab should be interrupted in this treatment cycle while R-
CHOP treatment may be resumed. In Arm A tafasitamab should be interrupted, while R-CHOP 
treatment may be resumed.  
If the above mentioned criteria are fulfilled, but the patient developed non-hematological 
toxicity as described in Table 4 due to lenalidomide, tafasitamab plus R-CHOP should continue 
even if lenalidomide is interrupted. Lenalidomide may be resumed at the next cycle if the criteria 
are met. Skipped doses of lenalidomide will not be made up for. 
If the above mentioned criteria are fulfilled, but the patient developed non-hematological 
toxicity due to tafasitamab (for example Grade 4 IRR), lenalidomide plus R-CHOP or R-CHOP 
should continue even if tafasitamab was discontinued. Note that visits on Day 8 and Day 15 
should still take place in such case as outlined in Section 10. 
Any individual component of R-CHOP may be omitted (or reduced in dose) due to specific 
toxicities related to Rituximab, Vincristin, Doxorubicin, Cyclophosphamide or Prednisone in 
accordance with institutional guidelines.  
Tafasitamab, lenalidomide as well as R-CHOP treatment, as long as permitted by the above rules, 
should be started on Day 1 (within the applicable visit window) of each cycle. 
8.5.6.1 Dose Modifications, Drug Interruptions and Discontinuation in Case of 
Hematological Toxicity (day 2-21 of each cycle) 
Patients will be evaluated for AEs at each visit with the NCI CTCAE v5.0 used as a guide for 
grading severity. The dose of lenalidomide for each patient will be checked, interrupted and/or 
modified following toxicity as described below. Refer to Table 3 and Table 4 for instructions on 
dosing interruptions/modifications and for lenalidomide dose reduction instructions. 
The toxicity management of R-CHOP will be performed according to institutional guidelines.  
Guidance on managing specific toxicities is summarised in Table 3 and Table 4. Note that even 
if tafasitamab is interrupted or discontinued due to toxicities, visits on Day 8 and Day 15 
should still take place as outlined in Section 10. 
 
 


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Table 3 
Dose modifications and drug interruptions and discontinuation in case of 
specific hematological toxicities*  
Hematological toxicity 
Lenalidomide** 
Tafasitamab 
Neutropenia Grade 4 
 
Interrupt lenalidomide 
Continue tafasitamab infusion per 
protocol 
If neutropenia has resolved to ≤ 
Grade 2 within 7 days, lenalidomide 
should be restarted in the subsequent 
cycle at the same dose.  
If neutropenia has not resolved to ≤ 
Grade 2 within 7 days, lenalidomide 
should be resumed in the next cycle 
at the next lower dose level (Table 
2).  
Note: Tafasitamab should not to be 
held for asymptomatic neutropenia 
of any grade 
Neutropenia ≥ Grade 3 
associated with infection ≥ 
Grade 3 
 
Interrupt lenalidomide  
Interrupt tafasitamab  
 
If infection is controlled, and 
neutropenia has resolved to ≤ Grade 
2, lenalidomide should be resumed in 
the next cycle at the next lower dose 
level (Table 2).  
If infection is controlled, continue 
tafasitamab per protocol. 
If a tafasitamab infusion is delayed 
for three or more days, then this 
infusion should be skipped and 
tafasitamab treatment continued only 
at the next scheduled timepoint (if 
infection is controlled).  
Neutropenia < Grade 3 
associated with infection ≥ 
Grade 3 
 
First occurrence  
Interrupt lenalidomide  
If infection is controlled, 
lenalidomide should be restarted in 
the subsequent cycle at the same 
dose. 
Interrupt tafasitamab  
If infection is controlled, continue 
tafasitamab per protocol. 
If a tafasitamab infusion is delayed 
for three or more days, then this 
infusion should be skipped and 
tafasitamab treatment continued only 
at the next scheduled timepoint (if 
infection is controlled). 
Reoccurence 
Interrupt lenalidomide  
 
If infection is controlled, 
lenalidomide should be restarted in 
the subsequent cycle at the next 
lower dose level.  


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Hematological toxicity 
Lenalidomide** 
Tafasitamab 
Trombocytopenia with 
bleeding*** 
Interrupt VTE prophylaxis  
 
Consider platelet transfusion  
 
If bleeding has been controlled and thrombocytopenia resolved to  
 ≤ grade 1, consider  change of VTE prophylaxis agent (e.g. change 
antiplatelet agent to low molecular weight heparin). 
 
VTE prophylaxis should be tailored to the patient’s individual risk/benefit 
profile by taking into account the individual thrombotic risk and bleeding 
risk. 
 
 
 
Thrombocytopenia Grade 4  
 
 
Interrupt VTE prophylaxis***  
 
Consider platelet transfusion  
 
If thrombocytopenia has resolved to  ≤ grade 1, consider  change of VTE 
prophylaxis agent (e.g. change antiplatelet agent to low molecular weight 
heparin).*** 
 
VTE prophylaxis should be tailored to the patient’s individual risk/benefit 
profile by taking into account the individual thrombotic risk and bleeding 
risk.*** 
 
 
Interrupt lenalidomide 
 
 
 
Continue tafasitamab infusion as per 
protocol (unless thrombocytopenia is 
severe, see below). 
If thrombocytopenia has resolved to 
≤ Grade 2 within 7 days, 
lenalidomide should be restarted in 
the subsequent cycle at the same 
dose.  
 
If thrombocytopenia has not resolved 
to ≤ Grade 2 within 7 days, 
lenalidomide should be resumed in 
Interrupt tafasitamab in case of very 
pronounced Grade 4 
thrombocytopenia (platelets < 
10,000/μL) unless platelet 
transfusion is administered 
If a tafasitamab infusion is delayed 
for three or more days, then this 
infusion should be skipped and 
tafasitamab treatment continued only 
at the next scheduled timepoint. 


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Hematological toxicity 
Lenalidomide** 
Tafasitamab 
the next cycle at the next lower dose 
level (Table 2).  
Abbreviations: ANC=absolute neutrophil count 
*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/relapse of the underlying disease, then it is at the 
physician’s discretion and assessment of the individual risk/benefit ratio to determine whether the patient should be dosed. The 
decision and rationale behind the decision should be documented in the source data.  
** Lenalidomide may be given only on Day 1 to 10 of each cycle and must not be administered beyond this period  
*** Patients in arm B and arm A (if applicable) 
8.5.7 Dose Modifications, Drug Interruptions and Discontinuation in Case of Non-
Hematological Toxicity 
Table 4 
Dose modifications, drug interruptions and discontinuation in case of 
specific non-hematological toxicity* 
Non-hematological toxicity
Lenalidomide** 
Tafasitamab 
Thromboembolic events  
Grade 3-4 
Discontinue permanently 
lenalidomide  
 
Continue tafasitamab infusion as per 
protocol if clinically appropriate 
 
Allergic reaction or 
hypersensitivity grade 2  
If related to lenalidomide then 
interrupt the dose 
 
If related to tafasitamab then 
interrupt the dose 
If toxicity resolves to ≤ Grade 1, 
restart lenalidomide at the next lower 
dose level (Table 2) 
If toxicity resolves to ≤ Grade 1, 
tafasitamab may be resumed  
If a tafasitamab infusion is delayed 
for three or more days, then this 
infusion should be skipped and 
tafasitamab treatment continued only 
at the next scheduled timepoint. 
Allergic reaction or 
hypersensitivity ≥ Grade 3  
If related to lenalidomide then 
discontinue permanently 
If related to tafasitamab then 
discontinue permanently  
 
Note: If the causality can not be determined and the AE may be related to 
lenalidomide and/or tafasitamab, discontinue both drugs permanently. 
  
Rash Grade 2 or 3 non-
desquamating (blistering) 
If related to lenalidomide then 
interrupt the dose 
If related to tafasitamab then 
interrupt the dose 


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Non-hematological toxicity
Lenalidomide** 
Tafasitamab 
If the AE resolves to ≤ Grade 1, 
restart lenalidomide at the same level 
(Table 2) 
 
If toxicity resolves to ≤ Grade 1, 
tafasitamab may be resumed  
If  a tafasitamab infusion is delayed 
for three or more days, then this 
infusion should be skipped and 
tafasitamab treatment continued only 
at the next scheduled timepoint. 
Rash  
Desquamating (blistering) ≥ 
Grade 3 
OR 
Non-desquamating Grade 4 
 
If related to lenalidomide then 
discontinue permanently 
If related to tafasitamab then 
discontinue permanently 
 
Note: If the causality can not be determined and the AE may be related to 
lenalidomide and/or tafasitamab, discontinue both drugs permanently. 
Tumor flare reaction Grade 
3-4*** 
Interrupt lenalidomide  
If the AE resolves to grade ≤1, 
restart lenalidomide and maintain the 
same dose level (Table 2) 
Continue tafasitamab infusion as per 
protocol if clinically appropriate 
 
Tumor flare reaction Grade 
1-2*** 
Continue lenalidomide  
Continue  tafasitamab infusion as per 
protocol 
Obstipation ≥ Grade 3 
 
Interrupt lenalidomide  
If the AE resolves to ≤ Grade 2, 
restart at same dose level 
Continue tafasitamab infusion as per 
protocol if clinically appropriate 
 
Other lenalidomide related 
nonhematologic 
AEs ≥ Grade 3 
Interrupt lenalidomide  
If the AE resolves to ≤ Grade 2, 
restart at the same or next lower dose 
level per the investigator’s discretion
Continue tafasitamab infusion as per 
protocol if clinically appropriate 
 
 
*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/relapse of the underlying disease, then it is at the 
physician’s discretion and assessment of the individual risk/benefit ratio to determine whether the patient should be dosed. The 
decision and rationale behind the decision should be documented in the source data.  
** Lenalidomide may be given only on Day 1 to 10 of each cycle and must not be administered beyond this period  
*** 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. (NCI-CTCAE version 3.0) 
Grade 1: Mild pain not interfering with function 


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Grade 2: Moderate pain; pain or analgesics interfering with function but not with activities of daily living 
Grade 3: Severe pain; pain or analgesics interfering with function and interfering with activities of daily living 
Grade 4: Disabling 
Grade 5: Death  
8.6 Tafasitamab and Lenalidomide Overdose Treatment 
MorphoSys is not recommending any specific treatment of a suspected overdose of tafasitamab 
and/or lenalidomide. In case an overdose of tafasitamab 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 trial, overdose of tafasitamab is defined as any tafasitamab dose above 
120% of the assigned dosage per single infusion as per protocol (see section 8.4).  
For lenalidomide the overdose is defined as any dose greater than the planned dose for a 
particular patient as per protocol (see section 8.4). 
 
“Overdose” should be entered in the eCRF. If accompanied by symptoms, the overdose should 
be reported as adverse event in the adverse event page of the eCRF together with the observed 
symptoms. 
8.7 Concomitant and Prohibited Medication 
For possible drug-drug interactions and contraindications of Lenalidomide or R-CHOP or any 
concomitant medication please refer to the respective SmPCs (section 4.5) or to the respective 
Prescribing Information (section Drug Interactions, section Contraindications). 
8.7.1 Prior and Concomitant Medication 
Corticosteroids administered/taken within three weeks before ICF signature will be recorded in 
the eCRF. Patients may continue the medications they were receiving at screening. Patients 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. Patients 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. 
8.7.1.1 Pre-Medication for Tafasitamab Infusions 
Tafasitamab infusions should be administered to patients after pre-medication with oral 
acetaminophen (e.g., 650−1000 mg), an antihistamine such as diphenhydramine hydrochloride 
(50−100 mg) and glucocorticosteroids (e.g. 100 mg IV prednisone or prednisolone or equivalent) 
30−60 minutes prior to starting each infusion (unless contraindicated). Note: the Day 1 steroid 
dose being part of CHOP (100 mg prednisone or prednisolone or equivalent, IV or PO) can be 
used 
as 
further 
component 
of 
premedication 
prior 
to 
Tafasitamab 
infusion.  
Premedication is mandatory for the first cycle. For patients who do not experience ≥ Grade 2 
IRRs / ≥ Grade 1 CRSs to tafasitamab during the first cycle, premedication will be optional for 
subsequent antibody infusions at the discretion of the investigator. Otherwise, the premedication 
should be continued for subsequent administrations. 


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8.7.1.2 Steroid Pre-Phase 
In patients with urgent need for a steroid pre-phase before initiation of therapy, the use of oral 
prednisone 25-100 mg/d or equivalent over 7 days is allowed after screening tumor investigations 
(imaging, blood samples) have been completed.  
In exceptional circumstances and at the discretion of the investigator, the steroid pre-phase can 
be started prior to acquisition of PET.  
Any pre-phase steroid use must be recorded in the eCRF and adequately documented and 
justified in the patient’s source data. 
8.7.1.3 CNS Prophylaxis 
Central nervous system (CNS) prophylaxis with intrathecal chemotherapy may be given 
according to institutional practice. CNS prophylaxis with intravenous methotrexate is allowed 
only if it was pre-planned before randomization and it may be administered only after the last 
treatment cycle and after the End of Treatment tumor assessment by PET/CT or PET/MRI. 
8.7.1.4 G-CSF 
As per the National Comprehensive Cancer Network guidelines, CHOP belongs to 
chemotherapy regimens with an intermediate risk for febrile neutropenia. There is the potential 
for increased neutropenia risk with the addition of monoclonal antibodies such as Rituximab or 
tafasitamab, as well as lenalidomide. To mitigate the risk of febrile neutropenia, primary 
neutropenia prophylaxis with G-CSF or Peg-G-CSF is mandatory in this study. The dose and 
schedule of the selected drug will be done according to local practice and institutional guidelines.  
8.7.1.5 Pre-planned radiotherapy  
Pre-planned local radiotherapy may be administered to initial sites of bulky or extranodal disease 
according to institutional guidelines. Pre-planned radiotherapy may be administered only after 
the last treatment cycle and after the End of Treatment tumor assessment by PET/CT or 
PET/MRI. However, the decision to administer radiotherapy as well as the location to be treated 
must be determined before randomization. In this case, the radiotherapy will not count as a next 
anti-lymphoma treatment. All unplanned radiotherapy administered to patients or a decision to 
switch radiotherapy to a different lesion will be considered as a next anti-lymphoma treatment. 
8.7.1.6 Prophylaxis of Venous Thromboembolism (VTE) for Patients 
Receiving Lenalidomide 
Prophylaxis of VTE is mandatory in patients receiving lenalidomide (Arm B) due to increased 
risk of thrombosis in patients treated with lenalidomide without prophylaxis. Patients must 
receive e.g. aspirin 70-325mg p.o. daily or low molecular weight heparin. Patients with a history 
of VTE or thrombophilia may participate if they are willing to be on full anticoagulation during 
the treatment if randomized to Arm B. The choice of VTE prophylaxis agent is at investigator´s 
discretion and should be tailored to the patient’s individual risk/benefit profile by taking into 
account the individual thrombotic risk, bleeding risk, and the quality of compliance with the 
VTE prophylaxis. 
8.7.1.7 Prophylaxis of Hepatitis B Reactivation 
Patients in countries where prophylactic anti-viral medications for hepatitis B reactivation 


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are the standard of care may be treated prophylactically. Patients 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 the 
Schedule of Assessments (Section 10). 
8.7.1.8 Anti-Infectious Prophylaxis 
Anti-infectious prophylaxis including prophylaxis of opportunistic infections can be given as per 
institutional guidelines. 
8.7.1.9 Prophylaxis of tumor lysis syndrome   
In patients with high risk of tumor lysis syndrome (e.g. patients with large tumor burden, elevated 
LDH, or high proliferation rate of tumor cells), TLS prophylaxis should be considered. All 
approaches to mitigate the risk of developing TLS, such as adequate hydration or hypouricemic 
agents (e.g. allopurinol or rasburicase), may be used in high risk patients as per institutional 
guidelines. Patients with high risk of TLS should be followed closely and appropriate laboratory 
monitoring should be performed as per institutional guidelines.   
8.7.2 Prohibited Medication 
8.7.2.1 Anticancer Therapies 
No radiotherapy (including limited field radiotherapy) is permitted after the screening PET/CT 
scan for initial disease assessment has been performed, except for the pre-planned radiotherapy 
described in Section 8.7.1.5. Other than the study drugs, R-CHOP and permitted concomitant 
medication, patients should not receive any other DLBCL-specific therapy during the study 
treatment period. The patient should not receive any investigational agent other than tafasitamab 
and lenalidomide during the treatment period of the study. 
The use of concurrent antineoplastic therapies other than study drugs and R-CHOP, 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.  
After disease progression/relapse has been recorded or if an end of treatment tumor assessment 
indicates residual (partial metabolic response) or no metabolic response (SD), additional 
antineoplastic therapies are permitted at the discretion of the investigator and in accordance with 
the local guidelines. They should be recorded in the eCRF as next anti-lymphoma treatments. 
Patients should be encouraged to complete the Follow-up period in such case and may stay in 
the study unless they participate in another clinical study.  
8.7.2.2 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 end of 
treatment.  
Thereafter the decision to administer live vaccine is at the investigator’s discretion and should 
follow local guidelines for R-CHOP (the haematological status of individual patient, including 
B-cell depletion, should be considered). 


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8.8 End of Clinical Trial Treatment 
It is the responsibility of the investigator to provide follow-up medical care for all patients, 
who have completed study treatment (or discontinued study treatment early), or should refer 
them for appropriate ongoing care. 
 
 


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9 CLINICAL TRIAL PROCEDURES 
All study-required procedures should occur as outlined in Section 10. Excursions from the timing 
of assessments will be considered protocol deviations and should be recorded in the documents 
along with the reasons for excursion. 
9.1 Patient Numbering 
Each patient is identified in the study by a 7-digit Patient Number (Patient No.) that is assigned 
by the Interactive Response Technology (IRT) system when the patient is screened (i.e. signs the 
ICF), and is retained as the primary identifier for the patient throughout his/her entire 
participation in the trial. 
 The Patient No. consists of the 5-digit Center Number (assigned to the study site) and a 
sequential 2-digit patient number suffixed to it, so that each patient 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 patient to register them into the IRT system and 
assign a Patient No. 
 Once assigned, the Patient No. must not be reused for any other patient.  
9.2 Assigning Patients to Treatment Groups 
All patients who fulfil all inclusion criteria and who are not barred by any of the exclusion criteria 
will be treated with R-CHOP and randomly assigned to study drugs comprising tafasitamab or 
tafasitamab plus lenalidomide in a 1:1 ratio.  
Randomization will be done through IRT before the patient receives any study treatment. While 
all inclusion and exclusion criteria need to be reviewed again prior to randomization, laboratory 
results and results of assessments obtained during the screening period or on the day of 
randomization may be used for determining patient eligibility for study randomization.  
9.3 Re-Screening 
A patient can be re-screened at the discretion of the investigator under certain circumstances. 
Re-screening is restricted to one attempt per patient and can only be performed if one of the 
following criteria is met:  
1. The patient has already consented and met all of the inclusion and none of the exclusion criteria 
and his or her randomization was delayed due to an unexpected change in the patient’s personal 
situation (e.g. family issues).  
2. The patient previously failed to be eligible due to any event (e.g., planned surgery, laboratory 
test result) that has been resolved.  
Note: A patient should only be re-screened if there is a clear indication that the patient may be 
eligible according to the currently valid study protocol. 
If previous screening activities were discontinued and enrolment did not occur, the following 
procedures should be implemented:  
1. The eligible patient will receive a new Patient number via the IRT  


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2. A new electronic case report form (eCRF) will be completed  
3. The patient will be documented as re-screened in the source documents.  
A re-screened patient can be randomized, if all of the inclusion criteria are met and none of the 
exclusion criteria are met. 
9.4 Demographic Data/Relevant Medical History and Current Medical 
Conditions/Baseline Stage and Prognostic Classification 
Demographic variables to be recorded will include age, gender, race/ethnic origin.  
At the time of signing of the ICF, relevant medical history and current medical conditions should 
be recorded. The medical history of DLBCL should be documented in detail, including all 
symptoms at screening.  Also, examinations leading to the diagnosis of DLBCL should be 
documented in the patient’s source documents. This may include, for example, results of 
laboratory examinations, imaging results, or clinical symptoms related to DLBCL. The 
assessment of the lymphoma should include disease staging. In order to reflect the patient’s status 
at the time of screening, the standard Ann Arbor staging system used for DLBCL reflecting the 
number of sites of involvement and their relation to the diaphragm, the existence of B-symptoms, 
and the presence of extranodal disease, will be documented (Appendix C). Additionally, the 
disease risk assessment as per IPI (Appendix D) and patient status as per Eastern Cooperative 
Oncology Group (ECOG) performance status criteria (see Appendix B), will be recorded. 
Screening for CNS lymphoma involvement is not mandatory. Lumbar puncture with 
cerebrospinal fluid evaluation (cytology, flow cytometry) and/or head CT/ head MRI is 
recommended in patients with high risk disease to exclude CNS lymphoma involvement.  
9.5 Diagnostic Lymphoma Biopsy and Central Pathology Review 
For each participating patient suitable and sufficient archival tumor tissue material must be 
provided. A central pathologist will provide confirmation of the histological diagnosis of 
DLBCL. 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. 
The local pathology report indicating DLBCL diagnosis is acceptable for determining a patient’s 
eligibility for receiving the first trial treatment. Central pathology review is mandatory, but 
retrospective in nature. Tissue samples or archival tumor tissue material, as stated above should 
be submitted within 30 days of patient randomization. Archival paraffin blocks are preferred. In 
exceptional cases where no such blocks can be provided, unstained slides are also acceptable. In 
such case, tissue curls will be required in addition.  
In case of discrepancies between the assessments of the local and the central pathologists, the 
assessment of the central pathologist prevails. If the DLBCL diagnosis of the local pathologist 
cannot be confirmed by the central pathologist, and a patient’s treatment has already commenced, 
the patient may remain in the study. 
9.6 Bone marrow assessment 
As per the Lugano criteria (Cheson, 2014), a bone marrow aspiration and biopsy is not mandated 
in patients who undergo PET/CT or PET/MRI. However, bone marrow assessments may be 


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performed according to investigator´s discretion. The data of such examination will be collected 
in the eCRF. 
9.7 Radiographic Imaging Assessment  
Radiographic assessments will be performed at the timepoints indicated in the Schedule of 
Assessments (Section 10). Additional radiographic assessments may be performed by the 
investigator during the course of the study, if deemed necessary. 
A CT scan (with contrast unless contraindicated) covering at least the neck, chest, abdomen,  
pelvis, and any other disease sites as well as PET scans are required for the pre-treatment tumor 
assessment. The use of historical PET/CT or PET/MRI scans within a maximum of 21 days 
before signature of ICF is permitted as long as they are of acceptable quality and cover the 
aforementioned anatomical areas. Information on extranodal involvement (e.g. gastric or skin 
involvement) will be recorded in the source documents.  
During the course of the study, response assessments will be performed covering the 
aforementioned anatomical areas as for screening unless additional regions are deemed required 
to be covered.  
A mid-treatment CT/MRI should be performed at Cycle 3 D18 +/- 3 days, i.e. prior to the end of 
cycle 3; a mid-treatment PET/CT (or PET/MRI) is optional and should be triggered by local 
guidelines.  
An end of treatment PET/CT or PET/MRI should be performed 4-8 weeks after the last study 
treatment. 
During the follow-up period CT scans should be performed roughly every 6 months. 
If disease progression/relapse is diagnosed purely on the basis of clinical symptoms, a CT scan 
with IV contrast (or MRI if IV contrast is contraindicated) or PET/CT (or PET/MRI) is required 
within 4 weeks of diagnosing disease progression/relapse based on symptoms. If such imaging 
was performed, it does not need to be repeated at the Early Treatment Discontinuation visit.  
NOTE: PET/CT hybrid scanners may be used to acquire the required CT images only if the CT 
produced by the scanner is of diagnostic quality.  
If using a hybrid machine to acquire both PET and CT, the PET must be performed prior to the 
CT with IV contrast as to not compromise PET results.  
If independent CT and PET scanners are used, and the patient is receiving both scans on the same 
day, the PET must be performed prior to the CT with IV contrast. Assessment of PET results is 
based on Lugano classification (Cheson, 2014; see Appendix E) 
Lesion measurements and other parameters relevant for the response assessment based on 
Lugano classification (Cheson, 2014; see Appendix E) will be collected in the eCRF. 
9.8 Vital Signs 
Vital signs include blood pressure, heart rate, body temperature. 


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Vital signs will be measured at the time points described in the Schedule of Assessments (Section 
10). Vital signs are to be obtained pre-tafasitamab infusion, and then at least 3 times during the 
infusion, and as clinically indicated. 
The frequency or the length of the monitoring period may be adapted if clinically indicated, for 
example if in the opinion of the investigator the vital sign results, at the time of event onset, are 
clinically significant. In such a case the patient’s vital sign measurements should continue to be 
recorded until they have returned to normal or pre-infusion levels and corresponding AEs to be 
recorded. 
If possible, before vital signs are measured, the patient should be resting for at least 5 minutes. 
Ideally/Optimally, the same position should be used each time vital signs are measured for a 
given patient, and blood pressure should be measured from the arm contralateral to the site of 
study drug administration. Body temperature should be measured according to normal hospital 
practice.  
9.9  Electrocardiograms, Echocardiograms or Cardiac MUGA scans 
Standard 12-lead resting ECGs will be obtained at the various time points described in the 
Schedule of Assessments (Section 10). Ideally,  ECGs will be recorded after the patient has rested 
in a supine position for at least 5 minutes. ECG will first be interpreted locally. 
The investigator will evaluate the clinical significance of each ECG value outside the reference 
ranges, according to the nature and degree of the observed abnormality. Any new abnormal 
values or those deteriorating from baseline considered to be clinically significant should be 
reported as AEs.  
If clinically significant abnormalities are observed or artefacts are present that result in an 
inability to adequately interpret the results, the ECG will be repeated.  
The sponsor will further organize a central review of ECG tracings. In case of discrepancies 
between the outcome of the local and the central assessment, the assessment of the central 
reviewer will prevail.  
Echocardiogram or cardiac MUGA scan will be obtained at screening and at End of Treatment 
Visit or Early Study Treatment Discontinuation Visit to evaluate cardiac function, including 
assessment of LVEF (data will be collected in the eCRF).  
LVEF is the central measure of left ventricular systolic function. LVEF is the fraction of 
chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the 
ventricle at the end of diastole (end-diastolic volume). SV is calculated as the difference 
between EDV and end systolic volume (ESV). LVEF is calculated from: 
LVEF: [SV/EDV] x 100 
 


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9.10 Physical Examination (PE) 
Physical examination will be performed according to Schedule of Assessments (Section 10). 
A full PE will be performed by the investigator or a qualified designee during the screening and 
at the End of Treatment Visit or Early Study Treatment Discontinuation Visit.  
Full 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.  
Limited physical examination will be guided by the individual patient’s status and will include 
body systems associated with symptoms and/or the underlying DLBCL disease (lymph node 
status, liver, spleen). Limited PEs may be focused on tumor response assessment (e.g., lymph 
nodes, liver, spleen) and AEs per investigator discretion.  
9.11 Body Weight Measurement 
Body weight will be measured as indicated in the Schedule of Assessments (Section 10).  
The body weight measured on Day 1 of a cycle will be used to calculate the tafasitamab dose to 
be used throughout this cycle.  
9.12 B-symptoms, ECOG performance status 
B-symptoms and ECOG performance status will be assessed at the timepoints indicated in the 
Schedule of Assessments (Section 10).  
9.13 Hepatitis Virus Serology 
Patients will be examined according to the schedule in Section 10 for viral hepatitis B and C. 
Hepatitis B biomarkers include hepatitis B surface antigen (HBsAg), total anti-hepatitis B core 
antibody (anti-HBc) and anti-hepatitis B surface antibody (anti-HBs). Patients with a positive 
test for anti-HBc can only be included if hepatitis B viral DNA (HBV DNA) is not detected. In 
these patients only, HBV DNA should be assessed at various subsequent visits as outlined in 
Section 10.  
In the context of exclusion criteria, seropositive for or active viral infection with hepatitis B virus 
(HBV) means:  
a) HBsAg positive 
b) HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable HBV DNA.  
Note: Patients who are HBsAg negative, anti-HBc positive and HBV DNA negative are eligible. 
Note: Patients who exhibit the classical vaccination profile of anti-HBs positive, anti-HBc 
negative, and HBsAg negative are eligible.  
If HBV-DNA becomes detectable during treatment, patients should be prophylactically treated 
and followed-up for potential hepatitis B reactivation. If the HBV-DNA assay is positive, then 
patients can only stay in the study if they are assessed by a physician experienced in the treatment 


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of hepatitis B and pre-emptive treatment is initiated, if deemed appropriate, and/or according to 
local practice/guidelines.  
Hepatitis C serology is to be done at screening only. Hepatitis C biomarkers include anti-
hepatitis C virus antibody (anti-HCV). For patients who are positive for anti-HCV antibody, 
HCV-RNA should be measured.  
A positive Hepatitis C test is defined as a positive test for Hepatitis C Virus (HCV) antibodies 
and a positive test for HCV RNA.  
9.14 Pregnancy Testing 
A pregnancy test will be performed for females of childbearing potential (FCBP) at various time 
points either by urine pregnancy test or beta-human chorionic gonadotropin (β-HCG) test of a 
serum sample (see Section 10). The pregnancy test assay should have a minimum sensitivity of 
25 IU/mL.  
Applicable in all countries except US: FCBP must have two negative pregnancy tests prior to 
starting the study drug, even if true abstinence is the chosen method of birth control. The first 
pregnancy test must be performed during screening and the second pregnancy test must be 
performed within the 24 hours prior to the start of study drug. The patient must not receive study 
drug until the Investigator or Designee  has verified that the results of these pregnancy tests are 
negative. 
Applicable in US: FCBP must have two negative pregnancy tests prior to starting study drug, 
even if true abstinence is the chosen method of birth control. The first pregnancy test must be 
performed within 10-14 days before study drug initiation, the second pregnancy test must be 
performed within 24 hours prior to the start of study drug. The patient must not receive study 
drug until the Investigator or Designee has verified that the results of these pregnancy tests are 
negative. 
9.15 Local Laboratory Testing 
Local laboratory tests will be performed according to Section 10.  
Laboratory results are required for determining patient eligibility for study enrolment and will 
be used for the primary statistical analysis of the study results.  
During screening, it is permitted to repeat the local laboratory assessment of serum chemistry 
and hematology parameters due to the variability of the parameters and their dependence on 
multitude of factors (e.g., hydration, muscle mass). This is, provided no safety concerns arise 
and that such laboratory results might have been caused by a transient, medically plausible event, 
which resolved spontaneously or as result of a medical intervention in the meantime (e.g., 
dehydration, 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 “re- screening” for that patient.  
Local laboratory samples may be taken up to 24 hours before study drug administration. Local 
laboratory results will be used for taking treatment or clinically related decisions, or for the 
immediate safety management of a study patient.  The investigator or designee should review, 


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laboratory results before dosing so that the administration of the investigational medicinal 
product (IMP) may be adjusted or interrupted if necessary.  
The laboratory results will be kept in the patient’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.  
9.16 Immunogenicity (anti-tafasitamab antibodies) 
Serum samples for anti-tafasitamab antibody analysis will be collected according to the Schedule 
of Assessments (Section 10). 
Serum samples for anti-tafasitamab antibody analysis will be handled and stored as specified in 
the laboratory manual at the study site until shipment on dry ice to an external analytical 
laboratory. At each sampling time point, the obtained serum sample should be split into 2 aliquots 
(a primary and a back-up sample).  
9.17 Tafasitamab Pharmacokinetic Assessments 
Serum samples for tafasitamab PK analysis will be collected according to the Schedule of 
Assessments (Section 10). 
Serum samples for PK analysis of tafasitamab will be handled and stored as specified in the 
laboratory manual at the study site until shipment on dry ice to an external analytical laboratory. 
At each sampling time point, the obtained serum sample should be split into 2 aliquots (a primary 
and a back-up sample). 
9.18 Other Laboratory Evaluations 
Blood and tumor specimens for the analysis of exploratory biomarkers will be collected 
throughout the study according to the Schedule of Assessments (Section 10) and will be 
characterized for markers, which are important in the mechanism of action of tafasitamab, or 
could predict response to the study drugs.  
Samples for exploratory biomarker analysis will be handled and stored as specified in the 
laboratory manual. 


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10 SCHEDULE OF ASSESSMENTS  
Clinical Trial Schedule of Assessments  
Screening and Treatment Periods, and Early Study Treatment Discontinuation Visit or End of Treatment Visit  
 
 
SCR 
Baseline 
Cycle 1 (21d)
Cycle 2 (21d)
Cycle 3 (21d)
Cycle 4 (21d)
Cycle 5 (21d)
Cycle 6 (21d)
Early Study 
Treatment 
Discontinuation/ 
End  of 
Treatment Visit a 
 
D1 
D8 
D15 
D1 
D8 
D15 
D1 
D8 
D15 
D18 
D1 
D8 
D15 
D1 
D8 
D15 
D1 
D8 
D15 
Day* 
- 21– 0 
1 
8 
15 
1 
8 
15 
1 
8 
15 
18 
1 
8 
15 
1 
8 
15 
1 
8 
15 
6 weeks ± 2 
weeks from End 
of Treatment  
Starting Evaluations and Eligibility 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demography and Medical Historyb 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease staging/Ann Arbor 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease risk assessment (IPI) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-planned radiotherapy  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-planned CNS prophylaxis with IV Methotrexate 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Throughout Evaluations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior and concomitant Medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examination (F- Full / L-Limited)c 
F 
L 
 
 
L 
 
 
L 
 
 
 
L 
 
 
L 
 
 
L 
 
 
F 
ECOG performance status 
X 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Body weight  
X 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
B-symptoms 
X 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Vital signsd 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead resting ECG 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
Adverse events (AEs, SAEs and AESIs) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
New anti-lymphoma treatment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Laboratory 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
All countries: Serum Pregnancy test (FCBP)e (local) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
EU countries: Urine pregnancy test (FCBP)e (local) 
 
X1 
 
 
X1 
 
 
X1 
 
 
 
X1 
 
 
X1 
 
 
X1 
 
 
 
US only: Urine pregnancy test (FCBP) (local)m 
 
X1 
 
(X1) 
X1 
 
(X1) 
X1 
 
(X1) 
 
X1 
 
(X1) 
X1 
 
(X1) 
X1 
 
(X1) 
X 
Pregnancy and Risk Counsellinge 
X 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
US only: Pregnancy and Risk Interview guideline 
X 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Hematologyf and Serum chemistryg (local) 
X 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X 
Coagulation (aPTT or PTT, PT, INR) (local) 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Serology  Hepatitis B, Hepatitis C (local) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Hep. B DNA by PCR (if indicated; local)h 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Hep. C RNA by PCR (if indicated; local)h 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum IgG, IgA and IgM (local) 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
Thyroid Stimulating Hormone (TSH; local) 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 


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SCR 
Baseline 
Cycle 1 (21d)
Cycle 2 (21d)
Cycle 3 (21d)
Cycle 4 (21d)
Cycle 5 (21d)
Cycle 6 (21d)
Early Study 
Treatment 
Discontinuation/ 
End  of 
Treatment Visit a 
 
D1 
D8 
D15 
D1 
D8 
D15 
D1 
D8 
D15 
D18 
D1 
D8 
D15 
D1 
D8 
D15 
D1 
D8 
D15 
B-, T- and NK cell flow cytometry  (central) 
 
X1 
X1 
X1 
X1 
 
 
 
 
 
 
X1 
 
 
 
 
 
 
 
 
X 
Blood cell count and NKCC at baseline (central) 
 
X1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ctDNA in peripheral blood (central) 
 
X1 
 
 
X1 
 
 
 
 
 
 
X1 
 
 
 
 
 
 
 
 
X 
Immunophenotyping and functional assays PBMC 
(central) 
 
X1 
 
 
X1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Anti-tafasitamab antibodies (central) 
 
X1 
 
 
 
 
 
X1 
 
 
 
 
 
 
X1 
 
 
 
 
 
X 
PK tafasitamab (central) 
 
X2 
 
 
X2 
 
 
X2 
 
 
 
X2 
 
 
X2 
 
 
X2 
 
 
X 
Imaging and Tumor evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PET/CT or PET/MRI i 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
CT or MRI i 
 
 
 
 
 
 
 
 
 
 
Xl 
 
 
 
 
 
 
 
 
 
 
Echocardiogram or cardiac MUGA scan  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Tumor evaluationi 
X 
 
 
 
 
 
 
 
 
 
Xl 
 
 
 
 
 
 
 
 
 
X 
Biopsy /Tissue 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Bone marrow aspiration and biopsyj (local) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Tissue block  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fresh tumor tissue (only for participants of substudy) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xl 
Drug Administrationk 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mandatory pre-infusion medicationk 
 
X1 
X1 
X1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tafasitamab infusionk 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
If randomized to Tafasitamab + Lenalidomide 
arm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lenalidomide tablets allocation (incl. patient home 
intake record ) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
X 
 
 
 
 
 
 
 
X1: pre-dose; X2: pre-dose and 1 hour (± 15 min) after end of tafasitamab infusion 
 
 


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Footnotes:  
* 
A visit window of ± 2 days is allowed for all visits starting from C1D8 until C6D15. For C1D1 a visit window of +1 day applies. Study treatment should start within 24 
hours of randomization.  
a 
End of treatment Visit is defined as 6 ± 2 weeks after End of Treatment. End of Treatment is defined as day 21 of the last treatment cycle the patient started. Patients who 
discontinue early because of toxicity or withdraw consent at any time during the study should return for an Early Study Treatment Discontinuation Visit 6 +/-2 weeks after 
day 21 of the last treatment cycle the patient started. Patients who discontinue early because of progression/relapse of disease may have this visit earlier at the discretion of 
the investigator. 
b 
At screening, age, sex, race/ethnic origin and relevant medical history will be recorded. This includes history of prior non-hematologic cancers, e.g. prostate cancer, 
melanoma.  
c  
Full 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. Limited physical examination will be guided by the individual patient’s status and will include 
body systems associated with symptoms (e.g. respiratory, heart, skin) and/or the underlying DLBCL disease (lymph node status, liver, spleen). 
d 
Vital signs include blood pressure, heart rate, body temperature. Vital signs are to be obtained pre-tafasitamab infusion, and then at least 3 times during the infusion, and 
as clinically indicated.  
e 
Note: Risk counselling is mandatory for all participants, incl. males at screening. After randomization, risk counselling will only continue at the indicated frequency for 
patients that are randomized to Arm B. A serum/urine pregnancy test is mandatory only for females of childbearing potential (FCBP). For US only: the serum pregnancy 
test for FCBP at screening needs to be done within 10-14 days prior to treatment initiation.  
f 
Hematology lab includes hemoglobin, hematocrit, platelet count, red blood cell count, white blood cell count, percent and absolute white count differential (neutrophils, 
eosinophils, lymphocytes, monocytes, basophils).  
g 
At screening and during treatment, serum chemistry includes Na, K, Ca, phosphate, chloride, creatinine, total bilirubin, direct bilirubin, total protein, albumin, ALT, AST, 
LDH, AP, uric acid, calculated creatinine clearance and C-reactive protein, glucose.  
h 
HCV RNA by PCR only if the patient is anti-HCV antibody positive. In anti-HBc-positive patients, the HBV DNA titer needs to be determined using real-time PCR at Day 
1 of each cycle and until at least 1 year after the last treatment cycle. 
i 
Tumor measurements by PET/CT or PET/MRI of the neck, chest, abdomen and pelvis to be performed according to the Lugano criteria for malignant lymphoma (Cheson, 
2014; see Appendix E) at screening and 6 ±2 weeks after day 21 of the last treatment cycle the patient started. Note: A mid-treatment CT or MRI scan and tumor evaluation 
is required at Cycle 3 D18 ± 3 days prior to the end of cycle 3; a mid-treatment PET/CT is optional. Every effort should be made to use the same scan modality (CT or 
MRI) for all assessments. If progression/relapse is diagnosed purely on the basis of clinical symptoms, a CT-scan or PET/CT is required within 4 weeks of clinical diagnosis. 
In such case the imaging does not need to be repeated at the early treatment termination visit.  MRI scans may be used instead of CT-scans in patients for whom CT-scans 
are contraindicated. Screening visit PET/CT or PET/MRI: A PET/CT or PET/MRI of suitable quality that has been taken less than 21 days prior to signing the ICF may be 
used. 
j 
As per the Lugano criteria (Cheson, 2014), a bone marrow aspiration and biopsy is not mandated in patients who undergo PET/CT or PET/MRI. However, bone marrow 
assessments may be performed according to local guidelines. The data of such examination will be collected in the eCRF.  
k 
 Tafasitamab infusions should be given after pre-medication with oral acetaminophen (650 – 1000 mg), an antihistamine such as diphenhydramine hydrochloride (50-100 
mg), and glucocorticosteroids (e.g. 100 mg IV prednisone or prednisolone or equivalent) 30-60 minutes prior to starting each infusion in cycle 1. The Day 1 steroid dose 
being part of CHOP (100 mg prednisone or prednisolone or equivalent, IV or PO) can be used as part of the premedication prior to Tafasitamab infusion. After cycle 1, 
for patients who do not experience any grade 2 or higher infusion-related reactions (IRRs) with their previous infusion, pre-mediation at subsequent treatments may be 
omitted according to institutional treatment guidelines. NOTE: The R-CHOP treatment is considered to be standard of care (SoC) and will be given according to 
institutional guidelines. Rituximab is advised to be given approximately 30 minutes after the end of tafasitamab infusion, followed by the CHOP chemotherapy which 
will be given approximately 30 minutes after the end of the rituximab infusion.  
l  
In selected centres, if the patient progresses and agrees on an additional biopsy, fresh material shall be provided  
m 
Applicable in US: For FCBP who have regular menstrual cycles, urine pregnancy test should be performed on day 1 of each cycle and at the End of Tretment visit. For 
FCBP with irregular menstrual cycle,s urine pregnancy tests should be done on day 1 and on day 15 of each cycle, and at End of Treatment Visit.   


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Follow Up Period  
 
 
FU 1 
FU 2 
FU 3 
FU 4 
FU 5 
End of study 
Early FU term. 
Month after Early Study Treatment 
Discontinuation/  End of Treatment Visit* 
3 
6 
9 
12 
15 
18 
any 
Evaluations 
 
 
 
 
 
 
 
Survival follow-upa
X 
X 
X 
X 
X 
X 
X 
Concomitant Medication 
X 
X 
X 
X 
X 
X 
X 
Limited physical examinationb 
X 
X 
X 
X 
X 
X 
X 
ECOG performance status 
X 
X 
X 
X 
X 
X 
X 
Body weight  
X 
X 
X 
X 
X 
X 
X 
B-symptoms 
X 
X 
X 
X 
X 
X 
X 
Vital signsc 
X 
X 
X 
X 
X 
X 
X 
12-lead resting ECG (only if clinically indicated) 
 
 
 
 
 
X 
X 
Adverse events (AEs, SAEs and AESIs)d 
X 
X 
X 
X 
X 
X 
X 
New anti-lymphoma treatmente 
X 
X 
X 
X 
X 
X 
X 
Laboratory 
 
 
 
 
 
 
 
Serum Pregnancy test (FCBP)f 
X 
 
 
 
 
X 
X 
Hematology and Serum chemistry (local)g 
X 
X 
X 
X 
X 
X 
X 
HBV-DNA by PCR (if indicated; local)h 
X 
X 
X 
X 
 
 
X 
Thyroid Stimulating Hormon (TSH; local) 
 
 
 
 
 
X 
X 
B-, T- and NK cell flow cytometry (blood) (central) 
 
X 
 
 
 
 
 
Anti-tafasitamab antibodies (central) 
X 
X 
 
 
 
 
 
PK tafasitamab (central) 
X 
X 
 
 
 
 
 
Serum IgG, IgA and IgM (local) 
X 
X 
X 
X 
X 
X 
X 
ctDNA in peripheral blood (central) 
 
X 
 
 
 
 
 
Imaging and Tumor evaluation 
 
 
 
 
 
 
 
CT or MRIi 
 
X 
 
X 
 
X 
X 
Tumor evaluationi 
X 
X 
X 
X 
X 
X 
X 
Biopsy /Tissue 
 
 
 
 
 
 
 
Tissue block or slides at time of relapse (optional)j 
 
 
 
 
 
 
X 
Fresh tumor tissue (only for participants of substudy) 
 
 
 
 
 
 
Xk 
 
 
 


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Footnotes:  
* 
A visit window of ± 2 weeks is allowed throughout the follow-up period 
a 
Should the patient decease at any time, the date of death as well as cause of death should be reported (if available) 
b 
Limited physical examination will be guided by the individual patient’s status and will include body systems associated with symptoms (e.g. respiratory, heart, skin) and/or 
the underlying DLBCL disease (lymph node status, liver, spleen). 
c 
Vital signs include blood pressure, heart rate, body temperature.  
d  
During the FU period AEs (irrespective of the causality) will be reported. 
e 
For patients with disease progression/relapse during the follow-up period or in case end of treatment tumor assessment indicate residual disease (partial metabolic response) 
or no metabolic response (SD), additional antineoplastic therapies are permitted at the discretion of the investigator. Recording of new anti-lymphoma treatments is 
requested. 
f 
For females of childbearing potential (FCBP) only  
g 
Hematology lab includes hemoglobin, hematocrit, platelet count, red blood cell count, white blood cell count, percent and absolute white count differential (neutrophils, 
eosinophils, lymphocytes, monocytes, basophils). Serum chemistry includes Na, K, Ca, phosphate, chloride, creatinine, total bilirubin, direct bilirubin, total protein, 
albumin, ALT, AST, LDH, AP, uric acid, calculated creatinine clearance and C-reactive protein, glucose.  
h 
In anti-HBc-positive patients, the HBV DNA titer needs to be determined using real-time PCR at each FU visit until at least 1 year after the last treatment cycle.  
i 
Tumor measurements by CT or MRI of the (neck, if indicated), chest, abdomen and pelvis to be performed according to the Lugano criteria for malignant lymphoma 
(Cheson, 2014). MRI scans may be used instead of CT-scans in patients for whom CT-scans are contraindicated. In case of early termination, a CT/MRI and tumor 
evaluation should be performed unless contraindicated. Measurements of tumor response will be performed only until progression/relapse or follow-up completion, 
whichever comes first.   
j 
 Investigators are encouraged to collect an optional tumor biopsy at the time of disease progression/relapse. 
k 
In selected centres, if the patient progresses/relapses and agrees on an additional biopsy, fresh material shall be provided  
 
 
 
 


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11 EFFICACY, PHARMACOKINETIC, SAFETY AND OTHER 
VARIABLES 
11.1 Efficacy Assessments 
Efficacy assessments will be made according to the revised response criteria for malignant 
lymphoma based on the guidelines of the Lugano Classification (as reported by Cheson, 2014) 
and will be based on investigator assessment (Appendix E) 
Efficacy will be evaluated in terms of ORR, DoR, PFS, EFS, OS, TTP and TTNT (Please see 
section 13.12 and section 13.13 for the definition of efficacy endpoints). 
Imaging assessment of efficacy/disease response will be recorded at the end of cycle 3 and after 
the end of treatment (6±2 weeks after day 21 of the last treatment cycle the patient started) as 
well as approximately every 6 months during the FU period.  
11.2 Safety Assessments 
11.2.1 Local Safety and Hematology Laboratory Testing 
Any abnormal laboratory findings that constitute an AE should be reported as such and should 
be followed up until the outcome is known. Also, additional diagnostic tests may be indicated to 
determine a more precise diagnosis of the patient’s condition (e.g., ordering a white blood cell 
(WBC) differential count to help characterise a high or low WBC count, or ordering a 
determination of red blood cell (RBC) indices to help characterise a low hematocrit).  
11.2.2 Safety Monitoring 
The patients will be closely observed and questioned for any kind of AE during the study 
procedures and at follow-up appointments throughout the study period with non-leading 
questioning (e.g., “How do you feel?”). AEs also may be detected when they are volunteered by 
the patient during or between study visits or through physical examination, laboratory tests, or 
other assessments. 
 
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, cytokine release 
syndrome, 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 the study drug(s) or R-CHOP, any of the interventions required to treat 
it, and its outcome. 
 


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11.2.3 Definition of Adverse Events, Serious Adverse Events and Adverse Events of 
Special Interest 
An AE is defined as any untoward medical occurrence in a patient administered a medicinal 
product, which does not necessarily have a causal relationship to this treatment. 
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a study drug, whether or not 
it is considered related to that study drug. 
AEs include any clinically significant deterioration of a patient’s medical status after the signing 
of the ICF. Also, an increase in the frequency or intensity of a pre-existing event or conditions 
and events resulting from protocol mandated procedures (e.g., invasive procedures) fall under 
the definition of AEs.  
Please note that in the context of this protocol symptoms that are clearly associated to disease 
progression/relapse do not fall under the definition of AEs. 
The PI or designee should evaluate each AE to determine the following: 
 Relationship to the study drug or R-CHOP (suspected/not suspected)  
 Duration (start and end date, or if continuing at end of study) 
 Intensity: the intensity of all AEs will be graded as mild, moderate, or severe using the 
following definitions: 
o mild: 
 tolerable 
o moderate: 
interferes with normal activity 
o severe:  
 incapacitating (causes inability to perform usual activities or 
 
 
 work) 
 Severity, i.e., toxicity grade: determined according to the NCI-CTCAE version 5.0, using 
the following definitions: 
o grade 1:  
mild; asymptomatic or mild symptoms; clinical or diagnostic 
 
 
observations only; intervention not indicated 
o grade 2: 
moderate; minimal, local or noninvasive intervention indicated; 
 
 
limiting age-appropriate instrumental activities of daily living 
 
 
(refers to preparing meals, shopping for groceries or clothes, 
 
 
using the telephone, managing money, etc.) 
grade 3: 
severe or medically significant but not immediately life-
threatening; hospitalization or prolongation of hospitalization 
indicated; disabling; limiting self-care activities of daily living  
o grade 4: 
life-threatening consequences; urgent intervention indicated 
o grade 5: 
death related to AE 
 Outcome 
o All non-serious AEs must be followed up for a final outcome. An outcome of 
“unknown” is not considered to be an acceptable final outcome. An outcome of 
“not yet resolved” is an acceptable final outcome for non-serious AEs at the end 
of a patient’s participation in the study. All SAEs must be followed up for a final 


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outcome until resolution or, if resolution becomes unlikely, until stabilization or 
death. 
 Action taken (no action taken; study drug or R-CHOP temporarily interrupted; study drug 
or R-CHOP permanently discontinued due to this AE; medication taken; non-drug 
therapy given; hospitalization/prolonged hospitalization) 
 Seriousness: an SAE is defined as serious if it: 
o results in death 
o is life-threatening 
o requires inpatient hospitalization or prolongation of existing hospitalization 
(hospitalization signifies that the patient was an inpatient for at least one 
overnight stay) unless hospitalization is for: 
 routine treatment or monitoring of the studied indication, not associated with 
deterioration of symptoms related to DLBCL 
 elective or preplanned treatment for a pre-existing condition that is unrelated 
to DLBCL and has not worsened since signing of the informed consent 
 social reason and respite care in the absence of any deterioration in the 
patient’s general condition 
o results in persistent or significant disability or incapacity 
o is a congenital anomaly or birth defect 
o is medically significant, i.e., defined as an event that jeopardizes the patient or 
may require medical intervention to prevent one of the outcomes listed 
previously. 
The term “life-threatening” refers to an event in which the patient was, in the view of the 
reporting Investigator, at immediate risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it were more severe. Medical judgment 
should be exercised in deciding whether an AE is serious in other situations: important AEs that 
are not immediately life-threatening or do not result in death or hospitalization but may 
jeopardize the patient or may require intervention to prevent one of the other outcomes listed in 
the previous definitions should also be considered as serious. 
AEs of special interest (AESIs) for tafasitamab are: TLS, IRRs and allergic reactions to study 
drug ≥ grade 3, cytokine release syndrome, second primary malignancies, hepatitis B 
reactivation, progressive multifocal leukoencephalopathy (PML). 
AEs of special interest (AESIs) for lenalidomide: Second primary malignancies.  
Unlike routine safety assessments, SAEs and AESIs are monitored continuously and have special 
reporting requirements (see Section 11.2.4 below). 
For each AE, the investigator should determine the causality (relationship to the study drug or 
R-CHOP) based on his/her clinical experience and on the information given in the IB. The causal 
relationship of all AEs to the study drug or R-CHOP will be judged as either suspected or not 
suspected. A suspected causal relationship means at least a reasonable possibility that the event 
is caused by the study drug or R-CHOP. If no relationship has been provided by the investigator, 
the event will be considered as related to the study drug. 


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Information about adverse drug reactions already known about the investigational study drugs 
can be found in the IB or SmPC, or will be communicated in the form of Investigator 
Notifications. This information will be included in the patient ICF and should be discussed with 
the patient during the study, as needed. 
11.2.4 Reporting of AEs, SAEs and AEs of Special Interest 
All AEs that occur after the provision of informed consent until the end of the study will be 
recorded in the eCRF and in the patient’s medical records, whether or not the Investigator 
considers them to be related to the study drugs (tafasitamab, Lenalidomide) or R-CHOP. All AEs 
should be recorded in terms of diagnoses, if possible.  
For screening failure patients only SAEs will be recorded in the eCRF. Non-serious AEs will 
only be recorded in the patient’s medical records. 
In addition, SAEs and AESIs will be recorded on the SAE report form. Study centers and 
investigators are instructed to report SAEs and AESIs to the contract research organization 
(CRO) within 24 hours. NOTE: Follow-up SAE reporting has to be sent to the CRO within 24 
hours as well. Notification of initial or follow-up SAE/AESI information must be transmitted to 
the CRO as described in the investigator site file.  
The sponsor is responsible for submission of expedited (including 7-day and 15-day SUSAR) 
reports and periodic reports (including DSURs) to the regulatory authoritiess, IECs/IRBs and 
investigators as per country specific requirements. 
IRRs and allergic reactions to study drugs grade 3 or higher, cytokine release syndrome or TLS, 
which are AESIs in this study, should be reported as diagnosis along with their respective 
symptoms in one event term (e.g., “IRR with symptoms of hives, chills and fever” for IRRs; 
“TLS with symptom of hyperuricemia” for TLSs).  
Contact details of the Sponsor’s Medical Monitor, the CRO Medical Monitor (24/7 coverage), 
and for SAE reporting are provided in the Investigator Site File. 
11.2.5 Pregnancy 
Any pregnancy that occurs during study participation should be reported using a Clinical Trial 
Pregnancy Form. To ensure patient safety, each pregnancy of a study patient or a female partner 
of a study patient must also be reported within 24 hours of learning of its occurrence to the CRO 
as indicated in the investigator site file.  
Female study patients who become pregnant must be withdrawn from the study treatment period. 
A newly diagnosed pregnancy in a patient or female partner of a study patient who has received 
any study drug is not considered an SAE unless it meets any criteria of seriousness or it is 
suspected that the study drug interacted with a contraceptive method and led to pregnancy. 


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If the pregnancy results in clinical consequences/complications in mother or child, e.g., if the 
child is born with a birth defect, this should be reported as an SAE of mother or child as 
applicable. 
The pregnancy should be followed up to determine outcome, including spontaneous or voluntary 
termination, details of birth, and the presence or absence of any birth defects or congenital 
abnormalities or maternal and newborn complications. Every infant has to be followed up for 
2 months after delivery. 
11.3 Other Variables 
11.3.1 Biomarkers 
Biomarker assessments will include B-, T- and NK and other cell counts in peripheral blood or 
tumor tissue, the expression of CD19 and CD20 in tumor tissue, as well as analysis of prognostic 
and exploratory markers by IHC, FISH (e.g., MYC, BCL2 and BCL6 protein levels and gene 
rearrangements). Blood samples will be stored to enable the analysis of peripheral blood 
mononuclear cell populations (e.g. monocytes or CD4+ T-cells), to facilitate the investigational 
research topics that may arise during the course of the study. 
To assess the pharmacodynamic effect of tafasitamab, circulating tumor DNA (ctDNA) will be 
quantified serially in the peripheral blood as an early indicator of treatment response and to detect 
minimal residual disease (MRD). 
Gene expression profiling of tumor biopsies at screening will be used to determine the cell of 
origin (COO) subtype and to assess tumor infiltrating immune cells via their gene signature. 
Together, with the quantification of tumor-associated macrophages and tumor infiltrating NK 
cells by immunohistochemistry this will provide a deeper understanding of the mode of action 
of tafasitamab. 
 
Optional analysis of Biomarkers on fresh tumor biopsy samples 
In a selected subset of participating centers, and as an optional analysis that a patient needs to 
consent to individually, fresh biopsy samples will be collected and analysed at a central 
laboratory. Such analysis will include a quantitative assessment of CD19 and CD20 on malignant 
B-cells. The selection of centers will be driven by the logistical needs of the planned biomarker 
analyses. 
11.4 Appropriateness of Measurements 
All assessments and measurements are appropriate and generally regarded as standard medical 
practice. 
 
 
 


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12 DATA HANDLING AND QUALITY ASSURANCE 
12.1 Completing and Signing Case Report Forms 
For electronic CRFs, trained clinical trial site personnel will enter the data giving reasons for any 
missing data. Any errors should be corrected within the electronic system. The audit trail will 
record all changes made, the date and time of the correction, and the person correcting the error. 
The PI will provide his/her electronic signature on the CRF. 
12.2 Clinical Monitoring 
MorphoSys or designee will monitor the clinical trial conduct at the clinical trial sites to ensure 
data quality (accurate and complete data collection), patient’s safety and right protection. 
12.3 Audit and Inspection 
According to ICH E6-GCP, the sponsor or regulatory authorities may audit the investigational 
site.  The sponsor’s or CRO’s Quality Assurance Unit, independent of the Clinical Research and 
Development Department, is responsible for auditing the study. 
The investigator(s) must accept that regulatory authorities may conduct an inspection to verify 
compliance of study conduct with regulatory requirements and GCP. 
12.4 Clinical Data Management 
The sponsor will be responsible for the processing and quality control of the data.  The handling 
of data, including data quality control, will comply with applicable regulatory guidelines. 
Adverse events and concomitant medications terms will be coded using MedDRA and WHO 
medication dictionary. 
12.5 Archiving 
All study documentation at the clinical trial site and sponsor site will be archived in accordance 
with the applicable regulatory requirements as well as International Council for Harmonization 
(ICH) E6-Good Clinical Practice (GCP) and the sponsor’s quality standards and SOPs. 
 
 
 


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13 STATISTICAL METHODS AND PLANNED ANALYSIS 
13.1 General Statistical Considerations 
Tabulations of summary statistics, graphical presentations, and statistical analyses will be 
performed using SAS® software version 9.3 or higher. 
Continuous, quantitative variable summaries will include the number of patients (N) (with non-
missing values/valid cases), mean, standard deviation, minimum, 25th quartile, median, 75th 
quartile and maximum, except for PK metrics, where additional statistics may be used. 
Categorical, qualitative variable summaries will include the frequency and percentage of 
patients/entries in the particular category. 
Definition of baseline value: the last pre-administration observation will be used as the baseline 
value for calculating post-administration changes from baseline. 
All data obtained via the eCRF and entered into the database will be provided in separate data 
listings showing individual patient’s values. A Statistical Analysis Plan (SAP) detailing the 
statistical analyses will be finalized prior to first patient first visit. 
The planning and reporting of statistical analysis will be carried out as described in the sponsor’s 
SOPs governing clinical trials. 
The sponsor and/or designated CRO will analyze the data. Any data analysis carried out 
independently by the investigator should be submitted to the sponsor before publication or 
presentation. 
It is planned that the data from participating centers in this protocol will be combined, so that an 
adequate number of patients will be available for analysis. 
13.2 Timing of Analysis 
13.2.1 Safety Run-in Analysis 
Patient profiles and Listings of Adverse events will be provided in case a Safety Data Review is 
performed. For details please see Section 6.3.  
13.2.2 Primary Completion Analysis 
The primary completion analysis will be performed based on data cut-off 30 days after all 
patients have performed their End of Treatment Visit (EOT).  
Primary and Key Secondary Objectives will be analysed at the time of primary completion. 
Details will be provided in the SAP.  
13.2.3 Final Analysis 
After the last patient completed the last visit, a final analysis will be performed.  
At the time of Final Analysis, analyses performed during Primary Completion Analysis will be 
repeated using updated data in addition to the performance of Secondary and exploratory 
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Additional Safety and follow-up analyses may be performed by the sponsor as and when deemed 
necessary. 
13.3 Population for Analysis 
Patients who were screened but never started study treatment will be listed. Screening failures 
will not be included in any of the summary tables (except of the patient disposition table). 
13.3.1 Full Analysis Set (FAS) 
All patients who are randomized to either study arm will be included in FAS. Efficacy analysis 
will be performed on FAS. Patients will be analyzed according to the study treatment they were 
randomized to. 
13.3.2 Safety Set (SAF) 
All patients who received at least one dose of study drug (tafasitamab or tafasitamab plus 
lenalidomide). Safety analyses will be performed on SAF. 
Patients will be analyzed according to the study treatment they actually received, which is 
defined as the treatment the patient received on the first day of study treatment. 
13.3.3 Per Protocol Set (PPS) 
Patients included in FAS without any important protocol deviation that would influence efficacy 
endpoints. 
All protocol deviations or conditions leading to exclusion from the PPS will be detailed in the 
data handling plan and statistical analysis plan. Sensitivity analyses for efficacy endpoints may 
be performed using PPS. 
13.3.4 Pharmacokinetic Analysis Set (PKAS) 
All patients who have at least one quantifiable tafasitamab serum concentration.  
13.3.5 Immunogenicity Analysis Set (IAS) 
All patients with at least one anti-tafasitamab antibody assessment 
13.4 Patient Disposition, Demographics and Baseline Characteristics 
A table will be provided with the following information: 
 
Number of patients included in each analysis set. 
 
Number of patients screened, randomized, received at least one dose of trial treatment, 
discontinued treatment within first 21 days, discontinued treatment during the 6 cycles 
of treatment, prematurely discontinued trial and finished complete follow-up and had 
their scheduled last-visit. Reasons of end of treatment and end of study will be provided. 
 
Number of patients withdrawn from the trial and the reason for withdrawal. 
Demographic information will be summarised using descriptive statistics for the FAS. Gender 
and race/ethnic origin will be summarised by counts and percentages. 


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Medical history will be summarised by counts and percentages using MedDRA system organ 
class (SOC) and preferred term classifications. Concomitant medications will be recorded and 
coded using the WHO Drug Dictionary Enhanced and grouped by Anatomical Therapeutic 
Chemical (ATC) classes. Tabulations with counts/percentages will show the number of 
medications/percentage used in each class. 
The following baseline characteristics and medical history related to DLBCL will be summarised 
displaying the  
 duration of disease since initial diagnosis 
 IPI 
 Ann Arbor staging 
 Bulky vs non-bulky disease 
 COO (from local lab, if available, and which assay used e.g. gene expression profiling or 
IHC) 
 B symptoms 
 Extranodal involvement yes or no 
 Number of sites of extranodal involvement 
 Bone marrow involvement by PET yes or no 
 Bone marrow involvement by biopsy yes, no, not available 
 LDH above upper limit of normal yes or no 
Details will be provided in the Statistical Analysis Plan. 
13.5 Treatments (study treatment, concomitant therapies, compliance) 
13.5.1 Study Treatment 
Duration of study treatment exposure and cumulative dose will be summarized by treatment arm. 
The number of patients with dose changes/interruptions will be presented by treatment arm, 
along with reasons for the dose change/interruption. The safety set will be used for the tables and 
listings. 
13.5.2 Prior and concomitant therapies 
Corticosteroids administered/taken within three weeks before ICF signature and concomitant 
medications and significant non-drug therapies taken concurrently with the study treatment will 
be listed and summarized by Anatomical Therapeutic Chemical Classification System (ATC) 
term, preferred term and treatment arm. These summaries will include medications starting on 
or after the start of study treatment or medications starting prior to the start of study treatment 
and continuing after the start of study treatment. 
The safety set will be used for all above mentioned concomitant medication tables and listings. 
 


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13.5.3 New Anti-lymphoma therapies 
New anti-cancer therapies including medications (non-study drugs), surgery and radiotherapy,  
started after randomization will be listed and summarized by Anatomical Therapeutic Chemical 
Classification System (ATC) term, preferred term and treatment arm.  
The safety set will be used for all above mentioned concomitant medication tables and listings. 
13.6 Hypothesis 
As this is a Phase 1b study, no formal hypothesis testing will be performed.  
13.7 Sample Size Determination 
As this is a Phase Ib study primarily conducted to explore safety endpoints, no formal statistical 
hypothesis has been established for the sample size calculation of this trial.  
With a sample size of 12 patients in each arm, there is a 60% probability to observe 4 or more 
patients with unacceptable toxicity if the underlying incidence rate of these toxicities is 33%.  
With a sample size of 30 patients in each arm, there is a 55% probability to observe 10 or more 
patients with unacceptable toxicity if the underlying incidence rate of these toxicities is 33%. 
13.8 Procedures for Missing, Unused and Spurious Data 
Missing values will not be substituted by estimated values, but treated as missing in the statistical 
evaluation. All data from all patients dosed in the clinical trial will be included in all listings, 
plots, summary tables, and statistical analyses when appropriate. 
If a patient discontinues the trial for any reason other than treatment related toxicity or 
progression of disease or death, this patient may be replaced. 
In the event of a significant volume of missing data, sensitivity analyses for the efficacy and 
biomarker endpoints may be performed using the principle of multiple imputation.  
13.9 Procedures for Reporting Deviations from Original Statistical Plan 
Details of the analyses to be performed on data from this trial will be provided in a separate SAP. 
Any deviations from the statistical analysis outlined in this protocol will be described, and 
reasons for the deviations listed, in the clinical trial report. 
13.10 Primary Objective Analysis 
The Primary objective of this trial is to assess the safety and tolerability of tafasitamab in addition 
to R-CHOP and tafasitamab plus lenalidomide in addition to R-CHOP in patients with newly 
diagnosed DLBCL. To assess safety and tolerability, the incidence and severity of 
haematological and non-haematological AEs including clinically significant laboratory 
abnormalities will be determined.  AEs will be categorized with regards to seriousness, intensity, 
toxicity, study treatment relationship, outcome and action taken. AE reports will be graded 
according to National Cancer Institute (NCI) Common Terminology Criteria for adverse events 
(CTCAE), version 5.0. Further details are provided in Section 11.2. 


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13.11 Key Secondary Objective Analysis 
To assess efficacy of tafasitamab in addition to R-CHOP and tafasitamab plus lenalidomide in 
addition to R-CHOP in terms of ORR and PET-negative CR rate at end of treatment. 
13.11.1 Objective response Rate at the end of treatment 
The ORR is defined as the proportion of patients with CR or PR based on the response achieved 
at the end of treatment (tumor scans performed until 56 days after last date of study drug 
administration). 
The ORR along with 95% exact CI (using Clopper-Pearson exact method) will be presented for 
both treatment arms. 
The number and percentage of patients with CR and the number of patients with PR will be 
presented by treatment arm. 
13.11.2 The Metabolic, PET-negative complete response rate at the end of treatment 
The metabolic PET-negative CR rate is defined as the proportion of patients who achieved 
metabolic PET-negative CR based on PET/CTs performed  6±2 weeks after End of Treatment. 
The metabolic PET-negative CR rate along with 95% exact CI (using Clopper-Pearson exact 
method) will be presented for both treatment arms. 
13.12 Secondary Objectives Analysis 
Further details on the subsequent analyses will be specified in SAP. 
13.12.1 Long-term Safety Analysis  
Incidence and severity of AEs will be presented for patients in the follow-up period, starting 
from 31st day after End of Treatment to the End of Study Visit.  
13.12.2 Efficacy endpoints 
To assess efficacy (based on Lugano 2014 criteria) of tafasitamab in addition to R-CHOP and 
tafasitamab plus lenalidomide in addition to R-CHOP with respect to the following endpoints: 
13.12.2.1 
Best ORR until End of Study 
The best ORR is defined as the proportion of patients with CR or PR based on the best response 
achieved until the end of study. 
The best ORR along with 95% exact CI (using Clopper-Pearson exact method) will be presented 
for both treatment arms. 
The number and percentage of patients with CR and the number of patients with PR will be 
presented by treatment arm. 
13.12.2.2 
Metabolic, PET-negative Complete Response Rate at the End of 
Study  
The metabolic PET-negative CR rate is defined as the proportion of patients who achieved 
metabolic PET-negative CR based on PET/CTs performed until end of study. 
The metabolic PET-negative CR rate along with 95% exact CI (using Clopper-Pearson exact 
method) will be presented for both treatment arms. 


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13.12.2.3 
Progression Free Survival (PFS) Rate at 12 Months and 24 Months  
Tumor assessments will be performed by local radiologists using Lugano 2014 criteria (Cheson, 
2014). 
PFS is defined as the time from the date of randomization to the date of the first radiologically 
or histologically/cytologically documented disease progression or death due to any cause. If a 
patient has not progressed or died at the analysis cut-off date or when he/she receives further 
anti-neoplastic therapy, PFS will be censored on the date of the last adequate tumor evaluation 
before the earlier of the cut-off date or start of the further antineoplastic therapy date. 
Kaplan Meier plots will be used to estimate the distribution of PFS. The PFS probabilities at 12 
and 24 months, and the associate 95% CI will be summarized for each treatment arm. 
13.12.2.4 
Event-free Survival (EFS) Rate at 12 Months and 24 Months  
EFS is defined as the time from the date of randomization to the date of the first radiologically 
documented disease progression or death due to any cause or start of new anti-lymphoma 
treatment. If a patient has not progressed or died or started a new anti-lymphoma treatment at 
the analysis cut-off date, EFS will be censored on the date of last contact. 
Kaplan Meier plots will be used to estimate the distribution of EFS. The EFS probabilities at 12 
and 24 months, and the associate 95% CI will be summarized for each treatment arm. 
13.12.2.5 
Time to Next Anti-lymphoma Treatment (TTNT) 
Time to next anti-lymphoma treatment (TTNT) is defined as the time from the date of 
randomization to the date of administration of next anti-lymphoma treatment or death due to any 
cause. If a patient has not received next anti-lymphoma treatment or did not die until the analysis 
cut-off date, he/she will be censored on the date of last contact. 
Kaplan Meier plots will be used to estimate the distribution of TTNT. The TTNT probabilities 
at 12 and 24 months, and the associate 95% CI will be summarized for each treatment arm. 
13.12.2.6 
Overall Survival at 12 Months and 24 Months 
Overall survival (OS) is defined as the time from randomization until death from any cause and 
documented by the date of death.  
Kaplan Meier plots will be used to estimate the distribution of OS. The OS probabilities at 12 
and 24 months, and the associate 95% CI will be summarized for each treatment arm. 
13.12.3 Pharmacokinetic Analysis 
Tafasitamab serum concentrations will be summarized using descriptive statistics. Mean 
concentrations (on original and on log-linear scale) will be visualised in figures.  
13.12.4 Immunogenicity Analysis 
The absolute number and percentage of patients, who develop anti-tafasitamab antibodies, and 
the results of semi-quantitative anti-tafasitamab antibody titer determinations of confirmed 
positive samples will be tabulated.  


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13.12.5 ctDNA Analysis 
Descriptive statistics of ctDNA will be performed for both treatment arms and will be presented 
by means of Min, Max, Mean, Median, Q1, Q3 and 95% CI of mean will be presented by visit.  
13.12.6 NKCC Analysis 
Descriptive statistics of NKCC will be performed for both treatment arms and will be presented 
by means of Min, Max, Mean, Median, Q1, Q3 and 95% CI of mean will be presented by visit.  
13.13 Exploratory Objective Analysis 
The following efficacy endpoints: 
a. 
ORR and  
b. 
PFS 
will be assessed in both treatment arms based on the following biomarkers: 
i. 
Cell of origin 
ii. 
NK-cell count in the tumor tissue 
iii. 
NK-cell gene expression signature in the tumor tissue 
iv. 
Macrophage count in the tumor tissue 
v. 
Macrophage gene expression signature in the tumor tissue 
vi. 
Quantitative and semi-quantitative CD19 expression on tumor cells (in diagnostic 
biopsies and at progression/relapse) 
vii. 
Quantitative and semi-quantitative CD20 expression on tumor cells (in diagnostic 
biopsies and at progression/relapse) 
More details will be provided in the SAP. 
13.14 Safety Analysis 
The primary and one of the secondary objective of this study is to assess the safety and 
tolerability of tafasitamab in addition to R-CHOP and tafasitamab plus Lenalidomide in 
addition to R-CHOP in adult patients with newly diagnosed DLBCL.  
All Safety Analysis will be presented by treatment arms and overall.  
Primary Endpoint: 
Incidence and severity of TEAEs. 
Treatment emergent adverse events are all adverse events which start after the first dose of 
study treatment until 30 days after day 21 of the last treatment cycle the patient started. 
Secondary Endpoint: 
Incidence and severity of AEs will be presented for patients in the study starting from 31st day 
after End of Treatment to the End of Study Visit.  
Note: At the time of primary completion analysis, all non-treatment emergent AEs collected  
(AEs prior to first dose of study drug administration and after 30 days of End of Treatment) 
will be listed. 


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13.14.1 Adverse Events 
All adverse events which start after the first dose of study treatment until 30 days after day 21 of 
the last treatment cycle the patient startedwill be considered as a treatment emergent adverse 
event (TEAE). Adverse events that start during the study but before the time of the first dose of 
study treatment (e.g. screening period) will be classified as a non-treatment emergent adverse 
event and will be included in adverse events listings, but will not be summarized. 
TEAEs will be coded according to MedDRA SOC and preferred terms. Incidence and frequency 
of all AEs will be summarised by SOC, preferred term, relationship to treatment, severity and 
seriousness. 
An AE summary table will be presented showing the number of events, number of subjects and 
the percentage of subjects in each arm and overall having: 
 All Treatment-emergent adverse events (TEAEs) 
 TEAEs by maximum severity 
 SAEs 
 Drug-related TEAEs  
 Drug-related TEAEs in each severity/toxicity grading 
 TEAEs that led to treatment discontinuation 
 IRRs by grade. 
Adverse Events of Special Interests in this study are:  
 Infusion-related reactions ≥ grade 3 
 Cytokine release syndrome 
 Allergic reactions to tafasitamab ≥ grade 3 
 Second primary malignancies  
 PML 
 Hepatitis B reactivation 
 TLS 
The sponsor will describe AESIs, in addition to those reported as SAEs. AESI tabulations will 
be analogous to the tabulation of TEAEs. 
The sponsor will discuss other significant AEs as appropriate, e.g. laboratory abnormalities that 
qualify as AEs (other than those meeting the definition for serious) and any events that led to an 
intervention (including premature discontinuation of IMP, increase of dose interval, or 
significant additional concomitant therapy), in addition to those reported as SAEs. 
In addition to the investigator’s evaluation of normal or abnormal, the sponsor will internally 
evaluate each clinical laboratory result, vital sign result, and ECG result for whether it reflects 
a new abnormality, and for numeric data, whether it reflects a significant worsening from 
baseline or an outlying result or extreme value.  These terms are defined for clinical laboratory 
results, vital sign results, and ECG results as follows: 
 
A new abnormality will be any abnormal post baseline result for a patient whose 
baseline was within normal limits. 
 
A significant worsening will be any numeric clinical laboratory result, vital sign result, 
or ECG interval measurement that represents a change from baseline by 25% of the 


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baseline value, in the direction away from normal (i.e., in the direction that is clinically 
significant). 
 
An outlying result for any numeric laboratory result, vital sign result, or ECG interval 
measurement will be any post-administration change from baseline that meets either of 
the following criteria: 
<25th Percentile - 1.5 * (interquartile range) OR 
>75th Percentile + 1.5 * (interquartile range). 
 
An extreme value for any numeric laboratory result, vital sign result, or ECG interval 
measurement will be any post-administration change from baseline that meets either of 
the following criteria: 
<25th Percentile – 3 * (interquartile range) OR 
>75th Percentile + 3 * (interquartile range). 
Patients who demonstrate new abnormal results will be noted in data listings and reviewed by 
the sponsor. All results showing a significant worsening will be noted in data listings and 
reviewed by the sponsor. Outlying results or extreme values will be identified and reviewed in 
the context of the patient’s other abnormal results. 
13.14.2 Clinical Laboratory Evaluation 
The analysis of local laboratory parameters for each treatment arm will be presented, separated 
into blood parameters (e.g., hematology, serum chemistry, coagulation). All data collected in the 
course of the study will be listed. 
The following analyses will be performed, where appropriate, for measurements of hematology 
and blood chemistry tests: 
 Standard descriptive statistics for values measured at baseline and post-baseline visits 
including changes from baseline 
 For selected laboratory parameter, shifts in assessments from baseline to worst-post 
baseline value  
 Number (and percentage) of subjects with clinically notable changes for selected tests 
Each abnormal value measured in the local laboratory will be flagged to show whether it is a 
value below or above the reference range for the given local laboratory. For the assessment of 
laboratory variables, the investigator will need to judge their clinical significance. 
The assessment of the clinical relevance of central laboratory variables will be tabulated by time 
point for each clinical laboratory analyte using frequency tabulations.  
Clinical laboratory analytes with available NCI-CTCAE grades may be presented with additional 
frequency and shift tables based on these grades. 
 Laboratory values that are outside the reference range will also be flagged in the data listings, 
along with the corresponding reference ranges. 
The analyses will be performed on SAF. Further details will be specified in the SAP. 


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13.14.3 Vital Signs 
Descriptive summaries of actual values and changes from baseline will be calculated for vital 
signs. These summaries will be presented for the SAF at all time points. Each abnormal value 
will be flagged to show whether it is a value below or above the normal limit. 
13.14.4 Electrocardiograms 
Summary ECG assessment (categories: ‘normal’; ‘abnormal, clinically significant’; ‘abnormal, 
not clinically significant’) will be tabulated by time point using frequency tabulations. 
Each result of the 12-lead ECG (PR, QRS, RR and QT interval values) will be flagged to show 
whether it is a value below or above the normal limit. 
Summary statistics for all time points will be displayed for QT and both QTc correction methods. 
The Bazett’s correction method for QTc will be applied as follows: 
 
Bazett’s:  QTcB = QT/RR 
 
Fridericia’s:  QTcF = QT/3RR 
Where relative rate (RR) = 60/heart rate 
Also, the number and percentage of subjects with QTc values above the normal limit (>450 ms, 
>480 ms, >500 ms) and the number and percentage of subjects who experienced a change ≥30 ms 
or a change ≥60 ms will be presented by time point. 
14 SPECIAL REQUIREMENTS AND PROCEDURES 
14.1 Regulatory and Ethical Considerations 
This trial was designed and shall be implemented, executed and reported in accordance with the 
ICH Harmonized Tripartite Guidelines for Good Clinical Practice (ICH-GCP), with applicable 
local regulations and with the ethical principles laid down in the Declaration of Helsinki. 
Before starting this trial, the clinical trial protocol will be submitted to the IEC/IRB and/or  
regulatory authorities (in accordance with local regulations) for evaluation. The trial will not 
start before the IEC/IRB and/or regulatory authorities gives written approval or a favourable 
opinion as required. Any amendments to the protocol will require IEC/IRB and/or regulatory 
authority approval as required before implementation, except for changes necessary to eliminate 
an immediate hazard to patients. 
14.2 Investigator’s Responsibilities 
14.2.1 Overall Responsibilities 
Before initiating a trial, the investigator/institution must ensure approval/favorable opinion is 
obtained from the IEC/IRB for the protocol, written informed consent form, consent form 
updates, subject recruitment procedures (e.g., advertisements) and any other written information 
to be provided to subjects.  Prior to study start, the investigator is required to sign a protocol 
signature page confirming his/her agreement to conduct the study in accordance with the 
protocol, ICH-GCP, applicable local regulations and the ethical principles laid down in the 
Declaration of Helsinki.   


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The investigator is responsible to provide oversight of the conduct of the study at their site. 
Investigators will apply due diligence to avoid protocol deviations. If the investigator feels a 
protocol amendment is necessary to improve the conduct of the study, such an amendment is 
required to be agreed upon by the sponsor and approved by the IEC/IRB and/or regulatory 
authorities as required prior to implementation. Notwithstanding the need for approval of 
protocol amendments, the investigator is expected to take any immediate action required for the 
safety of any subject included in this trial, even if this action represents a deviation from the 
protocol. In such cases, the sponsor must be notified of this action, as well as the IEC/IRB and/or 
regulatory authorities as required. 
14.2.2 Patient Informed Consent 
The investigator or his/her representative is responsible to explain the nature of the study to the 
patient or his/her legally authorized representative and answer all questions regarding the study. 
Patients must be informed that their participation is voluntary. Patients or their legally authorized 
representative will be required to sign the informed consent form (ICF) prior to any study-
specific procedures being performed. The original ICF must be kept as part of the study records 
at the site, and a copy must be provided to the patients or their legally authorized representative. 
Patients must be re-consented to the most current version of the ICF(s) during their participation 
in the study. The process of obtaining informed consent must be documented in the patient’s 
source documents. 
14.2.3 Direct access to Source Data/ Documents 
The investigator has to give access to all relevant data and records to monitors, auditors, other 
designated agents of the sponsor, IEC/IRB, and regulatory authorities as required. Personal 
medical information will always be treated as confidential. If an inspection of the clinical site is 
requested by a regulatory authority, the investigator must inform the sponsor immediately that 
this request has been made. 
14.2.4 Confidentiality Regarding Clinical Trial Patients 
Patients will be assigned a unique identifier by the sponsor. The investigator must ensure that 
any patient´s data that are transferred to the sponsor will contain the identifier only; patient names 
or any information which would make the patient identifiable will not be transferred. 
 
14.2.5 Financial Disclosure 
Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators and 
sub-investigators are responsible for providing information on financial interests during the 
course of the study and for 1 year after completion of the study.  
14.3 Publication of trial protocol and results 
Information on the protocol will be posted in a publicly accessible database such as 
clinicaltrials.gov and/or the EU Clinical Trials Register. In addition, the results of this trial will 


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be submitted for publication and/or posted in a publicly accessible database in accordance with 
local regulations. 
14.4 Publication Policy 
Any presentation or publication of data from this trial will be intended as a joint publication by 
the investigator(s)/appropriate trial site personnel and appropriate sponsor personnel. Authorship 
will follow the International Committee of Medical Journal Editors Uniform Requirements for 
Manuscripts Submitted to Biomedical Journals and will be defined prior to the first publication. 
For multicentre studies, it is mandatory that the first publication be based on data from all centres, 
and that the data are analysed and submitted as stipulated in the protocol by a statistician assigned 
by the sponsor. 
Thus, no investigator or institution may publish any results of the trial conducted at their site, 
before such a first multicentre publication is made which covers the data from all sites. The 
authors have the final responsibility for the decision to submit their manuscript and shall be given 
full access to the data resulting from the trial. 
The coordinating investigator and/or authors shall coordinate any intended publication of trial 
results with the sponsor, to enable the sponsor to ensure that results are presented in a responsible 
and coherent manner. 
The sponsor reserves the right to review all manuscripts and abstracts at least 60 days before 
their submission for publication or presentation. This is not intended to restrict or hinder 
publication or presentation, but is to allow the sponsor to protect the confidentiality of 
information and to provide comments that may not yet be available to the investigator. 
At the sponsor’s request, any confidential information (other than trial results) will be deleted 
and all reasonable comments made by the sponsor will be incorporated prior to the submission 
for publication or presentation. In the rare event that such publication would affect the 
patentability of any invention to which the sponsor has rights, the sponsor has the right to request 
an additional delay to the proposed publication of no more than 90 days so as to allow the sponsor 
to protect its intellectual property rights. 
The results of the trial may be used by the sponsor for the purposes of national and international 
registration, publication, and information for medical professionals. If necessary, the authorities 
will be notified of the investigators’ names, addresses, qualifications, and extent of involvement. 
 
 


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Delarue R, Tilly H, Mounier N, et al. Dose-dense rituximab-CHOP compared with standard 
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study): a randomised phase 3 trial. Lancet Oncol. 2013;14(6):525-533. 
Flowers CR, Sinha R, Vose JM. Improving outcomes for patients with diffuse large B-cell 
lymphoma. CA Cancer J Clin. 2010;60(6):393-408. 
Ginaldi L, De Martinis M, Matutes E, et al. Levels of expression of CD19 and CD20 in chronic 
B cell leukaemias. J Clin Pathol. 1998;51(5):364–369. 
Habermann TM, Weller EA, Morrison VA, et al. Rituximab-CHOP versus CHOP alone or 
with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin 
Oncol. 2006;24(19):3121-3127. 
Hammer O. CD19 as an attractive target for antibody-based therapy. MAbs. 2012;4(5):571-
577. 
Johnson NA, Boyle M, Bashashati A, et al. Diffuse large B-cell lymphoma: reduced CD20 
expression is associated with an inferior survival. Blood. 2009;113(16):3773-3780. 


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Jurczak W, Zinzani PL, Gaidano G, et al. Phase IIa study of the CD19 antibody MOR208 in 
patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Ann Oncol. 
2018;29(5):1266-1272. 
Klisovic R, Winderlich M, Ambarkhane S, et al. Single-agent MOR208 in patients with 
relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): a single-arm phase II 
study. EHA Library (conference poster). 2017;180615:E839. 
Lenz G, Wright G, Dave SS, et al. Stromal gene signatures in large-B-cell lymphomas. N Engl 
J Med. 2008;359(22):2313-2323 
Lister TA, Crowther D, Sutcliffe SB, et al. Report of a committee convened to discuss the 
evaluation and staging of patients with Hodgkin's disease: Cotswolds meeting. J Clin Oncol. 
1989;7(11):1630-1636. 
Nowakowski GS, LaPlant B, Habermann TM, et al. Lenalidomide can be safely combined with 
R-CHOP (R2CHOP) in the initial chemotherapy for aggressive B-cell lymphomas: phase I 
study. Leukemia. 2011;25(12):1877-1881. 
Nowakowski GS, Hong F, Scott DW, et al. Addition of lenalidomide to R-CHOP (R2CHOP) 
improves outcomes in newly diagnosed diffuse large B-cell lymphoma (DLBCL): First report 
of ECOG‐ACRIN1412 A randomized Phase 2 US Intergroup study of R2CHOP vs R‐CHOP. 
Hematol Oncol. 2019;37(S2)37-38. 
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern 
Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-55. 
Olejniczak SH, Stewart CC, Donohue K, et al. A quantitative exploration of surface antigen 
expression in common B-cell malignancies using flow cytometry. Immunol Invest. 
2006;35(1):93-114. 
Pfreundschuh M, Schubert J, Ziepert M, et al. Six versus eight cycles of bi-weekly CHOP-14 
with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a 
randomised controlled trial (RICOVER-60). Lancet Oncol. 2008;9(2):105-116. 
Salles GA, Johannes Duell J, Eva González-Barca E, et al. Single-Arm Phase II Study of 
MOR208 Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large 
B-Cell Lymphoma: L-Mind. Blood. 2018;132(S1):227.  
Schmitz R, Wright GW, Huang DW, et al. Genetics and Pathogenesis of Diffuse Large B-Cell 
Lymphoma. N Engl J Med. 2018;378(15):1396-1407. 
Sehn LH, Congiu AG, Culligan DJ, et al. No Added Benefit of Eight Versus Six Cycles of 
CHOP When Combined with Rituximab in Previously Untreated Diffuse Large B-Cell 
Lymphoma Patients: Results from the International Phase III GOYA Study. Blood. 
2018;132(S1):783-783. 
Shipp MA, Harrington DP, Anderson JR, et al. A predictive model for aggressive non-
Hodgkin's lymphoma. N Engl J Med. 1993;329(14):987-994. 
Thieblemont C, Tilly H, da Silva MG, et al. First Analysis of an International Double-Blind 
Randomized Phase III Study of Lenalidomide Maintenance in Elderly Patients with DLBCL 
Treated with R-CHOP in First Line, the Remarc Study from Lysa. Blood. 128(22):471-471. 


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Tokunaga T, Tomita A, Sugimoto K, et al. De novo diffuse large B-cell lymphoma with a 
CD20 immunohistochemistry-positive and flow cytometry-negative phenotype: molecular 
mechanisms and correlation with rituximab sensitivity. Cancer Sci. 2014;105(1):35-43. 
Vaidya R, Witzig TE. Prognostic factors for diffuse large B-cell lymphoma in the R(X)CHOP 
era. Ann Oncol. 2014;25(11):2124-2133. 
Vitolo U, Chiappella A, Franceschetti S, et al. Lenalidomide plus R-CHOP21 in elderly 
patients with untreated diffuse large B-cell lymphoma: results of the REAL07 open-label, 
multicentre, phase 2 trial. Lenalidomide plus R-CHOP21 in elderly patients with untreated 
diffuse large B-cell lymphoma: results of the REAL07 open-label, multicentre, phase 2 trial. 
Lancet Oncol. 2014;15(7):730-737. 
Vitolo U, Trněný M, Belada D, et al. Obinutuzumab or Rituximab Plus Cyclophosphamide, 
Doxorubicin, Vincristine, and Prednisone in Previously Untreated Diffuse Large B-Cell 
Lymphoma. J Clin Oncol. 2017;35(31):3529-3537. 
Vitolo U, Witzig TE, Gascoyne RD, et al. ROBUST: First report of phase III randomized study 
of lenalidomide/R‐CHOP (R2‐CHOP) vs placebo/R‐CHOP in previously untreated ABC‐type 
diffuse large B‐cell lymphoma. Hematol Oncol. 2019;37(S2):36-37. 
Wilson WH, Sin-Ho J, Pitcher BN, et al. Phase III Randomized Study of R-CHOP Versus DA-
EPOCH-R and Molecular Analysis of Untreated Diffuse Large B-Cell Lymphoma: 
CALGB/Alliance 50303. Blood. 2016;128(22):469-469. 
Witzig TE, Reeder CB, LaPlant BR, et al. A phase II trial of the oral mTOR inhibitor 
everolimus in relapsed aggressive lymphoma. Leukemia. 2011;25(2):341-347. 
Woyach JA, Awan F, Flinn IW, et al. A phase 1 trial of the Fc-engineered CD19 antibody 
XmAb5574 (MOR00208) demonstrates safety and preliminary efficacy in relapsed CLL. 
Blood. 2014;124(24):3553-3560. 
 
 


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16 APPENDICES 
Appendix A 
Calculation of Creatinine Clearance Using the Cockcroft-Gault Formula  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix B 
ECOG Performance Status Scale (Oken, 1982) 
Grade 
Description 
0 
Fully active; able to carry on all pre-disease performance without restriction. 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out 
work of a light or sedentary nature (e.g., light housework or office work). 
2 
Ambulatory and capable of all self-care but unable to carry out any work 
activities. Up and about > 50% of waking hours. 
3 
Capable of only limited self-care; confined to a bed or chair > 50% of waking 
hours. 
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or 
chair. 
5 
Dead 
 
 
 


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Appendix C  
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 0C), 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 (i.e., proximal or 
contiguous extranodal disease) that can be encompassed within an irradiation field appropriate 
for nodal disease of the same anatomic extent. A single extralymphatic site as the only site of 
disease should be classified as IE, rather than Stage IV. 
b Involvement of bone marrow at screening will always qualify for Ann Arbor Stage IV and 
should be recorded as extranodal involvement. 
Adapted from: 
Carbone PP, Kaplan HS, Musshoff K, et al. Report of the committee on Hodgkin’s disease 
staging classification. Cancer Res. 1971;31:1860-1861. 
Lister TA, Crowther D, Sutcliffe SB, et al. Report of a committee convened to discuss the 
evaluation and staging of patients with Hodgkin’s disease: Cotswolds Meeting. J Clin Oncol. 
1989;7:1630-1636. 
 
 
 
 


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Appendix D  
International Prognostic Index 
IPI Risk Factor 
Ann Arbor Stage III or IV 
Age > 60 years 
Serum LDH >1 x ULN 
ECOG Performance status  2 
Extranodal involvement  21 
 
IPI Risk Groups 
 
 
 
 
 
 
Number of IPI Risk Factors 
 
Low 
 
 
 
 
 
 
 
 
 
0 or 1 
 
Low-Intermediate 
 
 
 
 
 
 
 
    2 
 
 
High-Intermediate 
 
 
 
 
 
 
 
    3 
 
High  
 
 
 
 
 
 
 
 
4 or 5 
 
 
 
1 Extranodal involvement per Cheson 2014 can include sites that have focal uptake by PET- 
CT (e.g. spleen, liver, bone, thyroid, cutaneous, gastrointestinal (GI), bone, kidneys, pleural or 
pericardial effusions, ascities). 
ECOG = Eastern Cooperative Oncology Group; FDG = fluorodeoxyglucose; IPI = 
International Prognostic Index; PET = positron emission tomography; ULN = upper limit of 
normal. 
Adapted from: 
Shipp MA, Harrington DP, Anderson JR, et al. A predictive model for aggressive non-
Hodgkin’s lymphoma. N Engl J Med. 1993;329:987-94. 
 
 


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Appendix E 
Lugano Response Criteria for Malignant Lymphoma (Cheson, 2014) 
Target and Non-Target Lesions 
Up to six of the largest target nodes, nodal masses, or other lymphomatous lesions that are 
measurable in two diameters should be identified from different body regions representative of 
the patient’s overall disease burden and include mediastinal and retroperitoneal disease, if 
involved. At baseline, a measurable node must be greater than 15 mm in longest diameter (LDi). 
Measurable extranodal disease may be included in the six representative, measured lesions. At 
baseline, measurable extranodal lesions should be greater than 10 mm LDi. 
All other lesions (including nodal, extranodal, and assessable disease) should be followed as 
nonmeasured disease as non-target lesions (e.g. cutaneous, GI, bone, spleen, liver, kidneys, 
pleural or pericardial effusions, ascites, bone, bone marrow). 
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 progressive disease. The LDi and smallest 
diameter (SDi) are no longer needed to determine progression. 
 
 
Response 
Imaging 
Lymph node 
and extra 
lymphatic 
sites 
Non target 
lesions 
Liver and 
spleen 
Bone marrow New lesion 
 
 
 
 
 
 
CR 
 
 
 
 
PET 
Score of 1, 2 
or 3a with our 
without a 
residual mass 
on 5PSb 
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 
 
 
 
 
 
 
Score 4 or 5 b 
with reduced 
uptake 
compared with 
 
 
 
 
 
 
Residual 
uptake higher 
than uptake in 
normal 
 
 
 


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Response 
Imaging 
Lymph node 
and extra 
lymphatic 
sites 
Non target 
lesions 
Liver and 
spleen 
Bone marrow New lesion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PR 
 
 
 
 
 
 
 
 
 
PET 
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 
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 x 5 mm 
as the default 
value 
When no 
longer visible, 
0 x 0 mm 
For a node > 5 
mm x 5 mm, 
but smaller 
than normal, 
use actual 
 
 
 
 
 
 
 
 
 
 
 
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 
Non target 
lesions 
Liver and 
spleen 
Bone marrow New lesion 
measurement 
for calculation
 
 
 
 
 
 
 
 
SD 
 
 
 
 
PET 
Score 4 or 5 b 
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 
progressive 
disease are met
 
 
 
 
No increase 
consistent with 
progression 
 
 
 
 
No increase 
consistent 
with 
progression 
 
 
 
 
 
Not applicable
 
 
 
 
 
None 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PD 
 
 
 
 
 
 
PET 
 
 
 
 
Score 4 or 5 b 
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 (e.g., 
infection, 
inflammation); 
if uncertain 
regarding 
etiology of 
new lesions, 
biopsy or 
interval scan 
may be 
considered 
 
 
 
 
 
 
 
An individual 
node/lesion 
must be 
abnormal with: 
LDi > 1.5 cm 
and 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Regrowth of 
previously 
resolved 
lesions 
A new node > 
1.5 cm in any 
axis 


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Response 
Imaging 
Lymph node 
and extra 
lymphatic 
sites 
Non target 
lesions 
Liver and 
spleen 
Bone marrow New lesion 
 
 
 
 
 
 
 
 
 
CT 
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 (e.g., 
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 non-
target lesions 
 
 
 
 
 
 
 
 
 
New or 
recurrent 
splenomegaly
 
 
 
 
 
 
 
 
 
New or 
recurrent 
involvement 
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 
 
 
 
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 (e.g., liver, spleen, kidneys, lungs), gastrointestinal involvement, cutaneous 
lesions, or those noted on palpation. Non-measured lesions: Any disease not selected as measured; 


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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 (e.g., GI tract, 
liver, bone marrow), FDG uptake may be greater than in the mediastinum with complete metabolic 
response, but should be no higher than surrounding normal physiologic uptake (e.g., 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. 
 


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Appendix F 
Information on Investigational and Registered Products 
The Investigator’s Brochure for tafasitamab, Summary of Product Characteristics (approved in 
EU) for lenalidomide will be supplied to the study sites. 
 
 


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Appendix G (Applicable in US only) 
Definition of Highly Effective, Effective and Unacceptable Methods of Birth Control and 
True Abstinence 
Highly effective birth control methods: Intrauterine device, hormonal methods (birth control 
pills, hormonal patches, injections, vaginal rings, or implants), tubal ligation, partner's 
vasectomy 
True abstinence: 
True abstinence is part of the preferred and usual lifestyle of the patient. Periodic abstinence 
(e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence 
for the duration of exposure to the investigational product, and withdrawal are not acceptable 
methods of contraception. 
Additional effective birth control methods: male latex or synthetic condom, diaphragm, 
cervical cap 
Unaccaptable methods of birth control are progesterone-only "mini-pills", IUD Progeserone 
T, female condoms, natural family planning (rhythm method)or breastfeeding, fertility 
awareness, withdrawal, and cervical shield (A cervical shield should not be confused with a 
cervical cap, which is an effective mehtod of contraception) 
 
 


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Appendix H 
Females of childbearing potential (FCBP)1 
Applicable in all countries except US: 
Criteria to assess whether a female is not of childbearing potential (at least 1 criterion must be 
fulfilled):  
a) Aged 50+ and naturally occurring amenorrhea of over 1 year (Amenorrhea that occurred as a 
result of cytostatic therapy or during breastfeeding period does not exclude the possibility that 
the patient is fertile) 
b) Premature ovarian failure that was confirmed by a gynecologist 
c) Bilateral salpingo-oophorectomy or hysterectomy as part of medical history 
d) XY genotype, Turner syndrome, uterine agenesis 
Applicable in US: 
Criteria to assess whether a female is not of childbearing potential (any of the following): 
a) Females who have been in natural menopause for at least 24 consecutive months 
b) Females who have had a hysterectomy and/or bilateral oophorectomy 
c) Females who have not started menstruating 
                                                 
1 This term is used synonymously with „females of reproductive potential“ or „women who can get pregnant“ 

SAP_001.pdf: 
 
 
STATISTICAL ANALYSIS PLAN  
MorphoSys AG  
MOR208C107 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
Version 4.0 
 
MorphoSys AG 
Semmelweisstr. 7 
D-82152 Planegg 
GERMANY 
 
A Phase Ib, open-label, randomized study to assess safety and preliminary efficacy of 
Tafasitamab in addition to R-CHOP or Tafasitamab plus Lenalidomide in addition to R-
CHOP in patients with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) – First-
MIND 
Protocol No: MOR208C107 
 
IND Number: 
145,009 
EudraCT Number: 
2019-001268-31 
Sponsor: 
MorphoSys AG 
Author: 
 
SAP Version: 
4.0 
Version Dates: 
31-Aug-2022 
 
 
 
This document contains confidential information of MorphoSys AG.  Any viewing or disclosure 
of such information that is not authorized in writing by MorphoSys AG is strictly prohibited.  
Such information may be used solely for the purpose of reviewing or performing this study. 


 
 
STATISTICAL ANALYSIS PLAN  
MorphoSys AG  
MOR208C107 
 
MorphoSys AG 
Confidential 
Page 2 of 77
 
 
STATISTICAL ANALYSIS PLAN 
SIGNATURE PAGE 
MorphoSys AG 
Semmelweisstr. 7 
D-82152 Planegg 
GERMANY 
 
A Phase Ib, open-label, randomized study to assess safety and preliminary efficacy of 
Tafasitamab in addition to R-CHOP or Tafasitamab plus Lenalidomide in addition to R-
CHOP in patients with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) – 
First-MIND 
Protocol No: MOR208C107 
 
 
 
 
 


 
 
STATISTICAL ANALYSIS PLAN  
MorphoSys AG  
MOR208C107 
 
MorphoSys AG 
Confidential 
Page 3 of 77
 
 
TABLE OF CONTENTS 
 
DOCUMENT HISTORY .................................................................................................................. 7 
 
CHANGE FROM PROTOCOL ...................................................................................................... 10 
 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .................................................... 11 
 
INTRODUCTION........................................................................................................................... 14 
 
STUDY OBJECTIVES AND ENDPOINTS .................................................................................. 15 
 
STUDY DESIGN ............................................................................................................................ 17 
 
General study design ..................................................................................................................... 17 
 
Schedule of assessments ................................................................................................................ 17 
 
Determination of sample size ........................................................................................................ 17 
 
Timing of analyses......................................................................................................................... 18 
 
Safety run-in analyses ........................................................................................................ 18 
 
Primary completion analysis .............................................................................................. 18 
 
Final analysis ..................................................................................................................... 18 
 
DEFINITIONS AND GENERAL METHODOLOGY ................................................................... 18 
 
Enrolment date ............................................................................................................................... 18 
 
Treatment arm ............................................................................................................................... 18 
 
Study drug and study treatment ..................................................................................................... 19 
 
Treatment cycle and treatment phase............................................................................................. 20 
 
Dates of study drug/study treatment administration ...................................................................... 21 
 
Date of first administration of study drug .......................................................................... 21 
 
Date of last administration of study drug ........................................................................... 21 
 
Date of first administration of study treatment .................................................................. 21 
 
Date of last administration of study treatment ................................................................... 21 
 
Reference start date, reference end date and study day ................................................................. 21 
 
Date of last contact ........................................................................................................................ 22 
 
Screening failure ............................................................................................................................ 22 
 
Time unit ....................................................................................................................................... 22 
 
Baseline ..................................................................................................................................... 22 
 
On-treatment event and post-treatment event ............................................................................ 23 
 
Analysis visit windows and eCRF visit windows ...................................................................... 23 
 
eCRF visit and anchoring date ....................................................................................... 23 
 
Analysis visit windows .................................................................................................. 24 
 
Selection of data in the event of multiple records in a window ................................................. 25 


 
 
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Unscheduled visits ..................................................................................................................... 25 
 
Analysis sets .............................................................................................................................. 25 
 
Screened patients population ......................................................................................... 25 
 
Full analysis set (FAS) ................................................................................................... 26 
 
Safety Set (SAF) ............................................................................................................ 26 
 
Per protocol set (PPS) .................................................................................................... 26 
 
PK analysis set (PKAS) ................................................................................................. 26 
 
Immunogenicity analysis set (IAS) ................................................................................ 27 
 
Reason of exclusion from analysis sets ......................................................................... 27 
 
Planned analyses for the different populations .............................................................. 28 
 
Withdrawal of informed consent ................................................................................... 29 
 
Medical coding .......................................................................................................................... 29 
 
STATISTICAL METHODOLOGY................................................................................................ 30 
 
General principles of statistical programming and handling analysis dataset ............................... 30 
 
Variable types and descriptive statistics ........................................................................................ 30 
 
Handling of incomplete or missing date/time information ............................................................ 31 
 
Data included in the analysis and cut-off date ............................................................................... 33 
 
Pooling of investigative sites ......................................................................................................... 34 
 
PATIENT DISPOSITION, BACKGROUND AND BASELINE CHARACTERISTICS .............. 34 
 
Patient disposition.......................................................................................................................... 34 
 
Enrollment status ............................................................................................................... 34 
 
Completion and premature discontinuation of study treatment and study drugs ............... 34 
 
Patient status in each treatment cycle ................................................................................ 35 
 
Patient status in follow-up period ...................................................................................... 35 
 
Protocol deviations ........................................................................................................................ 36 
 
Analysis sets .................................................................................................................................. 37 
 
Baseline and demographic characteristics ..................................................................................... 37 
 
Medical history and concomitant medical conditions.................................................................... 38 
 
Definition ........................................................................................................................... 38 
 
Data presentation ............................................................................................................... 38 
 
Prior and concomitant medications and non-drug treatments/procedures ..................................... 40 
 
Definitions ......................................................................................................................... 40 
 
Data presentation ............................................................................................................... 40 
 
DLBCL-specific prior therapies ........................................................................................ 41 


 
 
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New anti-lymphoma treatments ......................................................................................... 41 
 
Study treatment and study drug administration ............................................................................. 41 
 
Definitions ......................................................................................................................... 41 
 
Data Presentation ............................................................................................................... 45 
 
Listing presentation of exposure ........................................................................................ 47 
 
EFFICACY EVALUATION ........................................................................................................... 48 
 
Analysis of Response and progression evaluation ..................................................................... 48 
 
General definition .......................................................................................................... 48 
 
Objective response rate (ORR) at EOT and Best ORR.................................................. 49 
 
The metabolic, PET-negative complete response rate ................................................... 49 
 
Duration of Response and Duration of Complete Response .......................................... 50 
 
Progression-free survival ............................................................................................... 53 
 
Event-free survival......................................................................................................... 54 
 
Overall survival ............................................................................................................. 55 
 
Time to next anti-lymphoma treatment.......................................................................... 56 
 
Primary Refractoriness at EOT ...................................................................................... 57 
 
Listing of response assessment ...................................................................................... 57 
 
Analysis of Pharmacokinetic data ............................................................................................. 58 
 
Analysis of Immunogenicity data .............................................................................................. 58 
 
Analysis of Biomarker data ....................................................................................................... 59 
 
Analysis of B symptoms and ECOG status ............................................................................... 62 
 
SAFETY EVALUATION ............................................................................................................... 62 
 
Adverse events ........................................................................................................................... 62 
 
Definitions of AEs ......................................................................................................... 62 
 
Analysis of AEs ............................................................................................................. 64 
 
Definition of abnormality, significant worsening, outlying and extreme result in safety analysis
 
66 
 
Laboratory data .......................................................................................................................... 67 
 
Laboratory variables ...................................................................................................... 67 
 
Grading of laboratory data ............................................................................................. 68 
 
Analysis of Laboratory .................................................................................................. 69 
 
Vital signs .................................................................................................................................. 69 
 
Vital signs variables ....................................................................................................... 69 
 
Analysis of Vital signs ................................................................................................... 70 


 
 
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Physical examination ................................................................................................................. 70 
 
Electrocardiogram (ECG) .......................................................................................................... 70 
 
ECG variables ................................................................................................................ 70 
 
Analysis of ECG ............................................................................................................ 70 
 
Echocardiogram (ECHO) or cardio multigated acquisition (MUGA) ....................................... 71 
 
ECHO or MUGA variables............................................................................................ 71 
 
Analysis of ECHO or MUGA ........................................................................................ 71 
 
ANALYSES SPECIFIC TO COVID-19 PANDEMIC ................................................................... 71 
 
GENERAL GUIDANCE ON REPORTING .................................................................................. 73 
 
Document headers, footers and layout ....................................................................................... 73 
 
Presentation of output numbering and titles within this document ............................................ 74 
 
General rules for presenting tables and listings ......................................................................... 74 
 
Presentation of analysis sets ...................................................................................................... 75 
 
General rules for presenting frequencies and percentages ......................................................... 75 
 
Presentation of dates .................................................................................................................. 76 
 
REFERENCES ................................................................................................................................ 77 
 
 


 
 
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 DOCUMENT HISTORY 


 
 
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 CHANGE FROM PROTOCOL  


 
 
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 LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
AE 
Adverse event 
AESI 
Adverse Event of Special Interest 
ALP 
Alkaline phosphatase 
ALT 
Alanine amino Transferase 
ANC 
Absolute Neutrophil Count  
aPTT 
Activated Partial Thromboplastin Time 
AST 
Aspartate amino Transferase 
ATC 
Anatomical Therapeutic Chemical 
BLQ 
Below the Limit of Quantification 
CHOP 
Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone 
CI 
Confidence Interval  
Cmax 
Concentration max. 
CNS 
Central Nervous System 
COO 
Cell of Origin 
CR 
Complete Response 
CRO 
Contract Research Organization 
CT 
Computerised Tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
ctDNA 
Circulating Tumor DNA 
Ctrough 
Concentration trough 
CSR 
Clinical Study Report 
DLBCL 
Diffuse Large B-cell Lymphoma 
DNA 
Deoxyribonucleic Acid 
DOR 
Duration of Response 
DoCR 
Duration of Complete Response 
ECG  
Electrocardiogram 
ECHO 
Echocardiogram 
ECOG 
Eastern Cooperative Oncology Group  
eCRF 
Electronic Case Report Form 
EFS 
Event Free Survival 
EMA 
European Medicines Agency 
EOT 
End of Treatment 
FAS 
Full Analysis Set 
FCBP 
FDA 
Females of childbearing potential 
Food and Drugs Administration 
FDG 
Fluorodeoxyglucose 
FU 
Follow-up 
GCP 
Good Clinical Practice 
GI 
Gastrointenstinal 
HBV 
Hepatitis B Virus 
HCV 
Hepatitis C Virus 
Anti-HBc 
Hepatitis B Core Antibody 
Anti-HBs 
Hepatitis B Surface Antibody  
Anti-HCV 
Hepatitis C Virus Antibody 
IAS 
Immunogenicity Analysis Set 
ICF 
Informed Consent Form 


 
 
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ICH 
International Council for Harmonisation 
IHC 
Immunohistochemistry 
IgA 
Immunoglobulin A 
IgG 
Immunoglobulin G 
IgM 
Immunoglobulin M 
IMP 
Investigational Medicinal Product 
IPI 
International Prognostic Index  
IRR 
Infusion-related reaction 
IV 
Intravenous 
LDH 
Lactate Dehydrogenase 
LEN 
Lenalidomide 
LVEF 
Left Ventricular Systolic Function 
mAb 
Monoclonal Antibody 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
mL 
Millilitre 
MRD 
Minimal Residual Disease  
MUGA 
Multigated Acquisition 
NCI 
National Cancer Institute 
ng 
Nanogram 
NK 
Natural Killer 
NKCC 
Natural Killer Cell Count 
ORR 
Objective Response Rate 
OS 
Overall Survival 
PCR 
Polymerase Chain Reaction  
PD 
Progressive Disease 
PE 
Physical Examination 
PET 
Positron Emission Tomography 
PFS 
Progression Free Survival 
PK 
Pharmacokinetics 
PKAS 
Pharmacokinetic Analysis Set 
PML 
Progressive Multifocal Leukoencephalopathy 
PPS 
Per Protocol Set 
PR 
Partial Response 
PT 
Preferred Term 
PTT 
Partial Thromboplastin Time 
RBC 
Red Blood Cell 
R-CHOP 
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone 
RNA 
Ribonucleic Acid 
R/R 
Relapsed/Refractory 
SAP 
Statistical Analysis Plan 
SAE 
Serious adverse event 
SAF 
Safety Set 
StD 
Standard Deviation 
SoC 
System Organ Class 
SOP 
Standard Operating Procedure 
TEAE 
Treatment Emergent Adverse Event 
TLS 
Tumor Lysis Syndrome 


 
 
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TTNT 
Time to Next Anti-lymphoma Treatment 
TTP 
Time to Progression 
ULN 
Upper Limit of Normal 
WBC 
White Blood Cell 
WHO 
World Health Organisation 


 
 
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 INTRODUCTION 
This Statistical Analysis Plan (SAP) describes the planned analysis and reporting of data collected from 
MorphoSys protocol MOR208C107, Version 6.0, dated 05-Feb-2020. Any amendments to the protocol 
which do not affect the statistical aspects of the trial will not necessitate an SAP update. 
This study is an open-label, randomized, phase Ib study to assess safety and preliminary efficacy of 
Tafasitamab in addition to R-CHOP or Tafasitamab plus Lenalidomide in addition to R-CHOP in patients 
with newly diagnosed diffuse large B-cell lymphoma. The structure and content of this SAP provides 
sufficient detail to meet the requirements identified by the Food and Drug Administration (FDA), European 
Medicines Agency (EMA), and International Conference on Harmonization (ICH) of Technical 
Requirements for Registration of Pharmaceuticals for Human Use: Guidance on Statistical Principles in 
Clinical Trials. All work planned and reported from this SAP will follow internationally accepted guidelines, 
published by the American Statistical Association and the Royal Statistical Society, for statistical practice. 
The planned analyses identified in this SAP may be included in clinical study report (CSRs) and/or in 
relevant summary report documents (e.g. regulatory submissions, or future manuscripts). Also, post-hoc 
exploratory analyses not necessarily identified in this SAP may be performed to further examine study data 
and will not require updating the final SAP. Any post-hoc, or unplanned, exploratory analysis performed 
will be clearly identified as such and described in the final CSR. 
The following documents were reviewed in preparation of this SAP: 
• 
Clinical Trial Protocol MOR208C107, Version 6.0, dated 05-Feb-2020 
• 
Annotated electronic Case report forms (eCRFs), Version final 5.0, dated 03-Feb-2022 
• 
ICH Guidance on Statistical Principles for Clinical Trials (E9) 
The reader of this SAP is encouraged to also read the clinical trial protocol, and other identified documents, 
for details on the design and planned conduct of this study. Operational aspects related to collection and 
timing of planned clinical assessments are not repeated in this SAP unless relevant to the planned analysis. 
 
 
 


 
 
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 STUDY OBJECTIVES AND ENDPOINTS 
An overview of the study objectives and endpoints is depicted in Table 1. 
Table 1: Study objectives and endpoints 
 
Objective  
Endpoint 
SAP section 
Primary  
To assess safety and tolerability of 
tafasitamab in addition to R-CHOP 
and tafasitamab plus lenalidomide in 
addition to R-CHOP 
Incidence and severity of 
treatment emergent adverse 
events (TEAEs)  
Section 11.1 
Key 
Secondary  
To assess efficacy (based on Lugano 
2014 criteria) of  tafasitamab in 
addition to R-CHOP and tafasitamab 
plus lenalidomide in addition to R-
CHOP  
 
Objective Response Rate 
(ORR) at the end of 
treatment 
 
Section 10.1.2 
Metabolic, positron emission 
tomography (PET)-negative 
complete response (CR) rate 
at the end of treatment 
Section 10.1.3 
Secondary  
To assess long-term safety and 
tolerability of  tafasitamab in addition 
to R-CHOP and tafasitamab plus 
lenalidomide in addition to R-CHOP  
Incidence and severity of 
adverse events (AEs) in the 
follow-up period 
Section 11.1 
 
To assess long term efficacy (based on 
Lugano 2014 criteria) of  tafasitamab 
in addition to R-CHOP and 
tafasitamab plus lenalidomide in 
addition to R-CHOP 
Best Objective Response 
Rate (ORR) until the end of 
study 
Section 10.1.2 
Metabolic, PET-negative 
complete response (CR) rate 
until the end of study 
Section 10.1.3 
Progression-free survival 
(PFS) at 12 and 24 months  
Secion 10.1.5 
Event-free survival (EFS) at 
12 and 24 months 
Section 10.1.6 
Overall survival (OS) at 12 
and 24 months  
Section 10.1.77 
Time to next anti-lymphoma 
treatment (TTNT) 
Section 10.1.88 
 
To assess the pharmacokinetic (PK) 
profile of tafasitamab in each 
treatment arm  
Tafasitamab serum 
concentrations, i.e., 
Concentration trough 
(Ctrough) levels and 
Concentration max (Cmax) 
levels on Day 1 of each cycle 
Section 10.2 
 
To assess the potential 
immunogenicity of tafasitamab in 
each treatment arm  
Number and percentage of 
patients developing anti-
tafasitamab antibodies, and 
Section 10.3 


 
 
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Objective  
Endpoint 
SAP section 
semi-quantitative titer 
assessments.  
Exploratory* 
To evaluate residual disease burden by 
serial circulating tumor DNA 
(ctDNA) assessment 
Descriptive statistics of 
ctDNA by visit 
Section 10.4 
 
To assess the relationship between  
potential molecular or  cellular 
markers and efficacy of tafasitamab in 
addition to R-CHOP or tafasitamab 
and lenalidomide in addition to R-
CHOP 
The relationship of the 
following endpoints will be 
assessed for the following 
markers: 
Endpoints: 
i. 
ORR 
ii. 
PFS 
 
Biomarkers: 
i. 
Cell of origin  
ii. 
Quantitative and 
semi-quantitative 
CD19 expression on 
tumor cells (in 
diagnostic biopsies 
and at 
progression/relapse 
if available) 
iii. 
Quantitative and 
semi-quantitative 
CD20 expression on 
tumor cells (in 
diagnostic biopsies 
and at 
progression/relapse 
if available)  
Section 10.4 
*A limited number of biomarkers (listed above) will be considered and will be presented in CSR.  
 
 


 
 
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 STUDY DESIGN  
 General study design 
This is a multicenter, open-label, randomized, Phase Ib trial to assess safety and preliminary efficacy of 
tafasitamab in addition to R-CHOP or tafasitamab plus lenalidomide in addition to R-CHOP in adult patients 
with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Approximately 60 patients (approximately 
30 in each arm) will be randomized in this study. If a patient discontinues the trial for any reason other than 
treatment related toxicity, progression/relapse of disease or death, this patient may be replaced.  
The trial consists of two phases, see Figure 1.  
Figure 1: Trial design  
  
 
 
All patients are expected to receive 6 cycles of treatment (each cycle consisting of 21 days) and to be 
followed up for 24 months (or 731 days) from the date of randomization. 
 Schedule of assessments  
For a detailed schedule of assessments, please refer to the protocol section 10. 
 Determination of sample size 
As this is a Phase Ib study primarily conducted to explore safety endpoints, no formal statistical hypothesis 
has been established for the sample size calculation of this trial.  
With a sample size of 12 patients in each arm, there is a 60% probability to observe 4 or more patients with 
unacceptable toxicity if the underlying incidence rate of these toxicities is 33%.  
With a sample size of 30 patients in each arm, there is a 55% probability to observe 10 or more patients with 
unacceptable toxicity if the underlying incidence rate of these toxicities is 33%. 
 


 
 
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 Timing of analyses 
 Safety run-in analyses 
A safety run-in phase with 24 patients , 12 patients in each arm, will be performed. In order to evaluate the 
safety in accordance with the stopping rules, enrolment may be paused when12 patients in each arm have 
been recruited and have been followed for 21 days after cycle 1 day 1 (C1D1). Details of stopping rules can 
be referred to in protocol section 6.3. Sponsor safety review meetings will be performed on an ongoing basis 
by representatives of the sponsor with medical and pharmacovigilance expertise and the medical monitors 
of the contract research organization. A Safety Committee (SC) consisting of sponsor representatives with 
at least two representatives of the participating investigators of this clinical trial. This committee will meet 
regularly until all patients have completed treatment.  During the safety run-in the SC committee meets 
approximately on a monthly basis.  In addition, an independent Data and Safety Monitoring Board (iDSMB) 
consisting of independent haematologists will be established. The iDSMB will provide a recommendation 
at the end of safety run-in phase when all patients in both arms have finished their first treatment cycle.  
Details of the SC and the iDSMB are outlined in the respective Charters and corresponding SAPs as 
available.  
 Primary completion analysis 
The primary completion analysis will be performed based on a data cut-off 30 days after all patients have 
performed their End of Treatment (EoT) Visit or discontinued study treatment.  
Primary and key secondary objectives will be analyzed at the time of primary completion analysis. All 
results of the primary completion analysis will be made available to Morphosys AG prior to finalization of 
the primary completion analysis/CSR. 
 Final analysis 
After the last patient completed the last visit, a final analysis will be performed.  
At the time of final completion analysis, analyses performed during primary completion analysis will be 
repeated using updated data in addition to the performance of secondary and exploratory objectives. 
Additional safety and follow-up analyses may be performed by the sponsor as and when deemed necessary. 
 DEFINITIONS AND GENERAL METHODOLOGY 
 Enrolment date 
Enrolment date is defined to be the date that patients signed the informed consent form. 
 Treatment arm 
There are two treatment arms in this study, which are denoted as treatment arm A and treatment arm B 
respectively. Treatment arm A refers to the group of patients receiving tafasitamab in addition to R-CHOP 
as planned, whereas treatment arm B refers to the groups of patients receiving tafasitamab plus lenalidomide 
in addition to R-CHOP. 


 
 
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 Study drug and study treatment 
For the purpose of the SAP and data presentation/analysis, study drug refers to tafasitamab or lenalidomide 
or any component of R-CHOP.  
Study treatment refers to tafasitamab plus R-CHOP for treatment arm A and tafasitamab plus lenalidomide 
in addition to R-CHOP for treatment arm B. 
Study treatment completion refers to that the record of ‘Subject completed treatment per protocol’ is filled 
for all components of study treatment in the ‘End of Treatment/Early Study Treatment Discontinuation’ 
eCRF page for the patients. If a patient reduces lenalidomide or any component of R-CHOP, or interrupts 
tafasitamab/lenalidomide/any component of R-CHOP per investigators’ instruction, he/she is still counted 
as completing study treatment, as long as he/she finishes the End of Treatment visit without any permanent 
discontinuation record. Patients with permanent discontinuation of any component of the study treatment 
fail the concept of study treatment completion.   
Completion of Tafasitamab: Completion of Tafasitamab implies that the primary reason for stopping 
treatment is filled as ‘Subject Completed Treatment Per Protocol’ for the treatment “Tafasitamab” in the 
‘End of Treatment/Early Study Treatment Discontinuation’ eCRF page. 
Premature discontinuation of Tafasitamab: If the primary reason for stopping treatment is filled as anything 
other than ‘Subject Completed Treatment Per Protocol’ for the treatment “Tafasitamab” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page, then the patient is said to discontinue 
Tafasitamab prematurely. 
Completion of Lenalidomide: Completion of Lenalidomide implies that the primary reason for stopping 
treatment is filled as ‘Subject Completed Treatment Per Protocol’ for the treatment “Lenalidomide” in the 
‘End of Treatment/Early Study Treatment Discontinuation’ eCRF page. 
Premature discontinuation of Lenalidomide: If the primary reason for stopping treatment is filled as anything 
other than ‘Subject Completed Treatment Per Protocol’ for the treatment “Lenalidomide” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page, then the patient is said to discontinue 
Lenalidomide prematurely. 
Completion of Rituximab: Completion of Rituximab implies that the primary reason for stopping treatment 
is filled as ‘Subject Completed Treatment Per Protocol’ for the treatment “Rituximab” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page. 
Premature discontinuation of Rituximab: If the primary reason for stopping treatment is filled as anything 
other than ‘Subject Completed Treatment Per Protocol’ for the treatment “Rituxamab” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page, then the patient is said to discontinue 
Rituximab prematurely. 
Completion of Cyclophosphamide: Completion of Cyclophosphamide implies that the primary reason for 
stopping treatment is filled as ‘Subject Completed Treatment Per Protocol’ for the treatment 
“Cyclophosphamide” in the ‘End of Treatment/Early Study Treatment Discontinuation’ eCRF page. 
Premature discontinuation of Cyclophosphamide: If the primary reason for stopping treatment is filled as 
anything other than ‘Subject Completed Treatment Per Protocol’ for the treatment “Cyclophosphamide” in 
the ‘End of Treatment/Early Study Treatment Discontinuation’ eCRF page, then the patient is said to 
discontinue Cyclophosphamide prematurely. 


 
 
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Completion of Doxorubicin: Completion of Doxorubicin implies that the primary reason for stopping 
treatment is filled as ‘Subject Completed Treatment Per Protocol’ for the treatment “Doxorubicin” in the 
‘End of Treatment/Early Study Treatment Discontinuation’ eCRF page. 
Premature discontinuation of Doxorubicin: If the primary reason for stopping treatment is filled as anything 
other than ‘Subject Completed Treatment Per Protocol’ for the treatment “Doxorubicin” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page, then the patient is said to discontinue 
Doxorubicin prematurely. 
Completion of Vincristine: Completion of Vincristine implies that the primary reason for stopping treatment 
is filled as ‘Subject Completed Treatment Per Protocol’ for the treatment “Vincristine” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page. 
Premature discontinuation of Vincristine: If the primary reason for stopping treatment is filled as anything 
other than ‘Subject Completed Treatment Per Protocol’ for the treatment “Vincristine” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page, then the patient is said to discontinue 
Vincristine prematurely. 
Completion of Prednisone: Completion of Prednisone implies that the primary reason for stopping treatment 
is filled as ‘Subject Completed Treatment Per Protocol’ for the treatment “Prednisone” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page. 
Premature discontinuation of Prednisone: If the primary reason for stopping treatment is filled as anything 
other than ‘Subject Completed Treatment Per Protocol’ for the treatment “Prednisone” in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page, then the patient is said to discontinue 
Prednisone prematurely. 
Completion of R-CHOP: Completion of R-CHOP implies that the primary reason for stopping treatment is 
filled as ‘Subject Completed Treatment Per Protocol’ for all the components of  R-CHOP in the ‘End of 
Treatment/Early Study Treatment Discontinuation’ eCRF page. 
Premature discontinuation of R-CHOP: If the primary reason for stopping treatment is filled as anything 
other than ‘Subject Completed Treatment Per Protocol’ for any of the components of R-CHOP in the ‘End 
of Treatment/Early Study Treatment Discontinuation’ eCRF page, then the patient is said to discontinue R-
CHOP prematurely. 
Premature study treatment discontinuation refers to all components of study treatment have been 
prematurely discontinued. In other words, permanent study treatment discontinuation means that no 
components of treatment have ‘Subject completed treatment per protocol’ on the ‘End of Treatment/Early 
Study Treatment Discontinuation’ eCRF page.  
 Treatment cycle and treatment phase 
A complete treatment cycle is defined as 21 calendar days during which tafasitamab in addition to R-CHOP 
(treatment arm A) or tafasitamab and lenalidomide in addition to R-CHOP (treatment arm B) will be 
administered. Details of doses and dosing days of each component of study treatment administration is 
depicted in protocol section 8.1. 
In this study, treatment phase refers to the 6 cycles of study treatment. 
 


 
 
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 Dates of study drug/study treatment administration 
 Date of first administration of study drug  
Date of first administration of study drug, which is also named as ‘Start date of study drug’, refers to the 
date of first non-zero dose of administration of each study drug.  
 Date of last administration of study drug 
Date of last administration of study drug, which is also named as ‘End date of study drug’, refers to the date 
of last non-zero dose of administration in each study drug.  
 Date of first administration of study treatment 
Date of first administration of study treatment refers to the date of first non-zero dose of administration of 
any study treatment component in each treatment arm.  
 Date of last administration of study treatment 
Date of last administration of study treatment refers to latest of the last date of non-zero dose administration 
of any study treatment component in each treatment arm. For example, the date of administration of 
tafasitamab on cycle 6 day 15 ideally will be the date of last administration of study treatment for both arms, 
if none of the study drugs was discontinued early.  
 Reference start date, reference end date and study day 
For this randomized study the reference start date for all safety assessments (e.g. adverse event onset, 
laboratory/ vital sign measurement, study drug administration, prior and concomitant medication (CM), 
medical history (MH) etc.), demographic and baseline assessment, pharmacokinetics analysis and biomarker 
analysis will be the date of first administration of study treatment. The reference start date for efficacy 
assessments (e.g. tumor assessment, death, ECOG performance status) and duration of overall survival 
follow-up period will be the randomization date.   
The reference start date is designated as Study Day 1. Study Day –1 is the day that precedes Study Day 1. 
Study Day 0 is not defined.  
In this study, the reference end date is designated to be the date of end of treatment. As per protocol, end 
of treatment is defined as the day 21 of the last treatment cycle the patient started. Ideally, the date of end 
of treatment is cycle 6 day 21, if patient does not discontinue the treatment phase early. If a patient 
discontinues the treatment prematurely and stays in the study, the date end of treatment will be day 21 of 
the last treatment cycle the patient started. If the patient died or discontinued both the treatment and study, 
date of death or date of discontinuation of treatment will be taken as date end of treatment. The reference 
end date is identical with date of end of treatment, and it will be used only for defining treatment emergent 
adverse event and permissible visit window for capturing disease response at end of treatment visit/early 
study treatment discontinuation visit, but not be applied to the calculation of exposure of study treatment. 
The study day describes the day of the event or assessment date, relative to the reference start date. 
The study day will be calculated as: 


 
 
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• 
If the event/assessment is on or after the reference start date, study day = [Date of the event/assessment 
- reference start date + 1]  
• 
If the event/assessment precedes the reference start date, study day = [Date of the event/assessment - 
reference start date] 
The study day will be displayed in the data listings.  
 Date of last contact 
The date of last contact is derived as the latest date among the following: 
• 
Actual assessment dates considering all assessments, including scheduled and unscheduled visits 
(Laboratory sample collection dates, vital signs, ECOG performance status, B-symptoms, ECG 
measurement,  tumor imaging). 
• 
New anti-lymphoma treatment date administered after study drug discontinuation. 
• 
Adverse events end date. If the adverse event is still ongoing, then the adverse event start date will 
be used. 
• 
Date of last interaction with patient collected on the “End of study/Early Follow-up 
Discontinuation” eCRF page for the lost to follow-up patients. 
• 
Date of death from the from the “End of study/Early Follow-up Discontinuation” eCRF page. 
• 
Date of study completion or discontinuation from the “End of study/Early  Follow-up 
Discontinuation” eCRF page. 
• 
Date of study treatment completion or discontinuation from the “End of Treatment/Early Study 
Treatment Discontinuation” eCRF page. 
 Screening failure 
Patients who signed the informed consent form, but failed to fulfill the Inclusion/Exclusion criteria, are 
considered as screening failures. Information of screening failures will be presented in the listings of patient 
disposition, inclusion/exclusion criteria, death and protocol deviation. 
 Time unit 
Unless specifically mentioned, month will be used as the time unit for analysis.  A month-length is 30.4375 
days (365.25/12). If duration is to be reported in months, duration in days is divided by 30.4375.  If duration 
is to be reported in years, duration in days will be divided by 365.25. 
 Baseline 
Baseline is the result of an investigation describing the “true” uninfluenced state of the patient, defined as 
the period from the date of signing any informed consent document to the start date of study treatment or 
the date of randomization. Assessments, specified to be collected post-dose on the first date of treatment 
(e.g. vital signs assessments during the tafasitamab infusion)  are not considered as baseline values. 
For efficacy evaluations, the last non-missing assessment, including unscheduled assessments on or before 
the date of randomization is taken as “baseline” value or “baseline” assessment.  


 
 
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For safety evaluations, unless otherwise stated, the last non-missing assessment, including unscheduled 
assessments on or before the date of start of study treatment is taken as “baseline” value or “baseline” 
assessment.  
If patients have no value as defined above, the baseline result will be missing. 
Change from baseline calculation 
Absolute change from baseline will be calculated as  
[visit value – baseline value] 
and percentage change from baseline will be calculated as  
[ 
visit value−baseline value
baseline value
 × 100 ]. 
 On-treatment event and post-treatment event 
On-treatment and post-treatment event will be flagged.  
An on-treatment event is defined as any event happening after the start date of study treatment, i.e. events 
happening in the following time interval (including the lower and upper limits): [Reference start date; 
Reference end date + 30 days]. 
A post-treatment event is defined as events happening in the following time interval (including the lower 
and upper limits): [Reference end date + 30 days + 1; date of End of study or Date of Study Discontinuation].  
 Analysis visit windows and eCRF visit windows  
Unless otherwise specified, for parameters that will be summarized by visit, the nominal visit as collected 
in the eCRF page will be used. For hematology and biochemistry data, analysis visit window will be 
applied in addition to nominal visit. 
 eCRF visit and anchoring date 
In the eCRF, visits are derived based on the CxD1, where x refers to the cycle number. Day 1 of each cycle 
is defined as the day on which tafasitamab is first administered in the cycle. In case tafasitamab is skipped 
due to any reason, day 1 of the cycle will be the day when the first component of R-CHOP is administered. 
In treatment arm B, in case both tafasitamab and R-CHOP is skipped, day 1 of the cycle is the day when 
first dose of lenalidomide is taken. If none of the component of study treatment is administered, day 1 of 
the cycle is the day when the first procedure for this visit is conducted (denoted as ‘first assessment’ in the 
following content). This CxD1 will be referred as anchoring CxD1. Anchoring date will be applied in 
defining analysis visit window (in section 7.12.2). 
The concept of anchoring date is added to differentiate the actual date of study drug administration and the 
collected eCRF visit. For example, if the C1D1 is anchored on 2019-02-01, an allowed administration visit 
window of tafasitamab for C1D8, as per protocol, is between 2019-02-06 and 2019-02-10. If tafasitamab is 
infused on 2019-02-06, the anchoring date of C1D8 visit is 2019-02-06, even though it is presented in the 
eCRF as C1D8 visit. Likewise, if tafasitamab is interrupted for this visit, the administration of R-
CHOP/lenalidomide or the first assessment of this visit will be applied as anchoring date. The following 
table elaborate the scheme of applying anchoring date in each visit. 
 


 
 
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Table 2. Anchoring date of treatment arm A: 
Planned visit* 
Tafasitamab 
administration 
R-CHOP 
administration 
First 
assessment 
Anchoring date 
CxD1 
Yes 
Yes 
Yes 
Date of tafasitamab administration 
No 
Yes 
Yes  
Date of administration of  first component 
of R-CHOP  
No 
No 
Yes 
Date of the first assessment 
CxD8 / CxD15 
Yes 
Not applicable 
Yes 
Date of tafasitamab administration 
Interrupted 
Not applicable  
Yes 
Date of the first assessment 
*Cx refers to cycle 1 to cycle 6.  
Table 3. Anchoring date of treatment arm B: 
Planned 
visit* 
Tafasitamab 
administration 
RCHOP 
administration 
Lenalidomide 
administration 
First 
assessment 
Anchoring date 
CxD1 
Yes 
Yes 
Yes 
Yes 
Date of tafasitamab administration 
No 
Yes 
Yes 
Yes  
Date of administration of first component 
of R-CHOP 
No 
No 
Yes 
Yes  
Date of lenalidomide administration 
No 
No 
No 
Yes 
Date of the first assessment 
CxD8  
Yes 
Not applicable 
Yes 
Yes 
Date of tafasitamab administration 
No 
Not applicable  
Yes 
Yes 
Date of lenalidomide administration 
No 
Not applicable  
No 
Yes 
Date of the first assessment 
CxD15 
Yes 
Not applicable 
Not applicable 
Yes 
Date of tafasitamab administration 
No 
Not applicable  
Not applicable 
Yes 
Date of first assessment 
*Cx refers to cycle 1 to cycle 6. 
 Analysis visit 
windows                                                                                                                                                                                      
Analysis visit windows is based on anchoring date and it would be applied to hematology and biochemistry 
measurements only. The detailed strategy for analysis visit and analysis visit window is depicted in the 
table below. Any assessment that falls outside of the analysis visit window will be presented as unscheduled 
visit. 
Table 4. Analysis visit 
Start date* 
End date** 
Analysis visit 
Date of signing ICF 
Anchoring C1D1 minus 2 days 
Screening visit 
Anchoring C1D1 minus 1 day 
Anchoring C1D1 
C1D1 
Anchoring C1D1 plus 3 days 
Anchoring C1D8 
C1D8 


 
 
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Anchoring C1D8  plus 3 days 
Anchoring C1D15 
C1D15 
Anchoring CxD1 minus 3 days 
Anchoring CxD1 
CxD1 
Anchoring CxD1 plus 3 days 
Anchoring CxD8 
CxD8 
Anchoring CxD8 plus 3 days 
Anchoring CxD15 
CxD15 
*Cx refers to cycle 2 to cycle 6 and Dy refers to day (1, 8, 15). 
** Per protocol, local laboratory and central biomarker data should be collected at pre-dose timepoint. As a 
consequence, if the anchoring date is on basis of study treatment administration, post-dose assessments will be 
excluded from the corresponding analysis visit.   
 Selection of data in the event of multiple records in a window 
Unless otherwise noted throughout the rest of this document, when a single value is needed, the following 
rules apply:  
• 
If more than one assessment occurs during the same nominal visit time window of the planned 
visit, select the record closest to the nominal day for that particular visit day/timepoint. 
• 
If there are two assessments that are equidistant from the nominal planned visit day, the data of 
the assessment after the scheduled study day will be used.  
• 
If more than one assessment is collected on the same day, the latest assessment on that day  will 
be used.  
 Unscheduled visits 
In this study, unscheduled visits, following defined as unscheduled eCRF visits, are time points not planned 
in the protocol. In addition, the unscheduled analysis visits is defined as section 7.12. 
In listings, unscheduled eCRF visits will be listed. In addition, unscheduled analysis visits will also be 
presented in hematology and biochemistry data listings. All visits will be ordered chronologically including 
the dates of unscheduled eCRF visits. 
Unscheduled visit will be incorporated in the baseline calculation and overall post-baseline summary. If the 
date is incomplete, but it can be determined whether values were measured in the treatment phase, they will 
be incorporated in overall post-baseline summaries. Unscheduled visits will be excluded from the per 
timepoint/visit presentation. 
 Analysis sets 
 Screened patients population 
The screened patients population consists of all patients who signed the ICF and completed the informed 
consent eCRF page. 


 
 
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 Full analysis set (FAS) 
All patients who are randomized to either treatment arm will be included in FAS. Patients will be analyzed 
according to the study treatment they are randomized to. The FAS will be the primary population for the 
analysis of efficacy and baseline characteristics. 
 
 Safety Set (SAF) 
All patients who received at least one dose of any component of study treatment are included into safety set. 
Safety analyses will be performed on SAF, presented on the basis of the following actual treatment arm: 
Table 5. Actual treatment arm of SAF set 
Did patient receive at 
least 
one 
dose 
of 
tafasitamab 
Did patient receive at 
least 
one 
dose 
of 
lenalidomide 
Did patient receive 
at least one dose of 
R-CHOP 
Treatment arm in SAF set 
Yes 
Yes 
Yes 
Treatment arm B 
Yes  
No 
Yes 
Treatment arm A 
Yes  
Yes 
No 
Tafasitamab + Lenalidomide 
Yes 
No 
No 
Tafasitamab only 
No 
Yes 
Yes 
Lenalidomide + R-CHOP 
No  
Yes  
No 
Lenalidomide only 
No 
No 
Yes 
R-CHOP only 
No 
No 
No 
Excluded from SAF set 
If for a given actual treatment arm (except treatment arm A and treatment arm B) less than 5 patients are 
included, Safety analysis for these patients will only be listed. 
 Per protocol set (PPS) 
Patients included in FAS with at least one non-zero dose of any component of study treatment and one valid 
post-baseline response assessment, and without any important protocol deviation that would confound 
efficacy analysis are included into per protocol set.  
All protocol deviations or conditions leading to exclusion from the PPS will be detailed in protocol deviation 
specification and summarized in the disposition table. Sensitivity analyses apply to some secondary 
endpoints are performed using PPS (see section 7.15.8). 
 PK analysis set (PKAS) 
The PKAS will include all patients who received at least one non-zero dose of tafasitamab and have at least 
one quantifiable serum tafasitamab concentration. 


 
 
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 Immunogenicity analysis set (IAS) 
The IAS will include all patients who received at least one non-zero dose of tafasitamab and have at least 
one valid anti-tafasitamab antibody assessment. 
 
 Reason of exclusion from analysis sets 
Patients may be excluded from the analysis sets for the following reasons. Note that if a patient has more 
than one reason for not being included in any analysis set, then only the reason which is higher in the 
order of the reason numbering will be considered. That is for PPS, if a patient is excluded because of “Not 
randomized” and “No dose of any component of study treatment”, then only “Not randomized” will be 
counted while summarizing the reasons for excludion from PPS.  
Table 6. Reasons of exclusion from analysis sets 
Analysis set 
Reason of exclusion from analysis set 
Screened patients 
Not applicable 
FAS 
1. Not randomized 
SAF 
1. No dose of any component of study treatment 
PPS 
1. Not randomized 
2. Not centrally confirmed DLBCL NOS. 
3. No dose of any component of study treatment 
4. No post-baseline response assessment 
5. Major protocol deviations that influence efficacy 
PKAS 
1. No dose of tafasitamab 
2. No quantifiable serum tafasitamab concentration 
IAS 
1. No dose of tafasitamab 
2. No valid anti-tafasitamab antibody assessment 
 
 
 


 
 
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 Planned analyses for the different populations 
The number of patients in each analysis set will be summarized. Table 7 and Table 8 give an overview of 
the assessments performed on the different analysis sets. 
Table 7: Overview of the analyses performed on the different analysis sets for summary analyses 
Analysis 
All 
patients 
screened 
FAS 
PPS 
SAF 
PKAS 
IAS 
Patient disposition 
x 
x 
 
x 
 
 
Protocol deviation 
x 
 
 
 
 
 
Summary of Study Duration 
 
x 
 
 
 
 
Summary of baseline and demographic 
characteristics 
 
x 
x 
x 
 
 
Summary of incidence and severity of adverse 
event (except for pre-treatment AEs) 
 
 
 
x 
 
 
Summary of adverse events (except for pre-
treatment AEs) of other aspects 
 
 
 
x 
 
 
Summary of Pre-treatment AEs 
x 
 
 
 
 
 
Summary of death  
x 
 
 
x 
 
 
Metabolic, PET-negative complete response 
rate (CR) at end of treatmen visit and metabolic, 
PET-negative CR until end of study 
 
x 
 
 
 
 
PFS , OS, ORR, DoR 
 
x 
x 
 
 
 
All other Efficacy Endpoints 
 
x 
 
 
 
 
Descriptive biomarker analyses 
 
x 
 
 
 
 
ORR and PFS stratified by biomarkers 
 
x 
 
 
 
 
Eastern Cooperative Oncology Group (ECOG) 
performance status and B-symptoms 
 
x 
 
   
 
 
Summary of study treatment and study drug 
administration 
 
 
 
x 
 
 
Summary of pre-medication, prior/concomitant 
medication, non-medication procedures and 
new anti-lymphoma treatment 
 
x 
 
x 
 
 
Summary of medical history and current 
medical condition 
 
x 
 
x 
 
 
Summary of  vital signs, electrocardiogram 
(ECG), local and central laboratory safety 
evaluations and physical examination 
 
 
 
x 
 
 
Pharmacokinetic analyses 
 
 
 
 
x 
 


 
 
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Analysis 
All 
patients 
screened 
FAS 
PPS 
SAF 
PKAS 
IAS 
Immunogenicity analyses 
 
 
 
 
 
x 
Table 8: Overview of the analyses performed on the different analysis sets for listing 
Analysis 
Analysis set  to be used 
Affiliated analysis set  to be 
flagged in additional column 
Patient disposition 
All patients screened 
FAS/SAF/PPS 
Protocol deviation 
All patients screened 
FAS/SAF/PPS 
Survival follow-up period, patient status, 
demographics and baseline charateristics 
FAS 
FAS/SAF/PPS 
Medical history and concomitant medication 
FAS 
FAS/SAF/PPS 
Study drug/treatment administration 
SAF 
FAS/SAF/PPS 
All efficacy endpoints, including tumor 
response, B symptoms and ECOG 
FAS 
FAS/SAF/PPS 
Descriptive biomarker analyses 
FAS 
FAS/SAF/PPS 
All safety endpoints (except for pre-treatment 
AEs) 
SAF 
NA 
Pre-treatment AEs 
All subects screened 
FAS/SAF/PPS 
Listing of deaths 
All patients screened 
FAS/SAF/PPS 
Pharmacokinetic analyses 
PKAS 
NA 
Immunogenicity analyses 
IMAS 
NA 
 Withdrawal of informed consent 
Any data collected in the clinical database after a patient withdraws informed consent from any further 
participation in the trial, will not be included in the analysis data sets. The date on which a patient withdraws 
full consent is recorded in the ‘End of Study/Early Follow-up Discontinuation’ eCRF page. Note: Patients 
who withdraw consent from study treatment but consent to study follow-up are considered as having only 
withdrawn consent of study treatment and this date captured in the eCRF is not to be considered as the date 
of withdrawal of full consent. Such post-treatment assessments will be included in the analysis data sets. 
Any data that is entered in the clinical database without the consent of the patient will be excluded from the 
analysis sets. Only exceptions are the information entered to identify date of withdrawal of consent e.g. End 
of Treatment, End of Study. 
Third party data, e.g. PK, biomarker etc., collected in the clinical database without having obtained consent 
for collection or if consent was withdrawn, will be excluded in the analysis data sets. 
 Medical coding 
Coding for adverse event, medical history and non-drug treatments and procedurewill be performed using 
the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.  


 
 
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Prior, concomitant and pre-medications will be recorded and coded using the current WHO Drug Dictionary 
Enhanced (WHO-DDE) and grouped by Anatomical Therapeutic Chemical (ATC) Level 2 class and 
preferred name. 
Toxicity grade of adverse event and medical history and are captured directly from eCRF. Toxicity grade 
of local laboratory data will be coded according to National Cancer Institute (NCI) Common Terminology 
Criteria for Adverse Events (CTCAE) V5.0 (exception for ‘Tumor Flare Reaction’ which will be coded 
using CTCAE V6.0).  
 STATISTICAL METHODOLOGY 
 General principles of statistical programming and handling analysis dataset 
The statistical analysis will be performed on the analysis study database with appropriate software, SAS® 
Software version 9.4 or above (SAS Institute, Cary, N.C.). 
For submission purpose all the source data from eCRF is implemented to agree with Study Data Tabulation 
Model (SDTM) v1.4 dataset and SDTM implementation guide v3.2 , and all analysis data for TLF creation 
is based on CDISC Analysis Data Model (ADaM) v2.1 dataset and ADaM implementation guide v1.1. 
Accordingly the complete metadata specification and data reviewers guide for both SDTM and ADaM will 
be provided. 
 Variable types and descriptive statistics 
Descriptive statistics will be calculated according to the data type as follows: 
Continuous variables (e.g. laboratory, vital signs, etc.): number of non-missing observations, number of 
missing observations, arithmetic mean, standard deviation (StD), minimum and maximum values and 
quartiles (median, Q1 and Q3) will be presented in the descriptive summary tables. For tafasitamab 
pharmacokinetics concentrations, coefficient of variation CV (%), geometric mean and geometric CV (%) 
will also be presented in the descriptive statistics. 
CV% = coefficient of variation (%) = StD/mean*100%                                                                         
Geometric CV% = sqrt (exp (variance for log transformed data)-1)*100%                                                      
If not otherwise specified, the following rules are applied: 
• 
Percentages are presented to 1 decimal points. 
• 
Percentage equal to 0 or 100 are presented as such without a decimal point. 
• 
Ratios/Event rate are reported to 3 decimal points. 
• 
The minimum and maximum will be reported to the same number of decimal places as the raw data 
recorded in the database.  The mean, median, lower quartile and upper quartile will be reported to 
one more decimal place than the raw data recorded in the database, while the StD will be reported 
to two more decimal places. In general, the maximum number of decimal places reported shall be 
four for any summary statistic. 
• 
If there are less than 5 observations, only the number of non-missing observations, arithmetic mean, 
median, minimum and maximum will be presented. 


 
 
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Categorical variables (e.g. Abnormality of laboratory evaluation): Number and percentage of 
patients/events will be tabulated. Unless otherwise specified, the percentage denominator will be the number 
of patients in the concerned analysis set who are still in the trial (including missing values) at the respective 
time point in the analysed population. Categories with frequency of 0 will not be presented if not differently 
specified.    
In case of subcategories, the relative frequencies will be calculated on the basis of the patients in the 
respective category, in this case a footnote will be added explaining the different denominators.   
Time variables (duration of DLBCL since diagnosis etc.): This will be summarized using arithmetic 
mean, StD, minimum and maximum values, median and quartiles (Q1, Q3) and will be presented in months 
(unless differently specified). 
Time to event variables (PFS, EFS, OS, etc.): Unless differently specified, Kaplan Meier estimates of Q1, 
Median, and Q3 along with their 95% Confidence Intervals will be presented. 
Incidence reporting (AE, CM, MH and non-medication procedures): Unless differently specified, 
number and percentage of patients, along with the event counts will be reported in the summary tables of 
adverse event, concomitant medication and medical history. Patient will be counted only once if he/she 
comes across more than one time of the same AE/CM/MH event capturing the highest 
intensity/toxicity/worst outcome ect. The AE, MH and non-medication procedures summary tables will be 
sorted in terms of decreasing frequency for system organ class (SOC) and the preferred term (PT) within 
SOC. The CM summary tables will be ordered in terms of decreasing frequency of ATC level and the 
preferred name within the ATC level. 
 Handling of incomplete or missing date/time information 
The dates that are missing or incomplete are derived as follows:  
• 
Dates are split in 3 parts: year, month and day. Year is the top-level, month is medium level and 
day is low level. If a part expected to contain a number is numeric but the value is outside a valid 
range, the complete date is handled as missing. For example, if date = 44Nov2000 the whole date 
is considered to be missing.  
• 
If a part is missing, all other parts of a lower level are considered to be missing. This means that a 
ddmmyy date ‘21--99’ is considered as ‘----99’.  
Missing parts for specific dates/times are changed into acceptable non-missing values as described in the 
table below.  
In the following, ‘lower limit’ and ‘upper limit’ refer to the minimum or maximum, respectively, of a 
possible date.  
For example, if the day is missing, the lowest limit is the first day of the given month and the upper limit is 
the last day of the given month.  
If the day and month are missing, the lower limit refers to the first day of the given year and the upper limit 
to the last day of the given year.  
For a partial date, the range of possible dates is defined as the period from lower to upper limit (both 
included).  
The earliest and the latest dates refer to the first or last date, respectively, when ordered in sequence.  
Other sources should be considered for possible dates including death date, cut-off date and date of 
withdrawal from study when determining possible dates.   


 
 
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Table 9 
  Convention for Missing Data 
Type of date/time   
Date/time is incomplete  
Date/time is missing  
Study drug/treatment 
start date  
- 
Day is missing: Replaced by the 
lower limit.  
- 
Day and month are missing: no 
replacement  
In case the resulting date is before 
randomization date, randomization date 
will be used.   
No imputation  
  
Study drug/treatment 
end date  
Use the earliest date 
among: upper limit, date of 
death, date of last contact.  
Use the earliest date 
among: date of death, date 
of last contact.  
Actual assessment 
dates (Labs, vital 
signs, performance 
status, tumor 
imaging,) including 
disease assessment 
date.  
Baseline Tumor  
Assessment  
The lower limit  
In case the lower limit is before reference 
start date, than ICF signature date will be 
used  
  
  
The lower limit  
  
No imputation, the assessment cannot 
be used  
  
  
  
No approximation, the assessment 
cannot be used  
New Anti-Lymphoma 
Treatment 
(NALT)/Prior and 
Con Meds 
The lower limit  
In case the lower limit is before Reference 
Start Date date, than Reference Start Date 
will be used  
No imputation, the therapy 
information cannot be used  
“Date of last contact”  
The lower limit  
In case the lower limit is before Reference 
Start Date, than Reference Start Datewill be 
used  
No imputation  


 
 
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Date of Death 
The Lower limit unless other qualifying 
study data support survival until a later date 
during the same month.  
 
 
No imputation 
The following imputation rules pertain to adverse event, concomitant medication  and will be implemented 
in ADaM datasets only: 
For adverse event and concomitant medication: no imputation will be performed for missing dates. 
Hence the worst case will be applied when defining TEAE and prior/concomitant medication.  
• 
If the start time of an AE is missing but the start date is on the same date with study treatment, an 
AE will be counted as TEAE unless the AE end date/time is before date of first treatment. 
• 
If start time and day are missing but the start month is complete, an AE will only be excluded from 
TEAE for the following scenarios: 1) start month is before month of first treatment; 2) start month 
is after end month of treatment-emergent period and this AE has no causality with any component 
of study treatment; 3) AE end date/time is before start of first treatment. 
• 
If start day and month are missing but the start year is complete, an AE will only be excluded from 
TEAE if it meets one of the following scenarios: 1) start year is before year of first treatment; 2) 
start year is after end year of treatment-emergent period and it has no causality with any component 
of study treatment; 3) AE end date/time is before start of first treatment. 
• 
If start date is completely missing, an AE will not be excluded from TEAE unless the AE end 
date/time is before start of first treatment. 
• 
If start day of a medication is missing, and the month appears to be the same month with study 
treatment, medication will be counted as both prior and concomitant medication, unless the end date 
is before treatment start, then this case will be counted as prior medication only. 
• 
If start day and month are missing but year of a medication appears to be the same year with study 
treatment, medication will counted as both prior and concomitant medication, unless the end date 
is before treatment start, then this case will be counted as prior medication only. 
 
The above will be applicable for assigning AEs to treatment cycles. 
 Data included in the analysis and cut-off date 
For primary completion analysis, cut-off date is defined as 30 days after all patients have performed their 
End of Treatment Visit or Early Study Treatment Discontinuation Visit. Analyses of patient disposition, 
demographics and baseline characteristics, medical history, prior and concomitant medications, study 
drug/treatment exposures, primary and key secondary endpoints and other safety analysis will be performed 
using data within cut-off date for the primary completion analysis. 
Any data assessed after the cut-off will be excluded from primary completion analysis, except for the data 
with an assessment date or event start date (e.g. vital sign assessment date or start date of an adverse event) 
prior to or on the cut-off date. For example, if the cut-off date is 2020-11-15 then an AE starting on 2020-
Nov-15 will be reported, whereas an AE with start date on 2020-Nov-17 will not be reported. 


 
 
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For adverse event and concomitant medication, events with an event start date either before or on the cut-
off date and an event end date after the cut-off date will be reported as “Ongoing” and the outcome of the 
adverse event will be reported as ‘Unknown’. The same rule will be applied to events starting either before 
or on the cut-off date and not having a documented end date. A footnote will be added in the corresponding 
tables and listings to indicate these events are ongoing based on cut-off date. For serious adverse events 
with admitted date of hospitalization after cut-off date, seriousness and admitted date of hospitalization will 
be reported as collected in the source data, no conversion will be performed.  
 Pooling of investigative sites 
In this study, data from all participating sites will be combined for the analyses. No site effect or treatment-
by-site interaction will be assessed.  
 PATIENT DISPOSITION, BACKGROUND AND BASELINE CHARACTERISTICS 
 Patient disposition 
Patient disposition will be performed for all screened patients, tabulated by treatment arm and overall. The 
detailed analysis are listed out as below:  
 Enrollment status 
1. Number and percentage of patients screened.  
2. Number and percentage of patients randomized/not randomized. Reasons of being not randomized 
(Reasons are obtained from “Randomisation” eCRF page) will be listed.  
3. Number and percentage of patients enrolled in each Analysis set by Treatment Arm.  
4. Summary of all enrolled subjects will be presented for each country. 
For all the above cases, the percentage will be based on the total number of patients screened.  
 Completion and premature discontinuation of study treatment and study drugs 
1. Number and percentage of patients who completed all 6 Cycles of treatment as per protocol. 
2. Number and percentage of patients who completed the first 3 Cycles of treatment. 
3. Number and percentage of patients who completed more than 3 Cycles of treatment. 
4. Number and percentage of patients who have a “premature study treatment discontinuation” 
(definition: section 7.3), including the reason for treatment discontinuation (in case of sequential 
discontinuation of the components, the reason that led to discontinuation of the drug that was 
discontinued latest will be presented). 
a. Number and percentage of patients who entered follow-up period after end of treatment. 
b. Number and percentage of patients who discontinued study after end of treatment, incl. the 
reasons for study discontinuation. 
5. Number and percentage of patients who completed study treatment (definition: section 7.3) 
a. Number and percentage of patients who entered follow-up period after end of treatment. 
b. Number and percentage of patients who discontinued study after end of treatment, incl. the 
reasons for study discontinuation. 
6. Number of patients who prematurely discontinued at least one but not all the components of study 
treatment, incl. the reasons for treatment discontinuation (in case of discontinuation of multiple 


 
 
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drugs, all reasons will be considered in the tabulation; that is, the numbers of discontinuation reasons 
may be larger than the number of patients who discontinued at least one but not all components of 
the study treatment). 
a. Number and percentage of patients who entered follow-up period after end of treatment. 
b. Number and percentage of patients who discontinued study after end of treatment, incl. the 
reasons for study discontinuation. 
7. Number and percentage of patients who completed whole study including study treatment, follow-
up and their scheduled last-visit. This information is obtained from “Did the subject complete the 
study?” in the “End of Study/Early Follow-up Discontinuation” eCRF page. 
8. Number and percentage of patients who completed each study drug as per study Clinical Trial 
Protocol (CTP). For definition see section 7.3. 
9. Number and percentage of patients who discontinued prematurely each study drug as per study 
CTP. For definition see section 7.3. Reason for premature discontiuantion will be presented for each 
study drug.  
10. Number and percentage of patients who completed all cycles of R-CHOP as per study CTP. For 
definition see section 7.3. 
11.  Number and percentage of patients who discontinued study treatment within the first 21 days of 
the study. 
In all the above cases, percentages will be based on the respective analysis set.  
 Patient status in each treatment cycle 
1. Number and percentage of patients who completed each component of study treatment as per study 
protocol in each treatment cycle. If a patient takes all the planned doses of a treatment component 
for a cycle, that patient is counted as one who completes that cycle as per protocol. 
2. Number and percentage of patients who have proceeded to next treatment cycle. A patient who 
discontinues a treatment component at a particular cycle will not be considered under this category 
for that treatment component. 
3. Number and percentage of patients who discontinue any component of study treatment will be 
presented per cycle along with reasons for discontinuation. 
4. Number and percentage of patients who have treatment cycle delay in each treatment cycle. This 
applies to cycle 2 to cycle 6, along with reasons of the delay of each treatment cycle.  
5. Summary of days of delay in each treatment cycle. This applies to cycle 2 to cycle 6. 
  Patient status in follow-up period 
The following will be summarized based on the FAS population: 
1. Number and percentage of patients who entered the follow-up period. 
2. Among patients who entered follow-up: 
a. Number and percentage of patients who completed the whole study (including study 
treatment, follow-up and their scheduled last-visit).  
b. Number and percentage of patients who discontinued study, along with reasons of 
discontinuation.  
 
Patient disposition listing will be provided for FAS to present patient identifier, age/sex/race, treatment arm, 
ICF signed date, date of randomization, date of first administration of study treatment, date of last 


 
 
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administration of study treatment, reference end date, reason for treatment discontinuation, date of death, 
cause of death, date of disease progression, date of last contact. 
A summary table will be presented showing number of patients enrolled into the study by country based on 
the FAS. 
In addition, patient status listing will be provided using FAS population to present patient identifier, 
treatment arm, visit, delay of treatment cycle (yes or no), number of days of delay, reason of delay. A patient 
visit listing will present date of each visit, using FAS population. For patients who fail the 
inclusion/exclusion criteria, a listing will be created to display the details. For FAS population, a listing will 
be created to present the randomized allocation to treatment. 
Summary information regarding the follow-up of patients is displayed in order to describe the maturity of 
data and quality of follow-up.   
Duration of Follow-up for PFS, EFS, OS and time to next anti-lymphoma treatment will be presented by 
means of reverse Kaplan Meier analysis, where the status indicator is reversed, meaning the event of interest 
(PFS or OS) will be considered as censored at that time point, and censor becomes event. The summary 
statistics as described for Time to event endpoints will be presented. For details please see the respective 
sections.  (Sections 10.1.5, 10.1.6, 10.1.7, 10.1.8) 
The following will also be presented: 
• 
Summary statistic of Randomization (recruitment) period = (Date of last patient randomized - 
Date of first patient randomized + 1)/30.4375 (months), 
• 
Date of 1st patient randomized. 
• 
Date of last patient randomized 
• 
Cut-off date 
Listings will also be provided. 
 Protocol deviations 
Protocol deviations will be identified based on reviews of the data prior to database lock. All important 
protocol deviations will be listed to describe the patient information, treatment arm, category, exact item 
and date of protocol deviation. In addition, a listing of patients excluded from the efficacy analysis will be 
provided. The protocol deviation consists of the following categories: 
• 
Entry criteria not satisfied 
• 
Developed withdrawal criteria but not withdrawn 
• 
Failure to collect data for primary/key secondary endpoint 
• 
Wrong treatment or incorrect dose 
• 
Prohibited concomitant treatment 
• 
GCP deviation 
• 
Study Procedures 
• 
Other 


 
 
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The number and percentage of patients in the FAS, with at least one of important protocol deviations, will 
be summarized by treatment arm and overall according to the above mentioned categories. 
 Analysis sets 
Number and percentage of patients included/excluded in each analysis set will be summarized by treatment 
arm and overall, along with reasons of exlusion from analysis sets (defined in section 7.15.7). The 
percentages will be calculated based on all screened patients. 
 Baseline and demographic characteristics 
Descriptive statistics will be tabulated for continuous variables. The number and percentage of patients in 
each category will be presented for categorical variables. All summaries will be presented for the FAS and 
the PPS, by treatment arm and overall. For categorical variables, the number and percentage of patients with 
missing data will be provided. Listings for demographic data will be produced. 
The following continuous variables will summarized:  
• 
Age at time of Informed Consent [years] 
• 
Weight at Baseline [kg] 
The following categorical variables will be summarized: 
• 
Age group at screening: 
o ≤ 60 vs.  > 60 years 
o < 65 vs ≥ 65 years 
o 18-64 vs. 65 – 84 vs. ≥ 85 years 
o ≤70 vs. >70 years. 
• 
Sex (Male or Female) 
• 
Race. If more than one races have been chosen, it will be presented as ‘Other’ with concatenated 
items.   
• 
Childbearing potential for female patients (Yes or No), along with reasons of no childbearing 
potential. 
• 
Pre-planned radiotherapy at screening (Yes or No) 
• 
Pre-planned intrathecal chemotherapy (Yes or No) 
• 
Pre-planned central nervous system (CNS) Prophylaxis with Intravenous (IV) Methotrexate at 
screening (Yes or No) 
All demographic data, along with childbearing potential, pregnancy and risk counseling, plan and result of 
pre-planned radiotherapy and pre-planned CNS prophylaxis will be listed. 


 
 
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 Medical history and concomitant medical conditions 
 Definition 
Generally, medical history is defined as medical records which start and end prior to study treatment, 
whereas current medical conditions are defined as medical records that start prior to study treatment and are 
ongoing when study treatment starts. Specifically for this study, the diagnosis of DLBCL is the prerequisite 
for the patients’ recruitment.  
 Data presentation 
For the non-DLBCL medical history, number and percentages of patients and number of events will be 
tabulated per SOC and PT for each treatment arm and overall, using FAS population. 
Based on the eCRF page ‘Diagnosis of DLBCL’ the following will be summarised using FAS population: 
- 
Time between Diagnosis and Start of Treatment (days) 
- 
Time between diagnostic biopsy was taken and Date of Diagnosis of DLBCL (days) 
- 
Biopsy taken from (Nodal vs Extra-nodal) and the nodal or extra-nodal site respectively 
- 
COO assessed locally (yes vs No).  
- 
Method of COO Used (IHC-Hans algorithm vs. Gene Expression Profiling vs Other)  
- 
Result of COO (GCB vs Non-GCB vs Unclassified vs ABC) 
 
Based on the eCRF page ‘DLBCL staging and disease risk assessment’ the following will be summarised 
using FAS population: 
- 
Ann Arbor Disease Staging Assessment performed (Yes or No) 
- 
Ann Arbor Disease Staging (Stage I, Stage II, Stage III or Stage IV) 
- 
Ann Arbor Disease Staging grouped by categories: Stage I/II vs Stage III/IV 
- 
International Prognostic Index (IPI) assessment performed (Yes or No) 
- 
Patients with age older than 60 (Yes or No) 
- 
Patients with lactate dehydrogenase level higher than normal (Yes or No) 
- 
Patients with ECOG performance status score of 2 or greater (Yes or No) 
- 
Patients with Stage III or IV disease (Yes or No) 
- 
More than one involved extranodal disease site (Yes or No) 
- 
IPI score (0 to 5) 
- 
IPI score grouped as Low: 0 or 1, Low-Intermediate: 2, High-Intermediate: 3, and High: 4 or 5 
- 
Age-adjusted IPI for patients <= 60 years (based on the risk factors: Ann Arbor Stage III or IV, 
Elevated LDH, and ECOG performance status >= 2) will be grouped and presented as Low: 0, Low-
intermediate: 1, High-intermediate: 2, and High: 3 
- 
Patients for whom screening for CNS lymphoma involvement has been performed (Yes or No) 
- 
Patients for whom diagnostic lumbar puncture with cerebrospinal fluid (CSF) evaluation (cytology, 
flow cytometry) was performed to exclude CNS infiltration (Yes or No) 
o Patients for whom lymphoma cells detected in the CSF (Yes or No) 
- 
Patients for whom head CT and/or head MRI performed to exclude CNS infiltration (Yes or No) 
o Signs of Lymphoma involvement (Yes or No) 
- 
Presence of bulky disease (Yes or No) 
- 
Based on the eCRF page ‘ECOG Performance Status’ the following will be summarised using FAS 
and SAF population 


 
 
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o ECOG at screening (0 to 4) 
 
Based on the eCRF page ‘Assessment of B-symptoms’, the following will be summarised using FAS 
population: 
- 
Patients for whom the assessment was performed (Yes or No) 
- 
Reasons for not performing the assessment will be listed.  
- 
Time between B-symptom assessment and start of treatment (days) 
- 
Unintentional weight loss of more than 10% of body weight within the previous 6 months (Present, 
Absent, or Unknown) 
- 
Fever for at least 3 consecutive days without evidence of infection (Present, Absent, or Unknown) 
- 
Drenching night sweats without evidence of infection (Present, Absent, or Unknown) 
 
Based on the eCRF page ‘Pre-planned Radiotherapy, or Pre-planned CNS Prophylaxis’, the following will 
be summarised using FAS population: 
- 
Patients for whom local radiotherapy pre-planned to be administered to initial sites of bulky or 
extranodal disease after the last treatment cycle and after the end of treatment tumor assessment by 
PET/CT or PET/MRI (Yes or No) 
- 
Location of irradiation (Nodal vs Extranodal) 
 
Based on the eCRF page ‘Bone Marrow Aspiration and Biopsy’, the following will be summarised using 
FAS population: 
- 
Patients for whom bone marrow assessment was performed (Yes or No) 
- 
Reasons for not doing the assessment will be listed.  
- 
Type of bone marrow assessment (Aspiration, Biopsy, or Aspiration and Biopsy) 
- 
Bone marrow ivolvement by DLBCL (Yes, No, or Not Applicable) 
- 
Percentage of bone marrow infiltration by DLBCL 
- 
Bone marrow involvement by different histological type of lymphoma (Yes, No, or Not Applicable) 
- 
Percentage of bone marrow infiltration by lymphoma subtype 
Based on the eCRF page ‘Pathology Central Diagnosis’, the following will be summarised using FAS and 
SAF population: 
- 
Cell of Origin by Hans Classifier: GC-type, Non GC-type, or Not applicable 
FISH Status (MYC rearrangement: Negative, Positive, or Not Done; BCL-2 rearrangement: Negative, 
Positive, or Not Done; BCL-6 rearrangement: Negative, Positive, or Not Done)  
For IPI score derivation, please refer to Section 16, Appendix D of the Clinical Trial Protocol (CTP). 
Listings will be created to present both general medical history, DLBCL-specific medical history, bone 
marrow aspiration, performance of tumor biopsy and fresh tumor tissue, biopsy and pathology central 
diagnosis, on the basis of FAS population. 


 
 
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 Prior and concomitant medications and non-drug treatments/procedures 
 Definitions 
• 
Pre-medication: Medication given prior to tafasitamab administration to mitigate potential infusion-
related 
reactions. 
Pre-medication 
encompasses 
oral 
acetaminophen, 
antihistamine 
and 
glucocorticosteroids. For details please refer to protocol section 8.7.1.1. All pre-medications are 
captured in eCRF page ‘Pre-infusion Medications for tafasitamab’.  
• 
Prior medication/non-drug treatment: If both the start and stop dates of the treatment are before the 
start date of study treatment, the medication will be classified as prior medication.  
• 
Concomitant medication/non-drug treatment: If the start date of medication is on or after the start 
date of study treatment, the medication will be considered as concomitant medication.  
• 
Prior and concomitant medication/non-drug treatment and procedures: Medications with start date 
before start date of study treatment but ongoing or with stop date after the start of study treatment will 
be considered both as prior and as concomitant medications. Therefore such case will be reported in 
both prior and concomitant medication summaries. 
• 
Prior corticosteroid Treatment: According to the protocol, patients are allowed to take one week 
prednisone or equivalent treatment prior to randomization. 
For any medication with missing start date, strategies depicted in section 8.3 will be applied to handle such 
cases. 
 Data presentation 
Summary tables will be performed on each treatment arm and overall patients. Prior/Concomintant 
medication will be presented by ATC class and preferred name, while the non-treatment procedures will be 
presented by SOC and PT name.The following topics will be tabulated: 
• 
Pre-medication. 
• 
Prior medications. 
• 
Concomitant medications. 
• 
Prior non-drug treatments and procedures. 
• 
Concomitant non-drug treatments and procedures. 
• 
Patients taking corticosteroid treatment prior to randomisation.  
• 
Prior and concomitant COVID-19 vaccinations by ATC class and preferred name (from eCRF form 
“Prior and Concomitant Medications”)  
• 
Concomitant medications due to COVID-19 by ATC class and preferred name (from eCRF form 
“Prior and Concomitant Medications”). 
All summaries will be conducted on FAS population. Listings will be shown for pre-medication, prior 
medication, and concomitant medication, prior and concomitant non-drug treatments/procedures. In 
particular, a listing of prior medication of steroids will be presented, using data collected in ‘Prior 
Medications - Steroids’ eCRF page. In addition, a supplementary list of WHO preferred name of steroids 


 
 
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may be utilized to identify steroids medication from ‘Prior and concomitant medication’ eCRF page. The 
above listings will cover patient number, ATC class and standard drug name, start/end date, start/end study 
day, dose and unit, route, frequency and indication. 
 DLBCL-specific prior therapies 
This section does not apply for this study. 
  New anti-lymphoma treatments  
9.6.4.1 Definition 
New anti-lymphoma treatments (NALT) applies to patients who have disease progression/relapse or if an 
end of treatment tumor assessment indicates residual (partial metabolic response, i.e. PR) or no metabolic 
response. In the eCRF page ‘New anti-lymphoma treatments’, the patients who have answered the question 
“Any new anti-lymphoma treatment administered?” as “Yes” will be considered as patients with NALT.  
9.6.4.2 Data presentation 
The following tabulation will be done for evaluating the new anti-lymphoma treatments ATC Level 2 class 
and preferred name on FAS and SAF population per treatment arm and overall patients: 
• 
Number and percentage of patients who receieves NALT. 
• 
Number and percentage of patients who receives NALT before the completing 6 cycles of study 
treatment as mentioned in the CTP.  
• 
Number and percentage of patients who receieves NALT after completing 6 cycles of study treatment 
as mentioned in the CTP.  
• 
Number and percentage of patients who receieves NALT after documented disease progression.  
• 
Number and percentage of patients who receieves NALT prior to documented disease progression.  
• 
Best documented response after receiving NALT 
Data collected from eCRF page ‘New anti-lymphoma treatment’ will be reported in listings, presenting 
patient number, medication/procedure name, start/end date (or ongoing), start/end study day, intention of 
ASCT proceeding. 
 Study treatment and study drug administration 
All the analysis realated to study drug administration and study treatment will be done based on the SAF.  
 Definitions 
 Duration of exposure to study drug/study treatment 
Study Drug 
Definition 
Tafasitamab 
Duration of exposure of Tafasitamab [days] = [last date of 
administration of the tafasitamab + (length of time interval – 1)]. 
Length of time interval is defined to be 7 days. In case a patient has  
the last contact date before the defined last date of exposure, the last 
date of exposure will be set as the last contact date. 


 
 
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Lenalidomide 
Duration of exposure of Lenalidomide [days] = [last date of 
exposure to Lenalidomide – date of first administration of 
Lenalidomide + 1]. 
Rituximab 
Duration of exposure of Rituximab [days] = [last date of exposure 
to Rituximab  + (length of time interval – 1)]. Length of time interval 
is defined to be 21 days. In case a patient has  the last contact date 
before the defined last date of exposure, the last date of exposure 
will be set as the last contact date. 
Cyclophosphamide 
Duration of exposure of Cyclophosphamide [days] = [last date of 
exposure to Cyclophosphamide + (length of time interval – 1)]. 
Length of time interval is defined to be 21 days. In case a patient 
has  the last contact date before the defined last date of exposure, 
the last date of exposure will be set as the last contact date. 
Vincristine 
Duration of exposure of Vincristine [days] = [last date of exposure 
to Vincristine + (length of time interval – 1)]. Length of time 
interval is defined to be 21 days. In case a patient has  the last contact 
date before the defined last date of exposure, the last date of 
exposure will be set as the last contact date. 
Doxorubicin 
Duration of exposure of Doxorubicin [days] = [last date of exposure 
to Doxorubicin + (length of time interval – 1)]. Length of time 
interval is defined to be 21 days. In case a patient has  the last contact 
date before the defined last date of exposure, the last date of 
exposure will be set as the last contact date. 
Prednisone 
Duration of exposure of Prednisone [days] = [last date of exposure 
to Prednisone – date of first administration of Prednisone + 1]. 
 
 Cumulative Expsoure 
Cumulative dose of tafasitamab [mg]: 
Dosage of tafasitamab in each infusion is calculated as: [40mg/ml * ml of tafasitamab added to the infusion 
bag * (Calculated volume of infusion/250ml)] 
The overall culmulative dose of tafasitamab of study treatment is calculated as the sum of all individual 
tafasitamab doses. 
Cumulative dose of lenalidomide [mg]: 
The cumulative dose of lenalidomide is defined as the total dose taken (in mg) by a patient across all the 
cycles of the study. Days where no lenalidomide pill is taken are counted as days with a dose of 0 mg. The 
difference in number of capsules dispensed and returned will not be considered.  
 
 
 


 
 
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Exemplified calculation: 
Cycle 
Dosing start 
day 
Dosing end 
day 
Days of 
lenalidomide taken 
Dose strengh 
[mg] 
Total dose 
1 
1 
10 
10 
25 
25 x 10 = 250 
2 
1 
10 
10 
25 
25 x 10 = 250 
3* 
1 
5 
5 
25 
25 x 5 = 125 
3* 
8 
10 
3 
20 
20 x 3 = 60 
4* 
1 
7 
7 
20 
20 x 7 = 140 
Cumulative dose = 250 + 250 +125 + 60 +140 = 825 [mg] 
*In this example the patient experienced dose interruption and dose reduction in cycle 3 and discontinued lenalidomide 
in cycle 4. 
 Dose Intensity, Planned Dose Intensity and Relative Dose Intensity 
Dose Intensity of Rituximab, Cyclophosphamide, Vincristine and Doxorubicin 
1. 
(Actual) Dose Intensity (ADI) 
- 
Definition: ADI is an index of an actual dose per cycle. 
- 
Unit: mg/m2 per cycle 
- 
Formula: [actual dose per cycle (mg/m2)] / cycle] 
 
2. 
Planned Dose Intensity (PDI) 
- 
Definition: PDI is an index of a scheduled dose per cycle. 
- 
Unit: mg/m2 per cycle 
- 
Formula: [planned dose per cycle (mg/m2)] / cycle] 
 
3. 
Relative Dose Intensity (RDI) 
- 
Definition: RDI expresses the amount of drug administered per unit of time compared to the planned 
amount of drug at the scheduled time. 
- 
Unit: % 
- 
Formula: [ADI/PDI] * 100 
Dose Intensity of Prednisone 
For Prednisone, the above will be defined in a similar fashion, only, instead of actual dose per cycle in 
mg/m2, total dose administered per cycle in mg  would be considered.  
 


 
 
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Average Relative Dose Intensity of R-CHOP (ARDI) 
- 
Definition: The intensity of the entire R-CHOP regimen is better defined by the ARDI, which is 
calculated as the mean of RDIs of all the components of R-CHOP for a particular cycle. 
- 
Unit: % 
Dose Intensity of Lenalidomide 
For Lenalidomide, the above will be defined in a similar fashion to Prednisone. 
 Dose Interruption 
Tafasitamab:  
There are two scenarios of tafasitamab interruption. Firstly, a patient can skip a visit and thus the 
administration of tafasitamab of that visit. This is defined as ‘Skipping of tafasitamab administration’. 
Secondly, tafasitamab administration can be interrupted during the infusion, this will be defined as 
‘Interruption of tafasitamab during infusion’. Furthermore, a patient interrupting Tafasitamab infusion can 
have the following scenarios: either the patient takes the full dosage after the infusion interruption or the 
patient does not take the full dose after the infusion interruption. 
Lenalidomide: 
If a patient does not take a particular dose of Lenalidomide, that is, skips a Lenalidomide dose, then it is 
considered as an interruption. 
Rituximab: 
There are two scenarios of Rituximab interruption. Firstly, a patient can skip a visit and thus the 
administration of Rituximab of that visit. This is defined as ‘Skipping of Rituximab administration’. 
Secondly, Rituximab administration can be interrupted during the infusion, this will be defined as 
‘Interruption of Rituximab during infusion’. Furthermore, a patient interrupting Rituximab infusion can 
have the following scenarios: either the patient takes the full dosage after the infusion interruption or the 
patient does not take the full dose after the infusion interruption.  
Cyclophosphamide: 
If a patient does not take a particular dose of Cyclophosphamide, that is, skips a Cyclophosphamide dose, 
then it is considered as an interruption. 
Vincristine: 
If a patient does not take a particular dose of Vincristine, that is, skips a Vincristine dose, then it is considered 
as an interruption. 
Doxorubicin: 
If a patient does not take a particular dose of Doxorubicin, that is, skips a Doxorubicin dose, then it is 
considered as an interruption. 
Prednisione: 
If a patient does not take a particular dose of Prednisione, that is, skips a Prednisione dose, then it is 
considered as an interruption. 


 
 
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 Dose Delay 
R-CHOP: 
If “Dose Delay” is ticked as ‘Yes’ for a patient for any of the components of R-CHOP in the R-CHOP 
Dosage Administration eCRF page, then it is considered as a delay for the corresponding R-CHOP 
component. 
 Dose Reduction 
Lenalidomide and R-CHOP: 
A dose reduction is defined as a decrease in dose from the protocol planned starting dose (e.g. for ‘25 mg 
daily’ to ‘20 mg daily’). Information of dose reductions is captured in the dosing eCRF page for 
lenalidomide and R-CHOP. 
 Data Presentation 
All study treatment and study drug administration and exposure related summaries would consider the 
SAF analysis population. 
For all the dose intensity parameters (relative dose intensity, average relative dose intensity of R-CHOP), 
descriptive statistics, viz. mean, standard deviation, median, Q1, Q3, minimum, and maximum will be 
presented per cycle and overall. 
Descriptive statistics, viz. mean, standard deviation, median, Q1, Q3, minimum, and maximum will be 
presented for duration of exposure and cumulative duration of exposure. 
For Tafasitamab and Rituximab interruptions/skipping, the following will be presented by cycle and overall: 
• 
Number and percentage of patients without any ‘Skipping of tafasitamab administration’. 
• 
Number and percentage of patients without any ‘Skipping of Rituximab administration’. 
• 
Number and percentage of patients with at least one ‘Skipping of tafasitamab administration’. 
Reasons of skipping will be listed. 
• 
Number and percentage of patients with at least one ‘Skipping of Rituximab administration’. The 
reasons of skipping will be listed. 
• 
Number and percentage of patients without any ‘Interruption of tafasitamab during infusion’. 
• 
Number and percentage of patients without any ‘Interruption of rituximab during infusion’. 
• 
Number and percentage of patients with at least one ‘Interruption of tafasitamab administration 
during infusion’, along with reasons of interruption. 
• 
Number and percentage of patients with at least one ‘Interruption of Rituximab administration 
during infusion’. Reasons of interruption will be listed. 
• 
Number and percentage of patients having Tafasitamab infusion interruption but completing the full 
dose. 
• 
Number and percentage of patients having Rituximab infusion interruption but completing the full 
dose. 
• 
Number and percentage of patients having Tafasitamab infusion interruption and not completing 
the full dose. 
• 
Number and percentage of patients having Rituximab infusion interruption but not completing the 
full dose. 


 
 
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For Lenalidomide, Cyclophosphamide, Vincristine, Doxorubicin, and Prednisone interruptions, the 
following will be presented: 
• 
Number and percentage of patients without any doses skipped. 
• 
Number and percentage of patients with at least one dose skipped. Reasons of skipping will be 
listed. 
• 
Number and percentage of patients with different numbers of skipped doses, i.e. number and 
percentage of patients with 1 dose skipped/2 doses skipped/3 doses skipped, etc. 
 
For dose delay, the number and percentage of patients with at least one delay of any R-CHOP component, 
along with reasons of delay will be presented. 
For lenalidomide dose reduction, the following will be presented: 
• 
Number and percentage of patients without any dose reduction 
• 
Number and percentage of patients with at least one dose reduction, along with reasons of dose 
reduction. 
• 
Number and percentage of patients with a reduction to the level of 20 mg (but not lower) 
• 
Number and percentage of patients with a reduction to the lowest level of 15 mg, namely, if a patient 
modifies his lenalidomide from 25 mg to 20 mg and 15 mg, this patient will be counted in the level 
group of 15 mg. 
• 
Number and percentage of patients with a reduction to the lowest level of 10 mg, namely, if a patient 
modifies his lenalidomide from 25 mg to 20 mg, 15 mg and 10 mg, this patient will be counted in the 
level group of 10 mg. 
 
For dose reduction of R-CHOP, the following will be summarized for each treatment arm and overall: 
• 
Number and percentage of patients without any dose reduction of all components of R-CHOP 
• 
Number and percentage of patients with  at least one dose reduction of any component of R-CHOP 
 
In addition, dose reduction of each component of R-CHOP, namely rituximab, cyclophosphamide, 
doxorubicin, vincristine and prednisone, will be summarized for the following points on each component: 
• 
Number and percentage of patients without any dose reduction 
• 
Number and percentage of patients with at least one dose reduction, along with reasons of dose reduction 
 
Additionally, the number and percentage of patients who skipped at least one dose of Lenalidomide and 
Tafasitamab will be presented for each cycle and overall. 
Number and percentage of patients who skipped Lenalidomide and Tafasitamab doses on individual 
treatment days will be presented for each cycle. 
Number and percentage of patients who skipped Lenalidomide and Tafasitamab doses will be presented for 
each cycle and overall by the number of doses skipped. 
Percentage of protocol based dose will be presented for each cycle and overall. This will be calculated as: 
[(Number of Lenalidomide doses administered to patients in a particular cycle)/(Expected number of 
Lenalidomide doses administered in that cycle)] * 100 %. 


 
 
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The above defined summaries will also be presented for Tafasitamab. 
According to the protocol, a patient in Arm B will be taking ten doses of Lenalidomide per cycle and patients 
in both arms will be taking three doses of Tafasitamab per cycle. 
 Listing presentation of exposure 
Listings will be created to present the study treatment for tafasitamab, lenalidomide and R-CHOP 
respectively, the following items should be included: patient identifier, treatment arm, visit, occurrence of 
administration, administered start date/time and end date/time, dosage and unit, reason if not done. For 
tafasitamab, the occurance of infusion interruption and the corresponding reason should be displayed in the 
listing. For lenalidomide and R-CHOP, the following two items should also be listed: Occurance of dose 
reduction and reason of dose reduction. For lenalidomide, a listing will be created to present number of 
capsules dispensed, number of capsules taken by patients, number of capsules returned, dose strength and 
reason for drug non-compliance. 
 
 
 


 
 
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 EFFICACY EVALUATION 
 Analysis of Response and progression evaluation 
 General definition  
10.1.1.1 Response criteria 
Efficacy assessments will be made according to the revised response criteria for malignant lymphoma based 
on the guidelines of the Lugano Classification (as reported by Cheson, 2014) and will be based on 
investigator assessment (See protocol appendix E). In this study, the response assessment is captured in 
eCRF page ‘Radiographic Imaging Assessment’ and ‘Disease Response Assessment’. 
10.1.1.2 Tumor assessment and assessment date 
Tumor response assessment is performed per schedule in protocol. The result, date and modality of tumor 
response assessment are documented in the eCRF page ‘Disease Response Assessment’. 
For efficacy summaries (e.g., ORR tables, PFS Kaplan-Meier analyses etc.), only response assessments as 
per Cheson 2014 criteria will be considered. That is, response assessments based on physical examination 
only (i.e., in absence of radiological evaluation or decisive biopsy/aspirate data) will not be considered. The 
following eCRF records will be taken into account: 
(1) 
Response assessments based on radiological evaluation (based on radiological evaluation only or 
radiological evaluation plus other assessments, e.g., physical examination). The tumor assessment date is 
the scan date of the radiological evaluation. 
(2) 
Response assesssments with outcome “Progressive Disease” based on biopsy (i.e., selected as ‘other 
evaluation’ and specified as ‘biopsy’ in Disease Response Assessment eCRF page).  For response outcomes 
of PD based on biopsy, the date of tumor biopsy as recorded in Tumor Biopsy eCRF page is taken into 
consideration when deriving the tumor response date. E.g., if disease response is based on radiological 
evaluation and biopsy, then tumor response date would be the scan date of radiological evaluation or the 
date of tumor biopsy recorded in Tumor Biopsy eCRF page whichever is earlier. 
10.1.1.3 Determination of missing adequate tumor assessments 
The term “missing adequate tumor assessment” is defined as a tumor assessment (TA) not done or 
tumor assessment with overall lesion response of  not evaluable or “UNK”. A “missing adequate 
tumor assessment” will be referred to as “missing assessment”. 
The censoring and event date options for PFS, EFS, DoR, TTNT depend on the presence and the 
number of missing assessments. For example: 
• In the analysis for PFS, an event occurring after two or more missing assessments or non-
adequate tumor assessments will be censored on the date of last adequate tumor assessment. 
For the purpose of this study, if no tumor assessments have happened in 394 days or longer (as in 
the follow-up phase, a CT/MRI tumor assessment is expected to happen every 6 months + 2 weeks), 


 
 
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then the patient will be considered as having two or more missed assessments. The handling of two 
or more missed assessments in discussed in each of the endpoint section.   
 Objective response rate (ORR) at EOT and Best ORR 
Post-baseline response assessments will be evaluated at C3D18, end of treatment visit/early study treatment 
discontinuation visit, follow-up visit 2, follow-up visit 4 and end of study/early discontinuation of follow-
up visit.  
The “ORR at EOT” is defined as the proportion of patients with CR or PR based on the response achieved 
at the end of treatment visit/early treatment discontinuation visit.   
In addition, “Best objective response rate” is calculated as the proportion of patients with CR or PR as the 
best objective response at any time on the study. This will be denoted as  “Best ORR”.   
“Best response in the study” is defined as the best achieved response at any time on the study. The order of 
responses are: CR>PR>SD>PD>Not Evaluable. The “Not evaluable” category includes patients who have 
all response assessments after NALT, who do not have a single evaluable post-baseline response assessment 
as per Investigtor, or who have no post-baseline response assessment available (e.g., due to prior death or 
ICF withdrawal). 
The denominator of “ORR at EOT” and ORR is the total number of patients in the analysis set. 
CR or PR after start of NALT (as defined in section ERROR! REFERENCE SOURCE NOT FOUND.) will not 
be considered as responder for either “ORR at EOT” or “Best ORR”. CR or PR after a disease progression, 
will also not be considered. These assessments will be denoted as “Other” and will be considered in the 
denominator for calculating the response rates.  
The analysis of “ORR at EOT” and ORR will be performed on FAS and PPS by treatment arm and overall 
as below:  
• 
Number and percentage of patients with CR/PR/SD/PD/Not evaluable/Other/Missing by visit. 
• 
Number and percentage of patients classified as having “ORR at EOT” with associated 95% 
confidence limits (using the Clopper-Pearson exact method) will be presented, along with number 
and percentage of patients with CR/PR/SD/PD/Not evaluable at EOT. The reasons for being not 
evaluable will be tabulated: 
o Not evaluable (as per investigator assessment) 
o Response assessment after start of new anti-lymphoma treatment 
o Assessment not performed 
o Missing (patient discontinued prior to EOT visit) 
• 
Number and percentage of patients classified as having Best ORR until end of study with associated 
95% confidence limits (using the Clopper-Pearson exact method) will be presented. 
• 
Number and percentage of patients with “Best Response in the study” as CR/PR/SD/PD/ Not 
evaluable as ORR until end of study. The “Not evaluable” category includes patients who have all 
response assessments after NALT, who do not have a single evaluable post-baseline response 
assessment as per Investigtor, or who have no post-baseline response assessment available (e.g., 
due to prior death or ICF withdrawal). 
 The metabolic, PET-negative complete response rate 
The above analysis described in Section 10.1.2 will be perfomed by considering the following modalities 
only: PET/CT and PET/MRI as enetered in “Radiographic Imaging Assessment”. For patients with disease 


 
 
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response assessment of modalities other than ‘PET/CT’ or ‘PET/MRI’, the results will be excluded, with 
associated reason of ‘PET/CT scan or PET/MRI scan’. 
This analysis will be performed on FAS. 
 
 Duration of Response and Duration of Complete Response 
Duration of Response 
For Duration of response (DoR), “Responders” are defined as any patient with a documented CR or PR 
prior to start of NALT or disease progression or cut-off which ever is earlier.  
All other patients will be considered as “Non-responders”.  
DoR is defined as the elapsed time between the date of first documented CR or PR evaluation and the date 
of event defined as first radiologically or histologically/cytologically documented disease progression or 
death (from any cause).  
DoR [months] = [(date of disease progression or death or date of censoring – date of assessment of first 
documented response of (CR or PR) + 1)/30.4375].  
Non-responders will not be considered in this analysis.  
The following table present the different censoring situations and rules for Responders. The DoR for these 
patients is:  
Situation 
Outcome 
Date of Censoring 
Censoring reason 
Patient is ongoing with 
No event  
Censored  
Date of last tumor assessment 
with CR or PR  
Ongoing without progression  
Lost to follow-up (based 
on EOT or EOS eCRF 
page) with No event  
Censored 
Date of last tumor 
assessment with CR or PR  
Lost to follow-up 
Patient received NALT 
prior to documented 
disease progression or 
death  
Censored 
Date of last tumor 
assessment with CR or PR 
before the earlier of the cut-
off date or start of new anti-
lymphoma treatment 
NALT started prior to event 
Death or progression with 
no assessments in the 
preceding 394 days 
Censored 
Date of last tumor assessment 
with CR or PR 
PD/Death documented after 
two or more missing tumor 
assessments 
PD with missing 
assessment date 
Cesnored 
Date of last tumor 
assessment with CR or PR 
Adequate assessment not 
available 


 
 
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Discontinued study with 
No event (Discontinued 
for any reason other than 
“Lost to follow-up”) 
Censored 
Date of last tumor 
assessment with CR or PR  
Discontinued study without 
event 
Completed study with no 
event 
Censored 
Date of last tumor 
assessment with CR or PR 
Completed as per protocol 
without any event 
 
The following analysis will be performed on FAS and PPS by treatment arm: 
• 
Number and percentage of patients who were responders/non-responders 
• 
Number and percentage of patients with first documented response as CR 
• 
Number and percentage of patients with first documented response as PR 
• 
Number and percentage of patients who achieved CR as best response 
• 
Number and percentage of patients who achieved PR as best response 
• 
Number and percentage of Responders who are censored with the censoring reason.  
• 
The distribution (median, Q1 and Q3 together with their 95% CI (Brookmeyer and Crowley 1982)) of 
DoR will be presented 
• 
The probabilities of DoR specific time points (1 month, 3 months, 6 months, 12 months, 18 months, 24 
months), and the associated 95% CIs (Greenwood formula) will be summarized. 
• 
A plot of the Kaplan-Meier curve for DoR  
• 
No formal hypothesis testing will be conducted. 
In addition, the above analysis of DoR will be repeated for the patients who achieved CR as best response 
through the course of study. 
Duration of Complete Response 
For Duration of Complete Response (DoCR), “Responders” are defined as any patient with a documented 
CR prior to start of NALT or disease progression or cut-off which ever is earlier.  
All other patients will be considered as “Non-responders”.  
DoCR is defined as the elapsed time between the date of first documented CR evaluation and the date of 
event defined as first radiologically or histologically/cytologically documented disease progression or death 
(from any cause).  
DoCR [months] = [(date of disease progression or death or date of censoring censored – date of assessment 
of first documented response of CR  + 1)/30.4375].  
Non-responders will not be considered in this analysis.  
 
 
 
 
 


 
 
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The following table present the different censoring situations and rules for Responders.  
Situation 
Outcome 
Date of Censoring 
Censoring reason 
Patient is ongoing with 
with No event 
Censored 
Date of last assessment with 
CR 
Ongoing without progression 
Lost to follow-up (based 
on EOT or EOS eCRF 
page) with No event 
Censored 
Date of last assessment with 
CR 
Lost to follow-up 
Patient received NALT 
prior to documented 
disease progression or 
death  
Censored 
Date of last tumor 
assessment with CR before 
the earlier of the cut-off date 
or start of NALT 
NALT started prior to event 
Death or progression with 
no assessments in the 
preceding 394 days 
Censored 
Date of last tumor assessment 
with CR 
PD/Death documented after 
two or more missing tumor 
assessments 
PD with missing 
assessment date 
Cesnored 
Date of last tumor 
assessment with CR 
Adequate assessment not 
available 
Discontinued study with 
No event (Discontinued 
for any reason other than 
“Lost to follow-up”) 
Censored 
Date of last tumor 
assessment with CR  
Discontinued study without 
event 
Completed study with no 
event 
Censored 
Date of last tumor 
assessment with CR 
Completed as per protocol 
without any event 
 
The following analysis will be performed on FAS by treatment arm: 


 
 
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• 
Number and percentage of patients who were responders/non-responders 
• 
Number and percentage of Responders who are censored with the censoring reason.  
• 
The distribution (median, Q1 and Q3 together with their 95% CI (Brookmeyer and Crowley 1982)) of 
DoCR will be presented. 
• 
The probabilities of DoCR specific time points (1 month, 3 months, 6 months, 12 months, 18 months, 
24 months), and the associated 95% CIs (Greenwood formula) will be summarized. 
• 
A plot of the Kaplan-Meier curve for DoCR  
• 
No formal hypothesis testing will be conducted. 
 
 Progression-free survival  
PFS is defined as the time from the date of randomization to the date of the first radiologically or 
histologically/cytologically documented disease progression (as per Lugano 2014)  or death due to any 
cause. If a patient has not progressed or died at the analysis cut-off date, PFS will be censored as discussed 
sebelow. 
Situation 
Outcome 
Date of Censoring 
Censoring reason 
Ongoing and No event 
until data cut-off 
Censored 
Date of last adequate tumor 
assessment 
Ongoing without event 
No baseline tumor 
assessment 
Censored 
Reference start date 
No baseline tumor assessment 
Lost to follow-up (based 
on EOT or EOS eCRF 
page) without 
documented progression 
or death 
Censored 
Date of last adequate tumor 
assessment or  
reference start date in case 
of study discontinuation 
before any post-baseline 
assessment 
Lost to follow-up 
Patient received NALT 
prior to documented 
disease progression or 
death 
Censored 
Date of last adequate tumor 
assessment before the earlier 
of the cut-off date or start of 
new anti-lymphoma 
treatment 
NALT started prior to event 
Death or progression  with 
no assessments in the 
preceding 394  days  
Censored 
Date of last adequate tumor 
assessment prior to the event 
Event documented after two or 
more 
missing 
tumor 
assessments 
PD with missing 
assessment date 
Cesnored 
Date of last adequate tumor 
response assessment 
Adequate assessment not 
available 
Discontinued study 
without documented 
progressive disease or 
death (for any reason 
other than “Lost to 
follow-up”) 
Censored 
Date of last adequate tumor 
assessment or  
reference start date in case 
of study discontinuation 
without progression before 
any post-baseline assessment 
Discontinued study without 
event 


 
 
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Completed study with no 
event 
Censored 
Date of last adequate tumor 
response assessment 
Completed as per protocol 
without any event 
Note: Event = Any one of the following: Documented disease progression or Death  
Date of event: The first of the two (Documented disease progression or Death)  
Analysis of PFS is performed per treatment arm and overall, using FAS and PPS population sets. Detailed 
analysis is present as below: 
• 
Number and percentage of patients with PFS events/censoring will be described according to the type 
of event or censored (death, disease progression or censored). 
• 
The reason for censoring will be tabulated 
• 
The distribution of PFS will be estimated using the Kaplan-Meier (K-M) method. The median PFS time, 
25% and 75% percentiles, with associated 95% confidence intervals will be presented (Brookmeyer and 
Crowley 1982).  
• 
The PFS probabilities at specific time points (3 months, 6 months, 12 months, 18 months, 24 months), 
and the associated 95% CIs (Greenwood formula) will be summarized. 
• 
The median follow-up time for PFS including a 95% confidence interval (Brookmeyer and Crowley 
1982) will be calculated using the reverse Kaplan-Meier method. This method utilizes the reversed 
status indicator from Kaplan-Meier method. All censored cases from Kaplan-Meier method will be 
reversed as event in the reverse Kaplan-meier method and vice versa. 
• 
A plot of the Kaplan-Meier curve for PFS will be provided to estimate the distribution of PFS.  
• 
No formal hypothesis testing will be conducted. 
 Event-free survival  
Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first 
radiologically or histologically/cytologically documented disease progression or death due to any cause or 
start of NALT. If a patient has not progressed or died or started a new anti-lymphoma treatment by the 
analysis cut-off date, EFS will be censored on the Date of last adequate tumor assessment. More details 
about EFS censoring is presented below:. 
Situation 
Outcome 
Date of Censoring 
Censoring reason 
Ongoing and No event 
until data cut-off 
Censored 
Date of last adequate tumor 
assessment 
Ongoing without event 
No baseline tumor 
assessment 
Censored 
Reference start date 
No baseline tumor assessment 
Lost to follow-up (based 
on EOT or EOS eCRF 
page) without 
documented progression 
or death or start of NALT 
Censored 
Date of last adequate tumor 
assessment or  
reference start date in case 
of study discontinuation 
before any post-baseline 
assessment 
Lost to follow-up 
Death or progression with 
no assessments in the 
preceding 394 days 
Censored 
Date of last adequate tumor 
assessment prior to the event 
Event documented after two or 
more 
missing 
tumor 
assessments 


 
 
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Start of NALT or PD with 
missing assessment date 
Cesnored 
Date of last adequate tumor 
response assessment 
Adequate assessment not 
available 
Discontinued study 
without documented 
progressive disease or 
start of NALT or death 
(for any reason other than 
“Lost to follow-up”) 
Censored 
Date of last adequate tumor 
assessment or reference start 
date in case of study 
discontinuation without 
progression before any post-
baseline assessment 
Discontinued study without 
event 
Completed study with no 
event 
Censored 
Date of last adeuate tumor 
response assessment 
Completed as per protocol 
without any event 
Note: Event = Any one of the following- Documented disease progression or Death due to any cause or start 
of NALT 
Date of event: The first of the three (Documented disease progression or Death or start of NALT)  
Analysis of EFS is performed per  treatment arm and overall in final analysis using FAS population set. 
Detailed analysis is present as below: 
• 
Number and percentage of patients with EFS events/censoring will be described according to the type 
of event or censored (death, documented tumor progression, start of new anti-lymphoma treatment or 
censored). 
• 
The reason for censoring will be tabulated.  
• 
The distribution of EFS will be estimated using the Kaplan-Meier (K-M) method. The median EFS time, 
25% and 75% percentiles, along with 95% confidence intervals will be presented (Brookmeyer and 
Crowley 1982).  
• 
The EFS probabilities at specific time points (3 months, 6 months, 12 months, 18 months, 24 months), 
and the associated 95% CIs (Greenwood formula) will be summarized. 
• 
The median follow-up time for EFS including a 95% confidence interval (Brookmeyer and Crowley 
1982) will be calculated using the reverse Kaplan-Meier method. This method utilizes the reversed 
status indicator from Kaplan-Meier method. All censored cases from Kaplan-Meier method will be 
reversed as event in the reverse Kaplan-meier method and vice versa. 
• 
A plot of the Kaplan-Meier curve for EFS will be provided to estimate the distribution of EFS. 
• 
No formal hypothesis testing will be conducted. 
 Overall survival  
Overall survival (OS) is defined as the time from randomization date until death from any cause and 
documented by the date of death. The censoring rules are presented in details below: 
Situation 
Outcome 
Date of Censoring 
Censoring reason 
Ongoing and No event 
until data cut-off 
Censored 
Date of Last Contact 
Ongoing without event 
Lost to follow-up (based 
on EOT or EOS eCRF 
page) without 
documented death 
Censored 
Date of Last Contact 
Lost to follow-up 


 
 
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Discontinued study 
without documented death 
(for any reason other than 
“Lost to follow-up”) 
Censored 
Date of Last Contact 
Discontinued study without 
event 
Completed study with no 
event 
Censored 
Date of Last Contact  
Completed as per protocol 
without any event 
 Note: Event = Death  
Analysis of overall survival is performed per treatment arm and ovreall, using FAS and PPS population sets. 
Detailed analysis is present as below: 
• 
Number and percentage of patients with OS events/censoring will be described (death or censored). 
• 
The reasons for censoring will be tabulated 
• 
The distribution of OS will be estimated using the Kaplan-Meier (K-M) method. The median OS time, 
25% and 75% percentiles,  along with 95% confidence intervals will be presented (Brookmeyer and 
Crowley 1982).  
• 
The OS probabilities at specific time points (6 months, 12 months, 18 months, 24 months), and the 
associated 95% CIs (Greenwood formula) will be summarized. 
• 
The median follow-up time for OS including a 95% confidence interval (Brookmeyer and Crowley 
1982) will be calculated using the reverse Kaplan-Meier method. This method utilizes the reversed 
status indicator from Kaplan-Meier method. All censored cases from Kaplan-Meier method will be 
reversed as event in the reverse Kaplan-meier method and vice versa. 
• 
A plot of the Kaplan-Meier curve for OS will be provided to estimate the distribution of OS. 
• 
No formal hypothesis testing will be conducted. 
• 
Sensitivity Analysis will be performed considering deaths related to COVID-19 as censored events, 
with the date of death as censoring date. This analysis will be performed only if COVID-19 related 
deaths is >5.  
 Time to next anti-lymphoma treatment  
The time to next anti-lymphoma treatment (TTNT) is defined as the time from the date of randomization to 
the start of next anti-lymphoma therapy (therapies include- medication, surgery or radiotherapy for any 
reason including disease progression, treatment toxicity and patient preference)  or death due to any cause, 
whatever comes first.  
Patients without documented start of a new anti-neoplastic therapy will be censored at the date of last 
contact. 
Situation 
Outcome 
Date of Censoring 
Censoring reason 
Ongoing and No event 
until data cut-off 
Censored 
Date of Last Contact 
Ongoing without event 
Lost to follow-up (based 
on EOT or EOS eCRF 
Censored 
Date of Last Contact 
Lost to follow-up 


 
 
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page) without death or 
start of NALT 
Discontinued study 
without start of NALT or 
death (for any reason 
other than “Lost to 
follow-up”) 
Censored 
Date of Last Contact 
Discontinued study without 
event 
Completed study with no 
event 
Censored 
Date of Last Contact  
Completed as per protocol 
without any event 
Note: Event = Any one of the following- start of NALT or death due to any cause 
Date of event: The first of the two (start of NALT or death due to any cause)  
 
Analysis of TTNT is performed per treatment arm and overall, using FAS.. Detailed analysis is present as 
below: 
• 
Number and percentage of patients with TTNT events/censoring will be described (start of new anti-
lymphoma treatment or censored). 
• 
The reasons for censoring will be tabulated. 
• 
The distribution of  TTNT will be estimated using the Kaplan-Meier (K-M) method. The median TTNT, 
25% and 75% percentiles, along with 95% confidence intervals will be presented (Brookmeyer and 
Crowley 1982).  
• 
The TTNT probabilities at specific time points (6 months, 12 months, 18 months, 24 months), and the 
associated 95% CIs (Greenwood formula) will be  summarized. 
• 
The median follow-up time for TTNT including a 95% confidence interval (Brookmeyer and Crowley 
1982) will be calculated using the reverse Kaplan-Meier method. This method utilizes the reversed 
status indicator from Kaplan-Meier method. All censored cases from Kaplan-Meier method will be 
reversed as event in the reverse Kaplan-Meier method and vice versa. 
• 
A plot of the Kaplan-Meier curves for TTNT will be provided. 
• 
No formal hypothesis testing will be conducted. 
 Primary Refractoriness at EOT 
Primary refractoriness at EOT is defined for those patients who did not have any CR or PR during treatment, 
or patients who progressed or died due to DLBCL within 6 months after EOT or patients who had PD at 
EOT. The number and percentage of patients with primary refractoriness  will be presented at EOT. 
 Listing of response assessment  
Response assessment along with radiographic imaging assessment will be listed out in the patient data 
listing.  


 
 
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 Analysis of Pharmacokinetic data 
Serum samples for the tafasitamab pharmacokinetic (PK) analysis will be collected prior and 1 hour (+/-15 
mins) after the tafasitamab infusion during the course of the treatment phase, end of treatment visit and the 
first two follow-up visits.  
The following elapsed time will be calculated for each record: 
• 
Elapsed time from the first administration of tafasitamab [days]: Date/time of assessment – 
date/time of the first administration of tafasitamab 
For samples collected 1h after the end of the tafasitamab infusion, results will be excluded from summary 
statistics if the deviation of the actual collection time is beyond ± 15 min from the scheduled collection time. 
Such values will be flagged accordingly in the listing of PK data.  
Results of tafasitamab concentrations below the limit of quantification (BLQ) will be presented in the listing. 
In the summary statistics and contentration-time profile graph the value of BLQ is set to be 0 for the cycle 
1 day 1 pre-dose assessment, and treated as missing data in the assessments of other timepoints. 
The tafasitamab serum concentration data [ng/mL] will be summarized and visualized for each treatment 
arm and overall using the PKAS population set. Detailed analyses are presented as below: 
• 
Descriptive statistics of tafasitamab concentrations will be tabulated by visit and timepoint, 
including n, n-missing, arithmetic mean, geometric mean, StD, coefficient of variation CV (%) and 
geometric CV (%), median, minimum and maximum.  
• 
Serum concentration-time profile with mean +/- StD will be visualized across visit and timepoint. 
This will be performed on both original serum concentration value and log(serum concentration 
value). 
• 
Listings of PK data will be generated to display the patient identifier, treatment arm, visit, date/time 
of assessment, assessment timepoint, result, elapsed time, flag of collection time deviation, reason 
for undone assessment. The concentration data will be presented with maximum three decimals.  
 Analysis of Immunogenicity data 
Serum samples for the assessment of anti-tafasitamab antibodies are collected in cycles 1, 3, 5, end of 
treatment visit and the first two follow-up visits. In order to determine the patient’s anti-tafasitamab antibody 
status, as a first step, a screening assay is performed. Then all screened positive samples are tested again in 
a confirmatory assay. For all confirmed positive samples, a titer assay and a specificity assay will be 
performed.  
Anti-tafasitamab antibody samples are defined as “negative” if they are screened or confirmed negative. 
Anti-tafasitamab antibody samples are defined as “positive” if they are reported positive in both the 
screening and the confirmatory assay. For all positive samples, an anti-tafasitamab antibody titer will be 
determined. 
The immunogenicity data will be summarized for each treatment arm and overall, using the IAS population 
set. Detailed analyses are presented as below: 
• 
Number and percentage of patients with anti-tafasitamab antibody response (Positive or Negative 
or Missing) by visit. 


 
 
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• 
Descriptive analysis of anti-tafasitamab antibody titers determinations by visit. 
• 
A summary table of anti-tafasitamab antibody status will be created to present the following 
categories:  
o Number and percentage of patients with pre-existing anti-tafasitamab antibodies, which is 
defined as the patients with positive anti-tafasitamab antibody response on C1D1. 
o Number and percentage of patients with negative response during treatment, which is 
denoted as the patients with negative anti-tafasitamab antibody response on all occasions 
after C1D1, irrespective of the result on C1D1. 
o Number and percentage of patients with positive response during treatment, which is 
defined as the patients who had positive anti-tafasitamab antibody response on any occasion 
after C1D1, irrespective of the result on C1D1. 
o Number and percentage of patients with treatment-induced anti-tafasitamab antibodies, 
which is defined as the patients with negative anti-tafasitamab antibody response on C1D1 
and developed positive response on any other occasion after C1D1. 
o Number and percentage of patients with treatment-boosted anti-tafasitamab antibodies, 
which is defined as the patients with positive anti-tafasitamab antibody response on C1D1 
and developed a higher titer on any other occasion after C1D1. 
• 
Listings of the immunogenicity data will be generated to display the patient identifier, treatment 
arm, visit, date/time of assessment, assessment timepoint, type of assay, result, and reason for 
undone assessment.  
 Analysis of Biomarker data 
10.4.1 General definition and analysis 
A limited number of biomarkers are considered for exploratory analyses those will be presented in this CSR. All 
others will be presented in a future biomarker report. Biomarker assessments including B-cell, T-cell, NK-cell,  
and ctDNA will be quantified in peripheral blood per schedule visits in the protocol (protocol section 10). 
In addition, the biomarkers of CD19 and CD20, will be measured in the tumor tissue, which is collected in 
the screening visit.  
The data of above mentioned biomarkers is collected in eCRF page ‘Pathology central diagnosis’, 
‘Biomarker analysis by IHC’ and external dataset. 
The following biomarker analysis per treatment arm and overall, using FAS population set: 
BTNK 
• 
Descriptive statistics, including number of non-missing observations, number of missing 
observations, arithmetic mean, StD, minimum and maximum values, quartiles (median, Q1 and Q3) 
and 95% CIs, will be tabulated for absolute values and percent change from baseline, of the B-, T-, 
and NK cell quantitative variables by eCRF visit.  
 
 


 
 
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ctDNA 
• 
Descriptive statistics, including number of non-missing observations, number of missing 
observations, arithmetic mean, StD, minimum and maximum values, quartiles (median, Q1 and Q3) 
and 95% CIs, will be tabulated for ctDNA quantitative variables by eCRF visit. 
• 
BLQ results of ctDNA will be treated in two separate ways:  
o as missing in descriptive analysis 
o Imputed as the Lowest Limit of Detection (LOD) to provide a number, which represents 
the maximum amount of ctDNA that could be present in each individual sample 
• 
The rate with 95% CI, in percent, of MRD-negative patients among patients with evaluable MRD 
results (sum of MRD-negative and MRD-positive) by eCRF visit. 
• 
Notes on BLQ value of ctDNA: 
ctDNA measurements (fraction of ctDNA among cfDNA) (ANLOC = BLOOD & SPCT=cfDNA) 
result can be categorized in three tiers (MRDSTAT): 
o NEGATIVE (below limit of detection and below limit of quantification) 
o POSITIVE BQN (above limit of detection and below limit of quantification) 
o POSITIVE (above limit of detection and above limit of quantification) 
If a measurement is above the Limit Of Detection (LOD) the measurement is considered positive, 
indicated in MRDSTAT as POSITIVE or POSITIVE BQN. However, only for POSITIVE results 
(above limit of detection and above limit of quantification) the TESTCD MRDRSLT containing 
the numeric ctDNA result is provided. Any measurement that is indicated as NEGATIVE in 
MRDSTAT is below the LOD and hence, these are also below limit of quantification (BLQ) – 
LOD is already per definition smaller than the limit of quantification. Several measurements using 
markers (SUBTARG) can exist for each subject visit. 
(1) The numeric ctDNA result of a subject visit is the maximum of all available ctDNA results 
(MRDRSLT) of a subject visit. 
(2) For subgroup analysis, only the subjects who have MRDRSLT value at baseline are included 
(i.e., subjects who have MRDSTAT=’POSITIVE’ record at C01D01). Subjects who have no 
MRDRSLT (either no assessment performed or no positive MRDSTAT at baseline) will be 
excluded. Therefore, subjects who have assessed the ctDNA but with no POSITIVE 
MRDSTAT at C01D01 will not be identified as BLQ, and such subjects will not be further 
imputed as LOD/ or counted as ‘<= Median’.  
(3) For baseline and post-baseline by-visit summary of ctDNA numeric values (MRDRSLT), 
subjects who have assessed the ctDNA but with no positive MRDSTAT will be identified as 
BLQ and treated in 2 ways: 
a. treated as missing (applied to ASH 2022 abstract and final analysis) 
b.  imputed as the Lowest Limit of Detection (LOD) (applied to final analysis 
only) 
(4) For the baseline and post-baseline by-visit summary of MRD status (MRDSTAT) in final 
analysis, the following algorithm will be applied: 
➢ The subject visit is considered as POSITIVE if at least one of the measurements of 
subject visit is indicated as MRD-positive (i.e., MRDSTAT=’POSITIVE’) .  
➢ The subject visit is considered as POSITIVE BLQ if at least one of the measurements 
of subject visit is indicated as positive BQN ((i.e., MRDSTAT=’POSITIVE BQN’). 
➢ The subject visit is considered as NEGATIVE if all of the measurements of subject 
visit are indicated as MRD-negative (i.e., MRDSTAT=’NEGATIVE’). 


 
 
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CD19 and CD20 expression by IHC 
• 
Descriptive statistics of CD19 and CD20, , including number of non-missing observations, number 
of missing observations, arithmetic mean, StD, minimum and maximum values, quartiles (median, 
Q1 and Q3) and 95% CIs, will be presented.  
• 
CD19 and CD20 expression will be dichotomised into subgroups, if median = maximum then the 
subgroups will be < median and >= median. If median = minimum then the subgroups will be <= 
median and > median. 
Biomarker Subgroups 
• 
Summary of number and percentage of patients  by subgroups of  cell of origin based on central 
assessment of IHC (Hans algorithm) and gene expression profiling, ctDNA (<= Median and > 
Median), CD19 (<= Median and > Median), and CD20 (<= Median and > Median). 
 
A listing will be created to present the result of biomarkers from pathology central diagnosis and external 
dataset.  
 
Additional exploratory biomarker analyses may be conducted and will not be part of this CSR.  
10.4.2 Relationship between survival endpoints and biomarkers 
The relationship between ORR/PFS with the following biomarkers serves as exploratory endpoints: 
• 
Cell of origin (based on central assessment of IHC-Hans algorithm [Non-GCB vs. GCB]  and gene 
expression profiling [GCB vs. ABC]) at screening 
• 
ctDNA at screening 
• 
Quantitative and semi-quantitative CD19 expression on tumor cells at screening 
• 
Quantitative and semi-quantitative CD20 expression on tumor cells at screening 
 
The analysis of “ORR at EOT” and ORR until end of study, will be performed using FAS population per 
subgroups of each biomarker for each treatment arm as below:  
• 
Number and percentage of patients classified as having “ORR at EOT” with associated 95% 
confidence limits (using the Clopper-Pearson exact method) will be presented. Number and 
percentage of patients with CR/PR/SD/PD/Not evaluable/Other/Missing at EOT will also be 
presented. 
• 
Number and percentage of patients classified as having ORR until end of study with associated 95% 
confidence limits (using the Clopper-Pearson exact method) will be presented. Number and 
percentage of patients with CR/PR/SD/PD/Death/Not evaluable /Missing as best objective response 
until end of study will also be presented. This apply to final completion analysis only. 
• 
ORR at EOT, ORR until end of study with it’s associated 95% CI will be presented in forest plots 
for the different subgroups of all abovementioned biomarkers. 
The analysis of PFS, will be performed using FAS population per subgroups of each biomarker for each 
treatment arm and overall as below:  


 
 
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• 
The distribution of PFS will be estimated for the stratified biomarker groups using the Kaplan-Meier 
method. The median PFS time, 25th and 75th percentiles,  along with 95% confidence intervals will 
be presented (Brookmeyer and Crowley 1982).  
• 
A plot of the Kaplan-Meier curve for PFS will be provided to estimate the distribution of PFS. 
• 
The median PFS time along with its 95% CI will be presented in a forest plot for the different 
subgroups of all above mentioned biomarkers. 
• 
No hypothesis testing will be performed. 
To note, analysis of PFS will not be performed if less than 5 events occur in all of the subgroups per 
treatment arm. 
10.4.3 Optional analysis of biomarkers on tumor biopsy samples 
A quantitative and semi-quantitative assessment of CD19 and CD20 on malignant B-cells may be applied 
in a selected subset of sites, the data from the above assessment will be listed in the patient listing. 
 Analysis of B symptoms and ECOG status 
B symptoms and ECOG status on patients are evaluated in each visit throughout the whole study.  If any of 
the systemic symptoms, i.e. weight loss, fever or night sweat, is present, then B symptoms are defined as 
present. Otherwise B symptoms are absent.  For ECOG status, data are categorized from 0 to 5. 
Absolute and relative frequencies are tabulated for B symptoms and ECOG status per visit for each treatment 
arm and overall using FAS population.  Detailed information of B symptoms and ECOG collected from the 
eCRF will be presented in patient data listings.  
 SAFETY EVALUATION 
 Adverse events 
 Definitions of AEs 
Adverse Event (AE): 
An AE is defined as any untoward medical occurrence in a patient after his/her provision of informed 
consent until the end of the study and it will be recorded in the eCRF , irrespective of causal relationship to 
this treatment. Therefore an AE can be any unfavorable and unintended sign (including an abnormal 
laboratory finding) or symptom, whether or not it is considered related to study treatment.  
The detailed categorization of AE with regards to seriousness, intensity, toxicity, study drug relationship, 
outcome and action taken is depicted in protocol section 11.2.3. 
As per protocol, an abnormal safety assessment that qualify as AEs, e.g. laboratory abnormalities, ECG 
abnormalities, might be documented in the eCRF as an AE. From programming aspect, no additional 
derivation of AE entries will be applied for such case.  
 
 


 
 
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Adverse Event prior to study treatment (Pre-treatment AE): 
Any adverse event start prior to date of first administration of study treatment and without any increase of 
severity after study treatment will be classified as Pre-AE. 
Treatment-emergent Adverse Event (TEAE): 
TEAE is defined as any adverse event reported in the following time interval (including the lower and upper 
limits): [Reference start date of treatment administration; Reference end date of treatment administration + 
30 days]. An adverse event present prior to study drug administration but increased in severity after 
treatment start, will also be included as TEAE.  
Events with missing onset dates will be included as TEAE if the end date is not before the reference start 
date. 
If the start date and time of an AE are partially or completely missing, the AE will be assumed to be a TEAE 
if it cannot be definitely shown that the AE did not occur or worsen during the treatment-emergent period 
(worst case approach). Missing dates and times will not be replaced. The methods for handling the missing 
dates for defining an TEAE is depicted in section 8.3. 
AEs in the follow-up period: 
If an AE occurs 30 days after the End of treatment (boundary not included), it is defined as an AE in the 
follow-up period.  
AEs of special interest (AESIs): 
Information of AESI is provided directly from the eCRF. AESIs for tafasitamab are:  
• 
Tumor lysis syndrome (TLS), 
• 
Second primary malignancy (SPM) 
• 
Infusion-related reactions (IRRs) ≥ grade 3 
• 
Allergic reactions to study drug ≥ grade 3 
• 
Cytokine release syndrome 
• 
Hepatitis B reactivation 
• 
Progressive multifocal leukoencephalopathy (PML) 
AESIs for lenalidomide:  
• 
Second primary malignancy (SPM).  
Death 
Information of death is captured in eCRF page ‘End of Study’ and ‘End of Treatment’ page. All deaths will 
be flagged as ‘On treatment’ or ‘Post-treatment’ and listed. The following summary tables will be generated 
for both primary completion and final analysis on all screened patients and SAF population: 
• 
A overall summary table of reasons of deaths. 
• 
A summary table of reasons of deaths before end of treatment. 
• 
A summary table of reasons of death after end of treatment. 


 
 
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 Analysis of AEs 
The following analysis of AEs will be tabulated per arm and overall patients, using SAF population set. The 
exception is the analysis of pre-treatment AEs, which will be based on all screened patients. 
TEAEs will be classified into the following categories: seriousness, causality, toxicity (determined 
according to the NCI-CTCAE version 5.0), intensity, outcome and action taken.  
Specifically, all summaries of study treatment related TEAEs (causality) will be divided into 5 sections: 
related to any component of study treatment, related to tafasitamab only, related to lenalidomide only, 
related to both tafasitamab and lenalidomide, and related to R-CHOP only.  
All summaries of TEAEs leading to permanent study treatment discontinuation will be divided into the 
following sections: permanent discontinuation of tafasitamab, permanent discontinuation of lenalidomide, 
permanent discontinuation of both tafasiatamab and lenalidomide, permanent discontinuation of R-CHOP, 
permanent discontinuation of rituximab, permanent discontinuation of vincristine, permanent 
discontinuation 
of 
doxorubicin, 
permanent 
discontinuation 
of 
cyclophosphamide, 
permanent 
discontinuation of prednisone and permanent discontinued study treatment (if such AE leads to permanent 
discontinuation of tafasitamab and R-CHOP, it is categorized as ‘discontinued study treatment’ for Arm A, 
and if such AE leads to permanent discontinuation of tafasitamab, lenalidomide and R-CHOP, it is 
categorized as ‘discontinued study treatment’ for Arm B).  
All summaries of TEAEs leading to study treatment interruption will be divided into following sections: 
interruption of tafasitamab, interruption of lenalidomide, interruption of both tafasitamab and lenalidomide, 
interruption of R-CHOP, interruption of rituximab, interruption of vincristine, interruption of doxorubicin, 
interruption of cyclophosphamide, interruption of prednisone and interruption of study treatment (if such 
AE leads to interruption of tafasitamab and R-CHOP, it is categorized as ‘interrupted study treatment’ for 
Arm A, and if such AE leads to interruption of tafasitamab, lenalidomide and R-CHOP, it is categorized as 
‘interrupted study treatment’ for Arm B). Note that, from the eCRF, for a particular patient, if all the R-
CHOP components are interrupted simultaneously for an AE, only then the action taken should be 
considered as interruption of R-CHOP for this AE. 
All summaries of TEAEs leading to R-CHOP reduction will be divided into following sections: dose 
reduction of R-CHOP, dose reduction of rituximab, dose reduction of vincristine, dose reduction of 
doxorubicin, dose reduction of cyclophosphamide and dose reduction of prednisone. Note that, from the 
eCRF, for a particular patient, if all the R-CHOP components are reduced simultaneously for an AE, only 
then the action taken should be considered as R-CHOP reduced for this AE. 
The incidence of TEAEs will be summarized in incidence tables. If a patient experiences more than one 
occurrence of the same AE, the occurrence with the greatest intensity/toxicity, worst outcome and the closest 
association with the study treatment will be counted in the summary tables.  
All AEs will be listed by patient, along with information of treatment arm, start date/time and end date/time, 
duration, seriousness,  causality of tafasitamab/lenalidomide/R-CHOP assessment, toxicity grade, action 
taken with tafasitamab/lenalidomide/R-CHOP, other actions taken, outcome, AESI flag and seriousness 
criteria. 
11.1.2.1 Overall Summary of Adverse Event 
An overall summary table of AEs will be provided with the number and percentage of patients (incidence) 
with at least one event, along with the total number of events presented for the following categories: 


 
 
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• 
Pre-treatment AEs 
• 
All TEAEs  
• 
Study treatment related TEAEs 
• 
Serious TEAEs 
• 
Study treatment related, serious TEAEs 
• 
Grade 3 or higher TEAEs 
• 
Study treatment related, grade 3 or higher TEAEs 
• 
TEAEs leading to permanent study treatment discontinuation 
• 
TEAEs leading to study treatment interruption 
• 
TEAEs leading to lenalidomide/R-CHOP reduction 
• 
TEAEs of special interest (AESIs) 
• 
TEAEs of special interest of grade 3 or higher 
• 
SAEs leading to death 
• 
AEs in the follow-up period 
11.1.2.2 AE summaries by SOC and PT 
Number and percentage of patients experiencing the following AEs and total number of events for the 
following will be summarized by SOC and PT: 
• 
Pre-treatment AEs 
• 
All TEAEs  
• 
TEAEs by intensity 
• 
TEAEs by toxicity grade, along with summary of grade 3 or higher TEAEs 
• 
TEAEs by causality  
• 
TEAEs by seriousness  
• 
Study treatment related, serious TEAEs 
• 
Study treatment related, grade 3 or higher TEAEs by toxicity grade 
• 
TEAEs leading to study treatment discontinuation 
• 
TEAEs leading to study treatment interruption 
• 
TEAEs leading to lenalidomide/R-CHOP reduction 
• 
TEAEs of special interest 
• 
TEAEs of special interest of grade 3 or higher by toxicity grade 
• 
SAEs leading to death 


 
 
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• 
AEs in the follow-up period 
• 
AEs in the follow-up period by intensity 
• 
AEs in the follow-up period by toxicity grade, along with summary of grade 3 or higher AEs 
• 
AEs in the follow-up period by causality  
• 
AEs in the follow-up period by seriousness  
• 
AESIs in follow-up period 
• 
SAEs in the follow-up period 
• 
Deaths in the follow-up period 
• 
Non-serious TEAE regardless of study drug relationship by grade  
 
11.1.2.3 AE summaries by cycle 
Number and percentage of patients experiencing any AEs and total number of events will be summarized 
by SOC and PT for each cycle. 
Bar plots representing the SOCs and PTs per arm will be presented for the same data by cycle. 
11.1.2.4 Specific AE listings 
Special AE listings displaying details of the event(s) captured on the eCRF will be provided for: 
• 
Pre-treatment AEs 
• 
All SAEs 
• 
All TEAEs 
• 
Serious TEAEs 
• 
TEAEs related to study treatment 
• 
TEAEs with toxicity grade higher than 3 
• 
TEAEs of special interest 
• 
TEAEs of special interest with toxicity grade higher than 3 
• 
TEAEs leading to discontinuation of study treatment 
• 
TEAEs leading to death 
• 
AEs in the follow-up period  
• 
Non-serious TEAE regardless of study drug relationship 
 Definition of abnormality, significant worsening, outlying and extreme result in safety analysis 
All results demonstrating new abnormal values, showing a significant worsening signs, and results of 
outlying or extreme values will be noted in laboratory/vital signs data and presented in the respective 
listings. Definitions and calculation rules of ‘new abnormal values’, ‘significant worsening’, ‘outlying 
result’ and ‘extreme value’ are described as follows: 
• 
 A new abnormality will be any abnormal post baseline result for patients whose baseline was 
within normal limits. 


 
 
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• 
A significant worsening will be any numeric clinical laboratory result or vital sign result that 
represents a change from baseline by 25% of the baseline value, in the direction away from 
normal (i.e., in the direction that is clinically significant). The value with 25% change from 
baseline but still remain within the normal reference change is not counted as significant 
worsening. 
• 
An outlying result for any numeric laboratory result or vital sign result will be any post-
administration change from baseline that meets either of the following criteria:   
<25th Percentile - 1.5 * (interquartile range) OR >75th Percentile + 1.5 * (interquartile range) 
• 
An extreme value for any numeric laboratory result or vital sign result will be any post-
administration change from baseline that meets either of the following criteria:  
<25th Percentile - 3 * (interquartile range) OR >75th Percentile + 3 * (interquartile range) 
 
 Laboratory data 
 Laboratory variables 
Laboratory blood assessment is analysed in local lab and it is classified into the following categories: 
Table 10. Laboratory parameters 
Hematology 
Biochemistry 
Coagulation 
Serology and PCR 
diagnostic 
Immunoglobulins 
White blood cells 
(WBC) 
Albumin 
Activated Partial 
Thromboplastin Time 
(aPTT) 
HBsAg 
Immunoglobulin G 
Red blood cells 
(RBC) 
Alkaline 
phosphatase  
Prothrombin Intl. 
Normalized Ration 
(INR) 
Hepatitis B surface 
antibody(Anti-HBs) 
Immunoglobulin A 
Haemoglobin 
(HGB) 
Alanine 
aminotransferase 
(ALT) 
Prothrombin Time  
Hepatitis B core 
antibody (Anti-HBc) 
Immunoglobulin M 
Haematocrit 
(HCT) 
Aspartate 
aminotransferase 
(AST) 
Partial 
Thromboplastin Time  
Hepatitis B virus - 
DNA(HBV-DNA) 
 
Platelet count 
Calcium 
 
Hepatitis C virus 
antibody (Anti-
HCV) 
 
Absolute 
lymphocytes 
Chloride 
 
Hepatitis C virus 
(HCV) RNA 
 
Lymphocytes % 
Calculated 
creatinine clearance 
 
 
 


 
 
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Absolute 
eosinophils 
Creatinine 
 
  
 
Eosinophils % 
Glucose 
 
 
 
Absolute 
basophils 
C reactive protein 
 
 
 
Basophils % 
Direct bilirubin 
 
 
 
Absolute 
monocytes 
Phosphate 
 
 
 
Monocytes % 
Potassium 
 
  
 
Absolute 
neutrophils 
Sodium 
 
  
 
Neutrophils % 
Total bilirubin 
 
  
 
 
Total protein 
 
 
 
 
LDH 
 
 
 
 
Uric acid 
 
 
 
 
TSH 
 
 
 
 
 Grading of laboratory data 
Laboratory data grades of severity will be derived according to the Common Terminology Criteria for 
Adverse Events (CTCAE) v5.0. CTCAE grade is applied to the converted measurement in SI units.  A 
severity grade of 0 will be assigned when the value is within normal limits. In the case when a local 
laboratory normal range overlaps into the higher (i.e. non-zero) CTCAE grade, the CTCAE grade will be 
taken. Grade 5 will not be used. Laboratory values having hyper and hypo shifts will be treated as separate 
CTCAE lab parameters and classified into absolute CTCAE grades. 
For laboratory tests for which grades of severity are not defined by CTCAE, results will be graded by the 
low/normal/high classifications based on laboratory normal ranges.  
For duplicate laboratory measurements taken at the last assessment date on or before the start date of study 
treatment, the value of lower CTCAE grade will be considered as the baseline value.  
In some cases when several records taken at the last assessment date have the same absolute  grade, but in 
different directions, 2 baselines should be created for presenting shift tables, the record with hypo shift 
should be the baseline of the 'Hypo' parameter, and the other record should be the baseline for the 'Hyper' 
parameters. 
For non-gradable labs with duplicate laboratory measurements taken at the last assessment date on or before 
the start date of study treatment: 
• 
If both within normal range: take average value. 
• 
If one within normal range and the other outside: take the one within normal range. 
• 
If both outside normal range: take the one closest to the normal range. 


 
 
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Laboratory values with missing units or normal range may not be able to be graded or included in laboratory 
tables. 
 Analysis of Laboratory 
All laboratory results, including hematology, biochemistry, coagulation, immunoglobulin and serology, 
collected in the course of study will be listed by patient, laboratory category and parameter, along with 
information of treatment arm, eCRF visit, sample collected date, result, reference range, within/out of 
reference range, clinical significance, flag of new abnormality/significant worsening/outlying 
result/extreme value, reason of undone assessment. The clinical significant abnormalities of each category 
will be additionally listed. In particular to hematology and biochemistry data, analysis visit will be added in 
the listing, given analysis visit deviate from eCRF visit. Besides urine and serum pregnancy test will be 
listed in laboratory section. 
Unless otherwise stated, the following analysis will be tabulated for each treatment arm and overall, using 
SAF population set. In particular, hematology and biochemistry data will be presented by both eCRF visit 
and analysis visit, only when analysis visit deviate from eCRF visit. Other laboratory parameters will be 
presented by eCRF visit only. 
• 
Descriptive statistics of each continuous parameter will be summarized, including absolute values 
and change from baseline by parameter and by visit. 
• 
For continuous laboratory parameters, a summary of number and percentage of patients of clinical 
assessment will be tabulated by parameter and visit.  Clinical assessment is classified into ‘Normal’, 
‘Abnormal, no clinical relevance’ and ‘Abnormal, clinical relevance’. 
• 
A summary of number and percentage of patients with worst post-baseline CTCAE grade will be 
presented by parameter and visit, for the applicable laboratory parameters. The result with highest 
toxicity grade will be taken as worst value for overall post-baseline assessment.  
• 
For categorical laboratory parameters, namely serology and PCR diagnostic laboratory assessments, 
number and percentage of patients with laboratory result will be listed by parameter and visit. 
• 
Shift tables to compare baseline to the worst post-baseline value will be produced using: 
o CTCAE grades for continuous laboratory parameters where CTCAE grades are defined. 
o The classifications relative to the laboratory reference ranges (low/normal/high) for continuous 
laboratory parameters where CTCAE grades are not defined. Specifically, if a patient experience 
both ‘low’ and ‘high’ assessments in the course of the study, two worst values will be derived 
as the overall post-baseline assessments. 
 
Spaghetti plots will be presented for the laboratory parameters absolute neutrophil count, platelets and 
haemoglobin for all patients across all the visits for each cycle. Box plots will also be presented for the 
above representation. 
 Vital signs 
 Vital signs variables 
The Vital Signs captured in the eCRF for each patient at each visit are the following: 
• 
Weight  
• 
Systolic Blood Pressure 
• 
Diastolic Blood Pressure 
• 
Heart Rate  


 
 
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• 
Temperature  
As per protocol, systolic blood pressure, diastolic blood pressure, heart rate, temperatue are to be measured 
pre-tafasitamab infusion, and then at least 3 times during infusion. The sequence of timepoint for the 
measurements during the infusion will be sorted and flagged according to the actual assessment time, to be 
‘First assessment during infusion’, ‘Second assessment during infusion’, ‘Third assessment during infusion’ 
and so on.  
 Analysis of Vital signs 
All vital sign results collected in the course of study will be listed by patient and vital sign parameter, along 
with information of treatment arm, visit, assessment date, result, clinical significance, flag of new 
abnormality/significant worsening/outlying result/extreme value, reason of undone assessment. The clinical 
significant abnormalities of each parameter will be additionally listed.  
The following summaries will be performed for weight, Systolic blood pressure, diastolic blood pressure, 
heart rate, respiratory rate and temperature for each treatment arm and overall, using SAF population: 
• 
Descriptive statistics of each vital signs parameters will be summarized, including absolute values 
and change from baseline by visit and timepoint.   
• 
A summary of number and percentage of patients of clinical assessment will be tabulated by visit 
and timepoint.  
 Physical examination 
Full physical examination is performed at screening and end of treatment visit, while limited physical 
examination is performed per individual status. All physical examination results collected in the course of 
study will be listed by patient and body system. Listings of physical examination is based on SAF 
population. 
 Electrocardiogram (ECG) 
 ECG variables 
A general interpretation of  local ECG result is captured in eCRF as “Normal”, “Abnormal, not clinically 
significant”,  “Abnormal, clinically significant and “Not Done”. 
Data listing of local ECG will be produced to present the patient identifier, treatment arm, visit, assessment 
time, result, abnormality and the reasons for “not done” records on the basis of SAF population.  
 Analysis of ECG 
The following analysis will be performed for each treatment arm and overall, using SAF population: 
• 
A summary of number and percentage of patients of ECG clinical assessmentby visit. 


 
 
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 Echocardiogram (ECHO) or cardio multigated acquisition (MUGA)  
 ECHO or MUGA variables 
Echocardiogram or cardiac MUGA scan will be obtained at screening and at End of Treatment Visit/ Early 
Study Treatment Discontinuation Visit to evaluate cardiac function, including assessment of left ventricular 
systolic function (LVEF). Listing will be generated on the basis of SAF population. 
 Analysis of ECHO or MUGA 
The following analysis will be performed for each treatment arm and overall, using SAF population: 
• 
Descriptive statistics of LVEF will be summarized, including absolute values and change from 
baseline by visit.   
• 
Number and percentage of patients with different method of ECHO or MUGA assessment. 
• 
A shift table to compare LVEF of baseline to EOT visit. The LVEF reference range is 50% to 70% 
(boundary included). The classifications relative to the reference ranges (low/normal/high) is 
applied. 
 
 ANALYSES SPECIFIC TO COVID-19 PANDEMIC  
The following applies for both the primary and final analyses. Analyses that were included with the 
amendment of SAP v2.1 were included after the time of the primary analysis and are only included in the 
final analysis.  
- 
Number and percentage of patients with positive test of COVID-19 
- 
Number and percentage of patients with at least one and at least two missed tumor assessments 
because of COVD-19  
- 
Number and percentage of patients with Study Treatment interruption/delay/discontinuation 
because of COVID-19 
- 
Number and percentage of patients whose primary cause of death is COVID-19 
- 
Number and percentage of patients who were hospitalized because of COVID-19 
- 
Number and percentage of patients who received treatment because of COVID-19, and the 
treatments by ATC Level 2 class. The details can be obtained from the AE page and the Conomitant 
Medication eCRF Page. Number and percentage of patients experiencing any AEs and total number 
of events due to COVID-19 will be summarized by SOC and PT by arm and overall. This will also 
be listed. 
- 
Number and percentage of patients experiencing any SAEs and total number of events due to 
COVID-19 will be summarized by SOC and PT by arm and overall. This will also be listed. 
- 
Number and percentage of patients experiencing any TEAEs and total number of events due to 
COVID-19 will be summarized by SOC and PT by arm and overall. This will also be listed. 
- 
Number and percentage of patients with non-AE COVID-19 impact. 
 
In terms of efficacy, the following sensitivity analyses will be performed: 
- 
For PFS and EFS, the descriptive reporting and treatment comparison for main 
analysis will be performed by changing the censoring strategy: deaths due to COVID-19 will be 
censored at the last adequate tumor assessment date.  


 
 
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- 
For OS, the descriptive reporting and treatment comparison for main analysis will be performed 
by changing the censoring strategy: deaths due to COVID-19 will be censored at the date of last 
contact before death.   
All protocol deviations in relation to COVID-19 will be identified based on reviews of the data prior to 
database lock. All important protocol deviations related to COVID-19 will be listed to describe the patient 
information, treatment arm, category, exact item and date of protocol deviation.  
The number and percentage of patients in the FAS patients, with at least one of important protocol deviations 
in relationship to COVID-19, will be summarized by treatment arm and overall according to the earlier 
described PD categories. 
 
 


 
 
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 GENERAL GUIDANCE ON REPORTING 
 Document headers, footers and layout 
The following table specifies general information of headers, footers and layout. 
Orientation 
Landscape 
Paper Size 
A4 
Margins 
Top: 2 cm  
Bottom: 2 cm 
Left: 2 cm 
Right: 2 cm 
Header: 1.27 cm 
Footer: 1.27cm 
Font 
Courier New 8pt 
Headers 
 
Protocol number – Type of Analysis (Cut-off date) (Left); Page 
X of Y (Right) 
TLF Number and Title 
Footers 
 
SAS program name 
Source Data 
Extract date 
Date,/Time of TLF generation 
The font size may be reduced as necessary to allow additional columns to be presented, but not at the expense 
of clarity. Also the orientation may be changed to portrait if appropriate. 
In the headers, the text Type of Analysis should be substituted to be either PA (initial of Primary Analysis) 
or FA (initial of Final Analysis). For example: MOR208C107 – PA (Cut-off date: 15NOV2019). 
All other table-unique footers should be presented above the aforementioned footers, as the following 
display: 
• 
footnote 1 
• 
footnote 2 
• 
footnote 3 
SAS program name  --  source data  --  extract date  --  date/time of TLF generation  
In the applicable outputs, the MedDRA version and WHO-DDE version used for reporting the study will 
be specified as a footnote. 
- MedDRA Version <xx.x> has been used for the reporting  
- WHO-DDE Version <xx.x> has been used for the reporting 
The latest available version of dictionaries at the time of reporting will be used. 
 


 
 
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 Presentation of output numbering and titles within this document 
In practice, the numbering and title for all tables, figures and listings in sections 14 and 16 defined in this 
document will be formatted as follows, respectively: 
Table 14.x.x.x 
Title Title Title Title Title Title 
Population 
 
Listing 16.x.x.x 
Title Title Title Title Title Title 
Population 
 
 General rules for presenting tables and listings 
Unless differently specified, a summary table will be produced by different study  arm and the overall 
number added up from by all possible arms. 
All other data as documented in the eCRF will be listed and/or tabulated using descriptive statistics or 
counts/percentages depending on the nature of data. All the data collected and derived in the trial will be 
presented in patient data listings. 
The following general rules for presenting listings should be applied by default for all listings. 
Unless differently mentioned, all listings should contain the following information in the first three columns: 
“Patient identifier”, “Treatment arm” and “Age/Sex/Race”. For data collected on visit level, the visit should 
be placed in the fourth column. The default sorting order is by patient number and event/assessment date 
unless otherwise stated. 
Where a listing or table has been planned, but no data meet the criteria, then a single line stating ‘No data 
meeting the criteria is present’ will be provided in the output. 
Specifically for this study, if analysis visit does not deviate from eCRF visit for all patients, a single line 
stating ‘This table is identical with the table of eCRF visit, as no deviation occurred between eCRF visit and 
analysis visit’. 
For all laboratory parameters, SI units are used as default. 
When a variable collected in the eCRF is linked to another variable, one or both variables will be presented 
in the same column of the listing or in adjacent columns if space permits this.  
For example: 
• 
‘Setting’=’OTHER’ and ‘Other, specify’=’Lung’ 
“OTHER: Lung” will be displayed in the column as ‘Setting’. 
• 
‘Dose’=’120’ and Dose unit =’mg’ 
‘120 mg’ will be displayed in the column as ‘dose (unit)’. 


 
 
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• 
If Date = “2012-05-12” and Study day =”5”, then “12MAY2012 / 5” will be displayed in the 
column as ‘Date / Study Day’. 
• 
If End date = “ ” and ongoing is ticked, then “Ongoing” will be displayed in the column as ‘End 
date / Study Day’. 
 Presentation of analysis sets 
The outputs to be produced based on this document will use ‘Screened Patients’, ‘FAS’, ‘PPS’, ‘SAF’, 
“PKAS’, ‘IAS” in the table/figure/listing titles. 
 General rules for presenting frequencies and percentages 
If a summary table displays only categorical variables then the convention illustrated in the following 
example will be used: 
However, if a summary table displays both continuous and categorical variables then the convention 
illustrated in the following example will be used: 
 
Preferred Term 
Tafasitamab + R-
CHOP 
 N=xx 
 n (%) 
Tafasitamab + 
Lenalidomide + R-
CHOP 
  N=xx 
  n (%) 
Overall 
  N=xx 
  n (%) 
Total 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Fatigue 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Nausea 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Anemia 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
Tafasitamab + R-
CHOP 
 
 N=xx 
Tafasitamab + 
Lenalidomide + R-
CHOP 
 
 N=xx 
Overall 
 N=xx 
Sex, n  (%) 
 
 
 
  Male 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Female 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Age (Years) 
 
 
 
   n 
xx 
xx 
xx 
   Mean 
xx.x 
xx.x 
xx.x 
   StD 
xx.xx 
xx.xx 
xx.xx 


 
 
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 Presentation of dates 
Calendar dates and times (optional) in all the listings will be displayed in the format:  
DDMONYYYY hh:mm e.g. 15JAN2019 08:20.  
Note: If time is not collected, calendar dates will be displayed as: DDMONYYYY.  
 
 
 
   Median 
xx.x 
xx.x 
xx.x 
   Minimum 
xx.x 
xx.x 
xx.x 
   Maximum 
xx.x 
xx.x 
xx.x 


 
 
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  REFERENCES 
1. ICH Topic E3: Note for Guidance on Structure and Content of Clinical Study Reports. Consensus 
Guideline; 30 November 1995, adapted by CPMP, December 95, issued asa CPMP/ICH/137/95. 
2. ICH Topic E9: Statistical Principles for Clinical Trials. 5 February 1998, adopted by CPMP, March 
1998, issued as CPMP/ICH/363/96. 
3. ICH E9 (R1): addendum on estimands and sensitivity analysis in clinical trials to the guideline on 
statistical principles for clinical trials. 17 February 2020 EMA/CHMP/ICH/436221/2017.  
4. EMA Guidance: Points to consider on implications of Coronavirus disease (COVID-19) on 
methodological aspects of ongoing clinical trials. 26 June 2020, EMA/158330/2020 Rev. 1.  
5. ICH Topic E10: Choice of Control Group and Related Issues in Clinical Trials, adopted by CPMP, 
20 July 2000, issued as CPMP/ICH/364/96. 
6. Guidance for Industry Providing Regulatory Submissions in Electronic Format – Standardized 
Study Data Verson 4.1, March 2018 
7. Cheson, B. D. et al. (2014) ‘Recommendations for Initial Evaluation, Staging, and Response 
Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification’, Journal of 
Clinical Oncology, 32, pp. 1–10. doi: 10.1200/JCO.2013.54.8800. 
8. Salles, G,  et al (2018) ‘Single-Arm Phase II Study of MOR208 Combined with Lenalidomide in 
Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: L-Mind’, in ASH. 
9. Okken, M.M. et al. (1982) ‘Toxicity and response criteria of the Eastern Cooperative Oncology 
Group.’ Am J Clin Oncol. Dec;5(6):649-55. 
10. Brookmeyer R, Crowley JJ. A confidence interval for the median survival time. Biometrics 1982, 
38:29-41.