A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

NCT02763319 | Completed Phase 2 Results DMC

• 2 other identifiers: MOR208C2042014-004689-11
• Study Type: interventional
• Target: 453
• Locations: 22 countries
• Sites: 157

Brief Summary

The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Diffuse Large B-cell Lymphoma; bendamustine; rituximab; combination therapy; CD19 monoclonal antibody; transplant ineligible

Outcome Measures

Primary Outcomes (2)

• Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population

  Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.

  up to 41.4 months

• Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup

  Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.

  up to 46.5 months

Secondary Outcomes (21)

• Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population

  up to 77 months

• Best ORR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup

  up to 77 months

• Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Overall Population

  up to 40.2 months

• Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup

  up to 44.7 months

• Kaplan-Meier Estimate of Overall Survival in the Overall Population

  up to 50.0 months

Study Arms (2)

Tafasitamab and bendamustine

EXPERIMENTAL

Tafasitamab and bendamustine

Drug: Tafasitamab; Drug: Bendamustine (BEN)

Rituximab and bendamustine

ACTIVE COMPARATOR

Rituximab and bendamustine

Drug: Rituximab (RTX); Drug: Bendamustine (BEN)

Interventions

Rituximab (RTX) DRUG

Rituximab: Dose: 375 mg/m2 IV

Also known as: Rituxan, Mab Thera

Rituximab and bendamustine

Tafasitamab DRUG

Tafasitamab: Tafasitamab dose: 12 mg/kg intravenously (IV)

Tafasitamab and bendamustine

Bendamustine (BEN) DRUG

Also known as: Levact/Treanda

Rituximab and bendamustine; Tafasitamab and bendamustine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Histologically confirmed diagnosis, according to the World Health Organization (WHO, 2008) classification, of: DLBCL NOS, THRLBCL, EBV-positive DLBCL, composite lymphoma with a DLBCL component with a DLBCL relapse subsequent to DLBCL treatment, disease transformed from an earlier diagnosis of low grade lymphoma (i.e. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with a DLBCL relapse subsequent to DLBCL treatment.
• Fresh tumour tissue for central pathology review must be provided as an adjunct to participation in this study. Should it not be possible to obtain a fresh tumour tissue sample, archival paraffin embedded tumour tissue acquired ≤3 years prior to screening for this protocol must be available for this purpose.
• Patients must have:
• relapsed or refractory DLBCL
• at least one bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of ≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm at baseline. The lesion must be positive on PET scan
• received at least one, but no more than three previous systemic therapy lines for the treatment of DLBCL. At least one previous therapy line must have included a CD20-targeted.
• ECOG 0 to 2
• Patients after failure of ASCT or patients considered in the opinion of the investigator currently not eligible for HDC with subsequent ASCT.
• Patients must meet the following laboratory criteria at Screening:
• ANC ≥1.5 × 109/L (unless secondary to bone marrow involvement by DLBCL)
• PLTs ≥90 × 109/L (unless secondary to bone marrow involvement by DLBCL) and absence of active bleeding
• total serum bilirubin ≤2.5 × ULN unless secondary to Gilbert's syndrome (or pattern consistent with Gilbert's) 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 x ULN
• ALT, AST and AP ≤3 × ULN or \<5 × ULN in cases of documented liver involvement by lymphoma
• serum creatinine ≤2.0 x ULN or creatinine clearance must be ≥40 mL/min calculated using a standard Cockcroft-Gault formula (Cockroft \& Gault, 1976)

You may not qualify if:

• Patients who have: any other histological type of lymphoma including, e.g., primary mediastinal (thymic) large B-cell lymphoma (PMBL) or Burkitt's lymphoma, primary refractory DLBCL, patients with known "double/triple hit" DLBCL genetics, CNS lymphoma involvement in present or past medical history
• Patients who had a major surgery less than 30 days prior to Day 1 dosing
• Patients who have, within 14 days prior to Day 1 dosing:
• not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
• received live vaccines
• required parenteral antimicrobial therapy for active, intercurrent systemic infections
• Patients who:
• in the opinion of the investigator, have not recovered sufficiently from the adverse toxic effects of prior therapies, major surgeries or significant traumatic injuries
• were previously treated with CD19-targeted therapy or BEN
• have a history of previous severe allergic reactions to compounds of similar biological or chemical composition to Tafasitamab, RTX, murine proteins or BEN, or the excipients contained in the study drug formulations
• have undergone ASCT within a period of ≤3 months prior to signing the informed consent form. Patients who have a more distant history of ASCT must exhibit full haematological recovery before enrolment into the study.
• have undergone previous allogeneic stem cell transplantation
• concurrently use other anticancer or experimental treatments
• Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥3 years prior to Screening. Exceptions to the ≥3-year time limit include history of the following:
• basal cell carcinoma of the skin

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (158)

MorphoSys Research Site

Anaheim, California, 92801, United States

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MorphoSys Research Site

Bakersfield, California, 93309, United States

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Burbank, California, 91505, United States

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Fresno, California, 93701, United States

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Los Angeles, California, 90017, United States

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Whittier, California, 90603, United States

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Plainville, Connecticut, 06062, United States

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Skokie, Illinois, 60077, United States

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Detroit, Michigan, 48202, United States

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Rochester, Minnesota, 55905, United States

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Hattiesburg, Mississippi, 39401, United States

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Jackson, Mississippi, 39126, United States

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Morristown, New Jersey, 07960, United States

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New York, New York, 10029, United States

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Stony Brook, New York, 11794, United States

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Oklahoma City, Oklahoma, 73142-2015, United States

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Knoxville, Tennessee, 37909, United States

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Lubbock, Texas, 79415, United States

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MorphoSys Research Site

Adelaide, 5000, Australia

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Albury, 2640, Australia

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Bedford Park, 5042, Australia

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Box Hill, 3128, Australia

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MorphoSys Research Site

Concord, 2139, Australia

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Frankston, 3199, Australia

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MorphoSys Research SIte

Garran, 2605, Australia

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MorphoSys Research Site

Geelong, 3220, Australia

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Gosford, 2250, Australia

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Nedlands, 6009, Australia

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South Brisbane, 4101, Australia

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St Albans, 3021, Australia

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Innsbruck, 6020, Austria

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Edmonton, Alberta, T6G 1Z2, Canada

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Winnipeg, Manitoba, R3E 0V9, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Kingston, Ontario, K7L 5P9, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Saskatoon, S7N4H4, Canada

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MorphoSys Research Site

Zagreb, 10000, Croatia

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MorphoSys Research Site

Hradec Králové, 50005, Czechia

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Morphosys Research site

Olomouc, 77900, Czechia

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Prague, 12808, Czechia

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Prague, 15006, Czechia

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MorphoSys Research Site

Oulu, 90220, Finland

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Tampere, 33521, Finland

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Grenoble, 38043, France

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MorphoSys Research Site

Le Mans, 72037, France

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Aachen, 52074, Germany

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Berlin, 10967, Germany

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Berlin, 12351, Germany

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Düsseldorf, 40479, Germany

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Giessen, 35392, Germany

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Homburg, 66421, Germany

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Leipzig, 04103, Germany

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Mainz, 55131, Germany

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Munich, 81377, Germany

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Munich, 81737, Germany

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Mutlangen, 73557, Germany

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Münster, 48149, Germany

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Rostock, 18057, Germany

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Stuttgart, 70199, Germany

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Stuttgart, 70376, Germany

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MorphoSys

Traunstein, 83278, Germany

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MorphoSys

Budapest, 1083, Hungary

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Debrecen, 4032, Hungary

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Győr, 9024, Hungary

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MorphoSys

Szeged, 6725, Hungary

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MorphoSys Research Site

Haifa, 31096, Israel

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Jerusalem, 90131, Israel

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Jerusalem, 91120, Israel

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Kfar Saba, 44281, Israel

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Tel Aviv, 69710, Israel

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MorphoSys Research Site

Alessandria, 15121, Italy

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Bologna, 40138, Italy

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Campobasso, 86100, Italy

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Cona, 44124, Italy

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Genova, 16132, Italy

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Lecce, 73100, Italy

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Meldola, 47014, Italy

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Monza, 20900, Italy

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Napoli, 80131, Italy

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Novara, 28100, Italy

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Orbassano, 10043, Italy

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Parma, 43100, Italy

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Pavia, 27100, Italy

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Pisa, 56126, Italy

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Ravenna, 48121, Italy

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Reggio Emilia, 42100, Italy

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Rimini, 47923, Italy

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Rome, 00128, Italy

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Rome, 00144, Italy

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Morphosys Research Site

Terni, 05100, Italy

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Turin, 10043, Italy

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Morphosys Research Site

Turin, 10126, Italy

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MorphoSys Research Site

Addington, 8011, New Zealand

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Auckland, 2025, New Zealand

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Grafton, 1148, New Zealand

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Bydgoszcz, 85-796, Poland

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Gdynia, 81-519, Poland

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Krakow, 30-510, Poland

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Legnica, 59-220, Poland

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Lodz, 93-510, Poland

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Lublin, 20-090, Poland

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Warsaw, 02781, Poland

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Wroclaw, 50-556, Poland

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MorphoSys Research Site

Braga, 4710243, Portugal

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Coimbra, 3000-075, Portugal

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Coimbra, 3000075, Portugal

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MorphoSys Research Site

Matosinhos Municipality, 4464-504, Portugal

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MorphoSys Research Site

Porto, 4099001, Portugal

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Porto, 4200072, Portugal

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Pragal, 2901-951, Portugal

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MorphoSys Research Site

Bucharest, 022328, Romania

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Bucharest, 30171, Romania

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MorphoSys Research Site

Iași, 700483, Romania

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MorphoSys Research Site

Belgrade, 11000, Serbia

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MorphoSys Research Site

Kragujevac, 34000, Serbia

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MorphoSys Research Site

Singapore, 119074, Singapore

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MorphoSys Research Site

Singapore, 169610, Singapore

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MorphoSys Research Site

Singapore, 188770, Singapore

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MorphoSys Research Site

Singapore, 258499, Singapore

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MorphoSys Research Site

Busan, 49201, South Korea

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MorphoSys Research Site

Goyang-si, 10408, South Korea

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Incheon, 21565, South Korea

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MorphoSys Research Site

Jeonju, 54907, South Korea

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MorphoSys Research Site

Seongnam, 13620, South Korea

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MorphoSys Research Site

Seoul, 03722, South Korea

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MorphoSys Research Site

Seoul, 05505, South Korea

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MorphoSys Research Site

Seoul, 07985, South Korea

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MorphoSys Research Site

Seoul, 135710, South Korea

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MorphoSys Research Site

Ulsan, 44033, South Korea

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MorphoSys Research Site

Cadiz, 11009, Spain

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MorphoSys Research Site

Girona, 17007, Spain

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MorphoSys Research Site

L'Hospitalet de Llobregat, 08908, Spain

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MorphoSys Research Site

Madrid, 28007, Spain

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MorphoSys Research Site

Madrid, 28023, Spain

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MorphoSys Research Site

Madrid, 28050, Spain

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MorphoSys Research Site

Palma de Mallorca, 07198, Spain

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MorphoSys Research Site

Pamplona, 31008, Spain

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MorphoSys Research Site

Pozuelo de Alarcón, 28223, Spain

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MorphoSys

Sabadell, 08208, Spain

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Salamanca, 37007, Spain

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MorphoSys Research Site

Valencia, 46940, Spain

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Morphosys Research Site

Chang-hua, 50006, Taiwan

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Morphosys Research Site

Hualien City, 97002, Taiwan

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Morphosys Research Site

Taichung, 40447, Taiwan

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MorphoSys Research Site

Adana, 01330, Turkey (Türkiye)

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MorphoSys Research Site

Ankara, 06500, Turkey (Türkiye)

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MorphoSys Research Site

Ankara, 06590, Turkey (Türkiye)

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MorphoSys Research Site

Bornova, 35100, Turkey (Türkiye)

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MorphoSys Research Site

Gaziantep, 27310, Turkey (Türkiye)

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MorphoSys Research Site

Izmir, 35340, Turkey (Türkiye)

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MorphoSys Research Site

Manisa, 45010, Turkey (Türkiye)

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MorphoSys Research Site

Samsun, 55139, Turkey (Türkiye)

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Morphosys Research Site

Birmingham, B71 4HJ, United Kingdom

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MorphoSys Research Site

Leeds, LS97 TF, United Kingdom

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MorphoSys Research Site

Southend-on-Sea, SS0 0RY, United Kingdom

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MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; tafasitamab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Incyte Medical Director

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor: blinding on treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2016
• First Posted: May 5, 2016
• Study Start: November 28, 2016
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

AU (12); KR (10); CA (8); TU (8); GB (3); ES (12); SE (2); PT (7); RO (3); US (18); CZ (4); TW (3); CR (1); FI (2); DE (16); IT (22); NZ (3); IL (5); HU (4); PL (8); FR (2); SG (4)