Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
NCT04824092 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 899
Last updated 2026-04-01
Summary
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL
Conditions
- Diffuse Large B-cell Lymphoma
Interventions
- DRUG
-
Tafasitamab
Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
- DRUG
-
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Prednisone PO will be administered as per the schedule specified in the respective arm.
- DRUG
-
Tafasitamab placebo
0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Lenalidomide placebo
Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Incyte Medical Director · Incyte Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-11
- Primary Completion
- 2026-09-01
- Completion
- 2027-11-01
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Canada
- Colombia
- Czechia
- France
- Germany
- Hungary
- Ireland
- Israel
- Italy
- Japan
- Malaysia
- New Zealand
- Philippines
- Poland
- Romania
- Russia
- Serbia
- Slovakia
- South Korea
- Spain
- Taiwan
- Thailand
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
More Related Trials
-
R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma
NCT04214626 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma
NCT01004991 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Dynamic CtDNA-guided Targeted Therapy in DLBCL
NCT06748521 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy
NCT02889523 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL
NCT01279902 ·Status: UNKNOWN ·Phase: PHASE2
-
R2-CHOP in Untreated DEL-DLBCL：An Open-lable，Multicenter，Phase II Study
NCT04842487 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
NCT05040906 ·Status: UNKNOWN ·Phase: PHASE3
-
A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
NCT04529772 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma
NCT04980222 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
NCT05018520 ·Status: RECRUITING ·Phase: PHASE3
-
A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma
NCT02220842 ·Status: COMPLETED ·Phase: PHASE1
-
Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
NCT00118209 ·Status: COMPLETED ·Phase: PHASE3
-
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated High- or High-Intermediate-Risk Diffuse Large B-Cell Lymphoma
NCT01539174 ·Status: WITHDRAWN ·Phase: PHASE2
-
Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma
NCT01334502 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis
NCT00945724 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT06521255 ·Status: RECRUITING ·Phase: PHASE3
-
Mini-CHOP and Rituximab in Patients Aged Over 80 Years
NCT01087424 ·Status: COMPLETED ·Phase: PHASE2
-
Lenalidomide Combined With R-CHOP(R2-CHOP) in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients
NCT04164368 ·Status: COMPLETED ·Phase: PHASE2
-
R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma
NCT00137995 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
NCT00486759 ·Status: TERMINATED ·Phase: PHASE3
-
R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL
NCT02054559 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)
NCT04974996 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma
NCT02529852 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger
NCT00290498 ·Status: COMPLETED ·Phase: PHASE2
-
Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma
NCT02031419 ·Status: TERMINATED ·Phase: PHASE1