Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma
NCT06356129 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 850
Last updated 2026-02-12
Summary
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).
Conditions
Interventions
- DRUG
-
Golcadomide
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Doxorubicin
Specified dose on specified days
- DRUG
-
Vincristine
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
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
- 2024-06-19
- Primary Completion
- 2028-08-14
- Completion
- 2029-11-20
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Hungary
- India
- Italy
- Japan
- Malaysia
- Mexico
- Netherlands
- New Zealand
- Norway
- Poland
- Portugal
- Puerto Rico
- Romania
- Saudi Arabia
- Singapore
- Slovakia
- South Korea
- Spain
- Sweden
- Taiwan
- Thailand
- Turkey (Türkiye)
Study Locations
More Related Trials
-
A Real-world Study on Golidocitinib-based Therapeutic Regimens for the Treatment of Patients With Peripheral T-cell Lymphoma
NCT06963632 ·Status: NOT_YET_RECRUITING
-
Golidocitinib Plus CHOP in Newly Diagnosed PTCL
NCT06739265 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma
NCT06047080 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor
NCT03536039 ·Status: COMPLETED ·Phase: PHASE2
-
Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma
NCT00386321 ·Status: TERMINATED ·Phase: PHASE2
-
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.
NCT00801281 ·Status: COMPLETED ·Phase: PHASE3
-
R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
NCT02428751 ·Status: UNKNOWN ·Phase: PHASE3
-
Revlimid Dose 25 mg in Association With (R-CHOP) in the Treatment Follicular Lymphoma
NCT01393756 ·Status: COMPLETED ·Phase: PHASE2
-
Multicentre Study to Determine the Cardiotoxicity of R-CHOP Compared to R-COMP in Patients With Diffuse Large B-Cell Lymphoma
NCT00575406 ·Status: COMPLETED ·Phase: PHASE2
-
Go-CHOP as the Frontline Therapy for PTCL
NCT05963347 ·Status: RECRUITING ·Phase: PHASE2
-
Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL
NCT06151080 ·Status: RECRUITING ·Phase: PHASE2
-
High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma
NCT00965289 ·Status: COMPLETED ·Phase: PHASE2
-
Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL
NCT00379574 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Treatment of Disseminated High Grade Lymphoma
NCT00536393 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
NCT01448096 ·Status: COMPLETED ·Phase: PHASE2
-
Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma
NCT07300514 ·Status: RECRUITING ·Phase: PHASE3
-
R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma
NCT04214626 ·Status: COMPLETED ·Phase: PHASE2
-
Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma
NCT04323956 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL.
NCT00355199 ·Status: COMPLETED ·Phase: PHASE3
-
Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
NCT00670358 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin
NCT00268853 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
NCT06425302 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
NCT05578976 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
NCT01856192 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma
NCT05097443 ·Status: UNKNOWN ·Phase: PHASE3