Actively Recruiting
Phase 3 Study Comparing Safety and Effectiveness of Odronextamab Plus Chemotherapy Versus Rituximab Plus Chemotherapy in Adults With Diffuse Large B-cell Lymphoma
Led by Regeneron Pharmaceuticals · Updated on 2026-08-06
904
Participants Needed
172
Research Sites
75 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental drug called odronextamab combined with chemotherapy in adults with Diffuse Large B-cell Lymphoma DLBCL, including those who have not been treated before as well as those with relapsed or refractory disease. The study aims to assess the safety, tolerability, and dosing schedule of odronextamab with chemotherapy, and to compare its effectiveness against the current standard treatment of rituximab combined with chemotherapy. Additional goals include understanding side effects, drug levels in the blood, immune responses to the drug, and impact on quality of life and daily activities. The study consists of three parts Part 1A involves dose escalation to find a safe dose, Part 1B explores two dosing regimens of odronextamab combined with chemotherapy, and Part 2 randomly assigns participants to receive either odronextamab plus chemotherapy Odro-CHOP or rituximab plus chemotherapy R-CHOP. Odronextamab and rituximab are given by intravenous infusion, with chemotherapy drugs including cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone administered as part of the treatment regimen. Participants will be closely monitored throughout the study for side effects, disease progression, and response to treatment. Assessments include measuring dose limiting toxicities, treatment-emergent adverse events, progression free survival, quality of life questionnaires, and blood tests for drug levels and antibodies. The study follows participants for up to 5 years to track long-term outcomes and safety, with regular visits and evaluations scheduled during and after treatment.
CONDITIONS
Brief Title
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Research Team
C
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