Actively Recruiting
A Phase 3 Study Comparing Odronextamab Plus CHOP Versus Rituximab Plus CHOP in Adults with Previously Untreated Diffuse Large B-cell Lymphoma
Led by Regeneron Pharmaceuticals · Updated on 2026-05-15
904
Participants Needed
155
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an experimental drug called odronextamab, combined with chemotherapy, in adults with Diffuse Large B-cell Lymphoma DLBCL. The study includes patients who have not been treated before, as well as those whose lymphoma has returned or not responded to prior treatment. The goal is to evaluate the safety, dosing, and effectiveness of odronextamab combined with chemotherapy compared to the current standard treatment of rituximab plus chemotherapy. The study consists of three parts Part 1A involves dose escalation to find safe levels of odronextamab Part 1B explores two dosing schedules of odronextamab with chemotherapy and Part 2 compares the combination of odronextamab with chemotherapy against rituximab with chemotherapy. Odronextamab and rituximab are given by intravenous infusion, while chemotherapy drugs cyclophosphamide, doxorubicin, and vincristine are given intravenously and prednisone or prednisolone is taken orally. Participants will have regular evaluations including safety monitoring, blood tests to measure drug levels and antibodies, and assessments of quality of life and physical functioning. The study will track side effects, response to treatment, survival, and disease progression over several years. The total study duration can be up to five years, with ongoing assessments to understand the long-term impact of the treatments.
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of previously untreated CD20-positive Diffuse Large B-cell Lymphoma or relapsed/refractory DLBCL (Part 1A only)
- Measurable disease with at least one nodal or extranodal lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Life expectancy of at least 12 months
- International Prognostic Index (IPI) of 3 to 5 (Part 1) and 2 or more (Part 2) for untreated DLBCL
- Adequate blood cell counts and organ function as defined in the protocol
You will not qualify if you...
- Primary central nervous system lymphoma or known involvement by non-primary CNS non-Hodgkin lymphoma
- Another active cancer or significant medical condition
- Peripheral neuropathy of Grade 3 or higher
- Prior systemic anti-lymphoma therapy except for relapsed/refractory DLBCL or transformed lymphoma after prior treatment
- Use of other therapies or investigational treatments within 28 days or 5 half-lives before study treatment
- Recent major surgery, prior organ transplant, or standard radiotherapy
- Allergy or hypersensitivity to study drugs
- Active infections including COVID-19, uncontrolled HIV, hepatitis B or C, or cytomegalovirus infection
Research Team
C
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