- 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 — Recruiting • Phase III • Oncology • NCT06091865.
- What is being tested: Odronextamab (an experimental bispecific antibody) combined with chemotherapy versus the standard rituximab-chemotherapy regimen in treatment-Phase IIIïve adult patients with diffuse large B-cell lymphoma (DLBCL).
- Patient eligibility overview: Adult patients with previously untreated DLBCL who are eligible for chemotherapy and have not received prior anti-lymphoma treatment.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study…
- Key Inclusion Criteria: 1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only) 2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. Life expectancy ≥ 12 months 5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only 6. Adequate hematologic and organ function, as defined in the protocol. Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.