A study to learn how well odronextamab combined with chemotherapy works and how safe it is compared to rituximab and chemotherapy in adult participants with previously untreated follicular lymphoma
- Conditions
- Follicular lymphomaMedDRA version: 21.1Level: PTClassification code: 10061170Term: Follicle centre lymphoma follicular grade I II III Class: 100000004864Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2022-502113-28-00
- Lead Sponsor
- Regeneron Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 717
Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV, Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, Adequate bone marrow and hepatic function, NOTE: Other protocol defined inclusion criteria apply
Participants with central nervous system lymphoma or leptomeningeal lymphoma, Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma, Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, Recent major surgery and history or organ transplantation, A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol, NOTE: Other protocol defined exclusion criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method