Last updated 16 days ago
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
733 patients around the world
Available in Spain, Chile, United States
Regeneron Pharmaceuticals
1Research sites
733Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Follicular lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV.For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL who have not received R-CHOP or R-CVP.For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5.For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5.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.
- 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.
Sites
Clínica Universidad de los Andes
Recruiting
StudyOLYMPIA-2
SponsorRegeneron Pharmaceuticals
Conditions
Follicular lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06097364
