Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Follicular Lymphoma (FL)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma. Follicular lymphoma i...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
- Key
Exclusion
- 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 Inclusion/Exclusion criteria apply
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 29 2029
Estimated Enrollment :
733 Patients enrolled
Trial Details
Trial ID
NCT06097364
Start Date
November 14 2023
End Date
July 29 2029
Last Update
September 19 2025
Active Locations (144)
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1
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, United States, 33322
2
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States, 46062
3
University of Kentucky
Lexington, Kentucky, United States, 40536
4
Henry Ford Health System
Detroit, Michigan, United States, 48202