Status:
ACTIVE_NOT_RECRUITING
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of 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 (a type of non-Hodgkin...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
- Need for treatment as described in the protocol
- Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow function and hepatic function, as described in the protocol
- Key
Exclusion
- Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
- Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
- Treatment with any systemic anti-lymphoma therapy
- Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2031
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT06091254
Start Date
December 12 2023
End Date
November 6 2031
Last Update
October 1 2025
Active Locations (187)
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1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
3
UC Irvine Health
Orange, California, United States, 92868
4
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States, 46062