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A Phase II Study of Odronextamab in Treatment Naïve Patients With Low Tumor Volume Advanced Stage Follicular Lymphoma
The purpose of this study is to evaluate the safety and effectiveness of treating previously untreated Follicular Lymphoma (FL) with odronextamab. The name of the study drug in this research study is: -Odronextamab (a type of monoclonal antibody)
This prospective, phase 2, single-arm, open label study is to evaluate the safety and effectiveness of Odronextemab in participants with previously untreated Follicular Lymphoma (FL). Odronextemab is a type of immunotherapy is a cancer treatment that uses the body's own immune system to fight cancer cells. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, Computerized Tomography (CT) scans, Positron Emission (PET) scans, echocardiograms (ECGs), bone marrow biopsies and aspirations, and tumor biopsies. The U.S. Food and Drug Administration (FDA) has not approved odronextamab as a treatment for Follicular Lymphoma. Participants will receive the study drug for up to 6 cycles, or 126 days, and will be followed for up to 15 years. It is expected that about 35 people will take part in this research study. Regeneron Pharmaceuticals, Inc. is supporting this research study by providing the study drug, odronextamab and funding for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Start Date
September 8, 2025
Primary Completion Date
January 2, 2027
Completion Date
January 2, 2028
Last Updated
March 13, 2026
35
ESTIMATED participants
Odronextamab
BIOLOGICAL
Lead Sponsor
Gottfried von Keudell, MD PhD
Collaborators
NCT06337318
NCT07388563
Data Source & Attribution
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