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Study identifier: NCT06091254 Synced from ClinicalTrials.gov · July 28, 2026
● 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 Previously Untreated Follicular Lymphoma

Condition: Follicular Lymphoma (FL)  ·  Sponsor: Regeneron Pharmaceuticals

PhasePhase 3
Planned participants822
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Administrator  ·  844-734-6643  ·  clinicaltrials@regeneron.com

Always discuss trial participation with your own doctor first.

Locations (190)

University of Arizona Cancer CenterTucson, Arizona, United StatesRecruiting
David Geffen School of Medicine at UCLALos Angeles, California, United StatesRecruiting
UC Irvine HealthOrange, California, United StatesWithdrawn
Investigative Clinical Research of IndianaNoblesville, Indiana, United StatesRecruiting
Beth Israel Deaconess Medical CenterBoston, Massachusetts, United StatesRecruiting
Karmanos Cancer InstituteDetroit, Michigan, United StatesRecruiting
Hattiesburg ClinicHattiesburg, Mississippi, United StatesCompleted
Icahn School of Medicine at Mt SinaiNew York, New York, United StatesRecruiting
Stony Brook University HospitalStony Brook, New York, United StatesRecruiting
Clinical Research Alliance IncWestbury, New York, United StatesWithdrawn
University of North CarolinaChapel Hill, North Carolina, United StatesRecruiting
Levine Cancer InstituteCharlotte, North Carolina, United StatesRecruiting

+ 178 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06091254