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
Recruiting now · Phase 3
Conditions studied: Follicular Lymphoma (FL)
In brief
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.
Key facts
- Study ID
- NCT06091254
- Run by
- Regeneron Pharmaceuticals
- People needed
- 822
- Starts
- 2023-12-12
- Expected to finish
- 2029-11-03
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ordensklinikum Linz Gmbh, Elisabethinen — Linz, Austria (enrolling)
- Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III — Salzburg, Austria (enrolling)
- Alfred Hospital and Monash University — Melbourne, Victoria, Australia (enrolling)
- Ordensklinikum Linz — Linz, Osterreich, Austria (enrolling)
- Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
- University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
- Investigative Clinical Research of Indiana — Noblesville, Indiana, United States (enrolling)
- St Vincent's Hospital - Melbourne — Fitzroy, Victoria, Australia (enrolling)
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States (enrolling)
- University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
- Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Center for Oncology and Blood Disorders — Houston, Texas, United States (enrolling)
- Icahn School of Medicine at Mt Sinai — New York, New York, United States (enrolling)
- Huntsman Cancer Institute - Oncology Division — Salt Lake City, Utah, United States (enrolling)
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
- Stony Brook University Hospital — Stony Brook, New York, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Ingham Institute — Liverpool, New South Wales, Australia (enrolling)
- Icon Cancer Centre - Wesley — Auchenflower, Queensland, Australia (enrolling)
- Flinders Medical Centre — Bedford Park, South Australia, Australia (enrolling)
- Monash Health — Clayton, Victoria, Australia (enrolling)
- Epworth Freemasons — East Melbourne, Victoria, Australia (enrolling)
- Medical University of Vienna — Vienna, Austria (enrolling)
Full record on ClinicalTrials.gov
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