Odronextamab for Untreated Follicular Lymphoma
This study is testing a new drug called odronextamab for adults with follicular lymphoma (a type of non-Hodgkin lymphoma) that hasn't been treated before. The study has two parts: first, it will check how safe odronextamab is by itself. Then, it will compare odronextamab to rituximab combined with standard chemotherapy (like CHOP or CVP) to see how well it works. To join, you need to be at least 18 years old, have CD20+ follicular lymphoma (Grades 1-3a, stage II bulky or stage III/IV), and have measurable disease. Researchers will be looking at side effects and how well odronextamab is tolerated for up to two years.
- Study design
- This is an interventional study with a planned enrollment of 822 participants. It has two parts: an initial non-randomized part to assess safety, followed by a randomized, controlled part comparing odronextamab to standard treatments.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects for up to two years after starting treatment with odronextamab.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
190 sites across 93 statesStudy leadership
- Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals
Who to contact
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What this trial measures
- Incidence of Dose-Limiting Toxicities (DLTs) for odronextamabUp to 35 days
Part 1
- Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamabUp to 2 years
Part 1
- Severity of TEAEs of odronextamabUp to 2 years
Part 1
- Complete Response at 30 months (CR30) as assessed by independent central reviewUp to 30 months
Part 2