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.

NCT06091254

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
PHASE3Ages 18+InterventionalTreatment
Regeneron Pharmaceuticals
~822 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:OdronextamabRituximabCyclophosphamideDoxorubicinVincristinePrednisone/prednisolone

At a glance

Recruiting sites
145 of 190 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab
Measured over Up to 35 days
+3 more outcomes measured
Follicular Lymphoma (FL)
190 sites across 93 states
Spain18
Taiwan10
Italy9
Turkey (Türkiye)8
Brazil7
Israel7
France5
Victoria4
  • Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals

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  • 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