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
← catalyst calendarNCT06091254 · readout in 537 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
822estimated
Sites
190
Countries
Australia, Austria, Belgium +16
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-12 | actual | When the study began enrolling |
| Primary completion | 2028-02-07 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-11-03 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Follicular Lymphoma (FL)
Interventions
- Drug: Odronextamab — also filed as REGN1979
- Drug: Rituximab — also filed as Rituxan
- Drug: Cyclophosphamide — also filed as Cytoxan
- Drug: Doxorubicin — also filed as Adriamycin
- Drug: Vincristine — also filed as Oncovin
- Drug: Prednisone/prednisolone — also filed as Deltasone/Omnipred
- Drug: Bendamustine — also filed as Treanda
Primary outcomes
what the primary-completion date above is the date OFIncidence of Dose-Limiting Toxicities (DLTs) for odronextamab
measured Up to 35 days
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab
measured Up to 2 years
Severity of TEAEs of odronextamab
measured Up to 2 years
Complete Response at 30 months (CR30) as assessed by independent central review
measured Up to 30 months
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