A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
← catalyst calendarNCT06149286 · readout in 1,715 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
580estimated
Sites
171
Countries
Australia, Austria, Belgium +15
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 | 2023-12-28 | actual | When the study began enrolling |
| Primary completion | 2031-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Relapsed/Refractory Follicular Lymphoma
- Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)
Interventions
- Drug: Odronextamab — also filed as REGN1979, Ordspono
- Drug: Lenalidomide — also filed as REVLIMID
- Drug: Rituximab — also filed as Rituxan
Primary outcomes
what the primary-completion date above is the date OFIncidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide
measured Up to 35 days
Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide
measured Up to 2 years
Severity of TEAEs for odronextamab in combination with lenalidomide
measured Up to 2 years
Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR)
measured Up to 5 years
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