A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
← catalyst calendarNCT06091865 · readout in 588 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
904estimated
Sites
172
Countries
Australia, Austria, Belgium +17
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 | 2023-12-13 | actual | When the study began enrolling |
| Primary completion | 2028-03-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-09-12 | 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 | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Diffuse Large B-cell Lymphoma (DLBCL)
Interventions
- Drug: Odronextamab — also filed as REGN1979, Ordspono™
- Drug: Rituximab — also filed as RITUXAN®
- Drug: Cyclophosphamide — also filed as Cytoxan®
- Drug: Doxorubicin — also filed as Adriamycin®
- Drug: Vincristine — also filed as Oncovin®, Vincasar PFS®
- Drug: Prednisone/Prednisolone — also filed as Deltasone®/OMNIPRED®
Primary outcomes
what the primary-completion date above is the date OFIncidence of Dose Limiting Toxicities (DLTs)
measured Up to 35 days
Incidence of Treatment Emergent Adverse Events (TEAEs)
measured Up to 2 years
Severity of TEAEs
measured Up to 2 years
Progression Free Survival (PFS), assessed by Independent Central Review (ICR)
measured Up to 5 years
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