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
NCT06149286 · OLYMPIA-5 Phase 3Recruiting
- Lead sponsor
- Regeneron Pharmaceuticals (Industry)
- Enrollment
- 580 (estimated)
- Start date
- 28 Dec 2023
- Primary completion
- 30 Apr 2031 (estimated)
- Study completion
- 30 Apr 2031
- Last update posted
- 7 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- Odronextamab Drug
- Lenalidomide Drug
- Rituximab Drug
Conditions and primary outcome
- Relapsed/Refractory Follicular Lymphoma
- Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide (Up to 35 days); Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide (Up to 2 years); Severity of TEAEs for odronextamab in combination with lenalidomide (Up to 2 years); Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR) (Up to 5 years)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06149286.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06149286 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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