Odronextamab with Lenalidomide for Follicular Lymphoma and Marginal Zone Lymphoma

This study is testing if a combination of odronextamab and lenalidomide is safe and works better than rituximab and lenalidomide for adults with follicular lymphoma (FL) or marginal zone lymphoma (MZL). These are types of non-Hodgkin's lymphoma that have either come back after treatment (relapsed) or didn't respond to previous treatment (refractory). Odronextamab is an immunotherapy, a type of monoclonal antibody. The study aims to find the right dose of odronextamab and see how well it works and what side effects it might cause. You could be eligible if you are 18 or older and have FL or MZL that has relapsed or is refractory after at least one prior treatment.

Study design
This study plans to enroll 470 participants and has two parts: Part 1 is not randomized, and Part 2 is randomized and controlled.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06149286

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Regeneron Pharmaceuticals
~580 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:OdronextamabLenalidomideRituximab

At a glance

Recruiting sites
167 of 171 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide
Measured over Up to 35 days
+3 more outcomes measured
Relapsed/Refractory Follicular Lymphoma
Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)
171 sites across 88 states
Italy12
Spain12
Taiwan11
South Korea10
Israel7
Turkey (Türkiye)6
France5
Poland4
  • Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals

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  • Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomideUp to 35 days

    Part 1

  • Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomideUp to 2 years

    Part 1

  • Severity of TEAEs for odronextamab in combination with lenalidomideUp to 2 years

    Part 1

  • Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR)Up to 5 years

    Part 2