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Study identifier: NCT06149286 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Relapsed/Refractory Follicular Lymphoma · Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)  ·  Sponsor: Regeneron Pharmaceuticals

PhasePhase 3
Planned participants470
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug in combination with lenalidomide * How much st…

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Administrator  ·  844-734-6643  ·  clinicaltrials@regeneron.com

Always discuss trial participation with your own doctor first.

Locations (169)

David Geffen School of Medicine at UCLALos Angeles, California, United StatesRecruiting
Boca Raton Clinical Research (BRCR) GlobalPlantation, Florida, United StatesRecruiting
Indiana University and Comprehensive Cancer CenterIndianapolis, Indiana, United StatesRecruiting
Hattiesburg ClinicHattiesburg, Mississippi, United StatesRecruiting
Dartmouth Cancer CenterLebanon, New Hampshire, United StatesRecruiting
Stony Brook University HospitalStony Brook, New York, United StatesRecruiting
Clinical Research Alliance IncWestbury, New York, United StatesWithdrawn
Prohealth Care IncWaukesha, Wisconsin, United StatesRecruiting
Liverpool HospitalLiverpool, New South Wales, AustraliaRecruiting
Calvary Mater NewcastleWaratah, New South Wales, AustraliaRecruiting
Pindara Private HospitalBenowa, Queensland, AustraliaRecruiting
Royal Hobart HospitalHobart, Tasmania, AustraliaRecruiting

+ 157 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06149286