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 now · Phase 3
Conditions studied: Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)
In brief
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 study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality-of-life and ability to complete routine daily activities
Key facts
- Study ID
- NCT06149286
- Run by
- Regeneron Pharmaceuticals
- People needed
- 470
- Starts
- 2023-12-28
- Expected to finish
- 2029-01-23
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Boca Raton Clinical Research (BRCR) Global — Plantation, Florida, United States (enrolling)
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States (enrolling)
- Hattiesburg Clinic — Hattiesburg, Mississippi, United States (enrolling)
- Dartmouth Cancer Center — Lebanon, New Hampshire, United States (enrolling)
- Stony Brook University Hospital — Stony Brook, New York, United States (enrolling)
- Indiana University and Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
- Prohealth Care Inc — Waukesha, Wisconsin, United States (enrolling)
- Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
- Calvary Mater Newcastle — Waratah, New South Wales, Australia (enrolling)
- Pindara Private Hospital — Benowa, Queensland, Australia (enrolling)
- Royal Hobart Hospital — Hobart, Tasmania, Australia (enrolling)
- Epworth Freemasons — East Melbourne, Victoria, Australia (enrolling)
- Ordensklinikum Linz — Linz, Osterreich, Austria (enrolling)
- Kepler University Hospital — Linz, Upper Austria, Austria (enrolling)
- Medical University Vienna — Vienna, Austria (enrolling)
- Klinikum Wels-Grieskirchen — Wels, Austria (enrolling)
- Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur — Yvoir, Namur, Belgium (enrolling)
- Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital — Ghent, Oost-Vlaanderen, Belgium (enrolling)
- Algemeen Ziekenhuis AZ Delta — Roeselare, West-Vlaanderen, Belgium (enrolling)
- Ziekenhuis Netwerk Antwerpen Stuivenberg — Antwerp, Belgium (enrolling)
- Institut Jules Bordet — Brussels, Belgium (enrolling)
- Hospital Sao Rafael — Salvador, Estado de Bahia, Brazil (enrolling)
- Hospital Sirio Libanes Brasilia — Brasília, Federal District, Brazil (enrolling)
- Uopeccan Hospital do Cancer de Cascavel — Cascavel, Paraná, Brazil (enrolling)
- Hospital Erasto Gaertner — Curitiba, Paraná, Brazil (enrolling)
Full record on ClinicalTrials.gov
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