OncoMatch/Clinical Trials/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
Is NCT06149286 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Odronextamab and Lenalidomide for relapsed/refractory follicular lymphoma.
Treatment: Odronextamab · Lenalidomide · Rituximab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemo-immunotherapy — systemic
Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy
Must have received: immunotherapy — systemic
Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy
Must have received: anti-CD20 monoclonal antibody — systemic
Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody
Lab requirements
Blood counts
Adequate hematologic and organ function, as described in the protocol
Kidney function
Adequate hematologic and organ function, as described in the protocol
Liver function
Adequate hematologic and organ function, as described in the protocol
Adequate hematologic and organ function, as described in the protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- David Geffen School of Medicine at UCLA · Los Angeles, California
- Boca Raton Clinical Research (BRCR) Global · Plantation, Florida
- Indiana University and Comprehensive Cancer Center · Indianapolis, Indiana
- Hattiesburg Clinic · Hattiesburg, Mississippi
- Dartmouth Cancer Center · Lebanon, New Hampshire
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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