Study on Odronextamab and Lenalidomide vs. Rituximab and Lenalidomide for Treating Follicular and Marginal Zone Lymphoma
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT06149286
This clinical trial is testing a new combination of drugs, odronextamab and lenalidomide, to see if it is safe and more effective than the current standard treatment of rituximab and lenalidomide for adults with follicular lymphoma or marginal zone lymphoma that has returned or not responded to previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The study is exploring a new treatment using odronextamab combined with lenalidomide for patients with follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back or not responded to treatment. The study has two parts: Part 1 will test the safety and best dose of the new combination, while Part 2 will compare its effectiveness to the current standard treatment of rituximab and lenalidomide. Researchers will also look at potential side effects, how the drug is processed in the body, and its impact on quality of life.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with follicular lymphoma (FL) grade 1-3a or marginal zone lymphoma (MZL).
- The cancer must have returned or not responded after at least one previous treatment that included an anti-CD20 antibody.
- Have measurable cancer that can be seen on a CT or MRI scan.
- Be in good overall health with an ECOG performance status of 0 to 2.
- Have adequate blood and organ function.
- Understand the potential risks of lenalidomide, including its effects on pregnancy.
- Agree not to donate blood or share medication during and shortly after the study.
- Agree to receive counseling on pregnancy precautions and risks associated with lenalidomide.
Exclusion Criteria
- Have primary central nervous system (CNS) lymphoma or a history of CNS involvement by non-primary CNS NHL.
- Have a different type of lymphoma or cancer, unless treated and cancer-free for at least 3 years, with some exceptions for certain localized cancers.
- Have significant active diseases or medical conditions that could interfere with the study.
- Have allergies to the study drugs or their ingredients.
- Have an active infection.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| David Geffen School of Medicine at UCLA | 90095 | Los Angeles | California |
| Indiana University and Comprehensive Cancer Center | 46202 | Indianapolis | Indiana |
| Stony Brook University Hospital | 11794 | Stony Brook | New York |
| Clinical Research Alliance Inc | 11590 | Westbury | New York |
| Prohealth Care Inc | 53188 | Waukesha | Wisconsin |
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