Actively Recruiting
A Phase 3, Open Label, Randomized Study Comparing Odronextamab Plus Lenalidomide Versus Rituximab Plus Lenalidomide in Adults With Relapsed or Refractory Follicular and Marginal Zone Lymphoma
Led by Regeneron Pharmaceuticals · Updated on 2026-05-06
470
Participants Needed
169
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental drug called odronextamab combined with lenalidomide in adults who have relapsed or refractory follicular lymphoma FL or marginal zone lymphoma MZL, which are subtypes of Non-Hodgkins lymphoma. The study aims to assess the safety, tolerability, and proper dosing of this new combination and compare its effectiveness to the current standard treatment of rituximab combined with lenalidomide. The research also explores side effects, drug levels in the blood, immune responses to the drug, and impacts on quality of life and daily functioning. The study has two parts Part 1 is a safety phase where all participants receive odronextamab plus lenalidomide to determine the appropriate dose. Part 2 is randomized and compares two groupsone receiving odronextamab with lenalidomide, and the other receiving rituximab with lenalidomide followed by lenalidomide alone. Participants receive these treatments according to the study protocol during these phases. Throughout the study, participants will undergo various assessments including safety monitoring for side effects, measurement of drug concentrations and immune responses, imaging scans to evaluate disease status, and quality-of-life questionnaires. The primary outcomes include tracking dose-limiting toxicities up to 35 days and treatment-emergent adverse events up to 2 years. Longer-term outcomes such as progression-free survival and overall survival will be followed for up to 5 years, with ongoing evaluations to understand the treatments impact over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of follicular lymphoma grade 1-3a or marginal zone lymphoma (nodal, splenic, or extra nodal)
- Relapsed or refractory disease after at least one prior systemic treatment including an anti-CD20 monoclonal antibody
- Measurable disease on CT or MRI imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate blood counts and organ function as defined by the study
- Understanding of lenalidomide's potential teratogenic risks and agreement to pregnancy precautions
- Agreement to abstain from blood donation during treatment and for 28 days after stopping lenalidomide
- Agreement not to share study medication with others
You will not qualify if you...
- Primary central nervous system lymphoma or CNS involvement by non-primary CNS lymphoma
- History or current diagnosis of high-grade or diffuse large B-cell lymphoma or other lymphoma histologies besides follicular lymphoma grade 1-3a or marginal zone lymphoma
- Current or past significant CNS conditions
- Other active cancers unless treated and cancer free for at least 3 years (with some exceptions like localized prostate cancer or certain skin cancers)
- Any other serious medical condition that could interfere with study participation or increase risk
- Allergy or hypersensitivity to study drugs or their ingredients
- Active infections as defined by the study protocol
Research Team
C
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