Study on Mosunetuzumab and Lenalidomide Compared to Rituximab and Lenalidomide for Follicular Lymphoma
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT04712097
This clinical trial is comparing two treatment combinations for patients with follicular lymphoma that has returned or not responded to previous treatments. The study will evaluate the effectiveness and safety of mosunetuzumab with lenalidomide versus rituximab with lenalidomide.
Patient Parameters
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Program Overview
The purpose of this study is to determine how well the combination of mosunetuzumab and lenalidomide works compared to rituximab and lenalidomide in treating patients with follicular lymphoma that has come back or not responded to previous treatments. Participants must have received at least one prior treatment for their lymphoma.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
- Must have a confirmed diagnosis of CD20+ follicular lymphoma (Grades 1-3a).
- Must need systemic therapy based on tumor size or specific criteria.
- Must have received at least one prior treatment for lymphoma, including immunotherapy or chemoimmunotherapy.
- Must provide a tumor sample for confirmation of follicular lymphoma diagnosis.
- Must have adequate blood cell counts and organ function.
- Must agree to follow the lenalidomide risk minimization plan, including pregnancy prevention measures.
- Women of childbearing potential must agree to use effective contraception or remain abstinent during and after treatment.
- Men must agree to use contraception or remain abstinent and refrain from donating sperm during and after treatment.
Exclusion Criteria
- Have Grade 3b follicular lymphoma.
- Have a history of transformation to diffuse-large B cell lymphoma.
- Have not responded to lenalidomide or relapsed within 6 months of therapy.
- Have active or past central nervous system lymphoma.
- Have received certain cancer treatments within specified timeframes before the study.
- Have unresolved significant side effects from previous treatments.
- Are taking systemic immunosuppressive medications recently.
- Have a history of organ transplantation.
- Have severe allergic reactions to certain antibodies or components of the study drugs.
- Have a history of severe skin reactions to immunomodulatory drugs.
- Have lung diseases or autoimmune pneumonitis.
- Have active infections or recent major infections.
- Have a history of certain viral infections or liver disease.
- Have active hepatitis B or C, or HIV.
- Have a history of progressive multifocal leukoencephalopathy.
- Have received a live vaccine recently or plan to during the study.
- Have another cancer that could interfere with the study.
- Have active autoimmune diseases requiring treatment.
- Have had a stem cell transplant from a donor.
- Have conditions that prevent safe participation or compliance with the study.
- Have had major surgery recently or plan to during the study.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have any serious medical conditions that could affect participation or results.
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