Study on Valemetostat with Rituximab and Lenalidomide for Treating Relapsed or Refractory Follicular Lymphoma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05683171
This clinical trial is testing a new combination of drugs, including valemetostat, rituximab, and lenalidomide, to find the best dose and evaluate their safety and effectiveness in treating follicular lymphoma that has returned or not responded to previous treatments.
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Program Overview
The purpose of this study is to determine the best dose of valemetostat when used with rituximab and lenalidomide for patients with follicular lymphoma that has come back or is not responding to treatment. The study will also look at how safe this combination is and how well it works in controlling the disease.
Description
This study is divided into two phases. In Phase 1, researchers will focus on finding a safe and tolerable dose of valemetostat when combined with rituximab and lenalidomide (R2) for patients with relapsed or refractory follicular lymphoma (R/R FL). They will also study how the body processes valemetostat and its effects on the disease. In Phase 2, the study will evaluate how effective this drug combination is in treating the lymphoma, including how long patients respond to the treatment and the time until they need another treatment. Researchers will also monitor the safety and any side effects of the treatment, as well as changes in the cancer and immune system.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of follicular lymphoma, grades 1-3A.
- Previously treated with at least one systemic therapy and have relapsed or refractory disease.
- Require systemic therapy based on tumor size and location.
- Have at least one measurable tumor 2 cm or larger.
- Be in good overall health with an ECOG performance status of 0 to 2.
- Have adequate kidney, bone marrow, and liver function based on specific medical tests.
- Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 3 months after.
- Men must use effective birth control during the study and for 3 months after.
- Must be willing to comply with the study requirements and provide informed consent.
Exclusion Criteria
- Transformation to a more aggressive type of lymphoma.
- Recent treatment with certain therapies within specified timeframes before the study.
- Progressive disease while on prior lenalidomide or recent lenalidomide treatment.
- Recent major surgery or radiation therapy.
- Use of high-dose corticosteroids or recent stem cell transplant.
- Active or recent other cancers, except for certain non-threatening types.
- History of central nervous system involvement by lymphoma.
- Use of certain medications that affect drug metabolism.
- Serious medical conditions that could interfere with the study.
- Active infections like HIV, hepatitis B, or hepatitis C.
- Significant heart disease or abnormal heart rhythms.
- Pregnant or breastfeeding women.
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