Venetoclax + Lenalidomide + Rituximab for Mantle Cell Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs that affect liver enzymes (CYP3A inhibitors or inducers) within one week before starting the trial treatment.
What data supports the effectiveness of the drug combination of Venetoclax, Lenalidomide, and Rituximab for treating Mantle Cell Lymphoma?
Is the combination of Venetoclax, Lenalidomide, and Rituximab safe for humans?
The combination of Venetoclax, Lenalidomide, and Rituximab has been found to be safe in patients with untreated mantle cell lymphoma, with common side effects including low white blood cell counts (neutropenia) and low platelet counts (thrombocytopenia). Venetoclax, when used alone or with Rituximab, has also shown a manageable safety profile in patients with chronic lymphocytic leukemia.13467
What makes the drug combination of Venetoclax, Lenalidomide, and Rituximab unique for treating Mantle Cell Lymphoma?
This drug combination is unique because it combines Venetoclax, a BCL-2 inhibitor, with Lenalidomide and Rituximab to enhance treatment effectiveness for untreated Mantle Cell Lymphoma, achieving high response rates and minimal residual disease undetectability, which is not commonly seen with other treatments.13478
What is the purpose of this trial?
The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).
Research Team
Tycel Phillips, M.D.
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for adults over 18 with untreated Mantle Cell Lymphoma, who are in relatively good health (ECOG ≤2), not pregnant or breastfeeding, and can take oral medication. They must join the Revlimid REMS® program, agree to pregnancy testing if applicable, use contraception, and have no recent strong drug interactions or other cancers within 2 years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive venetoclax, lenalidomide, and rituximab. Rituximab is administered on specific days across multiple cycles, lenalidomide is given in varying doses across cycles, and venetoclax is administered with a ramp-up dose in cycle 1 and a consistent dose in cycles 2-12.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including PET, CT scans, and bone marrow examinations.
Treatment Details
Interventions
- Lenalidomide
- Rituximab
- Venetoclax
Lenalidomide is already approved in European Union, United States for the following indications:
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
University of Michigan Rogel Cancer Center
Lead Sponsor