Venetoclax + Lenalidomide + Rituximab for Non-Hodgkin's 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 use warfarin or certain other drugs like strong CYP3A inhibitors or inducers. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the drug combination Venetoclax, Lenalidomide, and Rituximab for Non-Hodgkin's Lymphoma?
Venetoclax, when used with rituximab, has shown effectiveness in treating chronic lymphocytic leukemia (CLL), providing durable responses and prolonging progression-free survival. Additionally, venetoclax has demonstrated activity in multiple myeloma, suggesting potential benefits when combined with other agents.12345
Is the combination of Venetoclax, Lenalidomide, and Rituximab generally safe for humans?
Venetoclax, when used alone or with Rituximab, has shown a manageable safety profile in patients with chronic lymphocytic leukemia. Rituximab, including its subcutaneous form with hyaluronidase, has comparable adverse events to its intravenous form, suggesting it is generally safe for use in humans.14678
What makes the drug combination of Venetoclax, Lenalidomide, and Rituximab unique for treating Non-Hodgkin's Lymphoma?
This drug combination is unique because Venetoclax is a first-in-class oral BCL-2 inhibitor that, when combined with Rituximab, has shown a synergistic effect, enhancing progression-free survival in other conditions like chronic lymphocytic leukemia. This suggests potential benefits in Non-Hodgkin's Lymphoma, especially when combined with Lenalidomide, which modulates the immune system.12349
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of venetoclax when given together with lenalidomide and rituximab hyaluronidase in treating patients with follicular lymphoma and marginal zone lymphoma that has come back after treatment (relapsed) or has not responded to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking the action of a protein called Bcl-2, that helps cancer cells survive. Immunotherapy with lenalidomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as rituximab and rituximab hyaluronidase, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this research is to determine if the combination of three drugs, venetoclax, lenalidomide, and rituximab hyaluronidase are safe to administer in patients whose low-grade lymphoma (follicular or marginal zone) has come back after initial therapy or was not responsive to initial therapy.
Research Team
Ubaldo R Martinez-Outschoorn, MD
Principal Investigator
Thomas Jefferson University
Eligibility Criteria
This trial is for adults with certain slow-growing lymphomas, like follicular and marginal zone lymphoma, that have either returned after treatment or haven't responded to previous therapy. Participants must have had at least one prior systemic therapy, be able to swallow pills whole, take daily aspirin or equivalent for blood clot prevention, and meet specific health criteria.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive venetoclax, lenalidomide, and rituximab hyaluronidase in a dose-escalation study. Venetoclax is administered daily, lenalidomide starting from cycle 2, and rituximab in cycles 2, 4, 6, 8, 10, and 12.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then for up to 5 years.
Treatment Details
Interventions
- Lenalidomide
- Rituximab
- Rituximab and Hyaluronidase Human
- 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?
Thomas Jefferson University
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
National Cancer Institute (NCI)
Collaborator