Lenalidomide + Ibrutinib for Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot take medications that strongly affect certain liver enzymes (CYP3A4) or those that cause heart rhythm issues. You also cannot be on blood thinners like warfarin or strong immunosuppressants.
What data supports the effectiveness of the drugs Lenalidomide and Ibrutinib for treating lymphoma?
Is the combination of Lenalidomide and Ibrutinib safe for humans?
The combination of Lenalidomide and Ibrutinib has been studied in various trials for different types of lymphoma and multiple myeloma. Common side effects include anemia (low red blood cell count), neutropenia (low white blood cell count), and skin rashes, but these were generally manageable. Overall, the combination appears to be safe and well-tolerated in patients with relapsed or refractory conditions.12356
How is the drug combination of Lenalidomide and Ibrutinib unique for treating lymphoma?
The combination of Lenalidomide and Ibrutinib is unique because it uses two drugs with different mechanisms to potentially enhance treatment effectiveness, especially in difficult-to-treat cases of lymphoma. This combination has shown promising results in improving response rates in patients with relapsed or refractory lymphoma, compared to using either drug alone.12345
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib in treating patients with B-cell non-Hodgkin lymphoma that has returned (relapsed) or not responded to treatment (refractory). Lenalidomide helps shrink or slow the growth of non-Hodgkin lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide with ibrutinib may work better in treating non-Hodgkin lymphoma than giving either drug alone.
Research Team
Beth A Christian
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with certain types of B-cell non-Hodgkin lymphoma that have relapsed or are refractory. Participants must have had at least one prior therapy, be in fairly good health (ECOG <=2), and not pregnant or nursing. They should understand the study and consent to participate. Those with active infections, recent major surgery, known allergies to trial drugs, or on specific medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenalidomide orally on days 1-21 and ibrutinib orally on days 1-28 in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ibrutinib
- Lenalidomide
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor