Rituximab + Pembrolizumab +/- Lenalidomide for Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are on systemic steroid therapy or other immunosuppressive treatments within 7 days before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination of Rituximab, Pembrolizumab, and Lenalidomide for lymphoma?
Is the combination of Rituximab, Pembrolizumab, and Lenalidomide safe for treating lymphoma?
The combination of Rituximab and Lenalidomide has been studied for lymphoma and is generally considered safe, with common side effects including low white blood cell counts, skin rashes, and digestive issues, which are usually manageable. Pembrolizumab, another drug in this combination, is also used in cancer treatments and has a known safety profile, but specific safety data for the three drugs combined is not detailed in the provided research.14678
What makes the drug combination of Rituximab, Pembrolizumab, and Lenalidomide unique for treating lymphoma?
This drug combination is unique because it combines the immunomodulatory effects of Lenalidomide, which enhances the immune system's ability to fight cancer, with Rituximab, an antibody that targets cancer cells, and Pembrolizumab, which helps the immune system recognize and attack cancer cells. This combination may offer a chemotherapy-free option that could be more effective for patients who have not responded to other treatments.12349
What is the purpose of this trial?
This phase II trial studies how well rituximab and pembrolizumab with or without lenalidomide works in treating patients with follicular lymphoma and diffuse large B-cell lymphoma that has returned after a period of improvement. Immunotherapy with monoclonal antibodies, such as rituximab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rutuximab with pembrolizumab and lenalidomide may work better at treating follicular lymphoma and diffuse large B-cell lymphoma.
Research Team
Ranjit Nair
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with relapsed follicular lymphoma or diffuse large B-cell lymphoma after at least one prior therapy including rituximab, or two therapies with CAR T cell treatment. Participants must have adequate organ function, not be pregnant or breastfeeding, agree to use contraception, and cannot have certain infections like HIV or hepatitis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive rituximab and pembrolizumab, with or without lenalidomide, depending on the cohort. Treatment cycles last up to 1 year for Cohort I and up to 2 years for Cohort II.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days, every 3 months for 1 year, and then every 6 months thereafter.
Treatment Details
Interventions
- Lenalidomide
- Pembrolizumab
- Rituximab
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?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator