Ibrutinib + Rituximab + Chemotherapy 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. However, you cannot participate if you require treatment with strong CYP3A inhibitors or anticoagulation with warfarin. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Ibrutinib, Rituximab, and Chemotherapy for Mantle Cell Lymphoma?
Research shows that Ibrutinib combined with Rituximab has shown promising results in treating mantle cell lymphoma, with studies indicating that this combination can lead to remission and reduce the need for extensive chemotherapy. Additionally, Ibrutinib with Bendamustine and Rituximab has shown clinical benefits in older patients with untreated mantle-cell lymphoma.12345
Is the combination of Ibrutinib, Rituximab, and Chemotherapy safe for humans?
The combination of Ibrutinib, Rituximab, and Chemotherapy has been studied in patients with mantle cell lymphoma, showing some safety concerns. Ibrutinib can cause side effects like diarrhea, serious infections, bleeding issues, and heart problems such as irregular heartbeat. It's important to discuss these potential risks with your healthcare provider.13567
How is the drug combination of Ibrutinib, Rituximab, and Chemotherapy unique for treating mantle cell lymphoma?
This treatment is unique because it combines Ibrutinib and Rituximab, which are targeted therapies, with chemotherapy to potentially reduce the amount of chemotherapy needed, aiming for remission with fewer side effects. This approach is different from traditional treatments that rely heavily on chemotherapy alone.13568
What is the purpose of this trial?
This phase II trial studies how well ibrutinib, rituximab, and consolidation chemotherapy consisting of cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate, and cytarabine work in treating young patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, 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 cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate, and cytarabine, 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 more than one drug (combination chemotherapy) may kill more cancer cells. Giving ibrutinib together with rituximab and consolidation chemotherapy may be a better treatment for mantle cell lymphoma.
Research Team
Luhua (Michael) Wang
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for young patients under 65 with newly diagnosed mantle cell lymphoma, who need immediate treatment and have measurable disease. They should be in good physical condition (ECOG <=2), have proper organ function, no serious medical conditions or active infections, and not be pregnant. High-risk factors like blastoid/pleomorphic variant or certain genetic mutations qualify them.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Ibrutinib Plus Rituximab
Patients receive ibrutinib orally once daily and rituximab intravenously over several hours. Treatment repeats every 28 days for up to 12 cycles.
Consolidation Therapy
Patients receive a combination of rituximab, dexamethasone, cyclophosphamide, doxorubicin, vincristine, methotrexate, and cytarabine. Treatment repeats every 28 days for up to 8 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
Treatment Details
Interventions
- Cyclophosphamide
- Cytarabine
- Dexamethasone
- Doxorubicin
- Doxorubicin Hydrochloride
- Ibrutinib
- Methotrexate
- Rituximab
- Vincristine
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?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator