Ibrutinib + Rituximab for Mantle Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well ibrutinib and rituximab work in treating patients with mantle cell lymphoma that has come back or has not responded to treatment or older 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. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Giving ibrutinib and rituximab may be an effective treatment for mantle cell lymphoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking warfarin or strong CYP3A4/5 inhibitors, you may need to stop them as they are not allowed during the trial.
Is the combination of Ibrutinib and Rituximab safe for humans?
Ibrutinib and Rituximab have been studied for safety in treating mantle cell lymphoma and other conditions. Ibrutinib can cause side effects like diarrhea, infections, bleeding issues, and heart problems such as atrial fibrillation (irregular heartbeat). These drugs have shown a generally well-tolerated safety profile, but it's important to consider potential side effects and interactions with other medications.12345
How is the drug combination of Ibrutinib and Rituximab unique for treating mantle cell lymphoma?
The combination of Ibrutinib and Rituximab is unique because it targets mantle cell lymphoma cells more effectively by combining Ibrutinib's ability to inhibit B-cell activity with Rituximab's targeting of B lymphocytes, potentially leading to more potent antitumor activity compared to using Ibrutinib alone.12678
What data supports the effectiveness of the drug combination Ibrutinib and Rituximab for treating Mantle Cell Lymphoma?
Research shows that Ibrutinib, when combined with Rituximab, can be effective for patients with mantle cell lymphoma, especially those who have already tried other treatments. In one study, adding Rituximab to Ibrutinib helped target cancer cells more effectively, potentially leading to better outcomes.12379
Who Is on the Research Team?
Preetesh Jain, MD, PHD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with relapsed/refractory Mantle Cell Lymphoma (MCL) or those over 65 newly diagnosed with MCL. Participants need functioning kidneys, acceptable liver function, and no major heart issues. They must not be pregnant, have HIV/Hepatitis B infection, or have taken Ibrutinib before.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ibrutinib daily and rituximab on a specified schedule for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ibrutinib
- Rituximab
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