Ibrutinib + Rituximab for Mantle Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether combining ibrutinib and rituximab can effectively treat mantle cell lymphoma, especially in patients whose cancer has returned or hasn't responded well to previous treatments. Ibrutinib blocks enzymes that aid cancer cell growth, while rituximab targets and destroys cancer cells. Individuals with mantle cell lymphoma that has relapsed or is newly diagnosed and untreated might be suitable for this trial, particularly if the disease impacts their daily life. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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 there any evidence suggesting that ibrutinib and rituximab are likely to be safe for humans?
Research has shown that ibrutinib, when used alone, is generally safe for patients with mantle cell lymphoma. Most patients in studies tolerated it well, though some experienced side effects that required dose adjustments. Combining ibrutinib with rituximab, an antibody treatment that helps destroy cancer cells, has been shown to slow cancer growth. While this combination can improve outcomes, awareness of possible side effects is important. These side effects can occur but are usually manageable. Overall, similar patient groups have considered the combination well-tolerated.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about ibrutinib and rituximab for treating mantle cell lymphoma because they offer a fresh approach compared to the standard treatments like chemotherapy and single-agent therapies. Unlike traditional therapies, ibrutinib works by specifically inhibiting Bruton's tyrosine kinase (BTK), a key player in cancer cell survival, which can potentially lead to more targeted destruction of cancer cells with fewer side effects. Rituximab, when used in combination, enhances this effect by targeting the CD20 protein on cancer cells, marking them for destruction by the immune system. This dual action not only promises to be more effective but could also lead to improved outcomes for patients.
What evidence suggests that ibrutinib and rituximab might be an effective treatment for mantle cell lymphoma?
This trial will evaluate the combination of ibrutinib and rituximab for treating mantle cell lymphoma, a type of cancer. Studies have shown that using ibrutinib and rituximab together is effective. Specifically, research indicates that patients taking these drugs experienced longer periods without cancer progression compared to those on other treatments. For older patients who had not been treated before, this combination led to a 52% chance of staying cancer-free for five years, significantly better than the 19% chance with other treatments. Additionally, patients experienced quicker improvements in their quality of life. This evidence suggests that ibrutinib and rituximab together can be a strong option for fighting this cancer.12346
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