Ibrutinib + Ixazomib for Waldenstrom's Macroglobulinemia
Trial Summary
What is the purpose of this trial?
This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib, and determines how well they work in treating patients with Waldenstrom macroglobulinemia that is newly diagnosed, has come back (recurrent) or does not respond to treatment (refractory). Enzyme inhibitors, such as ibrutinib and ixazomib citrate, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take strong CYP3A inducers or participate in other clinical trials during the study.
What data supports the effectiveness of the drug combination Ibrutinib and Ixazomib for treating Waldenstrom's Macroglobulinemia?
Research shows that Ibrutinib alone or combined with Rituximab is effective for treating Waldenstrom's Macroglobulinemia, especially in patients who have been previously treated or are resistant to Rituximab. While there is no direct data on the combination of Ibrutinib and Ixazomib, Ibrutinib has shown substantial activity in this condition.12345
Is the combination of Ibrutinib and Ixazomib safe for humans?
Ibrutinib has been generally well-tolerated in patients with Waldenström's macroglobulinemia, but there are reports of serious heart rhythm problems, including ventricular fibrillation (a dangerous heart rhythm). There is no specific safety data available for the combination of Ibrutinib and Ixazomib.23567
How is the drug combination of Ibrutinib and Ixazomib unique for treating Waldenstrom's Macroglobulinemia?
The combination of Ibrutinib and Ixazomib for Waldenstrom's Macroglobulinemia is unique because it combines two drugs with different mechanisms: Ibrutinib, which blocks a protein that helps cancer cells grow, and Ixazomib, which disrupts protein breakdown in cells, potentially offering a new approach for patients who may not respond to standard treatments.12345
Research Team
Asher A. Chanan-Khan, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for adults with Waldenstrom macroglobulinemia, whether newly diagnosed, relapsed or treatment-resistant. Participants must be able to give consent, provide blood and bone marrow samples, have certain minimum blood counts and organ function levels, not be pregnant or breastfeeding, use effective contraception if of childbearing potential, and have no major surgery planned.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ixazomib citrate orally on days 1, 8, and 15 and ibrutinib daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion every 3 months for up to 2 years.
Treatment Details
Interventions
- Ibrutinib
- Ixazomib Citrate
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?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator