Ibrutinib for Relapsed or Refractory Follicular Lymphoma
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well ibrutinib works in treating patients with follicular lymphoma that has come back after a period of improvement or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Research Team
Nancy L Bartlett
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for adults with relapsed or unresponsive follicular lymphoma, who've had at least one prior treatment. They must have measurable disease, acceptable blood counts and organ function, and be willing to provide samples for research. Pregnant women, those on certain drugs like CYP3A4/5 inhibitors or steroids, HIV-positive patients on antiretroviral therapy, individuals with active hepatitis B/C or other serious health issues are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ibrutinib orally once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion every 3 months until progressive disease, then every 6 months for 5 years.
Treatment Details
Interventions
- Ibrutinib
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?
National Cancer Institute (NCI)
Lead Sponsor