Ibrutinib for Hairy Cell Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well ibrutinib works in treating patients with hairy cell leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong CYP3A4/5 inhibitors at least 7 days before starting ibrutinib. If you are on warfarin or require daily corticosteroids at a high dose, you may need to stop or adjust these medications as well. It's important to discuss your current medications with the study team to ensure they don't interfere with the trial.
Is ibrutinib safe for humans?
How is the drug ibrutinib unique in treating hairy cell leukemia?
Ibrutinib is unique because it is an oral medication that targets a specific protein called Bruton's tyrosine kinase, which is involved in the growth of cancerous B-cells. This makes it different from traditional chemotherapy, as it specifically disrupts cancer cell signaling, offering a novel approach for patients who do not respond well to standard treatments.15678
What data supports the effectiveness of the drug Ibrutinib for treating Hairy Cell Leukemia?
Who Is on the Research Team?
Kerry A Rogers
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with relapsed Hairy Cell Leukemia who've had prior treatment. They should have certain blood count levels, be fit enough for daily activities (ECOG <=2), and not be pregnant or breastfeeding. Contraception is required during the study. Exclusions include uncontrolled illnesses, recent major surgery, other cancers within 3 years (some exceptions apply), known allergies to similar drugs, active hepatitis B/C infection, strong CYP3A inhibitors use recently, and certain cardiovascular diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ibrutinib orally once daily on days 1-28. Cycles repeat every 28 days for up to 8 cycles if lack of response, up to 12 cycles if failure to achieve an objective response, or continually at physician discretion.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
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