Ibrutinib for Hairy Cell Leukemia

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byKerry A Rogers

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

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.

Eligibility Criteria

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

Agreement to use adequate contraception for women of child-bearing potential and men

Specific laboratory criteria including creatinine, bilirubin, AST, PT/INR, PTT, and baseline peripheral blood cell counts

I have been diagnosed with hairy cell leukemia that needs treatment.

+4 more

Exclusion Criteria

Pregnant or breastfeeding women

Incarceration at the time of enrollment

I have lingering side effects from previous cancer treatments.

+21 more

Participant Groups

The trial tests Ibrutinib's effectiveness in patients whose Hairy Cell Leukemia has returned after initial improvement. It explores whether Ibrutinib can halt cancer cell growth by inhibiting enzymes necessary for their proliferation.

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib)Experimental Treatment6 Interventions

Patients receive ibrutinib PO QD on days 1-28. Cycles repeat every 28 days for up to 8 cycles if lack of response to therapy, up to 12 cycles if failure to achieve an objective response (CR/PR), or continually at per physician discretion in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow aspiration and biopsy, blood sample collection, and CT or ultrasound throughout the study.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: