Title: A Multicenter Phase 2 Study of the Bruton’s Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) for Treatment of Relapsed Hairy Cell Leukemia

Principal Investigator: Kerry A Rogers, MD, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio

Description: This phase 2 trial is studying how well ibrutinib works in treating patients with hairy cell leukemia that has returned after a period of improvement. The researchers hypothesize that ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The primary objective of this trial is to determine the overall response rate (complete response and partial response) in patients with hairy cell leukemia at 32 weeks after initiation of single-agent ibrutinib. Patients enrolled in this trial receive ibrutinib orally once daily on days 1-28. Cycles repeat every 28 days for up to 8 cycles if there is a lack of response to therapy and up to 12 cycles if there is a failure to achieve an objective response, or continually at per physician discretion in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

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Status: This study is open and recruiting patients as of April 30, 2013.

This study is sponsored by the National Cancer Institute.


Clinicaltrials.gov. Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia. NCT01841723. https://clinicaltrials.gov/ct2/show/NCT01841723. Accessed December 10, 2019.