Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia
This phase II trial studies how well ibrutinib works in treating patients with relapsed hairy cell leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Progressive Hairy Cell Leukemia, Initial Treatment
Refractory Hairy Cell Leukemia
Untreated Hairy Cell Leukemia
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 for Treatment of Relapsed Hairy Cell Leukemia|
- Overall response rate (CR and PR) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
- Frequency and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
- Progression-free survival (PFS) [ Time Frame: From the date of study registration to the date of event or the date of last follow-up if no event has occurred, assessed up to 2 years ] [ Designated as safety issue: No ]Kaplan-Meier curves will be used to estimate overall survival and time to next treatment.
- Overall survival (OS) [ Time Frame: From the date of study registration to the date of event or the date of last follow-up if no event has occurred, assessed up to 2 years ] [ Designated as safety issue: No ]Kaplan-Meier curves will be used to estimate overall survival and time to next treatment.
- Rate of molecular remission (MRD-negative CR) defined as resolution of all detectable disease below the limits of detection by immunohistochemistry and 4-color flow cytometry assay [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ibrutinib)
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studies
I. To determine the overall response rate (complete response [CR] and partial response [PR]) of hairy cell leukemia (HCL) at 32 weeks after beginning therapy with single-agent ibrutinib.
I. To characterize the toxicity and tolerability of single-agent ibrutinib when administered to patients with HCL.
II. To characterize the progression-free (PFS) and overall survival (OS) of single- agent ibrutinib when administered to patients with HCL.
III. To determine the rate of molecular remission (minimal residual disease [MRD]-negative CR) among all patients, defined as resolution of all detectable disease below the limits of detection by immunohistochemistry and/or 4-color flow cytometry assay at 32 weeks after beginning ibrutinib therapy.
IV. To characterize immunologic outcomes during single agent ibrutinib administration.
V. To explore the effect of PCI-32765 (ibrutinib) on traditional and new biomarkers in HCL including: confirmation of expression BRAFV600E in leukemia cell; pharmacodynamic effects of BTK inhibition on phospho extracellular signal-regulated kinase (ERK) regulation, as well as other potential protein kinase targets of ibrutinib (exploratory); serum soluble interleukin (IL)-2 receptor correlation with response to ibrutinib therapy; documentation of and quantification of minimal residual disease following maximal response, with flow cytometric analysis and immunohistochemical stains of the bone marrow, as predictors of remission duration after ibrutinib therapy.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Charles A. Schiffer 313-576-9363 firstname.lastname@example.org|
|Principal Investigator: Charles A. Schiffer|
|United States, Ohio|
|Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Jeffrey A. Jones 614-293-3507 email@example.com|
|Principal Investigator: Jeffrey A. Jones|
|Principal Investigator:||Jeffrey Jones||Ohio State University|