Physician VersionPatient Version

Protocol No.Principal InvestigatorPhaseAge GroupScopeSecondary Protocol No.Status
OSU-12200Jones, JeffreyIIAdultNational9268Open

Adapted from the National Cancer Institute's Physician Data Query (PDQ®) Cancer Clinical Trials (http://www.cancer.gov/clinicaltrials)

Title

A Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) for Treatment of Relapsed Hairy Cell Leukemia
Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia

Summary

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.

To view the NCI PDQ information for this trial, click here

To view the clinicaltrials.gov information for this trial, click here

Detailed Description/Objectives

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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 v-raf murine sarcoma viral oncogene homolog B V600E mutation (BRAFV600E) in leukemia cells; pharmacodynamic effects of Bruton agammaglobulinemia tyrosine kinase (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.

OUTLINE:

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.

Eligibility

Inclusion Criteria:

Exclusion Criteria:

Applicable Disease Sites

Chronic Lymphocytic Leukemia (CLL)

Participating Institutions

James Cancer Hospital
OSU Cancer Center
OSU Medical Center

Contact

Terri Hutchinson
Phone:614-293-4562
Email:Terri.Hutchinson@osumc.edu