PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

May 21, 2012

Primary Completion Date

July 28, 2016

Study Completion Date

December 31, 2025

Conditions
Prolymphocytic LeukemiaRecurrent Small Lymphocytic LymphomaRefractory/Relapsed Chronic Lymphocytic Leukemia
Interventions
DRUG

ibrutinib

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.

OTHER

Correlative laboratory samples

Blood samples will be collected and used for pharmacodynamic testing. Samples will be collected pre-dose on Cycle 1 Day 1 and 2 hours post-dose Cycle 1 Day 1, pre-dose on Day 2 and Day 8 of Cycle 1 and pre-dose on Day 1 of Cycles 2 and 3 and then every 3 cycles thereafter for 1 year (Cycle 15 Day 1). Samples will also be collected at the time of relapse and at any time when bone marrow biopsy is performed.

OTHER

quality of life assessment

During screening, sociodemographic information (e.g., age, race, marital status) and reports of recent (last year) stressful events will be obtained. The assessment will consist of measures of emotional distress, depressive symptoms, and quality of life. Quality of life measures will be administered during screening and on Days 1 (±3), 8 (±3),, 15 (±3),, 22 (±3), of Cycle 1, Day 1 (±3), of Cycle 2 and on day 1 (±7) of Cycles 3, 6, and then every 3 months thru month 24.

Trial Locations (1)

43210

Ohio State University Medical Center, Columbus

All Listed Sponsors
lead

Kami Maddocks, MD

OTHER

NCT01589302 - PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia | Biotech Hunter | Biotech Hunter