A Phase 1b, Multicenter, Open-label, Parallel-group Safety Study of a Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI 32765, in Combination With Chemotherapy in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI
32765 420 mg once daily oral (PO) administration in combination with 2 different
chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia
(CLL)/small lymphocytic lymphoma (SLL).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To measure the number of participants with prolonged hematologic toxicity
8 weeks from first dose
Yes
Thorsten Graef, MD
Study Director
Pharmacyclics
United States: Food and Drug Administration
PCYC-1108-CA
NCT01292135
February 2011
May 2013
Name | Location |
---|---|
Weill Medical College of Cornell University | New York, New York 10021 |
University of Rochester | Rochester, New York 14642 |
MD Anderson | Houston, Texas 77230 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Dana Farber Cancer Center | Boston, Massachusetts 02115 |
CLL Research and Treatment Program | New Hyde Park, New York 11042 |