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Brief Title: Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)
Official Title: 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
Study ID: NCT01292135
Brief Summary: The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).
Detailed Description: 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dana Farber Cancer Center, Boston, Massachusetts, United States
CLL Research and Treatment Program, New Hyde Park, New York, United States
Weill Medical College of Cornell University, New York, New York, United States
University of Rochester, Rochester, New York, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson, Houston, Texas, United States
Name: Thorsten Graef, MD
Affiliation: Pharmacyclics LLC.
Role: STUDY_DIRECTOR