Conditions: B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: no

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).

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: PCI-32765
Intervention descriptions: intervention 1: 420 mg daily

Protocol document: