Conditions: B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Prolymphocyctic Leukemia Richter's Transformation
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 71
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases

Detailed description:

Arms:
arm 1: In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing arm 2: In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1) arm 3: In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily

Interventions: intervention 1: PCI-32765 intervention 2: ofatumumab
Intervention descriptions: intervention 1: 420 mg PO daily intervention 2: per package insert as an IV infusion

Protocol document: