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A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia

Primary Objective: * To evaluate the safety and tolerability of acalabrutinib monotherapy in subjects with treatment-naive or relapsed/refractory chronic lymphocytic leukemia. Secondary Objective: * To evaluate the investigator-assessed overall response rate, duration of response, and progression-free survival in subjects receiving acalabrutinib monotherapy. Exploratory Objectives: * To evaluate safety in subjects using concomitant vitamin K antagonist with acalabrutinib monotherapy. * To evaluate the investigator-assessed overall survival in subjects receiving acalabrutinib monotherapy. * To evaluate the investigator-assessed treatment-free survival. * To evaluate patient-reported symptoms and health-related quality of life following treatment with acalabrutinib monotherapy.

Primary Objective: * To evaluate the safety and tolerability of acalabrutinib monotherapy in subjects with treatment-naive or relapsed/refractory chronic lymphocytic leukemia. Secondary Objective: * To evaluate the investigator-assessed overall response rate, duration of response, and progression-free survival in subjects receiving acalabrutinib monotherapy. Exploratory Objectives: * To evaluate safety in subjects using concomitant vitamin K antagonist with acalabrutinib monotherapy. * To evaluate the investigator-assessed overall survival in subjects receiving acalabrutinib monotherapy. * To evaluate the investigator-assessed treatment-free survival. * To evaluate patient-reported symptoms and health-related quality of life following treatment with acalabrutinib monotherapy.