Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

Exclusion Criteria

• •Known CNS lymphoma or leukemia.
• •Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
• •Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
• •Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor or a B-cell lymphoma-2 (BCL-2) inhibitor.
• •Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
• •Prior radio- or toxin-conjugated antibody therapy.
• •Prior allogeneic stem cell or autologous transplant.
• •Major surgery within 4 weeks before first dose of study drug.
• •Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease \> 3 years before Screening and at low risk for recurrence.
• •Significant cardiovascular disease within 6 months of screening.
• •Known history of infection with human immunodeficiency virus (HIV).
• •History of stroke or intracranial hemorrhage within 6 months before randomization.
• •History of bleeding diathesis.
• •Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
• •Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor/inducer.