SHS_492280 PAGJ CACT 15144
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia
This study is designed to evaluate PFS endpoint for ACE-196 vs ibrutinib in previously treated chronic lymphocytic leukemia.
ECOG performance status of 0 to 2. Diagnosis of CLL. Must have ≥ 1 of the following high-risk prognostic factors: Presence of 17p del by central laboratory; Presence of 11q del by central laboratory; or Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment - Must have received ≥ 1 prior therapies for CLL, Measurable nodal disease by CT, or Meet the protocol laboratory parameters.
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 BCR inhibitor or a BCL-2 inhibitor. Received any chemotherapy, external beam radiation therapy, anticancer antibodies 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. Currently active clinically significant cardiovascular disease within 6 months before first dose with study drug. Known history of infection with 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 28 days of first dose of study drug. Requires treatment with a strong CYP3A4 inhibitor/inducer
John Pagel, M.D.
Acerta Pharma BV