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.

Inclusion Criteria:
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.

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 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
Phase III
Cancer, All Other
John Pagel, M.D.
Acerta Pharma BV
Neil Bailey
  • Swedish Medical Center