SHS_492281 PAGJ CACT 15143
A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, ACP-196 in Combination With Obinutuzumab, and ACP-196 Monotherapy in Subjects With Previously Untreated CLL
This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil compared with ACP-196 in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL).
Men and women: ≥ 65 years of age OR > 18 and < 65 years of age, provided that they meet at least one of the following criteria: Creatinine clearance 30 to 69 mL/min; A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric; ECOG performance status of 0, 1, or 2; Diagnosis of CLL; Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment; Measurable nodal disease by CT; Meet the following laboratory parameters: a. ANC ≥ 750 cells/μL, or ≥ 500 cells/μL in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment; b.Platelet count ≥ 50,000 cells/μL, or ≥ 30,000 cells/μL in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded; c.Serum AST and ALT/SGPT < 3.0 x ULN; d.Total bilirubin ≤ 2.5 x ULN; e.Estimated creatinine clearance ≥ 30 mL/min.
Any prior treatment for CLL. 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. 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. 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. Known history of a bleeding diathesis. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 28 days of first dose of study drug.
John Pagel, M.D.
Acerta Pharma BV