Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M) - M19-708

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 122 人开始时间: 2023年12月18日最近更新: 2024年8月21日

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•Subject must be =18 years old, have newly diagnosed AML with intermediate or poor risk cytogenetics, have confirmation of CR or CRi following completion of intensive Induction and Consolidation chemotherapies; subject should be within one of the following time windows: have achieved first CR or CRi (after induction) within 120 days of the first dose of study drug (Cycle 1 Day 1) or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies until enrollment (Cycle 1 Day 1), and have an Eastern Cooperative Oncology Group (ECOG) performance status of =2., The key laboratory requirements are as follows: Subject must meet the following laboratory parameters, per laboratory reference range within the screening period prior to study drug administration: - creatinine clearance =30 mL/minute; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection; - bilirubin < 3.0 × upper limit of normal (ULN) (adequate liver function) for Parts 1 or bilirubin < 2.0 × ULN for Part 3; - absolute neutrophil count =1,500/µL; - platelets =100,000/µL.

•History of APL., History of active central nervous system involvement with AML., History of autologous stem cell transplantation for AML.

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