Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 22
- 主要终点
- Part I: The primary endpoint is dose-limiting toxicities of venetoclax in combination with AZA
研究概览
简要总结
Part I (Dose Confirmation): To determine the RPTD of venetoclax in combination with AZA as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional induction and consolidation chemotherapy Part III (Dose Finding): To determine the RPTD of venetoclax in combination with oral AZA as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional induction and consolidation chemotherapy. Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Part 3: Dose Finding
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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 ≤
- •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.
排除标准
- •History of APL.
- •History of active central nervous system involvement with AML.
- •History of autologous stem cell transplantation for AML.
研究组 & 干预措施
azacitidine, azacitidine
Participants receiving azacitidine, azacitidine
干预措施: AZACITIDINE (Drug)
结局指标
主要结局
Part I: The primary endpoint is dose-limiting toxicities of venetoclax in combination with AZA
Part I: The primary endpoint is dose-limiting toxicities of venetoclax in combination with AZA
Part III (Dose Finding): The primary endpoint is DLTs of venetoclax in combination with oral AZA
Part III (Dose Finding): The primary endpoint is DLTs of venetoclax in combination with oral AZA
Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.
Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.
次要结局
- Part 3 (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG