EUCTR2019-002217-19-DE进行中（未招募）1 期
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)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 Inductiion and Consolidation chemotherapies; subject should be within one of the following time windows:
- •have achieved first CR + 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 and 2, or bilirubin < 2.0 x ULN for Part 3; unless due to Gilbert's Syndrome;
- •absolute neutrophil count = 1,500/µL;
- •platelets = 100,000/µL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •History of APL.
- •History of active central nervous system involvement with AML.
- •History of autologous stem cell transplantation for AML.
研究者
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