EUCTR2019-002217-19-HU进行中（未招募）1 期
Randomized, Double-blind, 2-Arm, 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
- 482
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 confirmed CR or CRi following completion of intensive Induction and Consolidation chemotherapies, have achieved first CR or CRi (after induction) within 120 days of the first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both Induction and Consolidation) chemotherapies until enrollment, and have an Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
- •The key laboratory requirements are as follows:
- •- 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 × ULN for Part 3;
- •- 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 313
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 169
排除标准
- •History of APL.
- •History of active central nervous system involvement with AML.
研究者
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