ACTRN12606000514505尚未招募3 期
A Phase III Randomized Study of Cloretazine (VNP40101M) and Cytosine Arabinoside (AraC) in Patients with Acute Myeloid Leukemia in First Relapse to Improve the Overall Remission Rate
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients must have AML (any WHO classification excluding acute promyelocytic leukemia) in first relapse after a first CR (complete response) or CRp (meeting all criteria for CR except recovery of platelet counts to >100,000 uL) determined by bone marrow aspirates and/or biopsies that contain = 10% blasts. The duration of first CR or CRp must have been at least 3 months but less than 24 months, calculated from the day CR or CRp was documented following the initial induction regimen to the day leukemia relapse was confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology and/or histological proven central nervous system (CNS) or extramedullary disease.
排除标准
- •Uncontrolled active infection of any kind. Presence of any other severe medical condition that may compromise the safety of treatment.
研究者
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