NCT00512083已完成2 期
An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
Antisoma Research19 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2007年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 19
- 主要终点
- The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
研究概览
简要总结
The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary refractory or relapsed AML
- •confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)
- •aged at least 18 years
排除标准
- •initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
- •patient in blast crisis stage of chronic myeloid leukemia
- •received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months
- •interval of <6 months between first onset of last complete remission and current relapse
- •those with primary refractory leukemia who have received more than three previous induction cycles
- •relapsed patients who have received more than three previous treatment regimens
结局指标
主要结局
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
次要结局
未报告次要终点
研究者
研究点 (19)
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