NCT00559221Unknown2 期
Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia
Cooperative Study Group A for Hematology1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Complete remission rate, duration of complete remission, toxicities
研究概览
简要总结
- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
详细描述
- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.
- •Early relapse, occurring after a first CR lasting less than 12 months.
- •Patients with multiple relapses will be included.
- •Written informed consent must be given.
- •15 and 60 years of age.
- •2 or less by ECOG performance scale.
排除标准
- •acute promyelocytic leukemia
- •pregnant or lactating
研究组 & 干预措施
1
No Intervention
干预措施: FLAG+IDA (Drug)
结局指标
主要结局
Complete remission rate, duration of complete remission, toxicities
时间窗: 06/2008
次要结局
- progression-free survival, overall survival(06/2008)
研究者
研究点 (1)
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