NCT00180167已完成4 期
Therapy of AML in Patients Older Than 60 Years: Randomized Comparison of a Double Induction With Daunorubicin and AraC (as Continuous Infusion) With a Double Induction With Mitoxantrone and Intermittent, Medium High Dose AraC
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- Complete remission rate
研究概览
简要总结
Single Arm-Studies suggest improved remission and survival rates for a Protocol with Mitoxantron 10mg/m2 for 3 days combined with AraC 1g/m2 bid on days 1+3+5+7 compared to a conventional DA 7+3 protocol (45mg/m2 Daunorubicin).
详细描述
Randomized comparison of the two protocols.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML
- •no previous Chemo for AML
- •informed consent
- •Karnofsky >70
排除标准
- •uncontrolled Sepsis
- •uncontrolled HYpertension
- •respiratory failure
- •heart-failure NYHA IV, recent myocardial infarction
- •severe organ dysfunction of liver, kidneys,
- •HIV -infection or active Hepatitis B,C
研究组 & 干预措施
Daunorubicin + Ara-C
Active Comparator
干预措施: randomization between two established Chemotherapies (Drug)
Mitoxantrone + Ara-C
Experimental
干预措施: randomization between two established Chemotherapies (Drug)
结局指标
主要结局
Complete remission rate
Survival
次要结局
- toxicity
- Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value?
研究者
研究点 (1)
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