ISRCTN94206677已完成不适用
TRIAL Relapsed AML 2001/01: a randomised phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukaemia (AML)
Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands)0 个研究点目标入组 400 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Primary refractory acutye myeloid leukaemia (AML)
- •2. First relapsed AML
- •3. Second or subsequent relapsed AML, but not previously treated according to protocol Relapsed AML 2001/01
- •4. Below 18 years of age at initial diagnosis
- •5. Signed informed consent
排除标准
- •1. Symptomatic cardiac dysfunction (CTC grade 3 or 4), and/or a fractional shortening at echocardiography below 29%
- •2. Karnofsky performance status less than 40% (children aged 16 years and older) or Lansky performance status of less than 40% (younger children)
- •3. Any other organ dysfunction (CTC grade 4) that will interfere with the protocol treatment
- •4. Inability to apply to the protocol for other reasons
- •5. AML FAB type M3, acute promyelocytic leukaemia, and/or t(1517) and/or PML-RARalfa fusion gene
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