JPRN-UMIN000000511已完成2 期
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia - AML-05
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)0 个研究点目标入组 254 人开始时间: 2006年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
研究概览
简要总结
- CR rate, 3-year EFS and OS rates for the whole cohort (N=443) CR rate: 86.0% 3-year EFS: 54.3 % (95%CI, 49.3-59.0%) 3-year OS: 73.2 % (95%CI, 68.3-77.4%) 3-year relapse rate: 30.3% (95%CI, 25.9-34.7%) 2. 3-year EFS and OS rates according to the risk group 1) Low risk (LR) group (N=135) 3-year EFS: 69.4 % (95%CI, 60.3-76.8%) 3-year OS: 92.5 % (95%CI, 85.5-96.3%) 2) Intermediate risk (IR) group (N=183) 3-year EFS: 57.3 % (95%CI, 49.3-64.5%) 3-year OS: 73.2 % (95%CI, 65.0-79.8%) 3) High risk (HR) group (N=54) 3-year EFS: 53.4 % (95%CI, 39.2-65.6%) 3-year OS: 66.8 % (95%CI, 51.1-78.4%)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 18years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)CNS hemorrhage which is likely to interfere protocol therapy 2)uncontrolled DM 3)severe mental abnormalities 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)any inappropriate status judged by physician
研究者
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