NCT01095874已完成不适用
Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study Comparing Outcome of Patients Aged From 50 to 70 Years With or Without Donor
Saint-Louis Hospital, Paris, France1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2008年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- overall survival in patient with or without donor
研究概览
简要总结
The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 70 years
- •For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria:
- •IPSSintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality);
- •thrombopenia < 20x10ex9/L:
- •IPSS intermediate 2 or high
- •For CMML: patients can be included if they have at least one of these criteria:
- •2 of these criteria: hyperleucocytosis > 10x10exp9/L, splenomegaly>18cm, hemoglobin < 10gr/dl, platelet < 100x10ex9/L
- •IPSS intermediate 2 or high
排除标准
- •Patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including:
- •Renal failure with creatinine clearance < 30ml/min
- •Cirrhosis or hepatic failure
- •Respiratory disease with vital capacity < 30%
- •Uncontrolled cardiac failure
- •Uncontrolled neurological disease
- •Poor performance status with karnofsky < or = 60%
结局指标
主要结局
overall survival in patient with or without donor
时间窗: 36 months
次要结局
未报告次要终点
研究者
Marie Robin
Dr Marie Robin
Saint-Louis Hospital, Paris, France
研究点 (1)
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