NCT01674985已完成1 期
Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- complete remission
研究概览
简要总结
The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.
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
- 10 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
- •International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
- •bone marrow blasts > 11% or <= 10% and poor cytogenetics;
- •lack of an HLA-identical donor;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- •adequate cardiac and hepatorenal functions.
排除标准
- •have an HLA-identical donor
结局指标
主要结局
complete remission
时间窗: six months
次要结局
- disease-free survival(three years)
研究者
研究点 (1)
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