NCT03080922Unknown1 期
Treatment of Relapsed/Refractory Acute Myeloblastic Leukemia(AML) by Infusion of Donor High Dose Allogeneic Mismatched Hematopoietic Stem Cells After Chemotherapy
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 10 人开始时间: 2016年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.
详细描述
The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells.
no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.
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
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with relapsed and/or refractory AML
- •Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
排除标准
- •Previous treatment with investigational gene or cell therapy medicine products
- •Any uncontrolled active medical disorder that would preclude participation as outlined
结局指标
主要结局
complete remission rate
时间窗: 2 months
次要结局
- Disease-free survival(2 years)
- Overall survival(2 years)
- donor graft rate(6 months)
- Occurrence of study related adverse events(6 months)
研究者
研究点 (1)
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