Enhancement of Hematopoietic Stem Cell Engraftment by Multi Donor Stem Cell Transplantation (MDT) From 2 Mismatched Donors, a Phase I-II Open Study
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Day of neutrophil engraftment
研究概览
简要总结
The proposed research focuses on the development of innovative protocol of mismatched stem cell transplantation with combined 2 different haplo stem cell transplantation (SCT) donors which are mismatched to the recipient (and preferably to each other), in a patient in need for SCT, lacking an HLA match related or an unrelated donor. This innovative protocol named multi donor stem cell transplantation (MDT) is designed to facilitate engraftment even when reduced intensity conditioning or a low cell dose are used, improve the graft vs. leukemia (GVL) effect and enhance immune reconstitution (using quantitative and qualitative parameters).
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Day of neutrophil engraftment
时间窗: 30d
Day of platelet engraftment>20x10(9)L
时间窗: 30
Acute GVHD occurrence>2
时间窗: 100d
Disease free survival
时间窗: 100d
次要结局
- Transplant related toxicity(100d)
- Immune reconstitution(100d)
- Day of platelet engraftment>50x10(9)/L(30d)
- Time of acute GVHD(100d)
- GVHD grade(100d)
- Overall survival(100 days)
- Infections incidence(100d)
- transplant-related mortality(100d)
研究者
SHAPIRA MICHAEL
Prof Shapira
Hadassah Medical Organization