Natural Killer Cells Reconstitution Kinetics Post T Cells Repleted Haploidentical Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Immune Reconstitution differences between two group
研究概览
简要总结
Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution.
详细描述
Patients with hematological malignancies suitable for allo-HSCT but without HLA-identical related or unrelated donors were candidates for the HLA-haploidentical HSCT. Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution. Peripheral blood will be collected by day15, 30, 60, 90, 180, and 1 year post transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
排除标准
- •NR or refractory AML/ALL before transplantation donors from mother or collateral related
研究组 & 干预措施
experimental group
MMF withdrawal by engraftment post haplo-SCT
干预措施: MMF (Drug)
control group
MMF withdrawal by 2 month post haplo-SCT
干预措施: MMF (Drug)
结局指标
主要结局
Immune Reconstitution differences between two group
时间窗: 1 year
次要结局
- Cumulative incidence of TRM differences between two group(1 year)
- OS differences between two group(1 year)
- Cumulative incidence of chronic GVHD differences between two group(1 year)
- Cumulative incidence of Infection differences between two group(1 year)
- Cumulative incidence of relapse differences between two group(1 year)
- DFS differences between two group(1 year)
- Cumulative incidence of acute GVHD differences between two group(100 day)
研究者
Xiaojun Huang,MD
Professor
Peking University People's Hospital