Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Proportions of regulatory immune cells in peripheral blood.
研究概览
简要总结
The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient of the Nancy CHRU, for whom a CSH allograft is planned. or
- •hematopoietic stem cell donors received at Nancy's CHRU for the duration of the research
排除标准
- •Positive HIV
- •active hepatitis B or C infection
研究组 & 干预措施
Donor
干预措施: Blood sample (Biological)
Donor
干预措施: Allogeneic hematopoietic stem cell sample (Biological)
Recipient
干预措施: Blood Sample (Biological)
Recipient
干预措施: Bone marrow aspiration (Biological)
结局指标
主要结局
Proportions of regulatory immune cells in peripheral blood.
时间窗: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
次要结局
- Incidence of relapse(After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years)
- Incidence of infections(After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years)
- Progress-free survival(After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years)
- Overall survival(After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years)
- Occurrence of graft versus host (GVH) reaction after allografting of CSH(After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years)