Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- incidence of acute graft-versus-host disease
研究概览
简要总结
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT.
It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).
The study hypothesis:
Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute GVHD
详细描述
patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no severe diarrhea no serious infection
排除标准
- •serious diarrhea active,uncontrolled infection
研究组 & 干预措施
low-dose glucocorticoid
drug
干预措施: low-dose glucocorticoid Methylprednisolone (Drug)
no intervention after transplant
干预措施: low-dose glucocorticoid Methylprednisolone (Drug)
结局指标
主要结局
incidence of acute graft-versus-host disease
时间窗: paticipants will be followed for the duration of hospital stay,an expected average of 100 days
number of participants with acute graft-versus-host disease at 100 days
次要结局
- incidence of infection(participants will be followed for the duration of hospital stay,an expected average of 100 days)
研究者
Xiaojun Huang,MD
director of Peking University People's Hospital，Institute of Hematology
Peking University People's Hospital