A Novel Post-transplant Regimen of PT/FLU+CY for Selectively Promoting Unrelated Cord Blood Engraftment in Haploidentical-cord Transplantation in Childhood Leukemia: a Single-arm, Multi-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- rate of leukemia free survival
研究概览
简要总结
To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort
详细描述
PTCy is a well-established haploidentical transplant regimen strategy. Moreover, unrelated cord blood (UCB) plays a critical role in the effects of GVL. However, the engraftment of grafts is unpredictable in the setting of a haplo-cord subsequent transplant. Therefore, applying a novel post-transplant regimen of PT/CY+FLU may selectively promote UCB engraftment in the setting of haplo-cord transplant.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children acute leukemia
排除标准
- 未提供
研究组 & 干预措施
PT/FLU+CY
The group consisted of fludarabine (40mg/m2, day-5 to day-3 and day+3, day+4), busulfan (100mg/m2, day-6 to day-3), haplo-PBSC (day0), cyclophosphamide (50mg/kg, day+3, day+4) , and UCB (day+6)
干预措施: applying of FLU+CY post-HSCT (Procedure)
结局指标
主要结局
rate of leukemia free survival
时间窗: 3 years post-HSCT
determine the leukemia status post-HSCT
rate of UCB engraftment
时间窗: initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT
evaluate the regimen if it promotes UCB engraftment
rate of overall survival
时间窗: 3 years post-HSCT
determine the overall survival status post-HSCT
次要结局
未报告次要终点