A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Engraftment of neutrophils
研究概览
简要总结
Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.);
- •Graft failure after the first haploidentical stem cell transplantation;
- •Time from the first transplantation to the second transplantation is less than 180 days;
- •Age≥14 years.
排除标准
- •Active infections;
- •Active GVHD;
- •Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%<50% or symptomatic heart failure);
- •Eastern Cooperative Oncology Group (ECOG) score>2;
- •Expected life time<30 days;
- •Patients could not cooperate;
- •Other situations that are considered inappropriate for enrollment by the investigators,
结局指标
主要结局
Engraftment of neutrophils
时间窗: 28 days after second transplantation
Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.
次要结局
- TRM at 100 day(100 days after second transplantation)
- GVHD(Participants will be followed for an expected average of 1 year)
- LFS(Participants will be followed for an expected average of 1 year)
- OS(Participants will be followed for an expected average of 1 year)
- Engraftment of Platelet(100 days after second transplantation)
- TRM at 28 day(28 days after second transplantation)
- CIR(Participants will be followed for an expected average of 1 year)
研究者
Xiao-Jun Huang
Prof.
Peking University People's Hospital