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临床试验/NCT03717545
NCT03717545Unknown不适用

Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年3月1日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
入组人数
12
试验地点
1
主要终点
engraftment
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. We performed a prospective single-arm study to investigate the safety and efficacy of a novel regimen.

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

性别
All
接受健康志愿者
否

入选标准

  • •graft failure after first allogeneic stem cell transplantation
  • •no active infection or GVHD or severe organ dysfunction
  • •sign written informed consent

排除标准

  • •active infection, GVHD, organ failure
  • •expected life < 28 days

研究组 & 干预措施

intervention arm

Experimental

second allogeneic stem cell transplantation

干预措施: second allogeneic stem cell transplantation (Other)

结局指标

主要结局

engraftment

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 28 day(28 days after second transplantation)
  • Overall survival at 100d(day100 after second transplantation)
  • TRM at 100d(day 100 after second transplant)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaojun Huang,MD

Head of Peking University Institute of Hematology

Peking University People's Hospital

研究点 (1)

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