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: 2020年9月24日

适应症

试验速览

阶段: 不适用
发起方: Peking University People's Hospital
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

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

发起方

Peking University People's Hospital

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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