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临床试验/NCT04526223
NCT04526223Unknown不适用

Allogeneic HCT Outcomes in MF Patients Exposure to Ruxolitinib During Transplantation

xuna1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年4月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Time of neutrophils reconstruction

研究概览

简要总结

Increasing experience of Ruxolitinib pre-allo SCT and data concerning Ruxolitinib during transplantation

  1. Diagnosis MF(includ Post-ET,Post-PV,PMF,MDS/MPN with MF)
  2. With at least two month Ruxolitinib treatment prior to transplantation
  3. DAC+BF as myeloablative conditioning regimen
  4. CSA from day -3 and MMF from day +1 until day 28 ATG Neovii® at dose of 7.5mg/KG for mismatch donor
  5. received Rux at +6d in ASCT and continued to +60d

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 years old, gender is not limited;
  • Diagnosis MF(includ Post-ET,Post-PV,PMF) according to 2016 WHO
  • With at least two month Ruxolitinib treatment before transplantation
  • Informed consent of the patient or his legal representative

排除标准

  • HCT-CI score≥2
  • Woman who is pregnant or nursing
  • MPN Patients who have received allogeneic hematopoietic stem cell transplantation

结局指标

主要结局

Time of neutrophils reconstruction

时间窗: 1 year

Neutrophils count≧0.5G/L without G-CSF

次要结局

  • The incidence rate of GVHD(1 year)

研究者

发起方
xuna
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

xuna

doctor

Nanfang Hospital, Southern Medical University

研究点 (1)

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