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临床试验/EUCTR2010-024625-20-NL
EUCTR2010-024625-20-NL进行中(未招募)1 期

ADMINISTRATION OF HA-1 TCR TRANSDUCED VIRUS-SPECIFIC T-CELLS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGH-RISK LEUKEMIA (LUMC 2010-02) - HA-1 TCR transduced virus-specific T-cells

eiden University Medical Center0 个研究点目标入组 20 人开始时间: 2015年1月8日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age 18-75 years
  • WHO performance score 0-2
  • High-risk leukemia (see appendix D)
  • Complete remission (CR) or stable partial remission (PR) (see appendix D)
  • HLA-A*0201 positive
  • HA-1h positive
  • Availability of a suitable donor (see donor criteria)
  • Written informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 15
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • Life expectation < 3 months.
  • End stage irreversible multi-system organ failure.
  • Pregnant or lactating women.
  • Severe psychological disturbances.
  • HIV-positivity

研究者

发起方
eiden University Medical Center

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