跳至主要内容
临床试验/EUCTR2012-002418-38-NL
EUCTR2012-002418-38-NL进行中(未招募)不适用

Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor - CD4+ donor lymphocytes

eiden University Medical Center0 个研究点开始时间: 2012年6月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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 years
  • Patients with AML, myelodysplasia , ALL, CML in accelerated phase or blastic transformation, CLL, MM or (non) Hodgkin lymphoma, who are definitely planned to undergo an allo-SCT with an unrelated donor who is matched for HLA-A, B, C, DR and DQ.
  • Life expectation of > 3 months
  • WHO performance status of 0, 1 or 2
  • Written informed consent according to the rules and regulations of the Leiden University Medical Center.
  • 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 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Use of systemic immunosuppressive treatment (due to GVHD)
  • Acute GVHD of the skin > grade 2 or progressive acute GVHD
  • Progressive disease needing cytoreductive treatment
  • Any concomitant disease preventing the safe administration of donor lymphocytes
  • Severe psychological disturbances
  • Severely limited life expectation due to diseases other than the malignancy
  • Very high risk disease preceding allo-SCT for which already unselected DLI is planned to be given 3 months after allo-SCT.

研究者

发起方
eiden University Medical Center

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