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临床试验/EUCTR2012-002879-34-NL
EUCTR2012-002879-34-NL进行中(未招募)1 期

Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation - MiHA-loaded DC vaccination after allogeneic SCT

Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2012年8月24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

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

  • Patients with AML, myelodysplasia (MDS), ALL, CML (accelerated or blast phase), CLL, MM or malignant NHL, who underwent HLA-matched allo-SCT
  • Patients positive for HLA-A2, HLA-A24, HLA-B7 and/or HLA-B44
  • Patients positive for HA-1, LRH-1 and/or ARHGDIB transplanted with corresponding MiHA-negative donor
  • Patients >18 and <65 years of age
  • WHO performance 0-2
  • 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 10
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Life expectancy < 3 months
  • Severe neurological or psychiatric disease
  • Progressive disease needing cytoreductive therapy
  • HIV positivity
  • Patients with acute GVHD grade 3 or 4
  • Patients with extensive chronic GVHD
  • Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment
  • Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
  • Severe pulmonary dysfunction (CTCAE III-IV)
  • Severe renal dysfunction (serum creatinine > 3 times normal level)
  • Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level)
  • Patients with known allergy to shell fish

研究者

发起方
Radboud University Nijmegen Medical Centre

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