EUCTR2012-001335-31-CZ进行中（未招募）1 期
Adoptive transfer of CMV specific CD8+ T-cells to treat CMV infection after transplantation - Adoptive transfer of CMV-specific T-cells
niverzita Karlova v Praze, 2. lékarská fakulta0 个研究点目标入组 14 人开始时间: 2013年7月12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
- 14
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
- •Inclusion criteria for patients
- •- patients after allogeneic HSCT with progression of CMV viral load in peripheral blood (by RQ PCR) for 2 consecutive weeks despite the proper treatment with virostatics or patients unable to tolerate conventional GCV or FCV treatment due to severe toxicity
- •- reagents for HLA type of patient available
- •- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with
- •the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •- written informed consent from patient/patients’ guardian
- •and donor must be given prior patient registration to the trial according to ICH/GCP
- •Inclusion criteria for donors
- •- healthy CMV-seropositive third party haploidentical family donor
- •- CMV serological positivity proven by serology
- •- Male donors will be preferred due to lower risk of GVHD induction (due to pregnancy in female donors which increase alloreactivity of CD8+ T cells)
- •- Written informed consent from the donor must be given prior patient registration to the trial according to ICH/GCP
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion criteria for patients
- •- missing written informed consent from patient or donor
- •- medication with >1 mg/kg/day of Prednisolon
- •- acute GVHD grade III-IV
- •Exclusion criteria for donors
- •- missing written informed consent from patient or donor
- •- CMV negative donors
- •- diseases which may be harmful to donor or patient (as defined in the guidance for the eligibility of stem cell donors, e.g. HIV, Hepatitis B, Hepatitis C)
研究者
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