EUCTR2013-002492-17-AT进行中（未招募）1 期
Treatment of adenovirus and cytomegalovirus infection post human allogeneic stem cell transplantation with short-term expanded virus-specific T cells - VIsIT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •Children and adolescents (0-18 years) who undergo any type of allogeneic stem cell transplantation at the St Anna Children`s Hospital, Vienna.
- •Informed consent is signed
- •Presence of HAdV or CMV-specific T-cells in the donor or CMV-specific T-cells in the recipient pre-transplant
- •Stable (= 10E6) or increasing viraemia despite antiviral treatment post HSCT
- •Absence of virus-specific T cells post transplant
- •Karnofsky / Lansky score >50%
- •Pregnancy excluded
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Infusion of polyclonal or monoclonal T-cell directed antibodies within 28 days before seVirus T-Cell infusion
- •Multiple organ failure at screening-timepoint seVirus T-Cell infusion
- •History of GvHD Gr III-IV or actual GvHD Gr III-IV
- •Treatment with granulocyte transfusion within the last 72 hours
- •Karnofsky / Lansky score <50%
- •Subject is unwilling or unable to comply with the study procedures
- •High dose treatment with steroids (= 2mg/kg/d, methylprednisone-equivalent)
研究者
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