EUCTR2012-004240-30-DE进行中（未招募）1 期
Prospective, open-label, randomised, two-arm, controlled, multicentre clinical trial, phase I/IIa, for the evaluation of safety and efficacy of an adoptive immunotherapy with allogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+) for the prevention or treatment of reactivation of 'CMV and/or EBV in patients after allogeneic HLA-identical stem cell transplantation - MULTIVIR01
niversitätsklinikum Erlangen0 个研究点目标入组 50 人开始时间: 2013年12月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Male or female person of 18 to 75 years of age
- •Unlimited ability to provide informed consent
- •Written informed consent
- •Indication for allogeneic stem cell transplantation
- •HLA-identical donor, related or unrelated, HLA match: 10/10
- •Stem cell source: G-CSF mobilised peripheral blood stem cells
- •Positive EBV serology of the donor
- •Positive CMV serology of the donor
- •Effective contraception for females of child-bearing potential
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Donor seronegative for EBV
- •Donor seronegative for CMV
- •Bone marrow or umbilical blood as stem cell source
- •Alemtuzumab (Campath®) for conditioning
- •Sorror score >3
- •Known hypersensitivity to one of the ingredients of the IMP
- •Pregnant or breast-feeding female
研究者
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