ISRCTN75391842已完成1 期
A prospective phase I/II study to investigate the efficacy and safety of pre-emptive cytomegalovirus adoptive cellular therapy in patients receiving allogeneic haematopoietic stem cell transplant from an unrelated donor
Cell Medica Ltd (UK)0 个研究点目标入组 18 人开始时间: 2009年4月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 16 years or older, either sex
- •2. Allogeneic T-cell depleted (alemtuzumab-containing conditioning regimen) haematopoietic stem cell transplant (HSCT) recipient with CMV seropositive unrelated donor
- •3. Informed consent:
- •3.1. Prepared to undergo additional study procedures as per study schedule
- •3.2. Patient has undergone counselling about risk
- •To be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release):
- •4. Donor engraftment (neutrophils greater than 0.5 x 10^9/l)
- •5. Single positive CMV polymerase chain reaction (PCR) result
排除标准
- •1. Pregnant or lactating women
- •2. Co-existing medical problems that would place the patient at significant risk of death due to GvHD or its sequelae
- •3. Human immunodeficiency virus (HIV) infection
- •To be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release):
- •4. Active acute GvHD greater than Grade I
- •5. Concurrent use of systemic corticosteroids
- •6. Organ dysfunction as measured by:
- •6.1. Creatinine greater than 200 uM/l
- •6.2. Bilirubin greater than 50 uM/l
- •6.3. Alanine aminotransferase (ALT) greater than 3 x upper limit of normal
研究者
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