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临床试验/ISRCTN74928896
ISRCTN74928896已完成3 期

A phase III randomised study to investigate the use of adoptive cellular therapy (ACT) in combination with conventional antiviral drug therapy for the treatment of cytomegalovirus reactivation episodes in patients following allogeneic haematopoietic stem cell transplant

Cell Medica Ltd (UK)0 个研究点目标入组 75 人开始时间: 2008年3月4日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
75

研究概览

简要总结

2014 results abstract in: http://www.bloodjournal.org/content/124/21/1109 [added 10/05/2019]

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Sibling T cell depleted allogeneic HSCT recipients where donor and recipient are both CMV seropositive
  • 2. Aged 18 years or over

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 graft-versus-host disease (GVHD) or its sequelae
  • 3. Human immunodeficiency virus (HIV) infection
  • To be assessed prior to CMV-specific T cell infusion (confirmed 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 three times normal

研究者

发起方
Cell Medica Ltd (UK)

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