跳至主要内容
临床试验/NCT00769613
NCT00769613Unknown1 期

Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
1 期
入组人数
20
试验地点
2
主要终点
Safety

研究概览

简要总结

RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus.

PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.

详细描述

OBJECTIVES:

Primary

  • To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplantation.

Secondary

  • To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
  • To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL and observe whether the CTL infusion has any impact on level of virus.
  • To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have received a CMV vaccine.

研究设计

研究类型
Interventional
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Safety

Toxicity

次要结局

  • CMV DNA levels
  • Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL)
  • Time to development of cytomegalovirus (CMV)-specific immune reconstitution
  • Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors

研究者

申办方类型
Other

研究点 (2)

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