NCT00986557Unknown2 期
A Randomised Controlled Phase II Trial of the Adoptive Transfer of Selected Cytomegalovirus-Specific Cytotoxic T Lymphocytes (CMV-CTL) After Allogeneic Stem Cell Transplantation (SCT) in Patients at Risk of CMV Disease
University Hospital Birmingham2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2009年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- CMV reactivation in the first year after ASCT measured by quantitative PCR
研究概览
简要总结
RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant.
PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.
详细描述
OBJECTIVES:
Primary
- To determine the frequency of cytomegalovirus (CMV) reactivation during the first year after allogeneic stem cell transplantation (ASCT) in patients at risk for CMV infection treated with adoptive transfer of selected CMV-specific cytotoxic T-lymphocytes.
Secondary
- To monitor CMV-specific immune reconstitution within the first year following ASCT in these patients.
- To determine the time to CMV reactivation in these patients.
- To evaluate the use of antiviral therapy in these patients.
- To determine the incidence of secondary CMV reactivation and CMV disease in patients treated with this regimen.
- To determine the incidence of acute and chronic graft-versus-host disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Planning allogeneic peripheral blood stem cell transplantation (PBSCT) using a conditioning regimen containing alemtuzumab and radiotherapy
- •Sibling or matched unrelated donor available
- •Patients and donor matched for ≥ one of the following HLA alleles:
- •HLA-A*0101
- •HLA*0201
- •HLA-A*1101
- •HLA-A*2402
- •HLA-B*0702
- •HLA-B*0801
- •HLA-B*3502
- •No donors whose stem cells have already been collected and cryopreserved prior to transplant
- •Patient and donor must be CMV seropositive
- •Stem cell harvests ≥ 4.0 x 10^6 CD34 cells/kg
- •PATIENT CHARACTERISTICS:
- •See Disease Characteristics
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior bone marrow transplantation
- •No concurrent participation in another therapeutic transplantation study
排除标准
- 未提供
结局指标
主要结局
CMV reactivation in the first year after ASCT measured by quantitative PCR
次要结局
- CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT
- Time to CMV reactivation
- Use of antiviral therapy
- Incidence of secondary CMV reactivation and CMV disease
- Incidence of acute and chronic graft-versus-host disease
研究者
研究点 (2)
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