NCT00898118Unknown不适用
Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)
European Working Group of MDS in Childhood10 个研究点 分布在 9 个国家目标入组 125 人开始时间: 2007年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 125
- 试验地点
- 10
- 主要终点
- Number of patients with complete chimerism as measured by standard short tandem nucleotide polymorphism PCR in whole blood and the different cell populations
研究概览
简要总结
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood samples in young patients with cytopenia after undergoing a donor stem cell transplant.
详细描述
OBJECTIVES:
Primary
- To study hematopoietic chimerism in whole blood and different cell populations (i.e., CD14, CD15, CD 56, CD3, and CD19) as well as in dendritic cells and regulatory T cells after allogeneic hematopoietic stem cell transplantation with reduced intensity conditioning in patients with refractory cytopenia.
- To compare the results of chimerism obtained with standard short tandem nucleotide polymorphism PCR (sensitivity 1%) with those obtained with single nucleotide polymorphisms PCR (sensitivity 0.1- 0.01%).
Secondary
- To evaluate the relationship between mixed chimerism and hematological engraftment, overall survival, and event-free survival.
- To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T cells on the incidence of acute and chronic graft-versus-host-disease.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of patients with complete chimerism as measured by standard short tandem nucleotide polymorphism PCR in whole blood and the different cell populations
Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations
次要结局
- Number of patients with mixed chimerism and full hematological recovery at day 100
- Number of patients with mixed chimerism and acute or chronic graft-versus-host disease
研究者
研究点 (10)
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