Markers of Inflammation in Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
研究概览
简要总结
Objectives:
- To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
- To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant
- To determine if changes in a specific inflammatory product, or a combination of inflammatory products, can predict grade 2-4 acute graft-versus-host disease
详细描述
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is a successful treatment option for multiple malignant diseases (i.e. leukemia) and non-malignant disorders (i.e. metabolic disorders, genetic disorders, immunodeficiencies). Unfortunately, transplantation from an HLA-related family member is only available in 30-40% of stem cell transplant recipients. The other patients requiring HSCT must then receive their stem cells from either a matched-unrelated donor (MUD) or from cord blood. One major limitation upon receiving these unrelated stem cells are acute and chronic graft-versus-host disease. Specifically looking at acute graft-versus-host disease (aGVHD), up to 30% of the recipients of stem cells from an HLA-identical related donor will develop greater or equal to grade 2 of aGVHD despite immunosuppressive prophylaxis. The percentages of patients who develop aGVHD from unrelated donors are even higher.
The current standard treatment for aGVHD is corticosteroids. Unfortunately, only 40% of matched-siblings HSCT cases and 25% of MUD SCT cases show a complete response to these steroids. Those patients who do not respond to corticosteroids can show a dismal outcome. Given the poor outcome with refractory GVHD, there has been a lot of interest in trying to predict who will get GVHD. These findings could lead to augmentation of GVHD prophylaxis.
The purpose of this study is to look at a series of identified biomarkers to predict aGVHD. Once blood is drawn from the SCT recipient, a multiplex ligation-dependent probe amplification (MLPA) will test different biomarkers in the blood to result in about 30-45 target sequences being examined simultaneously.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Objective #1:
- •Healthy adult volunteers, affiliated to Children's Memorial Hospital
- •Male or female
- •Objective #2 & #3:
- •Recipient undergoing an allogeneic stem cell transplant
- •Receiving related or unrelated cord blood, related or unrelated bone marrow or peripheral blood stem cells
- •Any pre-transplant regimen
- •Ages of 0-21 years old
- •Male or female
排除标准
- •Inability for subject/parent to understand study and therefore unable to consent
- •Children under 7.0 kgs
结局指标
主要结局
To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
时间窗: Until September 2008
次要结局
- To determine if change in a specific inflammatory product, or a combination of inflammatory products, can predict grade 2-4 acute graft-versus-host disease(Until September 2008)
- To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant(Until September 2008)
研究者
Reggie E Duerst, MD
Clinical Director - Stem Cell Transplant
Ann & Robert H Lurie Children's Hospital of Chicago
