Regulatory T Cells at Engraftment as Predictors of Acute Graft-Versus-Host Disease Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of regulatory T-lymphocytes (Tregs) at engraftment
研究概览
简要总结
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict whether patients undergoing donor stem cell transplant will develop acute graft-versus-host disease.
PURPOSE: This clinical trial is studying T cells to see how well they help in predicting acute graft-versus-host disease in patients undergoing donor stem cell transplant.
详细描述
OBJECTIVES:
- To determine the association between regulatory T-lymphocyte (Treg) subsets present at engraftment and at day 28 with the incidence of acute graft-versus-host-disease (aGVHD) in patients undergoing allogeneic stem cell transplantation.
- To identify gut-homing and skin-homing Treg subsets and determine their role during engraftment and at day 28 as a predictor of gut and skin aGVHD, respectively.
OUTLINE: Patients undergo blood sample collection at the time of neutrophil engraftment prior to stem cell transplant (SCT) and post-SCT on days 7, 14, 21, and 28 days after allogeneic stem cell transplantation. Blood samples are analyzed for T-cell subsets and for the percentage of regulatory T-lymphocyte (Treg) or other T-cell subsets expressing specific homing receptors for the gut or skin via flow cytometry.
Patients' medical records are also reviewed periodically.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 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
Percentage of regulatory T-lymphocytes (Tregs) at engraftment
时间窗: day of stem cell transplant
percentage of Treg subsets present in patient's blood before they undergo stem cell transplant
次要结局
- Association between Treg subsets and acute graft-vs.-host disease outcomes(at stem cell transplant and at day 28)
研究者
Brian Engelhardt, MD
Assistant Professor of Medicine; Hematologist/Oncologist
Vanderbilt-Ingram Cancer Center