T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 8
- 主要终点
- Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP.
研究概览
简要总结
This clinical trial studies biomarkers in predicting response in patients with graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats the patient's blood with ultraviolet light outside the body and kills the white blood cells before returning blood back into the patient's body. Studying samples of blood from patients with GVHD may help doctors identify and learn more about biomarkers related to GVHD.
详细描述
PRIMARY OBJECTIVE:
I. To show that extracorporeal photopheresis (ECP)increases skin and gut homing T regulatory (T-reg) cells in patients with GVHD clinically responding to ECP.
SECONDARY OBJECTIVES:
I. Response rates of GVHD with extracorporeal photopheresis(ECP)as measured by NIH response criteria
II. Incidence of T-reg cell frequency(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with any NIH subtype of chronic GVHD that is being treated with ECP
- •Karnofsky Performance Scale (KPS) > 60% at time of study enrollment
- •Life expectancy > 3 months
- •Steroid dose not greater than 2 mg/kg prednisone equivalent at time of study enrollment
- •If patient has steroid refractory GVHD (defined as worsening of GVHD after 3 days of 2 mg/kg prednisone equivalent or no improvement after 7 days of 2 mg/kg prednisone equivalent), time interval from start of steroids to initiation of ECP should not be > 14 days
- •No use of an investigational agent within 2 weeks of starting ECP
- •No uncontrolled bacterial, fungal or viral disease (therapy for cytomegalovirus [CMV] viremia is permitted)
- •No evidence of relapse or progression of underlying disease (molecular evidence of relapse/progression or mixed chimerism is permitted)
- •Women of childbearing potential (WOCBP) should be willing to use 2 forms of contraception; male patients should be willing to use contraception
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
排除标准
- •Female patients who are breastfeeding or pregnant
- •Patients known to be human immunodeficiency virus (HIV) positive
- •Bronchiolitis obliterans as the sole indication of ECP
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Mechanical ventilation, renal replacement therapy, admitted in intensive care until at time of enrollment
- •Stage 4 gastrointestinal GVHD as per Seattle-Glucksberg criteria
结局指标
主要结局
Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP.
时间窗: 6 months after last patient is on study
次要结局
- Response rates of GVHD with ECP as measured by NIH response criteria(at 6 months)
- Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD(at 6 months)
- Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD(at 6 months)
研究者
Michael Byrne
Principal Investigator
Vanderbilt-Ingram Cancer Center