NCT00271869Unknown2 期
Phase II Study for Treatment of Chronic Graft-Versus-Host Disease of the Liver or Lungs With Adjunct Extracorporeal Photoimmunotherapy
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- GVHD response of the liver or lungs
研究概览
简要总结
Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation and the leading cause of death more than 2 years after transplantation.During the past 30 years survival of patients with chronic GVHD has not improved and steroids remained the most often used therapy. Extracorporeal photoimmunotherapy (ECP)has shown to be efficacious in patients with GVHD. We propose a phase II study to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of liver or lungs and need for systemic immunosuppression defined according to the NIH consensus criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Presence of at least one diagnostic clinical sign of chronic GVHD or an appropriate constellation of distinctive signs confirmed by biopsy or other relevant diagnostic tests
- •Presence of liver or lung manifestations of chronic GVHD
- •Indication for systemic immunosuppressive therapy defined according to NIH consensus
- •No prior immunosuppressive therapy for chronic GVHD of the liver or lungs
- •Adequate renal, hepatic, pulmonary and cardiac function
- •Karnofsky performance score >- 50%
- •Women of childbearing potential must agree to use a reliable method of birth control for the duration of the study
- •Signed written informed consent
排除标准
- 未提供
结局指标
主要结局
GVHD response of the liver or lungs
次要结局
- transplant-related mortality
- relapse-free survival
- overall survival
- time to complete resolution of chronic GVHD to first-line immunosuppressive therapy
- time to discontinuation of immunosuppressive therapy
- duration of response to first-line immunosuppressive therapy
- percentage of patients in need of secondary treatment for chronic GVHD
- incidence of bacterial, viral and fungal infections
- side effects of ECP
研究者
研究点 (2)
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