NCT00824954Unknown2 期
Evaluation of Extracorporeal Photochemotherapy in Children and Young Adults With Refractory Acute Graft Versus Host Disease After Allogeneic Stem Cell Transplantation
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- GVHD grading
研究概览
简要总结
Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy
详细描述
One arm. Six sessions in two weeks. Classification in complete response (resolution of all signs of GVHD), partial response (improvement of at least one grade) or absence of response (Glucksberg criteria). Tapering depending on patient condition during weeks 2 to 10. Final evaluation at week 10. Steroid therapy tapering at the discretion of the investigator.
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
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0 to 30 years
- •Acute GVHD refractory to steroids (disease progression after 2 days or absence of response after 4 days) and/or second line therapy (absence of response after 8 days)
- •patient consent and/or parent consent
排除标准
- •less of 10 kgs BW
- •clinical or biological state precluding the apheresis
- •previous GVHD therapy with anti-lymphocyte serum (excepted in the conditioning regimen)
结局指标
主要结局
GVHD grading
时间窗: during weeks 2 to 10
次要结局
- Overall survival Incidence of chronic GVHD(during weeks 2 to 10)
研究者
研究点 (2)
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