EUCTR2017-005162-22-FR进行中（未招募）1 期
A multi-center randomized phase II study comparing corticosteroids alone versus corticosteroids and extracorporal photopheresis (ECP) as first-line treatment of standard risk Grade II acute graft-versus-host disease after allogeneic stem cell transplantation - ECP-aGVHD
CHRU de Nancy0 个研究点目标入组 78 人开始时间: 2018年2月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age = 18 years ;
- •- Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft.
- •-with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation;
- •- acute GVHD in the first line treatment
- •-validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months;
- •- Leucocytes > 1.5 G/L
- •- Platelets > 30 G/L, Haematocrite > 27% (allowed transfusions)
- •-Patient affiliated to a French Sécurité Social regimen
- •-information consent form signed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •- acute GVHD of grade I
- •- acute GVHD of grade > II (Gastro intestinal stage > 1 or hepatic involvement) ;
- •- progressive hematologic disease at inclusion
- •-uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load.
- •-HIV positivity or replicative HBV or HCV infection ;
- •- Contraindications for UVADEX / photopheresis / stéroids
- •-Pregnancy ;
- •- Women of child bearing potentiel not using contaception
研究者
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