EUCTR2011-003237-33-NL进行中（未招募）不适用
Treatment of severe GVHD after allogeneic hematopoietic stem cell transplanatation with MSCs and steroid versus steroids alone.A prospective double-blind placebo-controlled randomized phase III trial - HOVON 112 MSC
HOVON Foundation0 个研究点目标入组 200 人开始时间: 2013年8月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •-Previously treated with allo-SCT/ DLI;
- •-Grade II-IV acute GVHD involving gut and/or liver, confirmed by histology of involved tissues, however, the first infusion of MSC can be given without final histological confirmation;
- •-WHO performance 0-3 ;
- •-Negative pregnancy test (if applicable);
- •-Patients must be willing and capable to use adequate contraception during therapy (if applicable);
- •-Written Informed Consent by the patient and/or parent(s) or legal guardian(s);
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •-Patients with active, uncontrolled infection;
- •-Rapid progressive hematological malignancy;
- •-Patients pre-treated with prednisolone > 1 mg/kg for GVHD, for more than 72 hours prior to randomization/application of MSC;
- •-Known uncontrolled toxicity for DMSO;
- •-Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
- •-Any psychological, familial, sociological and/or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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