NL-OMON41587招募中3 期
Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids. A prospective double-blind placebo-controlled randomized phase III trial - HOVON 112 MSC
HOVO0 个研究点目标入组 140 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •- Any age;
- •- Previously treated with allo-SCT/ DLI;
- •- Acute GVHD grade II iIV nvolving gut and/or liver,
- •- WHO performance 0-3 ;
- •- Negative pregnancy test (if applicable);
- •- Patients must be willing and capable to use adequate contraception during therapy ;
- •- Written Informed Consent by the patient and/or parent(s) or legal guardian(s);
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/placebo;
- •- 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
- •- Known uncontrolled toxicity for DMSO;
研究者
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