EUCTR2012-001188-55-BE进行中（未招募）不适用
Double umbilical cord blood transplantation in high-risk hematological patients.A phase II study focussing on the mechanism of graft predominance - HOVON 115 Double UCBT
HOVON Foundation0 个研究点目标入组 70 人开始时间: 2013年11月25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
- 70
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 18-70 years inclusive
- •Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT
- •Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required time period of = 2 months in case of urgently needed alloSCT
- •Availability of 2 (=4/6) matched UCB grafts with a total nuclear cell count > 4 x 107/kg
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Bilirubin and/or transaminases > 2.5 x normal value
- •Creatinine clearance < 40 ml/min
- •Cardiac dysfunction as defined by:ejection fraction < 45%,unstable angina, unstable cardiac arrhythmias
- •Pulmonary function test with VC, FEV1 and/ or DCO < 50%
- •Active, uncontrolled infection
- •History of high dose (= 8 Gy) total body irradiation
- •Pregnant or lactating females
- •HIV positivity
研究者
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