NL-OMON39426招募中2 期
Double umbilical cord blood transplantation in high-risk haematological patients. A phase II study focussing on the mechanism of graft predominance - HOVON 115 Double UCBT
HOVO0 个研究点目标入组 70 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age 18-70years 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 (see paragraph 8.2).
- •- WHO performance status 0-2
- •- Written informed consent
排除标准
- •- Bilirubin and/or transaminases > 2.5 x normal value
- •- Creatinine clearance < 40 ml/min
- •- Cardiac dysfunction (as defined in protocol in 8.1.2)
- •- Pulmonary function test with VC, FEV1 and/ or DCO < 50%
- •- Active, uncontrolled infection
- •- History of high dose total body irradiation
- •- Pregnant or lactating female
- •- HIV positivity;
研究者
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