JPRN-UMIN000018180招募中2 期
A phase II study to reveal safety and efficacy of TM5509 in cord blood transplantation - TM5509-4
Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata0 个研究点目标入组 21 人开始时间: 2015年7月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
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
- 20years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) History of ICH (2) Un-controrable infection (3) Un-controrable hypertension (4) Known active chronic hepatitis B (HBs Ag+) or C (HCV Ab+) (5) Liver disfunction; T-Bil, AST, ALT, gGTP or ALP > 2x upper limit of normal range (6) Renal failure; GFR less than 50ml/min (7) Sever complication with cardiovascular, pulmonary or gastrointestinal system (8) Plural of cancer (9) High titer of anti HLA antibody against donor specific HLA (10) Under using Pentostatin (11) Known hemolytic anemia by Fludarabine (12) Porphyria (13) Known allergy against Fludarabine, Melphalan, Methylprednisolone, Hydroxyzine, Cetirizine, Piperazinederivative, Aminophylline or Ethylenediamine (14) Male patients who do not agree with contraception during the study period. (15) Candidate mother, lactation or hope for pregnancy while the study period (16) Patient who had registered and medicated in the other clinical trial within 12 weeks before consent. (17) Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
研究者
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