A phase II trial to reveal safety and efficacy of TM5509 in allogeneic stem cell transplantation with TBI regimen - TM5509-5

Tohoku University School of Medicine, Molecular Medicine and Therapy, Toshio Miyata0 个研究点目标入组 15 人开始时间: 2015年7月10日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(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) Under using Pentostatin (10) Known allergy against Cyclophosphamide, Mesna, other thiol-compounds, Dexamethasone or Methylprednisolone or Granisetron. (11) Male patients who do not agree with contraception during the study period. (12) Candidate mother, lactation or hope for pregnancy while the study period (13) Patient who had registered and medicated in the other clinical trial within 12 weeks before consent. (14) 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.

发起方

Tohoku University School of Medicine, Molecular Medicine and Therapy, Toshio Miyata