A phase II study to reveal safety and efficacy of TM5509 in cord blood transplantatio
- Conditions
- Cord Blood Transplantation
- Registration Number
- JPRN-UMIN000018180
- Lead Sponsor
- Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 21
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Engraftment rate at day 18 after Cord Blood Transplantation
- Secondary Outcome Measures
Name Time Method