A phase II trial to reveal safety and efficacy of TM5509 in allogeneic stem cell transplantation with TBI regime
- Conditions
- Hematologic Malignancy
- Registration Number
- JPRN-UMIN000018191
- 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
- 15
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) 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) OAG (oral assessment guide) score until engraftment 2) Engraftment rate at day14
- Secondary Outcome Measures
Name Time Method