Hematologic Malignancy
Conditions
Sponsors
Tohoku University School of Medicine, Molecular Medicine and Therapy, Toshio Miyata
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Conditioning regimen; CY+TBI12Gy (2) Allogeneic stem cell transplantation (3) Expectation of life for 3 months (4) Without bleeding disease at starting conditioning regimen (5) HCT-CI less than 6 (6) PS (ECOG) 0 or 1 (7) From 20 to 55 year-old (8) Patient written consent by themselves is given before starting conditioning regimen
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) OAG (oral assessment guide) score until engraftment 2) Engraftment rate at day14 | — |
Countries
Japan
Contacts
Public ContactMakoto Onizuka
Tokai University School of Medicine Hematology/ Oncology
Outcome results
None listed