Cord Blood Transplantation
Conditions
Sponsors
Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Conditioning regimen; Flu+Mel (2) No HLA-matched sibling donor (3) CBT unit; HLA mismatched number less than 2 and number of nucleated cell over than 1.5x10*7/kg (4) expectation of life for 3 months (5) without bleeding disease at starting conditioning regimen (6) HCT-CI less than 6 (7) PS (ECOG) 0 or 1 (8) From 20 to 70 year-old (9) 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Engraftment rate at day 18 after Cord Blood Transplantation | — |
Countries
Japan
Contacts
Public ContactMakoto Onizuka
Tokai University School of Medicine Hematology/ Oncology
Outcome results
None listed