Hematologic malignancies
Conditions
Interventions
Intravenous injection of fludarabine (30mg/m2/day, for 6 days) and cyclophosphamide (50mg/kg/day,once) Use cyclospolin A and mycophenolate mofetil ( for 30 days) as a GVHD prophylaxis
Sponsors
RICBT Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis as hematological malignancy 2) Unavailability of HLA matched- related or unrelated donor , or needs urgent transplantation. 3) Availability of CB uint 4)As inappropriate requirements for myeloablative conditioning, satisfy one of the following criteria. a) Aged over 50 years b)Impaired organ function c)Previous stem cell transplantation (except re-transplantaion with CB unit ,but the entry is once.) 5) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Double cancer 2) Sever mental disease 3)Seropositive to HIV 4) History of adverse reaction for the agents included in the protocol in conditioning (fludarabine, cyclophosphamide), in GVHD prophylaxis (Cyclosporine A, mycophenolate mofetil) 5) Pregnant or lactating women 6)Inadequate to entry judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non relapse mortality on day 100 post transplantaion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Incidence and severity of acute GVHD 2)Incidence of hepatic veno-occlusive disease and thrombotic microangiopathy 3)Incidence of infectious disease 4)Disease-free survival and overall survival rate at 1 year and 2 years after transplantation 5)Engraftment rate 100 days after transplantation 6)Time to hematopoietic recovery | — |
Countries
Japan
Contacts
Public ContactHideki Kodo
Tokyo Cord Blood Bank Tokyo Cord Blood Bank
Outcome results
None listed