Acute myeloid leukemia, Myelodysplastic syndrome
Conditions
Interventions
The dose of busulfan is adjusted to acheieve target total daily AUC of 6000 &
micro
mol-min/l
Sponsors
Chiba University Hospital, Department of Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute myeloid leukemia and myelodysplastic syndrome age:from 56 to 69 year-old PS:0-2 No severe organ damages (less than CTCTAE grade 2) Creatinine clearance higher than 50 ml/min/m2 Cardiac ejection fraction: more than 50% No oxygen requirement Aquired written informed consent
Exclusion criteria
Exclusion criteria: Patient who receieved chemotherapy within 4 weeks prior the day of transplantation. Patients who received gemtuzumab ozogamicin within 3 months prior of transplantation Patients underwent allogeneic transplantation within 1 year HCI-CI higher than 3 points Patients with active double malignancies Patinets with active infection Positivith of HIV-Ab, TPHA, HBs-AB, and HCV-Ab Uncontrolable diabetes and hypertention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant related death in 100 days post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival (1-year) Non-relapse mortality (1-year, 2-year) Severe nonhematologic toxicity within 28days Engraftment rate at day 100 Fequency of SOS at day 100 frequency of grade2-4 aGVHD frequency of chronic GVHD | — |
Countries
Japan
Contacts
Public ContactChikako Ohwada
Chiba Univeersity Hospital Department of Hematology
Outcome results
None listed