Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Phase 2
- Conditions
- Acute myeloid leukemia, Myelodysplastic syndrome
- Registration Number
- JPRN-UMIN000010546
- Lead Sponsor
- Chiba University Hospital, Department of Hematology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transplant related death in 100 days post-transplant
- Secondary Outcome Measures
Name Time Method 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