This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Incidence of acute graft-versus-host disease, grades II-IV
MAGIC criteria
Time frame: 180 days
Incidence of chronic GVHD, moderate and severe (NIH criteria)
NIH criteria
Time frame: 365 days
Overall survival analysis
Kaplan-Meier survival analysis
Time frame: 365 days
Event-free survival analysis
Kaplan-Meier survival analysis
Time frame: 365 days
Non-relapse mortality analysis
Kaplan-Meier survival analysis, competing risk analysis
Time frame: 365 days
Incidence of graft failure and poor graft function
Kaplan-Meier survival analysis, competing risk analysis
Time frame: 365 days
Incidence of 30-Day Readmission
Kaplan-Meier survival analysis, competing risk analysis
Time frame: 365 days
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