Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD prophylaxis of PTCy 40 versus 50.
Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. In the clinical setting, reduced dose of PTCY (40mg/kg) was used for patients over 60 or with high HCT-CI and the overall incidence of acute GVHD was similar to PTCY 50mg/kg but chronic GVHD was slightly increased. To confirmed our observation, in this study, a prospective multiple-center randomized comparison is planned to evaluate the clinical outcomes of reduced dose of PTCY (40mg/kg) versus 50mg/kg as GVHD prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
138
PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis
Shenzhen People's Hospital
Shenzhen, GaungDong, China
Rui Jin Hospital
Shanghai, Shanghai Municipality, China
acute GVHD (grade II-IV)
clinical documentation of grade II-IV aGVHD
Time frame: day 100
Non-relapse mortality
Death without documentation of disease relapse or progression (bone marrow \>5% or with extra medullary diseases)
Time frame: 1 year
chronic GVHD
incidence of patients with clinical documentation of chronic GVHD
Time frame: 1 year
overall survival
Event defined as death of any causes
Time frame: 1 year
Disease-free survival
Event defined as death of any causes and disease relapse or progression
Time frame: 1 year
Survival without relapse and moderate to severe GVHD
Rate of patients remain alive without disease relapse or progression (bone marrow blast \>5% or extra medullary diseases) and without documentation of grade III-IV acute GVHD and moderate to severe chronic GVHD
Time frame: 1 year
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