About this trial
This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.
Eligibility criteria
Qualifiers
patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor;
normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/L); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%);
ECOG: 0-2;
Life expectation ≥3 months;
Disqualifiers
Pregnancies
active hepatitis (HBV-DNA≥1×103 copies/ml);
active infection require anti-biotics;
HIV infection
Trial design
Treatments tested in this trial
- reduced-dose PTCy
- Standard dose PTCY
Treatment groups
Sponsors and collaborators
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator