Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Jiao Tong University School of Medicine

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

316 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Collaborator