ATG Individualized Dosing Model in URD-PBSCT.
Trial Parameters
Brief Summary
Anti-thymocyte globulin (ATG) is widely used in allogeneic hematopoietic stem cell transplantation to prevent severe graft-versus-host disease (GVHD) and graft failure. However, overexposure to ATG may increase cytomegalovirus (CMV), Epstein-Barr virus (EBV) reactivation, non-relapse mortality, and disease recurrence. A targeted dosing strategy was established based on ATG concentration monitoring and conducted a phase 2 trial to evaluate the safety and efficacy of the dosing strategy in adult unmanipulated haplo-PBSCT, a encouraging result was attained. In this trial, The ATG-targeted dosing strategy was extended to adult unrelated donor allogeneic hematopoietic stem cell transplantation, ATG was administered for 4 days (-5 days to -2 days) during conditioning. The ATG doses on-3 days and- 2days were adjusted by our dosing strategy to achieve the optimal ATG exposure. The primary endpoint was CMV reactivation on +180 days.
Eligibility Criteria
Inclusion Criteria: 1. Patients with malignant hematological tumors who have indications for allogeneic hematopoietic stem cell transplantation. 2. HLA-matched unrelated donor 3. Patient age ≥14 years old and ≤65 years old 4. ALT and AST ≤ 2.5 times the upper limit of normal values, bilirubin ≤ 2 times the upper limit of normal values 5. Creatinine ≤ high limit of normal value 6. No uncontrollable infection or serious mental illness 7. Physical strength score is 0-2 (ECOG) 8. Sign the informed consent form Exclusion Criteria: 1. Unrelated donor who is not HLA matched 2. No indication for allogeneic hematopoietic stem cell transplantation 3. Patient age \<14 years old or \>65 years old 4. The donor or recipient are pregnant 5. Suffering from mental illness or other conditions and being unable to proceed as planned