ATG Individualized Dosing Model in URD-PBSCT.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-65
SponsorChinese PLA General Hospital
About this trial
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
Qualifiers
Patients with malignant hematological tumors who have indications for allogeneic hematopoietic stem cell transplantation.
HLA-matched unrelated donor
Patient age ≥14 years old and ≤65 years old
ALT and AST ≤ 2.5 times the upper limit of normal values, bilirubin ≤ 2 times the upper limit of normal values
Disqualifiers
Unrelated donor who is not HLA matched
No indication for allogeneic hematopoietic stem cell transplantation
Patient age <14 years old or >65 years old
The donor or recipient are pregnant
Trial design
Treatments tested in this trial
- individualized ATG dosing strategy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov