ATG Individualized Dosing Model in URD-PBSCT.

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.

Timeline

Start

2020-12-31

Primary completion

2024-12-30

Completion

2025-06-30

Publications

• Chen S, Wang L, Luan S, Wang H, Du J, Ge D, Li F, Wu Y, Gu Z, Dou L, Liu D. Reduced cytomegalovirus reactivation and viremia without increasing GVHD after URD-PBSCT: A prospective study using targeted ATG dosing strategy. Cancer Pathog Ther. 2025 Apr 5;4(2):145-152. doi: 10.1016/j.cpt.2025.04.001. eCollection 2026 Mar.

Drugs

Indications