Individualized Thymoglobulin ATG Dosing for Adults Undergoing Unrelated Donor Stem Cell Transplantation to Reduce Infection Risks

What this Trial Is About

Researchers are evaluating an individualized anti-thymocyte globulin ATG dosing strategy in adults undergoing unrelated donor allogeneic hematopoietic stem cell transplantation URD-HSCT to reduce complications like cytomegalovirus CMV reactivation. This phase 2 trial builds on previous findings in haploidentical peripheral blood stem cell transplantation, aiming to optimize ATG exposure and improve patient outcomes without increasing graft-versus-host disease GVHD or relapse. The study is sponsored by the Chinese PLA General Hospital and addresses the challenge of finding the best ATG dose considering various factors like donor type and conditioning intensity. The trial administers ATG over four days during conditioning, with fixed doses on days -5 and -4, and doses on days -3 and -2 adjusted based on active ATG concentration measurements to maintain an optimal drug exposure range. This targeted dosing approach seeks to balance effective GVHD prevention while minimizing risks of viral reactivation and other complications. Participants receive the individualized ATG regimen before their stem cell transplant, following specific timing and dosing protocols. Participants are monitored for CMV reactivation over 180 days after transplantation as the primary outcome. The study involves clinical assessments, blood tests for ATG levels and viral monitoring, and evaluations of overall safety and effectiveness. Researchers also track liver and kidney function, infection status, and physical condition. The total study duration includes the treatment period and follow-up to capture important transplant-related outcomes and adverse events.

ATG Individualized Dosing Model in URD-PBSCT.