Clinical Research Directory
Browse clinical research sites, groups, and studies.
Population PK-guided ATG Dosing for Haploidentical Hematopoietic Stem Cell Transplantation
Sponsor: Daihong Liu
Summary
To evaluate the safety and efficacy of a population pharmacokinetics (PK)-guided targeted ATG dosing strategy in haploidentical stem cell transplantation and to observe the GVHD-free, relapse-free survival (GRFS) in the cohort receiving this strategy.
Official title: A Randomized Controlled Trial of Population Pharmacokinetics-Guided Targeted Dosing of Anti-Thymocyte Globulin (ATG) in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation
Key Details
Gender
All
Age Range
14 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
324
Start Date
2026-08-01
Completion Date
2028-08-01
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
Anti-Thymocyte Globulin (ATG)
ATG (Thymoglobulin) IV, total dose 6-10 mg/kg (PK-guided, targeting AUC 100-148.5 IU·day/mL) for experimental arm; fixed 10 mg/kg for control arm, both given over Days -5 to -3 pre-transplant, combined with standard GVHD prophylaxis.
Locations (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China