Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07862127
PHASE3

Population PK-guided ATG Dosing for Haploidentical Hematopoietic Stem Cell Transplantation

Sponsor: Daihong Liu

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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