ATG Individualized Dosing Model in URD-PBSCT.

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 31, 2020

Primary Completion Date

December 30, 2024

Study Completion Date

June 30, 2025

Conditions
Cytomegalovirus InfectionsInfection ReactivationStem Cell Transplant Complications
Interventions
DRUG

individualized ATG dosing strategy

Investigators quantified active ATG exposure in 106 haploidentical peripheral blood stem cell transplantation (haplo-PBSCT) recipients, who received a conventional fixed dose of 10 mg/kg ATG during conditioning, the optimal concentration range of active ATG-AUC was determined through the application of machine learning methods, was found to be 100-148.5 × 10\^3 UE·d/L. This concentration range was associated with a reduction in CMV/EBV reactivation, without an increase in acute GVHD or malignant disease relapse. Mathematical function was then exploited to determine the total targeted ATG dose on -3days to -2days based on concentrations of active ATG on -5daysto -4days. Based on this function, investigators established a dosing strategy that aimed to maintain the active ATG-AUC within the optimal range.

Trial Locations (1)

Unknown

RECRUITING

Department of Hematology, First Medical Center of Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER