Factors Affecting the Tacrolimus Blood Concentration and Its Impact on Transplant-related Outcomes in Pediatric HSCT Recipients: a Single-center Retrospective Study

GEN/INT 0001973

The goal of this retrospective observational study is to investigate any possible association among tacrolimus (TAC) blood concentrations, clinical efficacy and tolerability. Therefore, the main questions it aims to answer are: 1. to clarify which variables, how and to what extent influence daily TAC blood concentrations in pediatric allo-hematopoietic stem cell transplantation (HSCT) recipients; 2. to investigate the incidence of graft-versus-host disease (GVHD) and graft failure according to TAC exposure. Pediatric patients administered TAC to prevent GVHD after an allogeneic bone marrow transplantation.

2023-09-29

2024-09-29

2025-09-29

Recruiting

150

Inclusion Criteria: * Age of the patients between 0 and 18 years (pediatric) * Patients undergoing allogeneic bone marrow transplantation * Patients' GVHD prophylaxis with tacrolimus * Signed informed consent Exclusion Criteria: * Patients undergoing autologous bone marrow transplantation * Patients not undergoing GVHD prophylaxis * Patients undergoing cyclosporin prophylaxis * Incomplete pharmacokinetic/pharmacodynamic data * Lack of any informed consent

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2023-10-12