Status:
COMPLETED
Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
Lead Sponsor:
University of Pisa
Conditions:
Graft Vs Host Disease
Transplant Failure
Eligibility:
All Genders
1-18 years
Brief Summary
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 ques...
Detailed Description
Patients undergoing allo-HSCT will be recruited at IRCC Burlo Garofolo, collecting demographic and clinical characteristics from electronic medical records in a retrospective manner: age, sex, primary...
Eligibility Criteria
Inclusion
- 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
- Patients undergoing autologous bone marrow transplantation
- Patients not undergoing GVHD prophylaxis
- Patients undergoing cyclosporin prophylaxis
- Incomplete pharmacokinetic/pharmacodynamic data
- Lack of any informed consent
Key Trial Info
Start Date :
September 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06080490
Start Date
September 29 2023
End Date
December 31 2024
Last Update
June 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Burlo Garofolo
Trieste, Italy, 34137