An observational study in Graft Vs Host Disease, Transplant Failure and Stem Cell Transplant Complications, sponsored by University of Pisa. Completed at 1 site in Italy. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by University of Pisa · Observational
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:
Pediatric patients administered TAC to prevent GVHD after an allogeneic bone marrow transplantation.
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 disease, donor type and stem cell source, body weight (BW), white blood cell (WBC) count, platelet count, red blood cell (RBC) counts, hemoglobin (HGB) and hematocrit (HCT) levels, red cell concentrate (RCC) transfusions. Other clinical laboratory data (i.e., liver and kidney function) will be included, as well as concomitant drugs administered to patients after allo-HSCT (i.e, mycophenolate mofetil, steroids, pantoprazole, voriconazole, methotrexate). Data will be collected, validated, and presented according to Good Clinical Practice (GCP) principles to support the statistical analyses and subsequent reporting. Once selected according to predefined inclusion requirements, data will be collected anonymously; an identification code will be assigned to each case. As per GCP, all collected information will be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification with user access restriction, and data will be retrievable by designated personnel only.
Because of the retrospective nature of the present research protocol, all eligible patients will be included in the study population only if their medical and laboratory records will be complete.
Statistical analyses (for descriptive and comparative aims) will be performed stratifying patients by body weight, age, gender, and source of stem cells. Univariate and multivariate tests will be used, together with Kaplan-Meyer tes, Cox proportional hazard model and ROC curve analysis.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 125 is above the median of 94 across 102 observational studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →University of Pisa is the lead sponsor of 111 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who underwent allo-HSCT procedure between January 2011and December 2022 at IRCC Burlo Garofolo
Exclusion Criteria:
Pharmacokinetics of TAC according to possible influencing factors
Also known as: Tacrolimus
TAC pharmacokinetics
Evaluation of factors affecting TAC blood concentration/dose (C/D) ratio
Time frame: 0-30 days
GVHD
Evaluation of GVHD in patients according to TAC C/D
Time frame: 0-180 days
Graft failure
Evaluation of graft failure in patients according to TAC C/D
Time frame: 0-180 days
Plan to share: Undecided — IPD sharing plan is under evaluation by local IRB
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University of Pisa