Investigating Tacrolimus Levels and Outcomes in Pediatric Stem Cell Transplant Patients
Factors Affecting the Tacrolimus Blood Concentration and Its Impact on Transplant-related Outcomes in Pediatric HSCT Recipients: a Single-center Retrospective Study
This study looks at how the levels of a medication called tacrolimus in the blood affect the health outcomes of children who have received stem cell transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Trieste) |
| Trial ID | NCT06080490 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between tacrolimus blood concentrations and clinical outcomes in pediatric patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT). It will analyze various demographic and clinical factors that may influence tacrolimus levels and assess the incidence of graft-versus-host disease (GVHD) and transplant failure based on these levels. Data will be collected retrospectively from electronic medical records, ensuring adherence to Good Clinical Practice principles for accurate reporting and analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 0 to 18 years who are receiving tacrolimus for GVHD prophylaxis after allogeneic bone marrow transplantation.
Not a fit: Patients undergoing autologous bone marrow transplantation or those not receiving tacrolimus for GVHD prophylaxis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of tacrolimus dosing and its impact on transplant outcomes, potentially improving patient care in pediatric HSCT.
How similar studies have performed: Previous studies have shown varying success in understanding tacrolimus pharmacokinetics and its effects on transplant outcomes, making this investigation relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trieste
- IRCCS Burlo Garofolo — Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Natalia Maximova, MD — IRCCS Burlo Garofolo - Trieste - ITALY
- Study coordinator: Natalia Maximova, MD
- Email: natalia.maximova@burlo.trieste.it
- Phone: 040.3785.111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.