Development of a Population Pharmacokinetic Model to Optimize Tacrolimus Dosing in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplant.

LCCC2034

The purpose of this research study is to evaluate tacrolimus plasma concentrations in patients who will undergo an allogeneic hematopoietic stem cell transplant (HCT). The study aims to identify associations between plasma concentrations, baseline demographic characteristics, clinical lab parameters, and genetic factors. These associations will help clinicians determine the best starting dose for tacrolimus in order to minimize risks of aGVHD and tacrolimus-induced toxicities.

2021-02-01

2023-10-15

2023-10-15

Completed

38

Inclusion Criteria: 1. ≥18 years of age 2. Patients who will undergo their first HCT 3. Patients who will start tacrolimus for aGVHD prophylaxis 4. Patients who have provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information Exclusion Criteria: 1. Patients who have cognitive impairments that could affect informed decision-making 2. Patients who are incarcerated 3. Patients started on a strong CYP3A4 inhibitor (i.e. posaconazole)

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood will be collected at baseline prior to the first dose of tacrolimus, and will will consist of 2 tubes of 5 mL blood (one for PK and one pharmacogenetics). Then, serial blood sampling will occur at 0.5, 1, 2, 4, 6, and 10h after the first tacrolimus dose. On Day -2 and Day -1, blood will be collected prior to the morning dose for the 24h and 48h estimates. On Day 0, blood will again be collected at 0.5, 1, 2, 4, 6, and 10. Also, 10 mL of blood on Day +1, Day +8, and Day +15 (30 mL total) for PD biomarker analysis. For haplo-transplant patients, blood sampling will be similar but will occur on Day +5, Day +6, Day +7, and Day +8 once tacrolimus is initiated, and blood for PD biomarkers will occur on Day +9, Day +16, and Day +23.'}, 'enrollmentInfo': {'count': 38, 'type': 'ACTUAL'}}

2023-10-17