Acute GVHD Clinical Trial
Official title:
Development of a Population Pharmacokinetic Model to Optimize Tacrolimus Dosing in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplant.
Verified date | October 2023 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | October 15, 2023 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | University of North Carolina, Chapel Hill |
United States,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tacrolimus clearance | Patient's clearance calculated after the first day on tacrolimus and patient's clearance calculated after 5-6 doses of tacrolimus after they reach steady-state | Day +1 of tacrolimus administration to Day +4 of tacrolimus administration | |
Secondary | Incidence and severity of aGVHD | The duration from the day of transplant to the first occurrence of aGVHD, censored at 100 days post-HCT. | Day +21 to Day +100 from HCT | |
Secondary | Incidence of tacrolimus-induced toxicities | The duration from the day of transplant to the first occurrence of tacrolimus-induced toxicities (AKI, hypertension, and metabolic abnormalities) | Day -3 to Day +100 from HCT | |
Secondary | Time to aGVHD | The duration from the day of transplant to the first occurrence of aGVHD, censored at 100 days post-HCT. | Day +21 to Day +100 from HCT | |
Secondary | Time to tacrolimus-induced toxicities (AKI, hypertension, metabolic panel abnormalities) | The duration from the day of transplant to the first occurrence of AKI, hypertension, and metabolic panel abnormalities, censored at 100 days post-HCT. | Day -3 to Day +100 from HCT |
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