Tacrolimus in Allogeneic Hematopoietic Stem Cell Transplant (HCT)
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|ClinicalTrials.gov Identifier: NCT04645667|
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : March 1, 2021
|Condition or disease||Intervention/treatment|
|Acute GVHD||Drug: Tacrolimus|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Development of a Population Pharmacokinetic Model to Optimize Tacrolimus Dosing in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplant.|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
Adult patients of allogeneic hematopoietic HCT
Patients who receive their first allogeneic HCT transplant and who receive tacrolimus for aGVHD prophylaxis per standard of care.
Patients will be enrolled into this group if they receive tacrolimus per standard of care. This is an observational study and no interventions will be made.
Other Name: Prograf
- Tacrolimus clearance [ Time Frame: Day +1 of tacrolimus administration to Day +4 of tacrolimus administration ]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
- Incidence and severity of aGVHD [ Time Frame: Day +21 to Day +100 from HCT ]The duration from the day of transplant to the first occurrence of aGVHD, censored at 100 days post-HCT.
- Incidence of tacrolimus-induced toxicities [ Time Frame: Day -3 to Day +100 from HCT ]The duration from the day of transplant to the first occurrence of tacrolimus-induced toxicities (AKI, hypertension, and metabolic abnormalities)
- Time to aGVHD [ Time Frame: Day +21 to Day +100 from HCT ]The duration from the day of transplant to the first occurrence of aGVHD, censored at 100 days post-HCT.
- Time to tacrolimus-induced toxicities (AKI, hypertension, metabolic panel abnormalities) [ Time Frame: Day -3 to Day +100 from HCT ]The duration from the day of transplant to the first occurrence of AKI, hypertension, and metabolic panel abnormalities, censored at 100 days post-HCT.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645667
|Contact: Jing Zhu, PharmDemail@example.com|
|Contact: Veronica Q Nguyen, PharmDfirstname.lastname@example.org|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27514|
|Contact: Jing Zhu, PharmD|
|Principal Investigator:||Daniel J Crona, PharmD, PhD||UNC Lineberger Comprehensive Cancer Center|