NCT04645667 is a clinical trial of Tacrolimus in Acute GVHD, sponsored by UNC Lineberger Comprehensive Cancer Center.

Who is sponsoring NCT04645667?

NCT04645667 is sponsored by UNC Lineberger Comprehensive Cancer Center.

What drugs are being tested in NCT04645667?

Interventions in NCT04645667: Tacrolimus.

What condition does NCT04645667 study?

NCT04645667 studies Acute GVHD.

Is NCT04645667 still recruiting?

NCT04645667 is currently completed. Last updated 17 October 2023.

Last reviewed 2023-10-17 · How we verify

NCT04645667

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Tacrolimus in Allogeneic Hematopoietic Stem Cell Transplant (HCT)

Completed Last updated 17 October 2023

What this trial tests

trial testing Tacrolimus in Acute GVHD in 38 participants. Completed in 15 October 2023.

Timeline

1 February 2021

Primary endpoint
15 October 2023

15 October 2023

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	38
Start date	1 February 2021
Primary completion	15 October 2023
Estimated completion	15 October 2023
Sites	1 location across United States

Drugs / interventions tested

Tacrolimus (TACROLIMUS) — full drug profile →

Conditions studied

Acute GVHD — all drugs for Acute GVHD →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Acute GVHD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Evaluation of the performance of a prior tacrolimus population pharmacokinetic kidney transplant model among adult allogeneic hematopoietic stem cell transplant patients.
Zhu J, Campagne O, Torrice CD, Flynn G, et al · · 2021 · cited 7× · PMID 33502111 · DOI 10.1111/cts.12956
Insights and lessons learned from a prospective clinical pharmacology study in allogeneic hematopoietic stem cell transplant during the COVID-19 pandemic.
Zhu J, Rao G, Armistead PM, Ptachcinski J, et al · · 2022 · cited 2× · PMID 34743423 · DOI 10.1111/cts.13177
A Tacrolimus Population Pharmacokinetic Model for Adult Allogeneic Hematopoietic Cell Transplant Recipients Provides Clinical Opportunities for Precision Dosing.
Dunlap TC, Zhu J, Weiner DL, Kemper RM, et al · · 2025 · PMID 40794300 · DOI 10.1007/s40262-025-01529-w

Verify or expand the search:

Other trials of Tacrolimus

Trials testing the same drug.

NCT07519174 — A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% i · NA · not yet recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
NCT07349771 — Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoie · Phase 2 · not yet recruiting
NCT06996119 — Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versu · Phase 1 · not yet recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting

Other recruiting trials for Acute GVHD

Currently open trials in the same condition.

NCT04373057 — Prebiotic Galacto-oligosaccharide and Acute GVHD · Phase 1, PHASE2 · recruiting
NCT02611180 — Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease · active not recruiting

Other UNC Lineberger Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT06656936 — The PharmFIT Study · NA · not yet recruiting
NCT05937659 — Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT · not yet recruiting
NCT07479199 — Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors · not yet recruiting
NCT07069595 — PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease · Phase 2 · recruiting
NCT04266730 — Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04645667 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 17 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04645667.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing