Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients
1 other identifier
interventional
10
1 country
1
Brief Summary
Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2019
CompletedFirst Submitted
Initial submission to the registry
July 30, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2019
CompletedResults Posted
Study results publicly available
August 7, 2020
CompletedAugust 7, 2020
August 1, 2020
4 months
July 30, 2019
July 14, 2020
August 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Median Tacrolimus Sublingual Trough Level
Trough level is the lowest concentration in the patient's bloodstream and was collected after four consecutive sublingual doses. Measured as ng/mL.
14 days
Secondary Outcomes (1)
Median Sublingual (SL) to Oral (PO) Ratio
14 days
Study Arms (1)
Allogeneic blood or marrow transplantation
EXPERIMENTALSubjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota
Interventions
Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.
Eligibility Criteria
You may qualify if:
- Individuals will be identified from within the adult allogeneic BMT program at Mayo Clinic in Rochester, Minnesota
- Adults prescribed tacrolimus for treatment or prevention of Graft Versus Host Disease (GVHD)
You may not qualify if:
- Vulnerable populations
- Patients with contraindications to tacrolimus, inclusive of hypersensitivity, history of posterior reversible encephalopathy syndrome or calcineurin-inhibitor induced thrombotic microangiopathy
- Lacking the capacity to consent in English and declining to participate in research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (1)
May HP, Bartoo GT, Wolf RC, Shah MV, Litzow MR, Hogan WJ, Alkhateeb H. Use of sublingual tacrolimus in adults undergoing hematopoietic cell transplant: A pilot study. J Oncol Pharm Pract. 2022 Mar;28(2):387-394. doi: 10.1177/1078155221995230. Epub 2021 Feb 16.
PMID: 33593135DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Heather P. May, Pharm.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Heather May, Pharm. D., R. Ph.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 30, 2019
First Posted
August 1, 2019
Study Start
June 17, 2019
Primary Completion
October 8, 2019
Study Completion
October 8, 2019
Last Updated
August 7, 2020
Results First Posted
August 7, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share