Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

Study Overview
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Brief Summary
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Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.

Detailed Description
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Initial doses will be given via sublingual route and a steady state trough level will be collected after 4 consecutive doses. Participants will then switched to oral tacrolimus, the dose adjusted for a goal trough 8-12ng/mL, and another steady state trough will be drawn.

Official Title
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Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients: a Pilot Study

Conditions
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Immunosuppression, Stem Cell Transplant, Bone Marrow Transplant

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogeneic blood or marrow transplantation<br>Subjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota | Drug: Tacrolimus<br>* 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.<br>Drug: Tacrolimus<br>* Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Sublingual (SL) to Oral (PO) Ratio | Total daily dose will be divided by the corresponding trough whole blood concentration for each route of administration to determine the dosing ratio of SL:PO. [(daily doseSL/blood concentrationSL)/(daily dosePO/blood concentrationPO)] for each individual participant. | 14 days |