Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2019-10-08

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.

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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.

Conditions

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Immunosuppression Stem Cell Transplant Bone Marrow Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allogeneic blood or marrow transplantation

Subjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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.

Tacrolimus

Intervention Type DRUG

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

Interventions

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Tacrolimus

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.

Intervention Type DRUG

Tacrolimus

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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No