Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Bone Marrow Transplant; Stem Cell Transplant; Immunosuppression

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT04041219

19-000181

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Allogeneic blood or marrow transplantation

Experimental group

Description:

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

Treatment:

Drug: Tacrolimus

Drug: Tacrolimus