Bone Marrow Transplant, Immunosuppression, Stem Cell Transplant
Conditions
Brief summary
Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.
Detailed 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.
Interventions
DRUGTacrolimus
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Tacrolimus Sublingual Trough Level | 14 days | Trough level is the lowest concentration in the patient's bloodstream and was collected after four consecutive sublingual doses. Measured as ng/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Sublingual (SL) to Oral (PO) Ratio | 14 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Allogeneic Blood or Marrow Transplantation Subjects who had allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota
Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.
Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Allogeneic Blood or Marrow Transplantation | — |
|---|---|---|
| Age, Continuous | 61 years | — |
| Hematologic Diagnosis of Acute myeloid leukemia | 6 Participants | — |
| Hematologic Diagnosis of Myelodysplastic syndrome | 2 Participants | — |
| Hematologic Diagnosis of Other | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Allogeneic Blood or Marrow Transplantation | Median Tacrolimus Sublingual Trough Level | 11.3 ng/mL |
Secondary
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.
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Allogeneic Blood or Marrow Transplantation | Median Sublingual (SL) to Oral (PO) Ratio | 1.02 ratio |