Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients
Study Details
Study Description
Brief Summary
Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Allogeneic blood or marrow transplantation Subjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota |
Drug: 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.
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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Heather May, Pharm. D., R. Ph., Mayo Clinic
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 19-000181
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Allogeneic Blood or Marrow Transplantation |
---|---|
Arm/Group Description | 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 |
Period Title: Overall Study | |
STARTED | 10 |
COMPLETED | 10 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Allogeneic Blood or Marrow Transplantation |
---|---|
Arm/Group Description | 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 |
Overall Participants | 10 |
Age (years) [Median (Inter-Quartile Range) ] | |
Median (Inter-Quartile Range) [years] |
61
|
Sex: Female, Male (Count of Participants) | |
Female |
5
50%
|
Male |
5
50%
|
Race and Ethnicity Not Collected (Count of Participants) | |
Region of Enrollment (participants) [Number] | |
United States |
10
100%
|
Hematologic Diagnosis of Acute myeloid leukemia (Count of Participants) | |
Count of Participants [Participants] |
6
60%
|
Hematologic Diagnosis of Myelodysplastic syndrome (Count of Participants) | |
Count of Participants [Participants] |
2
20%
|
Hematologic Diagnosis of Other (Count of Participants) | |
Count of Participants [Participants] |
2
20%
|
Outcome Measures
Title | Median Tacrolimus Sublingual Trough Level |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Allogeneic Blood or Marrow Transplantation |
---|---|
Arm/Group Description | 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 |
Measure Participants | 10 |
Median (Inter-Quartile Range) [ng/mL] |
11.3
|
Title | Median Sublingual (SL) to Oral (PO) Ratio |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Allogeneic Blood or Marrow Transplantation |
---|---|
Arm/Group Description | 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 |
Measure Participants | 10 |
Median (Full Range) [ratio] |
1.02
|
Adverse Events
Time Frame | Adverse Events were collected from three days prior to transplant to end study for a total of approximately 30 days for each subject. | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Allogeneic Blood or Marrow Transplantation | |
Arm/Group Description | 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 | |
All Cause Mortality |
||
Allogeneic Blood or Marrow Transplantation | ||
Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | |
Serious Adverse Events |
||
Allogeneic Blood or Marrow Transplantation | ||
Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Allogeneic Blood or Marrow Transplantation | ||
Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Heather P. May, Pharm.D. |
---|---|
Organization | Mayo Clinic |
Phone | 507-266-7405 |
May.Heather@mayo.edu |
- 19-000181