Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04041219
Collaborator
(none)
10
1
1
3.7
2.7

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

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients: a Pilot Study
Actual Study Start Date :
Jun 17, 2019
Actual Primary Completion Date :
Oct 8, 2019
Actual Study Completion Date :
Oct 8, 2019

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

  1. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
Heather P May, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04041219
Other Study ID Numbers:
  • 19-000181
First Posted:
Aug 1, 2019
Last Update Posted:
Aug 7, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Secondary Outcome
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

[Not Specified]

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
Email May.Heather@mayo.edu
Responsible Party:
Heather P May, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04041219
Other Study ID Numbers:
  • 19-000181
First Posted:
Aug 1, 2019
Last Update Posted:
Aug 7, 2020
Last Verified:
Aug 1, 2020