Trial Outcomes & Findings for Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients (NCT NCT04041219)

Results Overview

Trough level is the lowest concentration in the patient's bloodstream and was collected after four consecutive sublingual doses. Measured as ng/mL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

14 days

Results posted on

2020-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allogeneic Blood or Marrow Transplantation n=10 Participants 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
Age, Continuous	61 years n=10 Participants
Sex: Female, Male Female	5 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants
Hematologic Diagnosis of Acute myeloid leukemia	6 Participants n=10 Participants
Hematologic Diagnosis of Myelodysplastic syndrome	2 Participants n=10 Participants
Hematologic Diagnosis of Other	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Allogeneic Blood or Marrow Transplantation n=10 Participants 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
Median Tacrolimus Sublingual Trough Level	11.3 ng/mL Interval 6.0 to 17.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Allogeneic Blood or Marrow Transplantation n=10 Participants 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
Median Sublingual (SL) to Oral (PO) Ratio	1.02 ratio Interval 0.57 to 1.92

Adverse Events

Allogeneic Blood or Marrow Transplantation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather P. May, Pharm.D.

Mayo Clinic

Phone: 507-266-7405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place