ImmunosuppressionPhase 4NCT04041219

Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

A Phase 4 study testing Tacrolimus in people with Immunosuppression and Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Immunosuppression, Stem Cell Transplant, Bone Marrow Transplant
What is being tested?: Tacrolimus
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 17 Jun 2019to 8 Oct 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients: a Pilot Study

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

Read the 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.

Conditions: Immunosuppression, Stem Cell Transplant, Bone Marrow Transplant
Being tested: Tacrolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TacrolimusDrug
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.
TacrolimusDrug
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

Study groups in NCT04041219
Study group	Role	What they receive
Allogeneic blood or marrow transplantation	Experimental	Subjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota Receives: Drug: Tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 14 days

Secondary outcomes (1)

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.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 20198 Oct 2019

First posted1 Aug 2019
Study start17 Jun 2019
Primary completion8 Oct 2019
Study completion8 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ImmunosuppressionStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04041219
Sponsor's protocol ID: 19-000181
Status last verified: Aug 2020
First submitted: 30 Jul 2019
Last updated: 7 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

May HP, Bartoo GT, Wolf RC, Shah MV, Litzow MR, Hogan WJ, Alkhateeb H. Use of sublingual tacrolimus in adults undergoing hematopoietic cell transplant: A pilot study. J Oncol Pharm Pract. 2022 Mar;28(2):387-394. doi: 10.1177/1078155221995230. Epub 2021 Feb 16.
PubMed 33593135

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
Active, not recruitingPhase 1
CD4^LVFOXP3 in Participants With IPEX
IPEX

All Immunosuppression trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients: a Pilot Study
ClinicalTrials.gov ID: NCT04041219
Acronym / sponsor ID: 19-000181
Conditions: Immunosuppression, Stem Cell Transplant, Bone Marrow Transplant
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 17 Jun 2019 (actual)
Primary completion: 8 Oct 2019 (actual)
Study completion: 8 Oct 2019 (actual)
First posted: 1 Aug 2019 (actual)
Results: Posted 7 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Allogeneic blood or marrow transplantation	Experimental	Drug: TacrolimusSubjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TacrolimusRecommended 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	Allogeneic blood or marrow transplantation
TacrolimusRecommended 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	Drug	Allogeneic blood or marrow transplantation

Primary outcome

Median Tacrolimus Sublingual Trough Level
Time frame: 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.

1 secondary outcome

Median Sublingual (SL) to Oral (PO) Ratio
Time frame: 14 days

Results and safety

Results posted to the registry on 7 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allogeneic Blood or Marrow Transplantation	10	10

Primary outcome: Median Tacrolimus Sublingual Trough Level

Time frame: 14 days. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Allogeneic Blood or Marrow Transplantation n = 10
Value	11.3 (6 to 17.4)

1 secondary outcome is reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allogeneic Blood or Marrow Transplantation	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33593135May HP, Bartoo GT, Wolf RC, Shah MV, Litzow MR, Hogan WJ, Alkhateeb H. Use of sublingual tacrolimus in adults undergoing hematopoietic cell transplant: A pilot study. J Oncol Pharm Pract. 2022 Mar;28(2):387-394. doi: 10.1177/1078155221995230. Epub 2021 Feb 16.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Immunosuppression

Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
Active, not recruitingPhase 1
CD4^LVFOXP3 in Participants With IPEX
IPEX

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather May, Pharm. D., R. Ph. principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tacrolimus in people with Immunosuppression and Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Tacrolimus Sublingual Trough Level (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04041219, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.