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An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease


Phase 2
4 Years
N/A
Not Enrolling
Both
Oral Chronic Graft-versus-host Disease

Thank you

Trial Information

An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease


- Because no one knows which study option is best, participants will be "randomized" into
one of two study groups: topical dexamethasone or topical tacrolimus.

- Participants will take the medication by mouth rinse four times a day for 5 minutes at
a time. After rinsing they will spit out the medication and will not be able to eat or
drink for 15 minutes.

- Participants will also take anti-fungal medication (fluconazole) orally once a week.

- After two weeks on study treatment, participants will have a blood drawn to monitor
tacrolimus levels.

- After the final treatment (4 weeks), participants will have the following tests and
procedures: clinical examination; questionnaire; blood tests; oral culture; optional
tissue biopsy.


Inclusion Criteria:



- Patients with oral chronic graft-versus-host disease

- Patients 4 years of age or older

- Stable cGVHD medication regimen for the four weeks prior to study enrollment

Exclusion Criteria:

- Patients already on topical steroid or tacrolimus therapies

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate and characterize the clinical efficacy of topical steroid and topical tacrolimus therapies for the treatment of oral cGHVD.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nathaniel Treister, DMD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

08-027

NCT ID:

NCT00686855

Start Date:

August 2008

Completion Date:

March 2013

Related Keywords:

  • Oral Chronic Graft-Versus-Host Disease
  • tacrolimus
  • dexamethasone
  • oral rinse
  • Graft vs Host Disease

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Children's Hospital BostonBoston, Massachusetts  02115
Beth-Israel Deaconess Medical CenterBoston, Massachusetts