Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

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

The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)

• 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