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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Oral Chronic Graft-versus-host Disease

Treatments: Drug: Tacrolimus; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00686855

08-027

Details and patient eligibility

About

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)

Full description

• 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.

Enrollment: 46 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Tacrolimus

Experimental group

Description:

Tacrolimus Arm Closed to Accrual as of January 2012

Treatment:

Drug: Tacrolimus

Dexamethasone

Experimental group

Treatment:

Drug: Dexamethasone