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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Boston Children's Hospital; Boston Children’s Hospital; Dana-Farber Cancer Institute; Massachusetts General Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Tacrolimus

Criteria

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