Status:
COMPLETED
Dexamethasone to Prevent Oral Chronic Graft-versus-Host Disease
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
12-110 years
Phase:
PHASE2
Brief Summary
This study will determine if a dexamethasone mouth rinse can reduce the risk of developing oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow (stem cell) trans...
Detailed Description
Prevention of oral chronic graft versus host disease (GVHD) by topical agents is an attractive strategy because it would potentially avoid the adverse effects associated with systemic immunosuppressio...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- History of allogeneic hematopoietic stem cell transplantation within 60-90 days of enrollment.
- Age 12 or older.
- Ability to rinse and expectorate study medication rather than swallow it.
- Ability and willingness to come to Clinical Center for follow-up appointments and at the time of development of symptoms/signs suggestive of oral GVHD.
- EXCLUSION CRITERIA:
- Clinically significant oral chronic GVHD at the time of the screening.
- Active viral or fungal infection involving oral cavity not resolving by day 90.
- Platelet count less than 20,000/ml at the time of the screening appointment.
- Life expectancy less than 4 months at the time of enrollment.
- Documented hypersensitivity to dexamethasone.
- Pregnancy or lactation.
- Inability to understand the investigational nature of the study.
- Inability to provide informed consent.
Exclusion
Key Trial Info
Start Date :
November 24 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00391170
Start Date
November 24 2006
End Date
February 1 2021
Last Update
February 10 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892