Chronic Graft-versus-Host-Disease Clinical Trial
Official title:
An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease
This research study is evaluating the effectiveness of topical sirolimus combined with topical steroid therapy, as a possible treatment for oral cGVHD.
Topical steroid therapy can be effective in managing oral cGVHD symptoms. However, a certain
proportion of participants will not experience an adequate response to topical steroids and
continue to have some degree of discomfort. Sirolimus is a non-steroidal immunosuppressive
medication that has demonstrated efficacy in the management of cGVHD. Based on this, it is
believed that a topical formulation applied inside the mouth may also demonstrate efficacy on
a localized basis.
The purpose of this study is to assess the safety and efficacy of topical sirolimus as a
swish and spit solution for the treatment of oral cGVHD in participants that have not had an
adequate clinical response to topical steroid therapy alone.
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