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Clinical Trial Summary

This research study is evaluating the effectiveness of topical sirolimus combined with topical steroid therapy, as a possible treatment for oral cGVHD.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Chronic Graft-versus-Host-Disease
  • Graft vs Host Disease
  • Oral Mucosal Disease Due to Graft-versus-host Disease

NCT number NCT02123966
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Terminated
Phase Phase 2
Start date July 2014
Completion date May 2016

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