An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease

NCT02123966 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-07-24

Study results available
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Summary

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

Conditions

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

Interventions

DRUG

Sirolimus

Sponsors & Collaborators

Principal Investigators

  • Nathaniel S Treister, DMD, DMSc · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-05-31
Completion
2016-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02123966 on ClinicalTrials.gov