CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
sirolimusdrug
Likely dose
Sirolimus given orallyAI-extracted
Key inclusion· 3
  • ✓Biopsy-confirmed diagnosis of clinical extensive chronic GVHD with inadequate response to previous treatment and where secondary systemic therapy is indicated
  • ✓Evidence of clinical progression, new organ involvement, lack of improvement after 3 months of primary treatment, or continued high-dose prednisone requirement (≥1.0 mg/kg/day for >2 months)
  • ✓Able to provide informed consent
Key exclusion· 7
  • ✕Fungal or viral infection unresponsive to antimicrobial therapy with no radiographic improvement
  • ✕CMV antigenemia unresponsive to antiviral therapy
  • ✕Active disseminated VZV infection with persistent non-crusted lesions
  • ✕Unable to tolerate oral medications

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00079183
NCT00079183Phase 2Completed
CompareCT.gov

A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Sirolimus for Secondary Treatment of Chronic Graft-versus-Host Disease

Fred Hutchinson Cancer Center·interventional·Posted Mar 10, 2004·Updated Jun 20, 2017

In Brief

A Phase 2 clinical trial evaluating sirolimus for Graft Versus Host Disease. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This phase II trial studies the side effects and how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Versus Host Disease
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2004
Enrollment StartApr 1, 2002
Primary CompletionJul 1, 2009
Study CompletionJun 10, 2010
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 22.3 years ago

Interventions

sirolimusdrug

Given PO