At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 36 enrolled

Drug / intervention

Sirolimus +1 moredrug

Likely dose

Sirolimus 2 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00388362

NCT00388362Phase 2Completed

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A Phase II Trial of Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease

Stanford University·interventional·Posted Oct 16, 2006·Updated Apr 21, 2017

In Brief

A Phase 2 clinical trial evaluating Sirolimus and Prednisone for Graft vs Host Disease. Completed, enrolled 36 participants across 1 site.

Detailed Summary

To study the effectiveness of an immunosuppressive drug sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGraft vs Host Disease

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2005

First PostedOct 2006

Primary CompletionNov 2010

Study CompletionAug 2012

TodayJul 2026

First PostedOct 16, 2006

Enrollment StartNov 1, 2005

Primary CompletionNov 1, 2010

Study CompletionAug 1, 2012

TodayJul 2, 2026

Enrollment to primary: 5 yearsPosted 19.7 years ago

Interventions

Sirolimusdrug

Patients will receive sirolimus at 2 mg/day orally with monitoring of trough drug levels weekly for 2 weeks to achieve trough drug levels 7-12 ng/ml. Along with prednisone therapy.

Prednisonedrug

Prednisone therapy will remain at the dose the patient received at the time sirolimus was begun. Withdrawal of prednisone will began after first evidence of improvement of chronic GVHD.