NCT00079183

Sirolimus as Secondary Therapy in Chronic Graft-Versus-Host Disease Not Responding To Prior Treatment

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety of sirolimus administered at a dose which provides steady-state, whole blood trough levels of 5-10 ng/mL in patients with chronic GVHD. II. To determine whether administration of sirolimus provides benefit for patients with chronic GVHD that has not responded adequately to previous systemic treatment. OUTLINE: Patients receive sirolimus orally (PO) once daily (QD). Patients continue to receive prednisone and cyclosporine or tacrolimus at the discretion of the managing physician. After completion of study treatment, patients are followed up periodically.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	sirolimus	Given PO

Timeline

• Start date: 2002-04-01
• Primary completion: 2009-07-01
• Completion: 2010-06-10
• First posted: 2004-03-10
• Last updated: 2017-06-20
• Results posted: 2017-05-12

Locations

1 site across 1 country: United States