NCT00298324

Myfortic - Treatment for Extensive cGvHD

A Randomized Double Blinded Placebo-Controlled Phase III Trial Comparing Cyclosporine Plus Steroids With or Without Myfortic as Primary Treatment for Extensive Chronic Graft Versus Host Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: European Society for Blood and Marrow Transplantation · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the response to treatment for extensive chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and prednisone alone.

Detailed description

This clinical trial is a European, multi-center, randomized, double blinded placebo-controlled trial comparing CsA+PDN+MPA versus the reference treatment of CsA+PDN alone + placebo, in patients with extensive chronic GvHD. Randomization will be stratified according to: * Platelet number (low versus high risk) * Source of transplantable cells (marrow versus PBSC versus cord blood) Patients not in progression at 6 weeks post randomization (progression defined as primary failure) will be evaluated for remission (complete or partial) at 3, 6, 9, \& 12 months post randomization

Conditions

• Graft vs Host Disease

Interventions

Type	Name	Description
DRUG	Myfortic	1440mg twice daily
DRUG	Prednisone and Cyclosporine	Prednisone and Cyclosporine given according to protocol. The drugs are tapered according to patient response

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-11-01
• Completion: 2010-11-01
• First posted: 2006-03-02
• Last updated: 2015-04-03

Locations

8 sites across 8 countries: France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, Turkey (Türkiye)