Bortezomib for the Treatment of Refractory Chronic Graft-vs-Host Disease(cGVHD)

Chronic Graft-versus-host Disease Clinical Trial

Official title: Phase 2 Study of Bortezomib (Velcade) for the Treatment of Steroid Refractory Chronic Graft-vs-Host Disease

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to see if bortezomib (Velcade) is effective in the treatment of refractory cGVHD.

Clinical Trial Description

Graft vs. host disease represents the most formidable problem following allogeneic hematopoietic stem cell transplantation for hematological diseases. Chronic graft-versus-host disease (cGVHD) is the most serious and common long-term complication of this treatment in patients surviving more than 100 days. Some patients are requiring immunosuppressive therapy for years. cGVHD is associated with a high degree of morbidity and mortality and remains a major cause of late death. When standard treatment with steroids is ineffective or poorly tolerated, effective therapeutic options are limited. Patients with uncontrolled cGVHD with initial therapy including systemic steroids respond poorly to second line options. Recent studies have demonstrated Bortezomib safety in the prophylaxis, and improvement of GVHD suggesting its efficacy.This study is done to evaluate the potential of bortezomib in treating refractory cGVHD. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Graft-versus-host Disease
• Graft vs Host Disease

• NCT number: NCT01158105
• Study type: Interventional
• Source: Baylor Research Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2010
• Completion date: January 2017