NCT01158105

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Bortezomib	1.6 mg/m2 IV infusion on days 1, 8, 15, 22 of each 35 day cycle, for up to 6 cycles.Patients who continue to respond during the initial treatment phase with no ongoing significant adverse events will be eligible to receive up to 6 additional cycles.This maintenance dose will be administered on days 1 and 15.

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-05-01
• Completion: 2017-01-01
• First posted: 2010-07-08
• Last updated: 2016-01-18

Locations

1 site across 1 country: United States