NCT00815919

Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease

A Phase II Trial of Bortezomib (Velcade) Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine the effectiveness of bortezomib (Velcade) plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this drug combination in this patient population. Chronic GVHD is a medical condition that may occur after allogeneic stem cell transplantation. The donor's immune system may recognize the participants body (the host) as foreign and attempt to "reject" it. Bortezomib has been used in other research studies, and information from those studies suggests that this drug may help to control the abnormal immune responses that underlie cGVHD.

Detailed description

* Each treatment cycle lasts five weeks, during which time participants will come to the clinic to receive bortezomib intravenously once a week for the first 4 weeks. Prednisone will be taken orally on a daily basis and dose reduction may be initiated after 1 cycle of therapy. * During all treatment cycles, participants will have the following: physical exam and blood work. At the end of cycle 3 (week 15) the participants cGVHD will be evaluated. These assessments may include an eye examination, a skin examination, a pulmonary function test and/or, a flexion assessment test. * Participants will receive 3 cycles of bortezomib.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	bortezomib	Given intravenously at a dose of 1.3 mg/m\^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles
DRUG	Prednisone	Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-01-01
• Completion: 2013-01-01
• First posted: 2008-12-31
• Last updated: 2015-07-22
• Results posted: 2014-02-28

Locations

1 site across 1 country: United States