drugset / Trial / NCT00815919
Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease
Phase 2
Completed
22 enrolled
Dana-Farber Cancer Institute
Millennium Pharmaceuticals, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-12
- Primary completion
- 2012-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Prednisone | Other / unclassified | 1 mg/kg | Oral |