Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease
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.
Chronic Graft Versus Host Disease
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Bortezomib (Velcade) Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease|
- To Determine the Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD [ Time Frame: Patients had their cGVHD assessed at Baseline and at 15 weeks or end of therapy ] [ Designated as safety issue: No ]
- To Determine the Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD [ Time Frame: After 15 weeks of bortezomib plus prednisone therapy ] [ Designated as safety issue: No ]
- The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD [ Time Frame: Toxicities were collected during the course of study treatment ] [ Designated as safety issue: Yes ]
- To Determine the Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy [ Time Frame: 1 year after the start of study treatment ] [ Designated as safety issue: No ]
- To Assess Overall and cGVHD Progression-free Survival by 1 Year After Therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Experimental: Velcade (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
Other Name: VelcadeDrug: 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.
- 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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||John Koreth, MBBS, DPhil||Dana-Farber Cancer Institute|