Chronic Graft Versus Host Disease Clinical Trial
Official title:
A Phase II Trial of Bortezomib (Velcade) 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.
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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