Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
Status: | Archived |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | October 2010 |
A Phase II, Open-Label, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been
used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like
chronic GVHD. Information from studies in psoriasis and in other patients with GVHD suggests
that this drug may help to treat chronic GVHD. Chronic GVHD is a medical condition that can
develop after allogeneic stem cell transplantation. It occurs when the donor immune cells
(the "graft") attack and damage organs and tissue (the "host"). It is thought that T cells,
a subtype of immune cells, are responsible for the tissue damage in chronic GVHD. In this
research study we are looking to see how well Alefacept works in treating chronic GVHD that
has not resolved after therapy with corticosteroids.
- During the first week of treatment, participants will receive 2 doses of Alefacept
intravenously (Day 1 and Day 4). During weeks 2-12, Alefacept will be given
subcutaneously once weekly.
- On weeks 1, 2 and every other week through Week 12 of study treatment, participants
will have a physical exam, blood tests, and be asked general health and specific
questions about any problems they may be having.
- Every other week, participants will be asked to complete a questionnaire about their
physical symptoms, activity level and emotional well being.
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