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

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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.


We found this trial at
1
site
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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