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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compated to baseline in subects with steroid refractory cGVHD.
Corey Cutler, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Fred Hutch Cancer Research Center||Seattle, Washington 98103-1204|