NCT01226420

Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Chronic Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Alefacept	Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-10-22
• Last updated: 2013-08-13
• Results posted: 2013-08-13

Locations

3 sites across 1 country: United States