Overview

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

Status:
Terminated
Trial end date:
2012-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Astellas Pharma Inc
Brigham and Women's Hospital
Treatments:
Alefacept
Criteria
Inclusion Criteria:

- 18 years of age or older

- Diagnosed with cGVHD according to NIH criteria

- Active cGVHD despite treatment with corticosteroids AND one additional
immunosuppressive agent for at least 4 weeks, within 52 weeks of enrollment.

- Subject is a recipient of related or unrelated BMT or PBSCT

- Subject underwent transplantation at least 6 months prior to enrollment

- Subject is on stable immunosuppressive regimen for 2 weeks prior to enrollment.
Adjustment of immunosuppressive medications to maintain a therapeutic level is
permitted.

- Female of child bearing potential must have a negative pregnancy test prior to first
dose of alefacept and must agree to practice effective contraception during the study.
Men must also agree to use adequate contraception prior to study entry and for the
duration of the study.

- Meets medication restriction requirements and agrees to follow medications
restrictions during study.

Exclusion Criteria:

- Received donor lymphocyte infusions in the preceding 100 days

- Currently undergoing ECP

- Subject is recipient of related or unrelated UCB

- Subject has bronchiolitis obliterans, bronchiolitis obliterans with organizing
pneumonia or cryptogenic organizing pneumonia as the sole manifestation of cGVHD

- Uncontrolled intercurrent active infection.

- Absolute neutrophil count < 1000/L

- AST, ALT or total bilirubin > 2x institutional upper limit of normal unless this is a
manifestation of GVHD

- Recurrent or progressive malignancy at any time after HCT, as applicable for the
individual malignancy

- Subject was in any clinical study within the last 30 days

- Receipt of 5 or more prior agents to treat cGVHD

- Known hypersensitivity to alefacept or any components of the study medication

- Known to be positive for human immunodeficiency virus (HIV) antibodies

- Currently enrolled in any other study for chronic GVHD treatment and receiving
treatment under the study or previous participation in this study.

- Pregnant or nursing

- Concurrent illness which, in the opinion of the Investigator, may interfere with
treatment or evaluation of safety