Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
Condition: Chronic Graft-versus-host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Alefacept
Intervention description: Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12
Intervention MeSH terms: Alefacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GVHD; Alefacept; Amevive

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.
    

Eligibility 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