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

NCT ID: NCT01226420

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-08-31

Brief 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

Keywords

GVHD; Alefacept; Amevive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alefacept

Alefacept iv

Group Type: EXPERIMENTAL

Alefacept

Intervention Type: DRUG

Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12

Interventions

Alefacept

Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12

Intervention Type: DRUG

Other Intervention Names

Amevive

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Corey S. Cutler, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corey Cutler, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Fred Hutch Cancer Research Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

10-230

Identifier Type: -

Identifier Source: org_study_id