Status:
TERMINATED
Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Astellas Pharma Inc
Conditions:
Chronic Graft-versus-host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Info...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01226420
Start Date
October 1 2010
End Date
August 1 2012
Last Update
August 13 2013
Active Locations (3)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Fred Hutch Cancer Research Center
Seattle, Washington, United States, 98109-1024
3
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226