Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT01226420
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01226420
Study Brief:
Protocol Section:
NCT01226420