Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
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|ClinicalTrials.gov Identifier: NCT01226420|
Recruitment Status : Terminated (Discontinuation of drug supply from Astellas.)
First Posted : October 22, 2010
Results First Posted : August 13, 2013
Last Update Posted : August 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Graft-versus-host Disease||Drug: Alefacept||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12
Other Name: Amevive
- Efficacy [ Time Frame: 2 years ]Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.
- Safety of Alefacept Infusions in Patients With Chronic GVHD. [ Time Frame: 2 years ]Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226420
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Washington|
|Fred Hutch Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Corey Cutler, MD||Dana-Farber Cancer Institute|