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