Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
A Phase II, Multicenter Clinical Trial Evaluating the Use of Humanized Monoclonal Anti-CD3 Antibody Visilizumab(Nuvion) as Second-line Therapy for Glucocorticoid-Refractory, Acute Graft-Versus-Host Disease
1 other identifier
interventional
80
1 country
17
Brief Summary
The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment with standard agents will be considered for entry. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial. The research is being conducted at up to 20 clinical research sites in the US.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 15, 2002
CompletedFirst Posted
Study publicly available on registry
March 18, 2002
CompletedJune 24, 2005
October 1, 2003
March 15, 2002
June 23, 2005
Conditions
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- Facet Biotechcollaborator
Study Sites (17)
City of Hope National Medical Center
Duarte, California, 91910, United States
Stanford University Medical Center
Stanford, California, 94305-5623, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
University Hospital
Indianapolis, Indiana, 46202, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01605, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The New York Hospital Cornell Medical Center
New York, New York, 10021, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Duke University
Durham, North Carolina, 27705, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6310, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 15, 2002
First Posted
March 18, 2002
Study Start
March 1, 2002
Last Updated
June 24, 2005
Record last verified: 2003-10