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Home > "R" Clinical Trials Conditions > Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease  Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
For Condition: Graft-vs-Host Disease
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , Protein Design Labs
Synopsis: The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticord-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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Grade II to IV GVHD - Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea. - History of allogeneic hematopoietic cell transplant (HCT). - Patients must have failed to respond or clearly progress to previous therapy on or before day +100 posttransplant. - Patients must have adequate renal, hepatic, cardiac function and hematologic values
Total Enrollment: 80
Location and Contact Information:
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Stanford University Medical Center
Stanford, California, 94305-5623
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
City of Hope National Medical Center
Duarte, California, 91910
United States
Duke University
Durham, North Carolina, 27705
United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6310
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
The New York Hospital Cornell Medical Center
New York City, New York, 10021
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University Hospital
Indianapolis, Indiana, 46202
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Ohio State University
Columbus, Ohio, 43210
United States
Additional Information:
Study ID Numbers: 1589;
Study Start Date: March 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032279
Other Graft-Vs-Host Disease Studies:
1. Keratinocyte Growth Factor to Prevent Acute GVHD
2. Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
Related Studies:
Other Graft-vs-Host Disease Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
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