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Home > "R" Clinical Trials Conditions > Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease  Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease
Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease
For Condition: Graft vs Host Disease
Status: No longer recruiting
Sponsor(s): Protein Design Labs ,
Synopsis: The purpose of this Phase I/II, open-label, dose-escalation study is to evaluate an investigational monoclonal antibody administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment. The research is being conducted at up to 10 clinical research sites in the US.
Details: A Phase I/II, open-label, dose-escalation pilot study designed to obtain preliminary safety, pharmacokinetic (PK) and efficacy information on visilizumab administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). It is anticipated that up to 34 patients at up to 10 study centers could be eligible for enrollment in this study. Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment (2 mg/kg of methylprednisolone IV, or 10 mg/kg hydrocortisone IV, per day). Steroids will be rapidly tapered over one week following visilizumab administration.
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: - Patients who develop Grade II, III, or IV acute GVHD following allogeneic hematopoietic cell transplantation - Patients receiving GVHD prophylaxis including cyclosporine or tacrolimus - Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea. - Patients with an onset date of acute GVHD that is less than or equal to 100 days posttransplant.
Total Enrollment: 34
Location and Contact Information:
Duke University
Durham, North Carolina, 27705
United States
City of Hope National Medical Center
Duarte, California, 91910
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Stanford University Medical Center
Stanford, California, 94305-5623
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6310
United States
Additional Information:
Study ID Numbers: 291-405;
Study Start Date: March 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032292
Other Graft Vs Host Disease Studies:
1. Blood and Marrow Transplant Clinical Research Network
2. Stem Cell Transplant for Malignant Melanoma
3. Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
4. T-Cell Depletion in Unrelated Donor Marrow Transplantation
5. Donor Th2 Cells to Prevent Graft-Versus-Host Disease in Bone Marrow Transplants
Related Studies:
Other Graft vs Host Disease Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease
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