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Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease

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ClinicalTrials.gov Identifier: NCT00032292
Recruitment Status : Completed
First Posted : March 18, 2002
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
Facet Biotech

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Drug: Visilizumab Phase 1 Phase 2

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Dose-Escalation, Pilot Study to Evaluate Safety and Preliminary Efficacy of Visilizumab as Primary Therapy for Acute Graft-Versus-Host Disease After Hematopoietic Cell Transplantation
Study Start Date : March 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00032292


Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91910
Stanford University Medical Center
Stanford, California, United States, 94305-5623
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6310
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Facet Biotech
More Information
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Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00032292     History of Changes
Other Study ID Numbers: 291-405
First Posted: March 18, 2002    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases