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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00032292
First received: March 14, 2002
Last updated: March 9, 2012
Last verified: March 2012

March 14, 2002
March 9, 2012
March 2002
August 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00032292 on ClinicalTrials.gov Archive Site
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Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Graft vs Host Disease
Drug: Visilizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
August 2006
August 2006   (final data collection date for primary outcome measure)
  • 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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032292
291-405
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Facet Biotech
Facet Biotech
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Facet Biotech
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP