Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease - Full Text View

Sponsor:	PDL BioPharma, Inc.
Information provided by:	Facet Biotech
ClinicalTrials.gov Identifier:	NCT00032292

Purpose

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	Intervention	Phase
Graft vs Host Disease	Drug: Visilizumab	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Visilizumab

U.S. FDA Resources

Further study details as provided by Facet Biotech:

Estimated Enrollment:	34
Study Start Date:	March 2002

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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032292

Locations

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5623
City of Hope National Medical Center
Duarte, California, United States, 91910
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

PDL BioPharma, Inc.

More Information

No publications provided

Study ID Numbers:	291-405
Study First Received:	March 14, 2002
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00032292 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Immune System Diseases
Graft vs Host Disease

ClinicalTrials.gov processed this record on November 25, 2009