Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2003 by Facet Biotech. Recruitment status was Active, not recruiting

First Received on March 15, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	Facet Biotech
Information provided by:	Facet Biotech
ClinicalTrials.gov Identifier:	NCT00032279

Purpose

The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-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.

Condition	Intervention	Phase
Graft-vs-Host Disease	Drug: Visilizumab	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II, Multicenter Clinical Trial Evaluating the Use of Humanized Monoclonal Anti-CD3 Antibody Visilizumab(Nuvion) as Second-line Therapy for Glucocorticoid-Refractory, Acute Graft-Versus-Host Disease

Resource links provided by NLM:

Drug Information available for: Visilizumab

U.S. FDA Resources

Further study details as provided by Facet Biotech:

Estimated Enrollment:	80
Study Start Date:	March 2002

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032279

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, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
The New York Hospital Cornell Medical Center
New York, New York, United States, 10021
Westchester Medical Center
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6310
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Baylor College of Medicine
Houston, Texas, United States, 77030
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

Fred Hutchinson Cancer Research Center

Facet Biotech

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00032279 History of Changes
Other Study ID Numbers:	1589
Study First Received:	March 15, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Graft vs Host Disease
Immune System Diseases
Glucocorticoids
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012