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

Graft-vs-Host Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00032279
• Other study ID #: 1589
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 15, 2002
• Last updated: June 23, 2005
• Start date: March 2002

Study information

• Verified date: October 2003
• Source: Facet Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00042744

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-vs-Host Disease

Intervention

Drug:
• Visilizumab

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	University Hospital	Indianapolis	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	The New York Hospital Cornell Medical Center	New York	New York
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Westchester Medical Center	Valhalla	New York
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Facet Biotech

Country where clinical trial is conducted

United States,