Clinical trial NCT00032279: Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Graft-vs-Host Disease
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
Collaborators: name: Facet Biotech
First posted: 2002-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

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