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

Tracking Information
First Received Date ^ICMJE	March 14, 2002
Last Updated Date
Start Date ^ICMJE	March 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00032279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Graft-vs-Host Disease
Intervention ^ICMJE	Drug: Visilizumab
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	80
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00032279
Responsible Party
Study ID Numbers ^ICMJE	1589
Study Sponsor ^ICMJE	Fred Hutchinson Cancer Research Center
Collaborators ^ICMJE	Facet Biotech
Investigators ^ICMJE
Information Provided By	Facet Biotech
Verification Date	October 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP