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

Tracking Information
First Received Date ^ICMJE	March 14, 2002
Last Updated Date	August 1, 2008
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 NCT00032292 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 Acute Graft Versus Host Disease
Official Title ^ICMJE	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
Brief Summary	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.
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.
Study Phase	Phase I, 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	Completed
Enrollment ^ICMJE	34
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
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	NCT00032292
Responsible Party
Study ID Numbers ^ICMJE	291-405
Study Sponsor ^ICMJE	PDL BioPharma, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Facet Biotech
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP