Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease

Graft vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032292
• Other study ID #: 291-405
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 14, 2002
• Last updated: March 9, 2012
• Start date: March 2002
• Est. completion date: August 2006

Study information

• Verified date: March 2012
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• 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.

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

Intervention

Drug:
• Visilizumab

Locations

Country	Name	City	State
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
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

Sponsors (1)

Lead Sponsor	Collaborator
Facet Biotech

Country where clinical trial is conducted

United States,