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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Facet Biotech
• Treatments: Visilizumab

Criteria

• 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.