Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does not respond to steroid therapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abgenix
• Collaborator: Sangstat Medical Corporation

Criteria

Inclusion Criteria:

• Recipient of single allogeneic stem cell transplant from any donor type

• Time post transplant less than 100 days

• Received no treatment for GVHD other than steroids

Exclusion Criteria:

• Recipient of second allogeneic stem cell transplant or subsequent lymphocyte product from the donor post transplant

• IBMTR index less than A

• Received any murine product in the past

• Diagnosed with chronic GVHD

• Received Atgam later than day 10 post transplant

• Change to prophylactic regimen for acute GVHD within 72 hours of randomization