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

Completed · Phase 2/Phase 3

Conditions studied: Graft Vs Host Disease

In brief

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.

Key facts

Study ID

NCT00035880

Run by

Abgenix

People needed

95

Starts

1999-10-01

Expected to finish

2003-06-01

Last updated by the study team

2005-06-24

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Abgenix, Inc — Fremont, California, United States

Full record on ClinicalTrials.gov

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