Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease
Phase 2
Completed
- Conditions
- Graft Vs Host Disease
- Registration Number
- NCT00035880
- Lead Sponsor
- Abgenix
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Abgenix, Inc
🇺🇸Fremont, California, United States