Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease
Information source: Abgenix
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graft Vs Host Disease
Intervention: ABX-CBL (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Abgenix
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.
Clinical Details
Official title: A Phase II/III, Multicenter, Open Label, Randomized Clinical Trial Evaluating ABX-CBL When Compared to Atgam as Second Line Therapy in Patients With Steroid Resistant Acute Graft Versus Host Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Abgenix, Inc, Fremont, California 94555, United States
Additional Information
Starting date: October 1999
Last updated: June 23, 2005
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