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Study comparing ABX-CBL (monoclonal antibody) versus Atgam in Patients with Steroid Resistant Acute Graft versus Host Disease



Study comparing ABX-CBL (monoclonal antibody) versus Atgam in Patients with Steroid Resistant Acute Graft versus Host Disease

For Condition: Graft vs Host Disease
Status: Completed
Sponsor(s): Abgenix , Sangstat Medical Corporation
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 1 Year/
Genders: Both
Protocol Entry 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
Total Enrollment: 95

Location and Contact Information:

Abgenix, Inc
Fremont,  California,  94555
United States
 


Additional Information:
Study ID Numbers:
  ABX-CB-9906; 
Study Start Date: October 1999
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035880

Other Graft Vs Host Disease Studies:
1. T-Cell Depletion in Unrelated Donor Marrow Transplantation

2. Blood and Marrow Transplant Clinical Research Network

3. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes

4. Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease

5. Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis

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Study comparing ABX-CBL (monoclonal antibody) versus Atgam in Patients with Steroid Resistant Acute Graft versus Host Disease

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