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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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ClinicalTrials.gov Identifier: NCT00035880
Recruitment Status : Completed
First Posted : May 7, 2002
Last Update Posted : June 24, 2005
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Graft Vs Host Disease Drug: ABX-CBL Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 1999
Estimated Study Completion Date : June 2003

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035880

United States, California
Abgenix, Inc
Fremont, California, United States, 94555
Sponsors and Collaborators
Sangstat Medical Corporation
More Information

ClinicalTrials.gov Identifier: NCT00035880     History of Changes
Obsolete Identifiers: NCT00012077
Other Study ID Numbers: ABX-CB-9906
First Posted: May 7, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2003

Keywords provided by Abgenix:
Acute graft versus host disease
Stem Cell Transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases