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

This study has been completed.
Sponsor:
Collaborator:
Sangstat Medical Corporation
Information provided by:
Abgenix
ClinicalTrials.gov Identifier:
NCT00035880
First received: May 6, 2002
Last updated: June 23, 2005
Last verified: July 2003
History of Changes
  Purpose

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 Intervention Phase
Graft Vs Host Disease
 Drug: ABX-CBL
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Abgenix:

Estimated Enrollment: 95
Study Start Date: October 1999
Estimated Study Completion Date: June 2003
  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035880

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

No publications provided

ClinicalTrials.gov Identifier: NCT00035880     History of Changes
Obsolete Identifiers: NCT00012077
Other Study ID Numbers: ABX-CB-9906
Study First Received: May 6, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2013