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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014