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

This study has been completed.

First Received on May 6, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	Abgenix
Collaborator:	Sangstat Medical Corporation
Information provided by:	Abgenix
ClinicalTrials.gov Identifier:	NCT00035880

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 II Phase III

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:

Drug Information available for: Gavilimomab

U.S. FDA Resources

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 February 09, 2012