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

Tracking Information
First Received Date ^ICMJE	May 6, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	October 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00035880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Graft Vs Host Disease
Intervention ^ICMJE	Drug: ABX-CBL
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	95
Completion Date	June 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	1 Year and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00035880
Responsible Party
Study ID Numbers ^ICMJE	ABX-CB-9906
Study Sponsor ^ICMJE	Abgenix
Collaborators ^ICMJE	Sangstat Medical Corporation
Investigators ^ICMJE
Information Provided By	Abgenix
Verification Date	July 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP