Back to resultsStudy Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease
Primary Purpose
Graft Vs Host Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABX-CBL
Sponsored by
About this trial
This is an interventional treatment trial for Graft Vs Host Disease focused on measuring Acute graft versus host disease, Stem Cell Transplantation
Eligibility 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
Sites / Locations
- Abgenix, Inc
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00035880
First Posted
May 6, 2002
Last Updated
June 23, 2005
Sponsor
Abgenix
Collaborators
Sangstat Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00035880
Brief Title
Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease
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 Type
Interventional
2. Study Status
Record Verification Date
July 2003
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abgenix
Collaborators
Sangstat Medical Corporation
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Vs Host Disease
Keywords
Acute graft versus host disease, Stem Cell Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ABX-CBL
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Abgenix, Inc
City
Fremont
State/Province
California
ZIP/Postal Code
94555
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease
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