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

Sponsor
Abgenix (Industry)
Overall Status
Completed
CT.gov ID
NCT00035880
Collaborator
Sangstat Medical Corporation (Industry)
95
Enrollment
1
Location
44
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Oct 1, 1999
Study Completion Date :
Jun 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Abgenix, Inc Fremont California United States 94555

    Sponsors and Collaborators

    • Abgenix
    • Sangstat Medical Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00035880
    Other Study ID Numbers:
    • ABX-CB-9906
    • NCT00012077
    First Posted:
    May 7, 2002
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jul 1, 2003
    Keywords provided by , ,
    Acute graft versus host disease
    Stem Cell Transplantation
    Additional relevant MeSH terms:
    Graft vs Host Disease

    Study Results

    No Results Posted as of Jun 24, 2005