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

June 23, 2005 updated by: Abgenix

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

95

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94555
        • Abgenix, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abgenix

Collaborators

Sangstat Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

May 6, 2002

First Submitted That Met QC Criteria

May 6, 2002

First Posted (Estimate)

May 7, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABX-CB-9906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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