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CompletedNCT00035880Updated Jun 24, 2005

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

A Phase 2/3 interventional study of ABX-CBL in Graft Vs Host Disease, sponsored by Abgenix. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Abgenix · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
1 Year and older
Sex
All
01

Study 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.

02

Conditions studied

  • Graft Vs Host Disease

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Keywords

  • Acute graft versus host disease
  • Stem Cell Transplantation
03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 95 is above the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Abgenix is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
95 participants

Interventions

  • DrugABX-CBL
06

Study locations

1 site
  • Abgenix, Inc
    Fremont, California 94555, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00035880
Lead sponsor
Abgenix
Collaborators
Sangstat Medical Corporation
First posted
May 7, 2002
Start date
Oct 1999
Completion
Jun 2003
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2003. You cannot join it, but the record below documents what was studied.

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