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

Information source: Abgenix
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft Vs Host Disease

Intervention: ABX-CBL (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Abgenix


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Abgenix, Inc, Fremont, California 94555, United States
Additional Information

Starting date: October 1999
Last updated: June 23, 2005

Page last updated: August 20, 2015

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