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

Abgenix

Status and phase

Completed

Phase 3

Phase 2

Conditions

Graft Vs Host Disease

Treatments

Drug: ABX-CBL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00035880

ABX-CB-9906

Details and patient eligibility

About

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.

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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