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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00035880

Enrollment

Registered

2002-05-07

Start date

1999-10-31

Completion date

2003-06-30

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Vs Host Disease

Keywords

Acute graft versus host disease, Stem Cell Transplantation

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.

Interventions

DRUGABX-CBL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026