A phase 2/3 multicenter randomized clinical trial of ABX-CBL versus ATG as secondary therapy for steroid-resistant acute graft-versus-host disease

Blood. 2007 Mar 15;109(6):2657-62. doi: 10.1182/blood-2006-08-013995. Epub 2006 Nov 16.


Treatment for steroid-resistant acute graft-versus-host disease (GVHD) has had limited success. ABX-CBL is a hybridoma-generated murine IgM monoclonal antibody against the CD147 antigen, weakly expressed on human leukocytes and up-regulated on activated lymphocytes. A prospective, multicenter, open-label, randomized clinical trial comparing ABX-CBL to antithymocyte globulin (ATG) for treatment of steroid-resistant acute GVHD was conducted in 95 patients at 21 centers. Forty-eight patients received ABX-CBL daily for 14 consecutive days followed by up to 6 weeks of ABX-CBL twice weekly. Forty-seven patients received equine ATG, 30 mg/kg every other day for a total of 6 doses with additional courses as needed. By day 180, overall improvement was similar in the patients receiving ABX-CBL and in those receiving ATG (56% versus 57%, P = .91). Patient survival at 18 months was less favorable on ABX-CBL than on ATG (35% versus 45%), with the 95% confidence interval ruling out that ABX-CBL provides at least a 10.4% improvement. Data from this trial suggest that ABX-CBL does not offer an improvement over ATG in the treatment of acute steroid-resistant GVHD. This prospective, multicenter, randomized clinical trial for steroid-resistant acute GVHD serves as a model for future evaluation of new agents.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / immunology
  • Antibodies, Monoclonal / therapeutic use*
  • Antilymphocyte Serum / adverse effects
  • Antilymphocyte Serum / immunology
  • Antilymphocyte Serum / therapeutic use*
  • Basigin / immunology*
  • Child
  • Child, Preschool
  • Drug Resistance / drug effects*
  • Female
  • Graft vs Host Disease / drug therapy*
  • Graft vs Host Disease / immunology*
  • Graft vs Host Disease / pathology
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Steroids / pharmacology*
  • Survival Rate
  • Time Factors


  • Antibodies, Monoclonal
  • Antilymphocyte Serum
  • BSG protein, human
  • Steroids
  • Basigin