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 Blood, 15 March 2007, Vol. 109, No. 6, pp. 2657-2662.
Prepublished online as a Blood First Edition Paper on November 16, 2006; DOI 10.1182/blood-2006-08-013995.

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TRANSPLANTATION

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

Margaret L. MacMillan1, Daniel Couriel2, Daniel J. Weisdorf1, Gisela Schwab3, Nancy Havrilla3, Thomas R. Fleming4, Saling Huang3, Lorin Roskos3, Shimon Slavin5, Richard K. Shadduck6, John DiPersio7, Mary Territo8, Steve Pavletic9, Charles Linker10, Helen E. Heslop11, H. Joachim Deeg12, and Bruce R. Blazar1

1 Blood and Marrow Transplant Program, University of Minnesota, Minneapolis; 2 M. D. Anderson Cancer Center, Houston, TX; 3 Abgenix, Fremont, CA; 4 University of Washington, Seattle; 5 Hadassah Hebrew University Hospital, Jerusalem, Israel; 6 Western Pennsylvania Hospital, Pittsburgh; 7 Washington University School of Medicine, St Louis, MO; 8 University of California, Los Angeles (UCLA) Medical Center; 9 University of Nebraska Medical Center, Omaha; 10 University of California, San Francisco (UCSF) Stanford Healthcare; 11 Baylor College of Medicine, Houston, TX; 12 Fred Hutchinson Cancer Research Center, Seattle, WA

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.


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