A phase 2/3 multicenter randomized clinical trial of ABX-CBL versus ATG as secondary therapy for steroid-resistant acute graft-versus-host disease
| Autor: | Thomas R. Fleming, Charles A. Linker, Margaret L. MacMillan, Saling Huang, Gisela Schwab, Shimon Slavin, Nancy Havrilla, H. Joachim Deeg, Daniel J. Weisdorf, Daniel R. Couriel, Steve Z. Pavletic, John F. DiPersio, Mary C. Territo, Helen E. Heslop, Bruce R. Blazar, Lorin Roskos, Richard K. Shadduck |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Randomization Adolescent Immunology Drug Resistance Graft vs Host Disease Biochemistry Gastroenterology law.invention Randomized controlled trial Antigen law Internal medicine Immunopathology medicine Humans Multicenter Studies as Topic Child Aged Antilymphocyte Serum biology business.industry Antibodies Monoclonal Cell Biology Hematology Middle Aged medicine.disease Confidence interval Surgery Survival Rate Clinical trial Graft-versus-host disease Child Preschool Basigin biology.protein Female Steroids Antibody business |
| Zdroj: | Blood. 109:2657-2662 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood-2006-08-013995 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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