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Blood, 15 August 2004, Vol. 104, No. 4, pp. 1224-1226. Prepublished online as a Blood First Edition Paper on April 27, 2004; DOI 10.1182/blood-2004-01-0028. This Article Full Text (PDF) All Versions of this Article: 2004-01-0028v1 104/4/1224    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Ho, V. T Articles by Antin, J. H Search for Related Content PubMed PubMed Citation Articles by Ho, V. T Articles by Antin, J. H Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted January 12, 2004 Accepted April 7, 2004 Safety and Efficacy of Denileukin Diftitox in Patients with Steroid Refractory Acute Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation Vincent T Ho*, David Zahrieh, Ephraim Hochberg, Eileen Micale, Jesse Levin, Carol Reynolds, Steve Steckel, Corey Cutler, David C Fisher, Stephanie J Lee, Edwin P Alyea, Jerome Ritz, Robert J Soiffer, and Joseph H Antin Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Dept. of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA Biostatistics, Dana-Farber Cancer Institute, Boston, MA, USA Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA Ligand Pharmaceuticals, San Diego, CA, USA Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Dept. of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Ligand Pharmaceuticals, San Diego, CA, USA * Corresponding author; email: VTHO{at}partners.org. Denileukin diftitox (ONTAK®), a recombinant protein composed of human interleukin-2 fused to diphtheria toxin, has selective cytotoxicity against activated lymphocytes expressing the high affinity interleukin-2 receptor. We conducted a phase I study of denileukin diftitox in 30 patients with steroid refractory acute GVHD. Seven patients received 9 µg/kg IV on days 1 and 15; 18 received 9 µg/kg IV on days 1, 3, 5, 15, 17, 19; and 5 received 9 µg/kg IV days 1-5, 15-19. Hepatic transaminase elevation was the dose-limiting toxicity (DLT), and dose level two was the maximum tolerated dose (MTD). Overall, 71% of patients responded with complete resolution (12/24 [50%]) or partial resolution (5/24 [21%]) of GVHD. Eight of 24 patients (33%) are alive between 6.3 to 24.6 months (median, 7.2 months). Denileukin diftitox is tolerable, and has promising activity in steroid-refractory acute GVHD. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: A. M. Alousi, D. J. Weisdorf, B. R. Logan, J. Bolanos-Meade, S. Carter, N. DiFronzo, M. Pasquini, S. C. Goldstein, V. T. Ho, B. Hayes-Lattin, et al. Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network Blood, July 16, 2009; 114(3): 511 - 517. [Abstract] [Full Text] [PDF] S. S Kim Treatment Options in Steroid-Refractory Acute Graft-Versus-Host Disease Following Hematopoietic Stem Cell Transplantation Ann. Pharmacother., September 1, 2007; 41(9): 1436 - 1444. [Abstract] [Full Text] [PDF] H. J. Deeg How I treat refractory acute GVHD Blood, May 15, 2007; 109(10): 4119 - 4126. [Abstract] [Full Text] [PDF] J. Vieweg, Z. Su, P. Dahm, and S. Kusmartsev Reversal of Tumor-Mediated Immunosuppression Clin. Cancer Res., January 15, 2007; 13(2): 727s - 732s. [Abstract] [Full Text] [PDF] D. Weisdorf GVHD The Nuts and Bolts Hematology, January 1, 2007; 2007(1): 62 - 67. [Abstract] [Full Text] [PDF] F. Ghori, K. D. Polder, L. C. Pinter-Brown, A. O. Hoff, R. F. Gagel, S. I. Sherman, and M. Duvic Thyrotoxicosis after Denileukin Diftitox Therapy in Patients with Mycosis Fungoides J. Clin. Endocrinol. Metab., June 1, 2006; 91(6): 2205 - 2208. [Abstract] [Full Text] [PDF]

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