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, Joseph H. Antin

Research output: Contribution to journalArticle

128 Scopus citations

Abstract

Denileukin diftitox (Ontak), a recombinant protein composed of human interleukin 2 (IL-2) fused to diphtheria toxin, has selective cytotoxicity against activated lymphocytes expressing the high-affinity IL-2 receptor. We conducted a phase 1 study of denileukin diftitox in 30 patients with steroid refractory acute graft-versus-host disease (GVHD). Seven patients received 9 μg/kg intravenously on days 1 and 15; 18 received 9 μg/kg intravenously on days 1, 3, 5, 15, 17, and 19; and 5 received 9 μg/kg intravenously on days 1 to 5 and 15 to 19. Hepatic transaminase elevation was the dose-limiting toxicity (DLT), and dose level 2 was the maximum tolerated dose (MTD). Overall, 71% of patients responded with complete resolution (12 of 24; 50%) or partial resolution (5 of 24; 21%) of GVHD. Eight of 24 patients (33%) are alive at 6.3 to 24.6 months (median, 7.2 months). Denileukin diftitox is tolerable and has promising activity in steroid-refractory acute GVHD.

Original languageEnglish (US)
Pages (from-to)1224-1226
Number of pages3
JournalBlood
Volume104
Issue number4
DOIs
StatePublished - Aug 15 2004

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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    Ho, V. T., Zahrieh, D., Hochberg, E., Micale, E., Levin, J., Reynolds, C., Steckel, S., Cutler, C., Fisher, D. C., Lee, S. J., Alyea, E. P., Ritz, J., Soiffer, R. J., & Antin, J. H. (2004). Safety and efficacy of denileukin diftitox in patients with steroid-refractory acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation. Blood, 104(4), 1224-1226. https://doi.org/10.1182/blood-2004-01-0028