DAB389IL-2 (Denileukin Diftitox, ONTAK): Review of Clinical Trials to Date

Timothy M. Kuzel*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

13 Scopus citations


Clinical trials of DAB389IL-2 (denileukin diftitox, ONTAK) have been conducted in a variety of disease states as well as in normal volunteers. The individuals treated include 45 volunteers in pharmacokinetic testing, 195 patients with noncancer indications, and 216 patients with lymphoma, including ongoing trials. The noncancer trials involved patients with rheumatoid arthritis, psoriasis, HIV infection, and insulin-dependent diabetes mellitus. Two large trials involving 143 lymphoma patients provide the definitive data and formed the basis for seeking and receiving Food and Drug Administration approval for DAB389IL-2, The focus of this paper will be a review of the efficacy and toxicity trials with DAB389IL-2 completed to date in cancer, in particular those that involved patients with cutaneous T-cell lymphoma, as well as the rationale for these trials.

Original languageEnglish (US)
Pages (from-to)S33-S36
JournalClinical Lymphoma
Issue number1 SUPPL.
StatePublished - Nov 2000


  • DABIL-2
  • HIV infection
  • Lymphoma
  • Pharmacokinetics
  • Psoriasis
  • Rheumatoid arthritis

ASJC Scopus subject areas

  • Cancer Research


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