Denileukin diftitox for the treatment of CD25 low-expression mycosis fungoides and Sézary syndrome

H. Miles Prince, Ann G. Martin, Elise A. Olsen, David P. Fivenson, Madeleine Duvic

Research output: Contribution to journalArticle

14 Scopus citations


In a placebo-controlled study, denileukin diftitox (DD) was effective against cutaneous T-cell lymphoma (CTCL) expressing CD25. An open-label companion study examined the efficacy and safety of DD in 36 patients with skin biopsies containing < 20% CD25 cells by immunohistochemistry staining (CD25 low expression). Patients received DD 18 μg/kg/day for 5 consecutive days every 3 weeks for up to eight courses. The primary endpoint, overall response rate, was 30.6% (95% confidence interval: 16.3, 48.1), 33.3% for stage IIA or lower disease, and 26.7% for stage IIB or greater disease. Median progression-free survival (PFS) was > 487 days, and median time to treatment failure was 68.5 days. No difference in PFS by disease stage was observed. The safety profile of DD in CD25 low-expression disease was similar to that in CD25+ disease. These findings suggest that CD25 low expression does not preclude a meaningful clinical response to DD in patients with CTCL.

Original languageEnglish
Pages (from-to)69-75
Number of pages7
JournalLeukemia and Lymphoma
Issue number1
StatePublished - Jan 1 2013


  • Antigens
  • CD25
  • Cutaneous T-cell lymphoma
  • Denileukin diftitox
  • Mycosis fungoides
  • Sézary syndrome

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