A phase III open uncontrolled study of denileukin diftitox in 71 patients with stage IB-IVA CTCL has shown an OR rate of 30%, with 10% showing a complete clinical response.67 Only CTCL cases with biopsies showing >20% CD25+ (IL-2R) lymphocytes were enrolled. Median duration of response was 6-9 months. No difference in response rates or duration of response was noted between 9 and 18 micrograms/kg/day. The development of anti-denileukin diftitox antibodies apparently did not affect response rates.

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