A multicenter phase III randomized double-blind placebo-controlled study to evaluate the efficacy of two dose levels of DAB3891L-2 (9 and 18 mcg/kg/day) [denileukin diftitox; Ontak] in cutaneous T-cell lymphoma (CTCL) patients with stage Ia-III disease who, following less than or equal to 3 previous therapies, have recurrent or persistent disease that has been biopsy-documented to express CD25

Trial Profile

A multicenter phase III randomized double-blind placebo-controlled study to evaluate the efficacy of two dose levels of DAB3891L-2 (9 and 18 mcg/kg/day) [denileukin diftitox; Ontak] in cutaneous T-cell lymphoma (CTCL) patients with stage Ia-III disease who, following less than or equal to 3 previous therapies, have recurrent or persistent disease that has been biopsy-documented to express CD25

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2010

At a glance

  • Drugs Denileukin diftitox (Primary)
  • Indications Cutaneous T cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 08 Mar 2010 Results published in JCO.
    • 04 Jun 2007 Primary endpoint 'Objective clinical response rate' has been met.
    • 05 Sep 2005 New trial record.
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