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An open label six month study to evaluate the safety and efficacy of nitrogen mustard (NM) [chlormethine] 0.04% ointment formulation in patients with stage I or IIA mycosis fungoides (MF) who have completed an initial 12 month treatment with nitrogen mustard 0.02% but without a complete response.

Trial Profile

An open label six month study to evaluate the safety and efficacy of nitrogen mustard (NM) [chlormethine] 0.04% ointment formulation in patients with stage I or IIA mycosis fungoides (MF) who have completed an initial 12 month treatment with nitrogen mustard 0.02% but without a complete response.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 May 2022

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At a glance

  • Drugs Chlormethine (Primary)
  • Indications Mycosis fungoides
  • Focus Therapeutic Use
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 10 May 2022 Results of post-hoc analysis published in the American Journal of Clinical Dermatology.
    • 18 Feb 2021 According to a Helsinn Therapeutics media release, it is pleased to note two recent journal publications on the use of mechlorethamine gel 0.016% as a topical treatment of early stage mycosis fungoides-type cutaneous T-cell lymphoma . Bioanalytic testing results indicate lack of systemic absorption of mechlorethamine in plasma samples from the 201 and 202 pivotal study.
    • 06 Dec 2011 Actual end date (Mar 2011) added as reported by ClinicalTrials.gov.
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