A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)

Trial Profile

A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)

Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Mar 2017

At a glance

  • Drugs Chlormethine (Primary)
  • Indications Mycosis fungoides
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 07 Mar 2017 According to an Actelion Pharmaceuticals media release, based on the results of this trial the European Commission has granted marketing authorization for the use of Ledaga (chlormethine gel) 160 micrograms/g for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).
    • 16 Dec 2016 According to an Actelion Pharmaceuticals media release, final decision from European Commission is expected by the end of February 2017.
    • 16 Dec 2016 Results published in an Actelion Pharmaceuticals Media Release
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