Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma

Trial Profile

Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2017

At a glance

  • Drugs Mogamulizumab (Primary) ; Vorinostat
  • Indications Cutaneous T cell lymphoma; Mycosis fungoides; Sezary syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms MAVORIC
  • Sponsors Kyowa Hakko Kirin
  • Most Recent Events

    • 25 Aug 2017 According to a Kyowa Hakko Kirin media release, based on the data from this study U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to mogamulizumab which is being developed for the treatment of Mycosis Fungoides (MF) and Sezary Syndrome (SS), in adult patients who have received at least one prior systemic therapy.
    • 26 Apr 2017 Planned End Date changed from 1 Dec 2017 to 1 Dec 2018.
    • 07 Apr 2017 According to a Kyowa Hakko Kirin media release, company plans to discuss data from this trial with regulatory authorities in 2017, so as to pursue marketing authorisations for mogamulizumab for the treatment of cutaneous T-cell lymphoma.
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