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A Phase II, Single Arm, Open Label Study of Treatment-Free Remission in Chronic Myeloid Leukemia (CML) chronic phase (CP) patients After Achieving Sustained MR4.5 on Nilotinib

Trial Profile

A Phase II, Single Arm, Open Label Study of Treatment-Free Remission in Chronic Myeloid Leukemia (CML) chronic phase (CP) patients After Achieving Sustained MR4.5 on Nilotinib

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Jan 2019

At a glance

  • Drugs Nilotinib (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms ENESTop
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals; Novartis Pharmaceuticals Corporation
  • Most Recent Events

    • 13 Nov 2018 According to a Novartis media release, based on the results of two major Novartis studies (ENESTfreedom and ENESTop), the Health Canada has approved the inclusion of treatment discontinuation (TFR) data in the Tasigna product monograph.Tasigna is the TKI to include data in the product monograph on attempting treatment discontinuation in eligible Ph+ CML patients who have achieved a sustained molecular response.
    • 31 Aug 2018 Biomarkers information updated
    • 16 Jul 2018 Planned End Date changed from 1 Feb 2020 to 6 Feb 2025.
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