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: 20 Nov 2017

At a glance

  • Drugs Nilotinib (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms ENESTop; MACS1940
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 25 Jun 2017 Results (data cutoff, 7 Nov 2016) assessing the proportion of patients remaining in treatment-free-remission at 96 week, presented at the 22nd Congress of the European Haematology Association
    • 23 Jun 2017 According to a Novartis media release, this study is ongoing with planned follow-up to evaluate the ability of patients to sustain remission for longer durations following discontinuation of Tasigna.
    • 23 Jun 2017 According to a Novartis media release, the decision to add TFR data to the Tasigna SmPC is applicable to all 28 EU member states plus Iceland and Norway.
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