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 Feb 2018

At a glance

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

    • 20 Feb 2018 Results evaluating treatment free remission after second-line nilotinib treatment in patients with chronic myeloid leukemia, published in the Annals of Internal Medicine
    • 22 Dec 2017 According to a MolecularMD media release, the FDA has granted authorization of the MRDx BCR-ABL Test, as an aid in identifying Philadelphia chromosome positive Chronic Myeloid Leukemia patients in the chronic phase being treated with Tasigna (nilotinib) capsules who may be candidates for treatment discontinuation and for monitoring of treatment-free remission (TFR). The TFR data in the Tasigna label approved by the FDA includes the use of MRDx BCR-ABL test in ENESTfreedom and ENESTop studies.
    • 22 Dec 2017 According to a Novartis media release, based on the data of this trial and other trial (ENESTfreedom), the US FDA has approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna (nilotinib) US product label, which follows a priority review for a supplemental New Drug Application (sNDA) for Tasigna.
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