deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT01784068

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients (ENESTfreedom)

A Single-arm, Multicenter, Nilotinib Treatment-free Remission Study in Patients With BCR-ABL1 Positive Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease (MRD) Status on First Line Nilotinib Treatment.

Sponsor: Novartis Pharmaceuticals

Conditions Chronic Myelogenous Leukemia
Interventions Nilotinib followed by treatment-free
Updated 42 times since 2017 Last updated: Sep 8, 2025 Started: Mar 19, 2013 Primary completion: May 31, 2016 Completion: Jan 23, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Chronic Myelogenous Leukemia, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 42 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshot~Oct 2017 – ~Feb 2018 · 4 months · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~May 2020 · 3 months · monthly snapshot~May 2020 – ~Aug 2020 · 3 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~May 2022 · 5 months · monthly snapshot~May 2022 – ~Jun 2023 · 13 months · monthly snapshot~Jun 2023 – ~Jan 2024 · 7 months · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Jan 2025 · 2 months · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Apr 2025 · 59 days · monthly snapshot~Apr 2025 – ~Jun 2025 · 2 months · monthly snapshot~Jun 2025 – ~Aug 2025 · 2 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 11 months · monthly snapshot

Change History

42 versions recorded

  1. Oct 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2025 — Oct 2025 [monthly]

    Completed PHASE2

  3. Aug 2025 — Sep 2025 [monthly]

    Completed PHASE2

  4. Jun 2025 — Aug 2025 [monthly]

    Completed PHASE2

  5. Apr 2025 — Jun 2025 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 37 earlier versions

  1. Feb 2025 — Apr 2025 [monthly]

    Active Not Recruiting PHASE2

  2. Jan 2025 — Feb 2025 [monthly]

    Active Not Recruiting PHASE2

  3. Nov 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

  6. Mar 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

  7. Jan 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE2

  8. Jun 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE2

  9. May 2022 — Jun 2023 [monthly]

    Active Not Recruiting PHASE2

  10. Dec 2021 — May 2022 [monthly]

    Active Not Recruiting PHASE2

  11. Sep 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE2

  12. May 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2

  13. Mar 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE2

  14. Feb 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2

  15. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE2

  16. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  17. Aug 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

  18. May 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE2

  19. Feb 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE2

  20. Dec 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2

  21. Oct 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE2

  22. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2

  23. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE2

  24. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  25. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

  26. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE2

  27. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE2

  28. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

  29. Nov 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE2

  30. Jun 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE2

  31. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  32. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

  33. Oct 2017 — Feb 2018 [monthly]

    Active Not Recruiting PHASE2

  34. Aug 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  35. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

  36. Feb 2017 — Jul 2017 [monthly]

    Active Not Recruiting PHASE2

  37. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Mar 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aachen, Germany , Aarhus N, Denmark , Akita, Japan , Ancona, Italy , Athens, Greece , Barakaldo, Spain , Barcelona, Spain , Bayonne, France , Bayreuth, Germany , Berlin, Germany and 93 more locations