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Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) · Source last updated 2026-08-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening

   id

   FG000

   title

   NTCS Phase

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Pregnancy

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Subject/guardian decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         163

      comment

      Patients who should have satisfied all the inclusion and none of the exclusion criteria were to be enrolled into the consolidation phase where the patients were treated with nilotinib with the same dose as prior to study entry. Duration of the consolidation phase was 52 weeks or until a patient experienced unacceptable toxicity, disease progression, death, loss to follow-up, and/or treatment was discontinued at the discretion of the Investigator or due to withdrawal of consent.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         126

      comment

      The duration of the TFR phase was up to 528 weeks after the last patient entered the TFR phase. Patients stopped taking nilotinib on the day they entered TFR phase.

      type

      TFR Phase

   3. achievements

      1. group Id

         FG000

         num Subjects

         61

      comment

      Nilotinib treatment re-initiation (NTRI) phase: If a patient had a confirmed loss of MR4 (two consecutive BCR-ABL1 \>0.01% IS) or loss of MMR (BCR-ABL1 \>0.1% IS) in the TFR phase, the patient restarted nilotinib treatment.

      type

      NTRI Phase

   4. achievements

      1. group Id

         FG000

         num Subjects

         26

      comment

      Patients who were not eligible to enter into the TFR phase after completing the first 52-week NTCS phase entered the nilotinib treatment continuation (NTCT) phase and would continue treatment with nilotinib for another 52 weeks (a total of 104 weeks of treatment).

      type

      NTCT Phase

   5. achievements

      1. group Id

         FG000

         num Subjects

         7

      comment

      Patients who maintained MR4.5 during the NTCT phase (a total of 104 weeks of treatment) were eligible to cease nilotinib treatment and enter the TFR-2 phase. The duration of the TFR-2 phase was up to 528 weeks after the last patient entered the TFR phase.

      type

      TFR-2 Phase

   6. achievements

      1. group Id

         FG000

         num Subjects

         2

      comment

      If a patient had a loss of MMR or a confirmed loss of MR4 during the TFR-2 phase, he/she entered the nilotinib treatment re-initiation-2 (NTRI-2) phase and resume nilotinib treatment at a dose of either 300 mg or 400 mg b.i.d. The frequency of assessments for the NTRI-2 phase was similar to those of the NTRI phase.

      type

      NTRI-2 Phase

   7. achievements

      1. group Id

         FG000

         num Subjects

         14

      comment

      Patients who were not able to maintain MR4.5 and had a confirmed loss of MR4.5 during the NTCT phase were not eligible to enter the TFR-2 phase. These patients entered into the nilotinib treatment prolonged continuation phase (NTCT-P) and continued nilotinib treatment until 528 weeks after the last patient entered the TFR phase, or until the patients experience unacceptable toxicity, disease progression, death, lost to follow-up.

      type

      NTCT-P Phase

   8. achievements

      1. group Id

         FG000

         num Subjects

         152

      comment

      Completed = Completed 52 weeks of NTCS phase

      type

      COMPLETED

   9. achievements

      1. group Id

         FG000

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Informed consent was obtained from each participant in writing before screening before any study specific procedure was performed.

recruitment Details

Recruitment for the study comprised a total of 163 participants, who were enrolled at 63 clinical sites distributed across 18 different countries.. Argentina (2), Australia (3), Belgium (1), Brazil (6), Canada (4), France (5), Germany (5), Greece (3), Israel (3), Japan (7), Mexico (1), Poland (3), Russia (3), Singapore (1), South Korea (1), Spain (8), UK (2), US (5)

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Preserved source evidence · Not medical advice