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NCT01698905 · OUTCOME

Percentage of Participants in TFR Within 96, 144, 192, 264 Weeks, and Within the End of Years 6, 7, 8, 9 and 10 Following Nilotinib Cessation

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
first 96, 144, 192, 264 weeks, and within the end of years 6, 7, 8, 9 and 10 following nilotinib cessation.

What was measured

TFR is defined as no confirmed loss of MR4 (molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.

Analysis population: Full analysis set (FAS) included all patients who completed the consolidation phase successfully and entered the TFR phase.

Groups in this outcome

TFR Phase

TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
TFR Phase126

Reported measurements

Week 96
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase67Not reportedNot reportedNot reportedNot reported
Week 144
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase61Not reportedNot reportedNot reportedNot reported
Week 192
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase58Not reportedNot reportedNot reportedNot reported
Week 264
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase54Not reportedNot reportedNot reportedNot reported
Week 312
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase50Not reportedNot reportedNot reportedNot reported
Week 360
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase44Not reportedNot reportedNot reportedNot reported
Week 408
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase41Not reportedNot reportedNot reportedNot reported
Week 468
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase38Not reportedNot reportedNot reportedNot reported
Week 528
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase32Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        67
    title
    Week 96
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        61
    title
    Week 144
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        58
    title
    Week 192
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        54
    title
    Week 264
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        50
    title
    Week 312
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        44
    title
    Week 360
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        41
    title
    Week 408
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        38
    title
    Week 468
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        32
    title
    Week 528
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    units
    Participants
description
TFR is defined as no confirmed loss of MR4 (molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.
groups
  1. description
    TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.
    id
    OG000
    title
    TFR Phase
param Type
COUNT_OF_PARTICIPANTS
population Description
Full analysis set (FAS) included all patients who completed the consolidation phase successfully and entered the TFR phase.
reporting Status
POSTED
time Frame
first 96, 144, 192, 264 weeks, and within the end of years 6, 7, 8, 9 and 10 following nilotinib cessation.
title
Percentage of Participants in TFR Within 96, 144, 192, 264 Weeks, and Within the End of Years 6, 7, 8, 9 and 10 Following Nilotinib Cessation
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice