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NCT01698905 · OUTCOME

Treatment Free Survival (TFS) After the Start of the TFR Phase

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
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
nilotinib cessation up to approximately 580 weeks

What was measured

Treatment-free survival defined as the time from the date of start of TFR to the date of earliest occurrence of any of the following events: loss of MMR, confirmed loss of MR4, re-initiation of nilotinib treatment due to any cause, progression to acute phase (AP) or blast crisis (BC) or death due to any cause.

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

Groups in this outcome

TFS 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
TFS Phase126

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TFS Phase169Not reported27.9NAThe upper bound of the confidence interval was not estimable due to insufficient number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper bound of the confidence interval was not estimable due to insufficient number of events
        group Id
        OG000
        lower Limit
        27.9
        upper Limit
        NA
        value
        169
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    units
    Participants
description
Treatment-free survival defined as the time from the date of start of TFR to the date of earliest occurrence of any of the following events: loss of MMR, confirmed loss of MR4, re-initiation of nilotinib treatment due to any cause, progression to acute phase (AP) or blast crisis (BC) or death due to any cause.
dispersion Type
95% Confidence Interval
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
    TFS Phase
param Type
MEDIAN
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
nilotinib cessation up to approximately 580 weeks
title
Treatment Free Survival (TFS) After the Start of the TFR Phase
type
SECONDARY
unit Of Measure
Weeks

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice