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NCT01698905 · OUTCOME

Percentage of Participants in TFR Within 48-weeks 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 48 weeks 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

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase73Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        73
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 48 weeks following nilotinib cessation
title
Percentage of Participants in TFR Within 48-weeks Following Nilotinib Cessation
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice