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NCT01698905 · OUTCOME

Percentage of Participants With Stable MMR in Nilotinib Re-initiation 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
at 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks, 288 weeks, 336 weeks, 384 weeks and 432 weeks after re-initiating Nilotinib in the NTRI Phase

What was measured

Percentage of participants who were in stable MMR (stable MMR=BCR-ABL ≤ 0.1% IS) at multiple timepoints after achievement of that response in the nilotinib re-initiation phase for those timepoints.

Analysis population: Nilotinib treatment re-initiation (NTRI) Safety set included participants who achieved MMR at least once in nilotinib re-initiation phase

Groups in this outcome

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.

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

Analysis denominator · Participants

GroupSource count
NTRI Phase60

Reported measurements

Stable MMR for 48 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase52Not reportedNot reportedNot reportedNot reported
Stable MMR for 96 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase46Not reportedNot reportedNot reportedNot reported
Stable MMR for 144 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase41Not reportedNot reportedNot reportedNot reported
Stable MMR for 192 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase38Not reportedNot reportedNot reportedNot reported
Stable MMR for 240 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase31Not reportedNot reportedNot reportedNot reported
Stable MMR for 288 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase27Not reportedNot reportedNot reportedNot reported
Stable MMR for 336 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase24Not reportedNot reportedNot reportedNot reported
Stable MMR for 384 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase22Not reportedNot reportedNot reportedNot reported
Stable MMR for 432 weeks [
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NTRI Phase18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        52
    title
    Stable MMR for 48 weeks
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        46
    title
    Stable MMR for 96 weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        41
    title
    Stable MMR for 144 weeks
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        38
    title
    Stable MMR for 192 weeks
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    title
    Stable MMR for 240 weeks
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        27
    title
    Stable MMR for 288 weeks
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    Stable MMR for 336 weeks
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    Stable MMR for 384 weeks
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Stable MMR for 432 weeks [
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    units
    Participants
description
Percentage of participants who were in stable MMR (stable MMR=BCR-ABL ≤ 0.1% IS) at multiple timepoints after achievement of that response in the nilotinib re-initiation phase for those timepoints.
groups
  1. description
    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.
    id
    OG000
    title
    NTRI Phase
param Type
COUNT_OF_PARTICIPANTS
population Description
Nilotinib treatment re-initiation (NTRI) Safety set included participants who achieved MMR at least once in nilotinib re-initiation phase
reporting Status
POSTED
time Frame
at 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks, 288 weeks, 336 weeks, 384 weeks and 432 weeks after re-initiating Nilotinib in the NTRI Phase
title
Percentage of Participants With Stable MMR in Nilotinib Re-initiation Phase
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice