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NCT01784068 · OUTCOME

Percentage of Participants With Stable Major Molecular Response (MMR) at Multiple Time Points After First Achievement of MMR During Nilotinib Re-Initiation

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients · Source last updated 2026-08-13

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Weeks 48, 96, 144, 192, 240, 288, 336, 384, and 432 after first achievement of MMR during the nilotinib re-initiation phase

What was measured

The percentage of patients who were in stable MMR after achieving a response in the NTRI phase at multiple timepoints was calculated by dividing the number of participants achieving MMR any time during the NTRI phase and having the same response at those timepoints after the first achievement of MMR, irrespective of whether there was loss of MMR in between, by the number of patients who achieved MMR at any time during the NTRI phase.

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

Groups in this outcome

NTRI Phase

Participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase entered the nilotinib treatment re-initiation (NTRI) phase. During this phase, nilotinib treatment was re-initiated at a dose of 300 mg twice daily.

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 Phase89

Reported measurements

Stable MMR for 48 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase84.3Not reported75.091.1Not reported
Stable MMR for 96 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase78.7Not reported68.786.6Not reported
Stable MMR for 144 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase68.5Not reported57.878.0Not reported
Stable MMR for 192 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase60.7Not reported49.770.9Not reported
Stable MMR for 240 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase48.3Not reported37.659.2Not reported
Stable MMR for 288 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase42.7Not reported32.353.6Not reported
Stable MMR for 336 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase38.2Not reported28.149.1Not reported
Stable MMR for 384 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase34.8Not reported25.045.7Not reported
Stable MMR for 432 weeks
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NTRI Phase30.3Not reported21.041.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        75.0
        upper Limit
        91.1
        value
        84.3
    title
    Stable MMR for 48 weeks
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.7
        upper Limit
        86.6
        value
        78.7
    title
    Stable MMR for 96 weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.8
        upper Limit
        78.0
        value
        68.5
    title
    Stable MMR for 144 weeks
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.7
        upper Limit
        70.9
        value
        60.7
    title
    Stable MMR for 192 weeks
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.6
        upper Limit
        59.2
        value
        48.3
    title
    Stable MMR for 240 weeks
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.3
        upper Limit
        53.6
        value
        42.7
    title
    Stable MMR for 288 weeks
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.1
        upper Limit
        49.1
        value
        38.2
    title
    Stable MMR for 336 weeks
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25.0
        upper Limit
        45.7
        value
        34.8
    title
    Stable MMR for 384 weeks
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.0
        upper Limit
        41.0
        value
        30.3
    title
    Stable MMR for 432 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    units
    Participants
description
The percentage of patients who were in stable MMR after achieving a response in the NTRI phase at multiple timepoints was calculated by dividing the number of participants achieving MMR any time during the NTRI phase and having the same response at those timepoints after the first achievement of MMR, irrespective of whether there was loss of MMR in between, by the number of patients who achieved MMR at any time during the NTRI phase.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase entered the nilotinib treatment re-initiation (NTRI) phase. During this phase, nilotinib treatment was re-initiated at a dose of 300 mg twice daily.
    id
    OG000
    title
    NTRI Phase
param Type
NUMBER
population Description
The nilotinib treatment re-initiation (NTRI) safety set included all participants who achieved MMR at least once in nilotinib re-initiation phase
reporting Status
POSTED
time Frame
Weeks 48, 96, 144, 192, 240, 288, 336, 384, and 432 after first achievement of MMR during the nilotinib re-initiation phase
title
Percentage of Participants With Stable Major Molecular Response (MMR) at Multiple Time Points After First Achievement of MMR During Nilotinib Re-Initiation
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice