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NCT01698905 · OUTCOME

BCR-ABL Ratio (%) Over Time in Nilotinib Treatment Re-initiation Phase (NTRI)

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
MEAN
Unit
Percent
Interval / dispersion
Standard Deviation
Time frame
re-start of nilotinib up to approximately 48 weeks

What was measured

ABL= Abelson leukemia virus and BCR=Break point cluster region. The BCR-ABL ratio (%) represents the level of BCR-ABL fusion gene transcripts relative to a control gene (ABL) measured in peripheral blood samples using quantitative reverse transcription polymerase chain reaction (RT-PCR). Results are expressed as a percentage on the International Scale (IS), a standardized reporting method that allows comparison across laboratories. The BCR-ABL ratio is used to assess the molecular response to treatment, with lower values indicating a reduced disease burden.

Analysis population: Nilotinib treatment re-initiation (NTRI) Safety set: Patients who received at least 1 dose of study medication during treatment re-initiation phase after the TFR 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 Phase61

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
NTRI Phase61
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase1.533428.070454Not reportedNot reportedNot reported
Week 4

Analysis denominator · Participants

GroupSource count
NTRI Phase60
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase1.014364.354164Not reportedNot reportedNot reported
Week 8

Analysis denominator · Participants

GroupSource count
NTRI Phase58
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase0.448402.571063Not reportedNot reportedNot reported
Week 12

Analysis denominator · Participants

GroupSource count
NTRI Phase60
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase0.299522.232066Not reportedNot reportedNot reported
Week 16

Analysis denominator · Participants

GroupSource count
NTRI Phase58
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase0.330122.481822Not reportedNot reportedNot reported
Week 20

Analysis denominator · Participants

GroupSource count
NTRI Phase54
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase0.184111.330561Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
NTRI Phase58
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase0.003770.013461Not reportedNot reportedNot reported
Week 36

Analysis denominator · Participants

GroupSource count
NTRI Phase56
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase0.015990.106080Not reportedNot reportedNot reported
Week 48

Analysis denominator · Participants

GroupSource count
NTRI Phase53
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NTRI Phase0.020400.132190Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.070454
        value
        1.53342
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.354164
        value
        1.01436
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    Week 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.571063
        value
        0.44840
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Week 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.232066
        value
        0.29952
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    Week 12
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.481822
        value
        0.33012
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Week 16
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.330561
        value
        0.18411
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    Week 20
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.013461
        value
        0.00377
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Week 24
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.106080
        value
        0.01599
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      units
      Participants
    title
    Week 36
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.132190
        value
        0.02040
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Week 48
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    units
    Participants
description
ABL= Abelson leukemia virus and BCR=Break point cluster region. The BCR-ABL ratio (%) represents the level of BCR-ABL fusion gene transcripts relative to a control gene (ABL) measured in peripheral blood samples using quantitative reverse transcription polymerase chain reaction (RT-PCR). Results are expressed as a percentage on the International Scale (IS), a standardized reporting method that allows comparison across laboratories. The BCR-ABL ratio is used to assess the molecular response to treatment, with lower values indicating a reduced disease burden.
dispersion Type
Standard Deviation
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
MEAN
population Description
Nilotinib treatment re-initiation (NTRI) Safety set: Patients who received at least 1 dose of study medication during treatment re-initiation phase after the TFR phase
reporting Status
POSTED
time Frame
re-start of nilotinib up to approximately 48 weeks
title
BCR-ABL Ratio (%) Over Time in Nilotinib Treatment Re-initiation Phase (NTRI)
type
SECONDARY
unit Of Measure
Percent

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

Preserved source evidence · Not medical advice