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NCT01844765 · OUTCOME

Pharmacodynamics (BCR-ABL Transcript Levels Determined With Standard Protocols in Peripheral Blood): Best MMR Status by Cycle

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22

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
By 3, 6, 9, 12, 18, 24, 36, 48, 66 cycles

What was measured

BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL transcript levels were summarized by cohort and time point. MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR.

Analysis population: Full Analysis Set (FAS): All patients who received at least one dose of study medication.

Groups in this outcome

Resistant/Intolerant Ph+ CML in CP

Patients resistant or intolerant to either imatinib or dasatinib

Newly Diagnosed and Untreated Ph+ CML in First CP

Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.

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

Analysis denominator · Participants

GroupSource count
Resistant/Intolerant Ph+ CML in CP33
Newly Diagnosed and Untreated Ph+ CML in First CP25

Reported measurements

By Cycle 3
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP36.4Not reported20.454.9Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP12.0Not reported2.531.2Not reported
By Cycle 6
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP45.5Not reported28.163.6Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP52.0Not reported31.372.2Not reported
By Cycle 9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP51.5Not reported33.569.2Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP56.0Not reported34.975.6Not reported
By Cycle 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP57.6Not reported39.274.5Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP64.0Not reported42.582.0Not reported
By Cycle 18
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP57.6Not reported39.274.5Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP68.0Not reported46.585.1Not reported
By Cycle 24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP57.6Not reported39.274.5Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP68.0Not reported46.585.1Not reported
By Cycle 36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP57.6Not reported39.274.5Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP76.0Not reported54.990.6Not reported
By Cycle 48
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP60.6Not reported42.177.1Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP76.0Not reported54.990.6Not reported
By Cycle 66
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP60.6Not reported42.177.1Not reported
Newly Diagnosed and Untreated Ph+ CML in First CP76.0Not reported54.990.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.4
        upper Limit
        54.9
        value
        36.4
      2. group Id
        OG001
        lower Limit
        2.5
        upper Limit
        31.2
        value
        12.0
    title
    By Cycle 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.1
        upper Limit
        63.6
        value
        45.5
      2. group Id
        OG001
        lower Limit
        31.3
        upper Limit
        72.2
        value
        52.0
    title
    By Cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.5
        upper Limit
        69.2
        value
        51.5
      2. group Id
        OG001
        lower Limit
        34.9
        upper Limit
        75.6
        value
        56.0
    title
    By Cycle 9
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.2
        upper Limit
        74.5
        value
        57.6
      2. group Id
        OG001
        lower Limit
        42.5
        upper Limit
        82.0
        value
        64.0
    title
    By Cycle 12
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.2
        upper Limit
        74.5
        value
        57.6
      2. group Id
        OG001
        lower Limit
        46.5
        upper Limit
        85.1
        value
        68.0
    title
    By Cycle 18
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.2
        upper Limit
        74.5
        value
        57.6
      2. group Id
        OG001
        lower Limit
        46.5
        upper Limit
        85.1
        value
        68.0
    title
    By Cycle 24
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.2
        upper Limit
        74.5
        value
        57.6
      2. group Id
        OG001
        lower Limit
        54.9
        upper Limit
        90.6
        value
        76.0
    title
    By Cycle 36
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.1
        upper Limit
        77.1
        value
        60.6
      2. group Id
        OG001
        lower Limit
        54.9
        upper Limit
        90.6
        value
        76.0
    title
    By Cycle 48
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.1
        upper Limit
        77.1
        value
        60.6
      2. group Id
        OG001
        lower Limit
        54.9
        upper Limit
        90.6
        value
        76.0
    title
    By Cycle 66
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      25
    units
    Participants
description
BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL transcript levels were summarized by cohort and time point. MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    OG000
    title
    Resistant/Intolerant Ph+ CML in CP
  2. description
    Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
    id
    OG001
    title
    Newly Diagnosed and Untreated Ph+ CML in First CP
param Type
NUMBER
population Description
Full Analysis Set (FAS): All patients who received at least one dose of study medication.
reporting Status
POSTED
time Frame
By 3, 6, 9, 12, 18, 24, 36, 48, 66 cycles
title
Pharmacodynamics (BCR-ABL Transcript Levels Determined With Standard Protocols in Peripheral Blood): Best MMR Status by Cycle
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice