Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01844765 · OUTCOME

Best BCR-ABL Ratio Categories for Resistant/Intolerant Ph+ CML - Overall

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
Not reported
Time frame
up to 66 cycles (1 cycle = 28 days)

What was measured

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 (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL ratio by percentage: \> 0.0032 to ≤ 0.01% is equal to a log reduction category of \>= 4 to \<4.5 -log reduction (MR4); BCR-ABL ratio by percentage: \<=0.0032% is equal to a log reduction category of \>= 4.5-log reduction (MMR4.5)

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

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

Reported measurements

<=0.0032%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP12.1Not reportedNot reportedNot reportedNot reported
> 0.0032% - ≤ 0.01%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP15.2Not reportedNot reportedNot reportedNot reported
>0.01% - ≤ 0.1%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP33.3Not reportedNot reportedNot reportedNot reported
>0.1% - ≤ 1%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP21.2Not reportedNot reportedNot reportedNot reported
>1% - ≤ 10%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP9.1Not reportedNot reportedNot reportedNot reported
> 10%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP6.1Not reportedNot reportedNot reportedNot reported
Atypical transcripts at baseline
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP3.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12.1
    title
    <=0.0032%
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15.2
    title
    > 0.0032% - ≤ 0.01%
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
    title
    >0.01% - ≤ 0.1%
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        21.2
    title
    >0.1% - ≤ 1%
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9.1
    title
    >1% - ≤ 10%
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6.1
    title
    > 10%
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3.0
    title
    Atypical transcripts at baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
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 (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL ratio by percentage: \> 0.0032 to ≤ 0.01% is equal to a log reduction category of \>= 4 to \<4.5 -log reduction (MR4); BCR-ABL ratio by percentage: \<=0.0032% is equal to a log reduction category of \>= 4.5-log reduction (MMR4.5)
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    OG000
    title
    Resistant/Intolerant Ph+ CML in 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
up to 66 cycles (1 cycle = 28 days)
title
Best BCR-ABL Ratio Categories for Resistant/Intolerant Ph+ CML - Overall
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice