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NCT01844765 · OUTCOME

Best BCR-ABL Ratio Categories for Newly Diagnosed Ph+ CML-CP - 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

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
Newly Diagnosed and Untreated Ph+ CML in First CP25

Reported measurements

≤ 0.0032%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP44.0Not reportedNot reportedNot reportedNot reported
>0.0032% - ≤ 0.01%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP12.0Not reportedNot reportedNot reportedNot reported
>0.01% - ≤ 0.1%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP20.0Not reportedNot reportedNot reportedNot reported
>0.1% - ≤ 1%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP8.0Not reportedNot reportedNot reportedNot reported
>1% - ≤ 10%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP8.0Not reportedNot reportedNot reportedNot reported
>10%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP8.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        44.0
    title
    ≤ 0.0032%
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12.0
    title
    >0.0032% - ≤ 0.01%
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
    title
    >0.01% - ≤ 0.1%
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8.0
    title
    >0.1% - ≤ 1%
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8.0
    title
    >1% - ≤ 10%
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8.0
    title
    >10%
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    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 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
    OG000
    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
up to 66 cycles (1 cycle = 28 days)
title
Best BCR-ABL Ratio Categories for Newly Diagnosed Ph+ CML-CP - Overall
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice