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NCT02467270 · OUTCOME

Percentage of Participants With Major Molecular Response (MMR/MR3)

Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses · Source last updated 2026-03-17

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
12, 24 and 60 months after the first dose of study treatment

What was measured

MMR/MR3 was defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).

Analysis population: ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured, regardless of whether they received the assigned study drug. Seven participants were randomized but excluded from the ITT population because they had atypical transcripts (transcript type other than b2a2/b3a2) and were not evaluable for BCR-ABL1IS outcome.

Groups in this outcome

Treatment Period: Cohort A: Ponatinib 45 mg

Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.

Treatment Period: Cohort B: Ponatinib 30 mg

Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.

Treatment Period: Cohort C: Ponatinib 15 mg

Participants received ponatinib 15 mg orally once daily in each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Treatment Period: Cohort A: Ponatinib 45 mg93
Treatment Period: Cohort B: Ponatinib 30 mg93
Treatment Period: Cohort C: Ponatinib 15 mg91

Reported measurements

12 Months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg17.2Not reportedNot reportedNot reportedNot reported
Treatment Period: Cohort B: Ponatinib 30 mg20.4Not reportedNot reportedNot reportedNot reported
Treatment Period: Cohort C: Ponatinib 15 mg16.5Not reportedNot reportedNot reportedNot reported
24 Months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg24.7Not reportedNot reportedNot reportedNot reported
Treatment Period: Cohort B: Ponatinib 30 mg15.1Not reportedNot reportedNot reportedNot reported
Treatment Period: Cohort C: Ponatinib 15 mg19.8Not reportedNot reportedNot reportedNot reported
60 Months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg46.2Not reportedNot reportedNot reportedNot reported
Treatment Period: Cohort B: Ponatinib 30 mg29.0Not reportedNot reportedNot reportedNot reported
Treatment Period: Cohort C: Ponatinib 15 mg24.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17.2
      2. group Id
        OG001
        value
        20.4
      3. group Id
        OG002
        value
        16.5
    title
    12 Months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24.7
      2. group Id
        OG001
        value
        15.1
      3. group Id
        OG002
        value
        19.8
    title
    24 Months
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        46.2
      2. group Id
        OG001
        value
        29.0
      3. group Id
        OG002
        value
        24.2
    title
    60 Months
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    2. group Id
      OG001
      value
      93
    3. group Id
      OG002
      value
      91
    units
    Participants
description
MMR/MR3 was defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).
groups
  1. description
    Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    OG000
    title
    Treatment Period: Cohort A: Ponatinib 45 mg
  2. description
    Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    OG001
    title
    Treatment Period: Cohort B: Ponatinib 30 mg
  3. description
    Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
    id
    OG002
    title
    Treatment Period: Cohort C: Ponatinib 15 mg
param Type
NUMBER
population Description
ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured, regardless of whether they received the assigned study drug. Seven participants were randomized but excluded from the ITT population because they had atypical transcripts (transcript type other than b2a2/b3a2) and were not evaluable for BCR-ABL1IS outcome.
reporting Status
POSTED
time Frame
12, 24 and 60 months after the first dose of study treatment
title
Percentage of Participants With Major Molecular Response (MMR/MR3)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice