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NCT02467270 · OUTCOME

Percentage of Participants With Major Cytogenetic Response (MCyR)

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
95% Confidence Interval
Time frame
12 months after the first dose of study treatment

What was measured

MCyR was defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: 0% Ph + metaphases; PCyR: \>0 to 35% Ph + metaphases.

Analysis population: ITT Cytogenetic Population included all participants who were randomized and had a cytogenetic assessment at Baseline with ≥20 metaphases examined, regardless of whether they received the assigned study drug. Overall number of participants analyzed is the number of participants with data available for analysis.

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 mg91
Treatment Period: Cohort B: Ponatinib 30 mg90
Treatment Period: Cohort C: Ponatinib 15 mg89

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg48.4Not reported37.759.1Not reported
Treatment Period: Cohort B: Ponatinib 30 mg30.0Not reported20.840.6Not reported
Treatment Period: Cohort C: Ponatinib 15 mg43.8Not reported33.354.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.7
        upper Limit
        59.1
        value
        48.4
      2. group Id
        OG001
        lower Limit
        20.8
        upper Limit
        40.6
        value
        30.0
      3. group Id
        OG002
        lower Limit
        33.3
        upper Limit
        54.7
        value
        43.8
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      90
    3. group Id
      OG002
      value
      89
    units
    Participants
description
MCyR was defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: 0% Ph + metaphases; PCyR: \>0 to 35% Ph + metaphases.
dispersion Type
95% Confidence Interval
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 Cytogenetic Population included all participants who were randomized and had a cytogenetic assessment at Baseline with ≥20 metaphases examined, regardless of whether they received the assigned study drug. Overall number of participants analyzed is the number of participants with data available for analysis.
reporting Status
POSTED
time Frame
12 months after the first dose of study treatment
title
Percentage of Participants With Major Cytogenetic Response (MCyR)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice