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NCT02467270 · OUTCOME

Duration of Response in MR2 Responders

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to approximately 8.9 years

What was measured

Duration of response in "responders" was defined as any participants who achieved ≤1% BCR-ABL1IS (MR2) at any time during the study. Responders were defined as those participants who met all of the following: were randomized and treated, responded at 12 months after the initiation of study treatment, and underwent baseline polymerase chain reaction (PCR) assessment.

Analysis population: ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (i.e., participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug. Overall number of participants analyzed is the number of participants with MR2.

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 mg56
Treatment Period: Cohort B: Ponatinib 30 mg38
Treatment Period: Cohort C: Ponatinib 15 mg36

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mgNANot reported61.5NAMedian and upper limit of 95% CI were not available due to censoring.
Treatment Period: Cohort B: Ponatinib 30 mgNANot reportedNANAMedian and 95% CI were not available due to censoring.
Treatment Period: Cohort C: Ponatinib 15 mgNANot reportedNANAMedian and 95% CI were not available due to censoring.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of 95% CI were not available due to censoring.
        group Id
        OG000
        lower Limit
        61.5
        upper Limit
        NA
        value
        NA
      2. comment
        Median and 95% CI were not available due to censoring.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Median and 95% CI were not available due to censoring.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      56
    2. group Id
      OG001
      value
      38
    3. group Id
      OG002
      value
      36
    units
    Participants
description
Duration of response in "responders" was defined as any participants who achieved ≤1% BCR-ABL1IS (MR2) at any time during the study. Responders were defined as those participants who met all of the following: were randomized and treated, responded at 12 months after the initiation of study treatment, and underwent baseline polymerase chain reaction (PCR) assessment.
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
MEDIAN
population Description
ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (i.e., participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug. Overall number of participants analyzed is the number of participants with MR2.
reporting Status
POSTED
time Frame
Baseline up to approximately 8.9 years
title
Duration of Response in MR2 Responders
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice