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NCT02467270 · OUTCOME

Progression-free Survival (PFS)

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
Up to approximately 8.9 years

What was measured

PFS was defined as the interval between the first dose date of study treatment and the first date at which the criteria for progression were met (progression to the AP or BP of CML), or death due to any cause, censored at the last response assessment. Progression to AP was defined as: \>=15% and \<30% blasts in peripheral blood or bone marrow or \>=20% basophils in peripheral blood or bone marrow or \>=30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets/L in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP was defined as: \>=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.

Analysis population: All randomized participants were included in the 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 mg94
Treatment Period: Cohort B: Ponatinib 30 mg95
Treatment Period: Cohort C: Ponatinib 15 mg94

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mgNANot reported63.5NAMedian and upper limit of 95% CI were not available due to censoring.
Treatment Period: Cohort B: Ponatinib 30 mg75.04Not reported45.0NAUpper limit of 95% CI was not available due to censoring.
Treatment Period: Cohort C: Ponatinib 15 mgNANot reported45.8NAMedian and upper limit of 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
        63.5
        upper Limit
        NA
        value
        NA
      2. comment
        Upper limit of 95% CI was not available due to censoring.
        group Id
        OG001
        lower Limit
        45.0
        upper Limit
        NA
        value
        75.04
      3. comment
        Median and upper limit of 95% CI were not available due to censoring.
        group Id
        OG002
        lower Limit
        45.8
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    2. group Id
      OG001
      value
      95
    3. group Id
      OG002
      value
      94
    units
    Participants
description
PFS was defined as the interval between the first dose date of study treatment and the first date at which the criteria for progression were met (progression to the AP or BP of CML), or death due to any cause, censored at the last response assessment. Progression to AP was defined as: \>=15% and \<30% blasts in peripheral blood or bone marrow or \>=20% basophils in peripheral blood or bone marrow or \>=30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets/L in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP was defined as: \>=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
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
All randomized participants were included in the analysis.
reporting Status
POSTED
time Frame
Up to approximately 8.9 years
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice