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NCT02467270 · OUTCOME

Percentage of Participants With Complete Hematologic Response (CHR)

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
3 months after the first dose of study treatment

What was measured

CHR was defined as achieving all of the following measurements: white blood cells (WBC) \<= institutional upper limit of normal (ULN), platelets less than (\<)450,000 per cubic millimeter (/mm\^3), no blasts or promyelocytes in peripheral blood, \<5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood \<5%, and no extramedullary involvement (including no hepatomegaly or splenomegaly).

Analysis population: The analysis included all randomized participant who had been on study for at least 3 months, including the following defined as non-CHR: a) Any participant with end of treatment/early termination (EOT/ET) before 3 months, b) Any participant with CHR not evaluable or with no CHR results at 3 months, and c) Failed to achieve/maintain CHR at Month 3.

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Period: Cohort A: Ponatinib 45 mg87.2Not reported78.893.2Not reported
Treatment Period: Cohort B: Ponatinib 30 mg81.1Not reported71.788.4Not reported
Treatment Period: Cohort C: Ponatinib 15 mg81.9Not reported72.689.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        78.8
        upper Limit
        93.2
        value
        87.2
      2. group Id
        OG001
        lower Limit
        71.7
        upper Limit
        88.4
        value
        81.1
      3. group Id
        OG002
        lower Limit
        72.6
        upper Limit
        89.1
        value
        81.9
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    2. group Id
      OG001
      value
      95
    3. group Id
      OG002
      value
      94
    units
    Participants
description
CHR was defined as achieving all of the following measurements: white blood cells (WBC) \<= institutional upper limit of normal (ULN), platelets less than (\<)450,000 per cubic millimeter (/mm\^3), no blasts or promyelocytes in peripheral blood, \<5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood \<5%, and no extramedullary involvement (including no hepatomegaly or splenomegaly).
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
The analysis included all randomized participant who had been on study for at least 3 months, including the following defined as non-CHR: a) Any participant with end of treatment/early termination (EOT/ET) before 3 months, b) Any participant with CHR not evaluable or with no CHR results at 3 months, and c) Failed to achieve/maintain CHR at Month 3.
reporting Status
POSTED
time Frame
3 months after the first dose of study treatment
title
Percentage of Participants With Complete Hematologic Response (CHR)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice