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NCT04971226 · OUTCOME

Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP · Source last updated 2026-08-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
By week 48 and by week 96 (48 weeks and 96 weeks after last patient first dose); data collection/analysis is ongoing for the 96 week time point, and the data will be reported later

What was measured

The CCyR response status was to be based on bone marrow assessment. Bone marrow examination for cytogenetic assessment was to be performed locally by the Investigator at baseline for all participants. Thereafter, during the course of the study, cytogenetic assessment was not mandatory and only performed if clinically indicated.

Analysis population: The Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization and who had a valid bone marrow examination at week 48.

Groups in this outcome

Asciminib (All Asciminib )

Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.

Investigator Selected TKI (All Comparators)

Patients will take on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)

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

Analysis denominator · Participants

GroupSource count
Asciminib (All Asciminib )2
Investigator Selected TKI (All Comparators)0

Reported measurements

Source class 1

Complete cytogenetic response (CCyR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib )1Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Partial cytogenetic response (PCyR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib )1Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Minor cytogenetic response (mCyR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib )0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

Minimal cytogenetic response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib )0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported

No cytogenetic response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (All Asciminib )0Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (All Comparators)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Complete cytogenetic response (CCyR)
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Partial cytogenetic response (PCyR)
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Minor cytogenetic response (mCyR)
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Minimal cytogenetic response
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      No cytogenetic response
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      0
    units
    Participants
description
The CCyR response status was to be based on bone marrow assessment. Bone marrow examination for cytogenetic assessment was to be performed locally by the Investigator at baseline for all participants. Thereafter, during the course of the study, cytogenetic assessment was not mandatory and only performed if clinically indicated.
groups
  1. description
    Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.
    id
    OG000
    title
    Asciminib (All Asciminib )
  2. description
    Patients will take on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
    id
    OG001
    title
    Investigator Selected TKI (All Comparators)
param Type
COUNT_OF_PARTICIPANTS
population Description
The Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization and who had a valid bone marrow examination at week 48.
reporting Status
POSTED
time Frame
By week 48 and by week 96 (48 weeks and 96 weeks after last patient first dose); data collection/analysis is ongoing for the 96 week time point, and the data will be reported later
title
Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice