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NCT03106779 · OUTCOME

Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs · Source last updated 2026-08-18

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
at 24, 48, 72, 96, 120 and 144 weeks

What was measured

Cytogenic response included Complete, Partial, Major, Minor, Minimal and no response. Cytogenetic response was assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases; Partial (PCyR) - \>0 to 35% Ph+ metaphases; Major (MCyR) - 0 to 35% Ph+ metaphases; Minor (mCyR) - \>35 to 65% Ph+ metaphases; Minimal - \>65 to 95% Ph+ metaphases; None - \>95 to 100% Ph+ metaphases.

Analysis population: CCyR analysis set is a subset of FAS and included participants who were not in CCyR at baseline. FAS comprised of all randomized participants.

Groups in this outcome

Asciminib

Participants randomized to asciminib 40mg BID

Bosutinib

Participants randomized to bosutinib 500mg QD

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

Analysis denominator · Participants

GroupSource count
Asciminib103
Bosutinib62

Reported measurements

at Week 24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib42Not reportedNot reportedNot reportedNot reported
Bosutinib15Not reportedNot reportedNot reportedNot reported
at Week 48
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib41Not reportedNot reportedNot reportedNot reported
Bosutinib13Not reportedNot reportedNot reportedNot reported
at Week 72
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib39Not reportedNot reportedNot reportedNot reported
Bosutinib12Not reportedNot reportedNot reportedNot reported
at Week 96
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib41Not reportedNot reportedNot reportedNot reported
Bosutinib10Not reportedNot reportedNot reportedNot reported
at Week 120
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib37Not reportedNot reportedNot reportedNot reported
Bosutinib7Not reportedNot reportedNot reportedNot reported
at Week 144
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib35Not reportedNot reportedNot reportedNot reported
Bosutinib4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        15
    title
    at Week 24
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        13
    title
    at Week 48
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        12
    title
    at Week 72
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        10
    title
    at Week 96
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        7
    title
    at Week 120
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        4
    title
    at Week 144
denoms
  1. counts
    1. group Id
      OG000
      value
      103
    2. group Id
      OG001
      value
      62
    units
    Participants
description
Cytogenic response included Complete, Partial, Major, Minor, Minimal and no response. Cytogenetic response was assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases; Partial (PCyR) - \>0 to 35% Ph+ metaphases; Major (MCyR) - 0 to 35% Ph+ metaphases; Minor (mCyR) - \>35 to 65% Ph+ metaphases; Minimal - \>65 to 95% Ph+ metaphases; None - \>95 to 100% Ph+ metaphases.
groups
  1. description
    Participants randomized to asciminib 40mg BID
    id
    OG000
    title
    Asciminib
  2. description
    Participants randomized to bosutinib 500mg QD
    id
    OG001
    title
    Bosutinib
param Type
COUNT_OF_PARTICIPANTS
population Description
CCyR analysis set is a subset of FAS and included participants who were not in CCyR at baseline. FAS comprised of all randomized participants.
reporting Status
POSTED
time Frame
at 24, 48, 72, 96, 120 and 144 weeks
title
Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice