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NCT03106779 · OUTCOME

Duration of Complete Cytogenetic Response (CCyR)

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
MEDIAN
Unit
Weeks
Interval / dispersion
Full Range
Time frame
144 weeks

What was measured

Duration of CCyR was defined as the time between date of first documented CCyR and the earliest date of loss of CCyR, progression to AP/BC, or CML-related death for participants in the Cytogenetic Responder Set. The time was censored at the last cytogenetic assessment date on treatment for participants for whom none of the events was reported or last PCR evaluation on treatment indicating MMR.

Analysis population: CCyR responder set was a subset of FAS and included patients who did not have CCyR at baseline and achieved CCyR at any time on randomized treatment. 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
Asciminib52
Bosutinib22

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
AsciminibNANot reportedNANANA: Not estimable due to insufficient events observed
BosutinibNANot reported64.1NANA: Not estimable due to insufficient events observed
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: Not estimable due to insufficient events observed
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        NA: Not estimable due to insufficient events observed
        group Id
        OG001
        lower Limit
        64.1
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      22
    units
    Participants
description
Duration of CCyR was defined as the time between date of first documented CCyR and the earliest date of loss of CCyR, progression to AP/BC, or CML-related death for participants in the Cytogenetic Responder Set. The time was censored at the last cytogenetic assessment date on treatment for participants for whom none of the events was reported or last PCR evaluation on treatment indicating MMR.
dispersion Type
Full Range
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
MEDIAN
population Description
CCyR responder set was a subset of FAS and included patients who did not have CCyR at baseline and achieved CCyR at any time on randomized treatment. FAS comprised of all randomized participants.
reporting Status
POSTED
time Frame
144 weeks
title
Duration of Complete Cytogenetic Response (CCyR)
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice