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NCT00777036 · OUTCOME

Time to Major Cytogenetic Response (MCyR)

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib · Source last updated 2025-08-29

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
From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)

What was measured

Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on \>=20 Metaphases)

Analysis population: All treated participants with MCyR

Groups in this outcome

Cohort 1

Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.

Cohort 2

Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.

Cohort 3

Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.

Cohort 3a

Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.

Cohort 3b

Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.

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

Analysis denominator · Participants

GroupSource count
Cohort 126
Cohort 29
Cohort 381
Cohort 3a50
Cohort 3b31

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 13.1Not reported2.84.1Not reported
Cohort 21.6Not reported0.55.7Not reported
Cohort 33.0Not reported2.94.3Not reported
Cohort 3a3.3Not reported2.95.6Not reported
Cohort 3b3.0Not reported2.85.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        4.1
        value
        3.1
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        5.7
        value
        1.6
      3. group Id
        OG002
        lower Limit
        2.9
        upper Limit
        4.3
        value
        3.0
      4. group Id
        OG003
        lower Limit
        2.9
        upper Limit
        5.6
        value
        3.3
      5. group Id
        OG004
        lower Limit
        2.8
        upper Limit
        5.0
        value
        3.0
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      81
    4. group Id
      OG003
      value
      50
    5. group Id
      OG004
      value
      31
    units
    Participants
description
Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on \>=20 Metaphases)
dispersion Type
95% Confidence Interval
groups
  1. description
    Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    id
    OG000
    title
    Cohort 1
  2. description
    Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    id
    OG001
    title
    Cohort 2
  3. description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    id
    OG002
    title
    Cohort 3
  4. description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    id
    OG003
    title
    Cohort 3a
  5. description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    id
    OG004
    title
    Cohort 3b
param Type
MEDIAN
population Description
All treated participants with MCyR
reporting Status
POSTED
time Frame
From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
title
Time to Major Cytogenetic Response (MCyR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice