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NCT00777036 · OUTCOME

Complete Molecular Response (CMR) Rate

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of first treatment to date of CMR (assessed up to Jan 2025, approximately 15 years and 10 months)

What was measured

Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.

Analysis population: All treated participants

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 129
Cohort 217
Cohort 384
Cohort 3a51
Cohort 3b33

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 127.6Not reported12.747.2Not reported
Cohort 211.8Not reported1.536.4Not reported
Cohort 342.9Not reported32.154.1Not reported
Cohort 3a49.0Not reported34.863.4Not reported
Cohort 3b33.3Not reported18.051.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.7
        upper Limit
        47.2
        value
        27.6
      2. group Id
        OG001
        lower Limit
        1.5
        upper Limit
        36.4
        value
        11.8
      3. group Id
        OG002
        lower Limit
        32.1
        upper Limit
        54.1
        value
        42.9
      4. group Id
        OG003
        lower Limit
        34.8
        upper Limit
        63.4
        value
        49.0
      5. group Id
        OG004
        lower Limit
        18.0
        upper Limit
        51.8
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      84
    4. group Id
      OG003
      value
      51
    5. group Id
      OG004
      value
      33
    units
    Participants
description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
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
NUMBER
population Description
All treated participants
reporting Status
POSTED
time Frame
From date of first treatment to date of CMR (assessed up to Jan 2025, approximately 15 years and 10 months)
title
Complete Molecular Response (CMR) Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice