Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00777036 · OUTCOME

Major Molecular Response (MMR) 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 MMR (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). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL \<= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to \< 0.1% or a 3-log reduction from baseline was considered an MMR.

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 169.0Not reported49.284.7Not reported
Cohort 229.4Not reported10.356.0Not reported
Cohort 384.5Not reported75.091.5Not reported
Cohort 3a90.2Not reported78.696.7Not reported
Cohort 3b75.8Not reported57.788.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.2
        upper Limit
        84.7
        value
        69.0
      2. group Id
        OG001
        lower Limit
        10.3
        upper Limit
        56.0
        value
        29.4
      3. group Id
        OG002
        lower Limit
        75.0
        upper Limit
        91.5
        value
        84.5
      4. group Id
        OG003
        lower Limit
        78.6
        upper Limit
        96.7
        value
        90.2
      5. group Id
        OG004
        lower Limit
        57.7
        upper Limit
        88.9
        value
        75.8
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). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL \<= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to \< 0.1% or a 3-log reduction from baseline was considered an MMR.
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 MMR (assessed up to Jan 2025, approximately 15 years and 10 months)
title
Major Molecular Response (MMR) Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice