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NCT00777036 · OUTCOME

Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3

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 first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

What was measured

Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.

Analysis population: Secondary efficacy endpoint pre-specified only for participants treated in Cohort 1 and Cohort 3

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 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.

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 384

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 193.1Not reported77.299.2Not reported
Cohort 396.4Not reported89.999.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.2
        upper Limit
        99.2
        value
        93.1
      2. group Id
        OG001
        lower Limit
        89.9
        upper Limit
        99.3
        value
        96.4
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      84
    units
    Participants
description
Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.
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 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
    OG001
    title
    Cohort 3
param Type
NUMBER
population Description
Secondary efficacy endpoint pre-specified only for participants treated in Cohort 1 and Cohort 3
reporting Status
POSTED
time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
title
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice