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NCT00777036 · OUTCOME

Progression-Free Survival (PFS)

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
174 Months

What was measured

PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. Based on Kaplan-Meier methodology. Disease Progression was defined as any of the following criteria: -For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose -Increasing WBC -Loss of CHR (defined as any of the following: WBC count rises to \>20.0x10\^9/L; Platelet count rises to \>600x10\^9/L; appearance of extramedullary disease; appearance of \>5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood) -Loss of MCyR or increase in Ph+ bone marrow cells by \>=30% from nadir -Death from any case during treatment.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1NANot reported87.00NAInsufficient number of participants with events
Cohort 26.67Not reported0.9512.16Not reported
Cohort 3NANot reportedNANAInsufficient number of participants with events
Cohort 3aNANot reportedNANAInsufficient number of participants with events
Cohort 3bNANot reportedNANAInsufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events
        group Id
        OG000
        lower Limit
        87.00
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        0.95
        upper Limit
        12.16
        value
        6.67
      3. comment
        Insufficient number of participants with events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        Insufficient number of participants with events
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        Insufficient number of participants with events
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
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
PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. Based on Kaplan-Meier methodology. Disease Progression was defined as any of the following criteria: -For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose -Increasing WBC -Loss of CHR (defined as any of the following: WBC count rises to \>20.0x10\^9/L; Platelet count rises to \>600x10\^9/L; appearance of extramedullary disease; appearance of \>5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood) -Loss of MCyR or increase in Ph+ bone marrow cells by \>=30% from nadir -Death from any case during treatment.
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
reporting Status
POSTED
time Frame
174 Months
title
Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice