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NCT00306202 · OUTCOME

Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia · Source last updated 2021-02-26

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
Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])

What was measured

Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM.

Analysis population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.

Groups in this outcome

Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)

Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.

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

Analysis denominator · Participants

GroupSource count
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)11
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)9

Reported measurements

CCyR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)72.7Not reported39.094.0Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)88.9Not reported51.899.7Not reported
MCyR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)81.8Not reported48.297.7Not reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)88.9Not reported51.899.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.0
        upper Limit
        94.0
        value
        72.7
      2. group Id
        OG001
        lower Limit
        51.8
        upper Limit
        99.7
        value
        88.9
    title
    CCyR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.2
        upper Limit
        97.7
        value
        81.8
      2. group Id
        OG001
        lower Limit
        51.8
        upper Limit
        99.7
        value
        88.9
    title
    MCyR
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG000
    title
    Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
  2. description
    Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG001
    title
    Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
param Type
NUMBER
population Description
All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.
reporting Status
POSTED
time Frame
Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])
title
Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice