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NCT00306202 · OUTCOME

Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months)

What was measured

Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best response was CCyR). CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.

Analysis population: All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.

Groups in this outcome

Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.

Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose

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). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 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
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose14
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose12

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose48.1Not reported10.056.1Not reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose4.6Not reported1.217.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.0
        upper Limit
        56.1
        value
        48.1
      2. group Id
        OG001
        lower Limit
        1.2
        upper Limit
        17.4
        value
        4.6
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best response was CCyR). CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
    id
    OG000
    title
    Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
  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). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
    id
    OG001
    title
    Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
param Type
MEDIAN
population Description
All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.
reporting Status
POSTED
time Frame
From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months)
title
Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice