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NCT00306202 · OUTCOME

Best Cytogenetic Response (CyR) in 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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 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

Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample. Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:\>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:\>65%-95% Ph+ cells in metaphase in BM. No CyR:\>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases \[%Ph+ \<100%\]).

Analysis population: All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy. Stratum 2/3 dasatinib 80 mg/m\^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study.

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 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 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 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 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)6
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)8
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)9

Reported measurements

No Response (>95% - 100%)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Minimal (>65% - 95%)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Minor (>35% - 65%)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Partial (>0% - 35%)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Complete (0%)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)8Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)4Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)8Not reportedNot reportedNot reportedNot reported
Unable to determine
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)4Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    No Response (>95% - 100%)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Minimal (>65% - 95%)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Minor (>35% - 65%)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Partial (>0% - 35%)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        8
    title
    Complete (0%)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        0
    title
    Unable to determine
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      9
    units
    Participants
description
Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample. Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:\>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:\>65%-95% Ph+ cells in metaphase in BM. No CyR:\>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases \[%Ph+ \<100%\]).
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 Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG001
    title
    Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
  3. 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 60 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG002
    title
    Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
  4. 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
    OG003
    title
    Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
param Type
NUMBER
population Description
All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy. Stratum 2/3 dasatinib 80 mg/m\^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study.
reporting Status
POSTED
time Frame
Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 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
Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice