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NCT00306202 · OUTCOME

Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-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
Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])

What was measured

HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR): WBC in PB: \<10,000/mm\^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) \<5%; Basophils in PB: \<5%; Platelet count (untransfused): \<450,000/mm\^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly. Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.

Analysis population: All treated participants in stratum 1: 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 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.

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

Reported measurements

Best Confirmed HR-Complete
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)10Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Best Confirmed HR-No Response
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
Best Unconfirmed Hematologic Response-Complete
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)10Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Best Unconfirmed Hematologic Response-No Response
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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
    title
    Best Confirmed HR-Complete
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Best Confirmed HR-No Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
    title
    Best Unconfirmed Hematologic Response-Complete
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Best Unconfirmed Hematologic Response-No Response
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      6
    units
    Participants
description
HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR): WBC in PB: \<10,000/mm\^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) \<5%; Basophils in PB: \<5%; Platelet count (untransfused): \<450,000/mm\^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly. Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this 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 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)
param Type
NUMBER
population Description
All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.
reporting Status
POSTED
time Frame
Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])
title
Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice