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NCT00306202 · OUTCOME

Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML)

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 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])

What was measured

HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments.

Analysis population: All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.

Groups in this outcome

Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 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 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)6
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)6
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)6
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)6

Reported measurements

Best Confirmed HR-No Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)5Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Best Confirmed HR-Unable to Determine
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Best Unconfirmed HR-No Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)5Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Best Unconfirmed HR-Unable to Determine
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
    title
    Best Confirmed HR-No Response
  2. 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
    Best Confirmed HR-Unable to Determine
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
    title
    Best Unconfirmed HR-No Response
  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
    Best Unconfirmed HR-Unable to Determine
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    units
    Participants
description
HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments.
groups
  1. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG000
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
  2. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG001
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
  3. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG002
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
  4. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG003
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
param Type
NUMBER
population Description
All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.
reporting Status
POSTED
time Frame
Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])
title
Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice