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NCT00777036 · FLOW

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A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib · Source last updated 2025-08-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    id
    FG000
    title
    Cohort 1
  2. description
    Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    id
    FG001
    title
    Cohort 2
  3. description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    id
    FG002
    title
    Cohort 3
  4. description
    Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.
    id
    FG003
    title
    PK Sub-Study
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        42
      4. group Id
        FG003
        num Subjects
        0
      type
      Reached 18 years of age and transitioned to commercial drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        0
      type
      Administrative Reason By Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      type
      Failure to Meet Study Criteria
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Pregnancy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Non-compliance with Study Drug
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Maximum Clinical Benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      type
      Participant Request to Discontinue Study Treatment
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      type
      Study Drug Toxicity
    11. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Progressive Disease
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Not Reported
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        84
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        84
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    On Treatment
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        4 Participants Joined PK Sub-study from Cohort 3
        group Id
        FG003
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        All 7 participants Completed. 4 participants who joined from cohort 3 re-joined Cohort 3 after PK Sub-study completed.
        group Id
        FG003
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    PK Sub-Study
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        0
      type
      Reason Not Specified
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      type
      Missing - Administrative Reasons in Russia
    milestones
    1. achievements
      1. comment
        Not all participants who discontinued treatment entered the follow-up period
        group Id
        FG000
        num Subjects
        21
      2. comment
        Not all participants who discontinued treatment entered the follow-up period
        group Id
        FG001
        num Subjects
        12
      3. comment
        Not all participants who discontinued treatment entered the follow-up period
        group Id
        FG002
        num Subjects
        47
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Follow-Up
pre Assignment Details
The PK sub-study analysis is not part of the pre-specified primary and secondary outcome measures.
recruitment Details
Participants were enrolled at 80 sites (Argentina, Australia, Brazil, Canada, France, Germany, Great Britain, India, Italy, Korea, Mexico, Netherlands, Romania, Russia, Singapore, South Africa, Spain, and USA).
Complete source fields
groups
  1. description
    Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    id
    FG000
    title
    Cohort 1
  2. description
    Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    id
    FG001
    title
    Cohort 2
  3. description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    id
    FG002
    title
    Cohort 3
  4. description
    Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.
    id
    FG003
    title
    PK Sub-Study
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        42
      4. group Id
        FG003
        num Subjects
        0
      type
      Reached 18 years of age and transitioned to commercial drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        0
      type
      Administrative Reason By Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      type
      Failure to Meet Study Criteria
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Pregnancy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Non-compliance with Study Drug
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Maximum Clinical Benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      type
      Participant Request to Discontinue Study Treatment
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      type
      Study Drug Toxicity
    11. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Progressive Disease
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Not Reported
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        84
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        84
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    On Treatment
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        4 Participants Joined PK Sub-study from Cohort 3
        group Id
        FG003
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        All 7 participants Completed. 4 participants who joined from cohort 3 re-joined Cohort 3 after PK Sub-study completed.
        group Id
        FG003
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    PK Sub-Study
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        0
      type
      Reason Not Specified
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      type
      Missing - Administrative Reasons in Russia
    milestones
    1. achievements
      1. comment
        Not all participants who discontinued treatment entered the follow-up period
        group Id
        FG000
        num Subjects
        21
      2. comment
        Not all participants who discontinued treatment entered the follow-up period
        group Id
        FG001
        num Subjects
        12
      3. comment
        Not all participants who discontinued treatment entered the follow-up period
        group Id
        FG002
        num Subjects
        47
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Follow-Up
pre Assignment Details
The PK sub-study analysis is not part of the pre-specified primary and secondary outcome measures.
recruitment Details
Participants were enrolled at 80 sites (Argentina, Australia, Brazil, Canada, France, Germany, Great Britain, India, Italy, Korea, Mexico, Netherlands, Romania, Russia, Singapore, South Africa, Spain, and USA).

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