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NCT00306202 · FLOW

Participant flow

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.

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. Once daily (QD), as long as clinical benefit was maintained.
    id
    FG000
    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
    FG001
    title
    Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
  3. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
    id
    FG002
    title
    Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
periods
  1. milestones
    1. achievements
      1. comment
        Started = Treated. 18 were enrolled; 1 no longer met study criteria and was never treated
        group Id
        FG000
        num Subjects
        17
      2. comment
        Started=Treated. 20 were enrolled;3 never treated(2 no longer met study criteria;1 withdrew consent)
        group Id
        FG001
        num Subjects
        17
      3. comment
        Started = Treated. 25 were enrolled; 1 no longer met study criteria and was never treated
        group Id
        FG002
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. comment
        Completed = Off-treatment
        group Id
        FG000
        num Subjects
        17
      2. comment
        Completed = Off-treatment
        group Id
        FG001
        num Subjects
        17
      3. comment
        Completed = Off-treatment
        group Id
        FG002
        num Subjects
        24
      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
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
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. Once daily (QD), as long as clinical benefit was maintained.
    id
    FG000
    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
    FG001
    title
    Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
  3. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
    id
    FG002
    title
    Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
periods
  1. milestones
    1. achievements
      1. comment
        Started = Treated. 18 were enrolled; 1 no longer met study criteria and was never treated
        group Id
        FG000
        num Subjects
        17
      2. comment
        Started=Treated. 20 were enrolled;3 never treated(2 no longer met study criteria;1 withdrew consent)
        group Id
        FG001
        num Subjects
        17
      3. comment
        Started = Treated. 25 were enrolled; 1 no longer met study criteria and was never treated
        group Id
        FG002
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. comment
        Completed = Off-treatment
        group Id
        FG000
        num Subjects
        17
      2. comment
        Completed = Off-treatment
        group Id
        FG001
        num Subjects
        17
      3. comment
        Completed = Off-treatment
        group Id
        FG002
        num Subjects
        24
      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
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice