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NCT01088984 · FLOW

Participant flow

Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia · Source last updated 2016-05-23

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

groups
  1. description
    Bendamustine 90 mg/m\^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    FG000
    title
    Bendamustine 90 mg/m^2
  2. description
    Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    FG001
    title
    Bendamustine 120 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. comment
        completed follow-up up to 12 month from last dose of study drug
        group Id
        FG000
        num Subjects
        0
      2. comment
        completed follow-up up to 12 month from last dose of study drug
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Phase 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        25
      type
      DIsease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. comment
        completed follow-up up to 12 month from last dose of study drug
        group Id
        FG000
        num Subjects
        0
      2. comment
        completed follow-up up to 12 month from last dose of study drug
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        32
      type
      NOT COMPLETED
    title
    Phase 2
recruitment Details
Of the 46 patients screened, 43 patients at 24 centers from the United States, Australia, South Korea, Israel, Mexico, and Brazil met entry criteria and were considered eligible for enrollment. Of the 3 patients who were not enrolled, 2 patients died prior to study enrollment, and 1 patient was ineligible because inclusion criteria were not met.
Complete source fields
groups
  1. description
    Bendamustine 90 mg/m\^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    FG000
    title
    Bendamustine 90 mg/m^2
  2. description
    Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    FG001
    title
    Bendamustine 120 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. comment
        completed follow-up up to 12 month from last dose of study drug
        group Id
        FG000
        num Subjects
        0
      2. comment
        completed follow-up up to 12 month from last dose of study drug
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Phase 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        25
      type
      DIsease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. comment
        completed follow-up up to 12 month from last dose of study drug
        group Id
        FG000
        num Subjects
        0
      2. comment
        completed follow-up up to 12 month from last dose of study drug
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        32
      type
      NOT COMPLETED
    title
    Phase 2
recruitment Details
Of the 46 patients screened, 43 patients at 24 centers from the United States, Australia, South Korea, Israel, Mexico, and Brazil met entry criteria and were considered eligible for enrollment. Of the 3 patients who were not enrolled, 2 patients died prior to study enrollment, and 1 patient was ineligible because inclusion criteria were not met.

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Preserved source evidence · Not medical advice