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NCT02393859 · BASELINE

Baseline characteristics

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2026-06-26

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

denoms
  1. counts
    1. group Id
      BG000
      value
      57
    2. group Id
      BG001
      value
      54
    3. group Id
      BG002
      value
      111
    units
    Participants
groups
  1. description
    One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
    id
    BG000
    title
    HC3 Chemotherapy
  2. description
    One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
    id
    BG001
    title
    Blinatumomab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.3
          value
          6.6
        2. group Id
          BG001
          spread
          4.4
          value
          7.3
        3. group Id
          BG002
          spread
          4.4
          value
          7.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          58
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          53
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          107
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          96
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Other, Not Specified
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Black or African American
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          80
        title
        1 to 9 years
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          31
        title
        Other (< 1 year and > 9 years)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Age Category
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          32
      title
      M1 Marrow + MRD level ≥ 10^-3
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          71
      title
      M1 Marrow + MRD level < 10^-3
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      M2 Marrow
    description
    M1: representative bone marrow aspirate or biopsy with blasts \< 5%, with satisfactory cellularity and with regenerating hematopoiesis; M2: representative bone marrow aspirate or biopsy with ≥ 5% and \< 25% blasts; MRD=minimal residual disease levels ≥ 10\^-3 or \< 10\^-3, by polymerase chain reaction (PCR) or flow cytometry.
    param Type
    NUMBER
    title
    Stratification Factor: Marrow/Minimal Residual Disease (MRD)
    unit Of Measure
    participants
population Description
The FAS included all randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      57
    2. group Id
      BG001
      value
      54
    3. group Id
      BG002
      value
      111
    units
    Participants
groups
  1. description
    One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
    id
    BG000
    title
    HC3 Chemotherapy
  2. description
    One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
    id
    BG001
    title
    Blinatumomab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.3
          value
          6.6
        2. group Id
          BG001
          spread
          4.4
          value
          7.3
        3. group Id
          BG002
          spread
          4.4
          value
          7.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          58
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          53
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          107
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          96
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Other, Not Specified
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Black or African American
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          80
        title
        1 to 9 years
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          31
        title
        Other (< 1 year and > 9 years)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Age Category
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          32
      title
      M1 Marrow + MRD level ≥ 10^-3
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          71
      title
      M1 Marrow + MRD level < 10^-3
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      M2 Marrow
    description
    M1: representative bone marrow aspirate or biopsy with blasts \< 5%, with satisfactory cellularity and with regenerating hematopoiesis; M2: representative bone marrow aspirate or biopsy with ≥ 5% and \< 25% blasts; MRD=minimal residual disease levels ≥ 10\^-3 or \< 10\^-3, by polymerase chain reaction (PCR) or flow cytometry.
    param Type
    NUMBER
    title
    Stratification Factor: Marrow/Minimal Residual Disease (MRD)
    unit Of Measure
    participants
population Description
The FAS included all randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.

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

Preserved source evidence · Not medical advice