Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01207388 · BASELINE

Baseline characteristics

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-02-10

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
      116
    units
    Participants
groups
  1. description
    Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
    id
    BG000
    title
    Blinatumomab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.4
          value
          44.6
    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
          36
      title
      ≥ 18 and <35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          41
      title
      ≥ 35 and < 55 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      ≥ 55 and < 65 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      ≥ 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          68
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          102
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Mixed
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Unknown
    description
    Race was not permitted to be collected in France.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          111
      title
      Negative
    param Type
    NUMBER
    title
    Philadelphia Chromosome Disease Status
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          88
        title
        No
      3. measurements
        1. group Id
          BG000
          value
          23
        title
        Unknown
    description
    t(4;11)(q21;q23) translocation, resulting in the fusion of the mixed lineage leukemia (MLL) gene on chromosome 11 and the AF4 gene on chromosome 4
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Confirmed t(4;11) Translocation / MLL-AF4+ ALL
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      ≥ 10^-1 and < 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          45
      title
      ≥ 10^-2 and < 10^-1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          52
      title
      ≥ 10^-3 and < 10^-2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      < 10^-3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Below Lower Limit of Quantification
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Unknown
    description
    Measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory; Lower limit of quantification was at least 10\^-4 leukemic cells.
    param Type
    NUMBER
    title
    MRD Level at Baseline by Central Laboratory
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
      title
      ≤ 30,000/mL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      > 30,000/mL
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Unknown
    param Type
    NUMBER
    title
    White Blood Cells at First Diagnosis
    unit Of Measure
    participants
population Description
Full analysis set (all participants who received any infusion of blinatumomab)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      116
    units
    Participants
groups
  1. description
    Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
    id
    BG000
    title
    Blinatumomab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.4
          value
          44.6
    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
          36
      title
      ≥ 18 and <35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          41
      title
      ≥ 35 and < 55 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      ≥ 55 and < 65 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      ≥ 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          68
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          102
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Mixed
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Unknown
    description
    Race was not permitted to be collected in France.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          111
      title
      Negative
    param Type
    NUMBER
    title
    Philadelphia Chromosome Disease Status
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          88
        title
        No
      3. measurements
        1. group Id
          BG000
          value
          23
        title
        Unknown
    description
    t(4;11)(q21;q23) translocation, resulting in the fusion of the mixed lineage leukemia (MLL) gene on chromosome 11 and the AF4 gene on chromosome 4
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Confirmed t(4;11) Translocation / MLL-AF4+ ALL
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      ≥ 10^-1 and < 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          45
      title
      ≥ 10^-2 and < 10^-1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          52
      title
      ≥ 10^-3 and < 10^-2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      < 10^-3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Below Lower Limit of Quantification
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Unknown
    description
    Measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory; Lower limit of quantification was at least 10\^-4 leukemic cells.
    param Type
    NUMBER
    title
    MRD Level at Baseline by Central Laboratory
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
      title
      ≤ 30,000/mL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      > 30,000/mL
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Unknown
    param Type
    NUMBER
    title
    White Blood Cells at First Diagnosis
    unit Of Measure
    participants
population Description
Full analysis set (all participants who received any infusion of blinatumomab)

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

Preserved source evidence · Not medical advice