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NCT01620216 · BASELINE

Baseline characteristics

Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia · Source last updated 2021-11-04

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
      4
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      0
    6. group Id
      BG005
      value
      0
    7. group Id
      BG006
      value
      0
    8. group Id
      BG007
      value
      12
    units
    Participants
groups
  1. description
    Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
    id
    BG000
    title
    Group I (Dasatinib)
  2. description
    Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sunitinib: Given PO Sunitinib Malate: Given PO
    id
    BG001
    title
    Group II (Sutinib Malate)
  3. description
    Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sorafenib: Given PO Sorafenib Tosylate: Given PO
    id
    BG002
    title
    Group III (Sorafenib Tosylate)
  4. description
    Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ponatinib: Given PO Ponatinib Hydrochloride: Given PO
    id
    BG003
    title
    Group IV (Ponatinib Hydrochloride)
  5. description
    Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pacritinib: Given PO Pharmacological Study: Correlative studies
    id
    BG004
    title
    Group V (Pacritinib)
  6. description
    Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ruxolitinib: Given PO
    id
    BG005
    title
    Group VI (Ruxolitinib)
  7. description
    Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Idelalisib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
    id
    BG006
    title
    Group VII (Idelalisib)
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          69
          upper Limit
          74
          value
          70.5
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          53
          value
          50
        3. group Id
          BG002
          lower Limit
          31
          upper Limit
          72
          value
          57.5
        4. group Id
          BG007
          lower Limit
          31
          upper Limit
          74
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG007
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG007
          value
          5
        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
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG007
          value
          9
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG007
          value
          3
        title
        Hispanic or Latino
      title
      Race/Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Zero patients were enrolled in the Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      0
    6. group Id
      BG005
      value
      0
    7. group Id
      BG006
      value
      0
    8. group Id
      BG007
      value
      12
    units
    Participants
groups
  1. description
    Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
    id
    BG000
    title
    Group I (Dasatinib)
  2. description
    Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sunitinib: Given PO Sunitinib Malate: Given PO
    id
    BG001
    title
    Group II (Sutinib Malate)
  3. description
    Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sorafenib: Given PO Sorafenib Tosylate: Given PO
    id
    BG002
    title
    Group III (Sorafenib Tosylate)
  4. description
    Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ponatinib: Given PO Ponatinib Hydrochloride: Given PO
    id
    BG003
    title
    Group IV (Ponatinib Hydrochloride)
  5. description
    Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pacritinib: Given PO Pharmacological Study: Correlative studies
    id
    BG004
    title
    Group V (Pacritinib)
  6. description
    Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ruxolitinib: Given PO
    id
    BG005
    title
    Group VI (Ruxolitinib)
  7. description
    Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Idelalisib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
    id
    BG006
    title
    Group VII (Idelalisib)
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          69
          upper Limit
          74
          value
          70.5
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          53
          value
          50
        3. group Id
          BG002
          lower Limit
          31
          upper Limit
          72
          value
          57.5
        4. group Id
          BG007
          lower Limit
          31
          upper Limit
          74
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG007
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG007
          value
          5
        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
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG007
          value
          9
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG007
          value
          3
        title
        Hispanic or Latino
      title
      Race/Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Zero patients were enrolled in the Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.

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Preserved source evidence · Not medical advice