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NCT00075725 · BASELINE

Baseline characteristics

Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia · Source last updated 2021-04-27

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
      246
    2. group Id
      BG001
      value
      106
    3. group Id
      BG002
      value
      296
    4. group Id
      BG003
      value
      246
    5. group Id
      BG004
      value
      232
    6. group Id
      BG005
      value
      710
    7. group Id
      BG006
      value
      246
    8. group Id
      BG007
      value
      696
    9. group Id
      BG008
      value
      302
    10. group Id
      BG009
      value
      34
    11. group Id
      BG010
      value
      12
    12. group Id
      BG011
      value
      28
    units
    Participants
groups
  1. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG000
    title
    Dexamethasone and Capizzi Methotrexate Patients < 10 Years
  2. description
    Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG001
    title
    Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
  3. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG002
    title
    Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
  4. description
    Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG003
    title
    Dexamethasone, High Dose Methotrexate (IM) < 10 Years
  5. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG004
    title
    Prednisone, Capizzi Methotrexate <10 Years
  6. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG005
    title
    Prednisone, Capezzi Methotrexate >= 10 Years
  7. description
    Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG006
    title
    Prednisone and High Dose Methotrexate < 10 Yrs Old
  8. description
    Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG007
    title
    Prednisone and High Dose Methotrexate >=10 Years
  9. description
    Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG008
    title
    Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
  10. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG009
    title
    Prednisone, Capezzi Methotrexate (Down's Syndrome)
  11. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG010
    title
    Dexamethasone, Capizzi Methotrexate Down Syndrome
  12. description
    Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
    id
    BG011
    title
    Prednisone and High Dose Methotrexate (Non Randomly Assigned)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          246
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          275
        4. group Id
          BG003
          value
          246
        5. group Id
          BG004
          value
          232
        6. group Id
          BG005
          value
          641
        7. group Id
          BG006
          value
          246
        8. group Id
          BG007
          value
          610
        9. group Id
          BG008
          value
          266
        10. group Id
          BG009
          value
          30
        11. group Id
          BG010
          value
          10
        12. group Id
          BG011
          value
          26
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          69
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          86
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          2
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.3
          value
          4.0
        2. group Id
          BG001
          spread
          6.0
          value
          9.3
        3. group Id
          BG002
          spread
          2.8
          value
          14.1
        4. group Id
          BG003
          spread
          2.2
          value
          4.1
        5. group Id
          BG004
          spread
          2.2
          value
          4.2
        6. group Id
          BG005
          spread
          3.3
          value
          14.7
        7. group Id
          BG006
          spread
          2.2
          value
          4.2
        8. group Id
          BG007
          spread
          3.2
          value
          14.5
        9. group Id
          BG008
          spread
          2.9
          value
          14.6
        10. group Id
          BG009
          spread
          5.7
          value
          10.5
        11. group Id
          BG010
          spread
          6.6
          value
          12.3
        12. group Id
          BG011
          spread
          2.9
          value
          14.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          135
        4. group Id
          BG003
          value
          117
        5. group Id
          BG004
          value
          106
        6. group Id
          BG005
          value
          321
        7. group Id
          BG006
          value
          108
        8. group Id
          BG007
          value
          288
        9. group Id
          BG008
          value
          128
        10. group Id
          BG009
          value
          18
        11. group Id
          BG010
          value
          7
        12. group Id
          BG011
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          117
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          161
        4. group Id
          BG003
          value
          129
        5. group Id
          BG004
          value
          126
        6. group Id
          BG005
          value
          389
        7. group Id
          BG006
          value
          138
        8. group Id
          BG007
          value
          408
        9. group Id
          BG008
          value
          174
        10. group Id
          BG009
          value
          16
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          17
        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
          54
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          55
        5. group Id
          BG004
          value
          62
        6. group Id
          BG005
          value
          167
        7. group Id
          BG006
          value
          61
        8. group Id
          BG007
          value
          168
        9. group Id
          BG008
          value
          69
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          217
        4. group Id
          BG003
          value
          182
        5. group Id
          BG004
          value
          165
        6. group Id
          BG005
          value
          516
        7. group Id
          BG006
          value
          179
        8. group Id
          BG007
          value
          504
        9. group Id
          BG008
          value
          219
        10. group Id
          BG009
          value
          27
        11. group Id
          BG010
          value
          10
        12. group Id
          BG011
          value
          20
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          27
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          24
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          21
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          27
        9. group Id
          BG008
          value
          18
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          55
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          51
        9. group Id
          BG008
          value
          19
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          187
        5. group Id
          BG004
          value
          175
        6. group Id
          BG005
          value
          534
        7. group Id
          BG006
          value
          187
        8. group Id
          BG007
          value
          519
        9. group Id
          BG008
          value
          227
        10. group Id
          BG009
          value
          26
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          24
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          83
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          82
        9. group Id
          BG008
          value
          31
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      246
    2. group Id
      BG001
      value
      106
    3. group Id
      BG002
      value
      296
    4. group Id
      BG003
      value
      246
    5. group Id
      BG004
      value
      232
    6. group Id
      BG005
      value
      710
    7. group Id
      BG006
      value
      246
    8. group Id
      BG007
      value
      696
    9. group Id
      BG008
      value
      302
    10. group Id
      BG009
      value
      34
    11. group Id
      BG010
      value
      12
    12. group Id
      BG011
      value
      28
    units
    Participants
groups
  1. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG000
    title
    Dexamethasone and Capizzi Methotrexate Patients < 10 Years
  2. description
    Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG001
    title
    Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
  3. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG002
    title
    Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
  4. description
    Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG003
    title
    Dexamethasone, High Dose Methotrexate (IM) < 10 Years
  5. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG004
    title
    Prednisone, Capizzi Methotrexate <10 Years
  6. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG005
    title
    Prednisone, Capezzi Methotrexate >= 10 Years
  7. description
    Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG006
    title
    Prednisone and High Dose Methotrexate < 10 Yrs Old
  8. description
    Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG007
    title
    Prednisone and High Dose Methotrexate >=10 Years
  9. description
    Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG008
    title
    Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
  10. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    BG009
    title
    Prednisone, Capezzi Methotrexate (Down's Syndrome)
  11. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    BG010
    title
    Dexamethasone, Capizzi Methotrexate Down Syndrome
  12. description
    Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
    id
    BG011
    title
    Prednisone and High Dose Methotrexate (Non Randomly Assigned)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          246
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          275
        4. group Id
          BG003
          value
          246
        5. group Id
          BG004
          value
          232
        6. group Id
          BG005
          value
          641
        7. group Id
          BG006
          value
          246
        8. group Id
          BG007
          value
          610
        9. group Id
          BG008
          value
          266
        10. group Id
          BG009
          value
          30
        11. group Id
          BG010
          value
          10
        12. group Id
          BG011
          value
          26
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          69
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          86
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          2
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.3
          value
          4.0
        2. group Id
          BG001
          spread
          6.0
          value
          9.3
        3. group Id
          BG002
          spread
          2.8
          value
          14.1
        4. group Id
          BG003
          spread
          2.2
          value
          4.1
        5. group Id
          BG004
          spread
          2.2
          value
          4.2
        6. group Id
          BG005
          spread
          3.3
          value
          14.7
        7. group Id
          BG006
          spread
          2.2
          value
          4.2
        8. group Id
          BG007
          spread
          3.2
          value
          14.5
        9. group Id
          BG008
          spread
          2.9
          value
          14.6
        10. group Id
          BG009
          spread
          5.7
          value
          10.5
        11. group Id
          BG010
          spread
          6.6
          value
          12.3
        12. group Id
          BG011
          spread
          2.9
          value
          14.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          135
        4. group Id
          BG003
          value
          117
        5. group Id
          BG004
          value
          106
        6. group Id
          BG005
          value
          321
        7. group Id
          BG006
          value
          108
        8. group Id
          BG007
          value
          288
        9. group Id
          BG008
          value
          128
        10. group Id
          BG009
          value
          18
        11. group Id
          BG010
          value
          7
        12. group Id
          BG011
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          117
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          161
        4. group Id
          BG003
          value
          129
        5. group Id
          BG004
          value
          126
        6. group Id
          BG005
          value
          389
        7. group Id
          BG006
          value
          138
        8. group Id
          BG007
          value
          408
        9. group Id
          BG008
          value
          174
        10. group Id
          BG009
          value
          16
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          17
        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
          54
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          55
        5. group Id
          BG004
          value
          62
        6. group Id
          BG005
          value
          167
        7. group Id
          BG006
          value
          61
        8. group Id
          BG007
          value
          168
        9. group Id
          BG008
          value
          69
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          217
        4. group Id
          BG003
          value
          182
        5. group Id
          BG004
          value
          165
        6. group Id
          BG005
          value
          516
        7. group Id
          BG006
          value
          179
        8. group Id
          BG007
          value
          504
        9. group Id
          BG008
          value
          219
        10. group Id
          BG009
          value
          27
        11. group Id
          BG010
          value
          10
        12. group Id
          BG011
          value
          20
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          27
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          24
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          21
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          27
        9. group Id
          BG008
          value
          18
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          55
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          51
        9. group Id
          BG008
          value
          19
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          187
        5. group Id
          BG004
          value
          175
        6. group Id
          BG005
          value
          534
        7. group Id
          BG006
          value
          187
        8. group Id
          BG007
          value
          519
        9. group Id
          BG008
          value
          227
        10. group Id
          BG009
          value
          26
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          24
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          83
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          82
        9. group Id
          BG008
          value
          31
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice