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NCT00372593 · BASELINE

Baseline characteristics

Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2021-03-24

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
      531
    2. group Id
      BG001
      value
      532
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      1070
    units
    Participants
groups
  1. description
    Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    id
    BG000
    title
    Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome
  2. description
    Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    id
    BG001
    title
    Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome
  3. description
    Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    id
    BG002
    title
    Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2336.55
          value
          3352.86
        2. group Id
          BG001
          spread
          2283.45
          value
          3466
        3. group Id
          BG002
          spread
          1979.95
          value
          4206.71
        4. group Id
          BG003
          spread
          2310
          value
          3409.43
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    days
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          516
        2. group Id
          BG001
          value
          510
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1033
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          37
        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
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          277
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          541
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          271
        2. group Id
          BG001
          value
          255
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          529
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          52
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          122
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          383
        2. group Id
          BG001
          value
          394
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          782
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          108
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          197
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          411
        2. group Id
          BG001
          value
          416
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          834
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          39
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          473
        2. group Id
          BG001
          value
          480
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          958
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          68
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          34
      title
      Australia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Switzerland
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
      title
      New Zealand
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      531
    2. group Id
      BG001
      value
      532
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      1070
    units
    Participants
groups
  1. description
    Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    id
    BG000
    title
    Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome
  2. description
    Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    id
    BG001
    title
    Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome
  3. description
    Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    id
    BG002
    title
    Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2336.55
          value
          3352.86
        2. group Id
          BG001
          spread
          2283.45
          value
          3466
        3. group Id
          BG002
          spread
          1979.95
          value
          4206.71
        4. group Id
          BG003
          spread
          2310
          value
          3409.43
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    days
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          516
        2. group Id
          BG001
          value
          510
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1033
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          37
        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
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          277
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          541
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          271
        2. group Id
          BG001
          value
          255
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          529
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          52
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          122
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          383
        2. group Id
          BG001
          value
          394
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          782
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          108
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          197
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          411
        2. group Id
          BG001
          value
          416
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          834
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          39
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          473
        2. group Id
          BG001
          value
          480
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          958
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          68
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          34
      title
      Australia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Switzerland
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
      title
      New Zealand
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice