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NCT00534430 · BASELINE

Baseline characteristics

Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer · Source last updated 2026-06-03

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
      30
    units
    Participants
groups
  1. description
    IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant busulfan cyclosporine etoposide mycophenolate mofetil allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
    id
    BG000
    title
    Busulfan, FTBI and VP16
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          19
          upper Limit
          50
          value
          37
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
    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
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Hispanic
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      White, Not Hispanic
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          34
          value
          26
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
    description
    A risk score for mortality after allogeneic hematopoietic cell transplantation. Ann Intern Med 2006; 144(6):407-414. Parimon T, Au DH, Martin PH, Chien JW. "We generated 4 categories of PAM scores by setting cutoffs according to the probability of death. Scores ranged from 9 to 16 for category 1 (probability of death, \< 25%), from 17 to 23 for category 2 (probability of death, 25% to 50%), from 24 to 30 for category 3 (probability of death, 50% to 75%), and from 31 to 44 for category 4 (probability of death, \> 75%)."
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Patient Assessment of Mortality (PAM) Score
    unit Of Measure
    units on a scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      AML in First Complete Remission
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      AML in First Relapse
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      AML in Induction Failure
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      untreated RAEB-t
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      ALL in First Relapse
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      ALL in Second Relapse
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      ALL in Induction Failure
    description
    Disease classification was based on WHO criteria \[Vardiman, Blood 2002\]: Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL), and untreated refractory anemia with excess blasts in transformation (RAEB-t).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status at Transplant
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Indeterminate
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Intermediate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Unfavorable
    description
    Cytogenetics were based on Southwest Oncology Group criteria \[Leith CP, Blood 1997; Pullarkat V, Blood 2008\]. Intermediate: normal and all other cytogenetic abnormalities. Unfavorable: -5/5q-, -7/7q-, inv(3), 11q abn, 17p abn or i(17q), del(20q), dmins/hsrs, +13, t(9; 22), complex (\>3 abn) karyotypes. Indeterminate: all other clonal cytogenetic abnormalities.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetics
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Bone Marrow
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          29
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Peripheral Blood
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stem Cell Source
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.9
          upper Limit
          29.2
          value
          3.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Patients with active disease
    title
    WBC pre-conditioning
    unit Of Measure
    x10^9 cells/L
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          95
          value
          16.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Patients with active disease
    title
    Percent Blasts in Bone Marrow
    unit Of Measure
    percent of leukocytes
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          92
          value
          3.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Patients with Active Disease
    title
    Percent Blasts in Peripheral Blood
    unit Of Measure
    percent of leukocytes
population Description
Enrolled on protocol after screening for eligiblility
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      30
    units
    Participants
groups
  1. description
    IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant busulfan cyclosporine etoposide mycophenolate mofetil allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
    id
    BG000
    title
    Busulfan, FTBI and VP16
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          19
          upper Limit
          50
          value
          37
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
    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
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Hispanic
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      White, Not Hispanic
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          34
          value
          26
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
    description
    A risk score for mortality after allogeneic hematopoietic cell transplantation. Ann Intern Med 2006; 144(6):407-414. Parimon T, Au DH, Martin PH, Chien JW. "We generated 4 categories of PAM scores by setting cutoffs according to the probability of death. Scores ranged from 9 to 16 for category 1 (probability of death, \< 25%), from 17 to 23 for category 2 (probability of death, 25% to 50%), from 24 to 30 for category 3 (probability of death, 50% to 75%), and from 31 to 44 for category 4 (probability of death, \> 75%)."
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Patient Assessment of Mortality (PAM) Score
    unit Of Measure
    units on a scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      AML in First Complete Remission
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      AML in First Relapse
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      AML in Induction Failure
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      untreated RAEB-t
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      ALL in First Relapse
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      ALL in Second Relapse
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      ALL in Induction Failure
    description
    Disease classification was based on WHO criteria \[Vardiman, Blood 2002\]: Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL), and untreated refractory anemia with excess blasts in transformation (RAEB-t).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status at Transplant
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Indeterminate
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Intermediate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Unfavorable
    description
    Cytogenetics were based on Southwest Oncology Group criteria \[Leith CP, Blood 1997; Pullarkat V, Blood 2008\]. Intermediate: normal and all other cytogenetic abnormalities. Unfavorable: -5/5q-, -7/7q-, inv(3), 11q abn, 17p abn or i(17q), del(20q), dmins/hsrs, +13, t(9; 22), complex (\>3 abn) karyotypes. Indeterminate: all other clonal cytogenetic abnormalities.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetics
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Bone Marrow
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          29
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        units
        Participants
      title
      Peripheral Blood
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stem Cell Source
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.9
          upper Limit
          29.2
          value
          3.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Patients with active disease
    title
    WBC pre-conditioning
    unit Of Measure
    x10^9 cells/L
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          95
          value
          16.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Patients with active disease
    title
    Percent Blasts in Bone Marrow
    unit Of Measure
    percent of leukocytes
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          92
          value
          3.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Patients with Active Disease
    title
    Percent Blasts in Peripheral Blood
    unit Of Measure
    percent of leukocytes
population Description
Enrolled on protocol after screening for eligiblility

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Preserved source evidence · Not medical advice