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NCT00253513 · BASELINE

Baseline characteristics

Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome · Source last updated 2012-06-01

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
      60
    units
    Participants
groups
  1. description
    Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
    id
    BG000
    title
    Treosulfan and Fludarabine Conditioning
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      < 21 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
      title
      Between 21 - 50 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Between 50 - 60 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Acute Lymphoblastic Leukemia(ALL)2nd/3rd remission
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          26
      title
      Acute Myelogenous Leukemia(AML)1st remission
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      AML, 2nd or greater remission.
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      AML, relapsed or primary refractory
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Myelodysplastic Syndrome(MDS): Refract. Anemia(RA)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      MDS: RA with excess blasts in transformation
    param Type
    NUMBER
    title
    Disease status at transplantation
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
      title
      Low - AML/ALL in 1st rem., MDS with IPSS=0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Standard (ALL or AML in 2nd or greater rem.)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      High -relapsed/refract. ALL/AML/MDS w/ IPSS>=2.5
    description
    Low-risk disease: AML or ALL in first remission, MDS with IPSS (International Prognosis Scoring System)=0; standard risk: ALL or AML in second or greater remission, MDS with IPSS 0.5-2; high risk: relapsed/refractory ALL or AML, MDS with IPSS\>=2.5.
    param Type
    NUMBER
    title
    Disease risk group
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Good
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Intermediate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          36
      title
      Poor
    description
    Good risk cytogenetics: t(8;21), t(15;17), or inversion 16 for AML, hyperdiploidy for ALL, -Y, del(5q), del(20q), or normal for MDS; poor risk: 11q23 abnormalities, monosomy 7, monosomy 5, deletion 5q, or abnormalities of 3q for AML, t(9;22) or extreme hypodiploidy for ALL, chromosome 7 abnormalities in MDS,$3 chromosome abnormalities for any disease type; Intermediate risk: all others
    param Type
    NUMBER
    title
    Cytogenetic risk group
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      1-2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          28
      title
      >=3
    description
    Risk of mortality after allograft (0 is lower risk, \>=3 is higher risk)
    param Type
    NUMBER
    title
    Hematopoietic Cell Transplantation Comorbidity Index (HCT CI)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      title
      HLA (human leukocyte antigen) -identical sibling
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      title
      HLA-matched unrelated donor
    param Type
    NUMBER
    title
    Donor type
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Bone marrow
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          53
      title
      Filgrastim-mobilized PBPC
    param Type
    NUMBER
    title
    Stem cell source
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      60
    units
    Participants
groups
  1. description
    Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
    id
    BG000
    title
    Treosulfan and Fludarabine Conditioning
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      < 21 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
      title
      Between 21 - 50 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Between 50 - 60 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Acute Lymphoblastic Leukemia(ALL)2nd/3rd remission
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          26
      title
      Acute Myelogenous Leukemia(AML)1st remission
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      AML, 2nd or greater remission.
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      AML, relapsed or primary refractory
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Myelodysplastic Syndrome(MDS): Refract. Anemia(RA)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      MDS: RA with excess blasts in transformation
    param Type
    NUMBER
    title
    Disease status at transplantation
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
      title
      Low - AML/ALL in 1st rem., MDS with IPSS=0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Standard (ALL or AML in 2nd or greater rem.)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      High -relapsed/refract. ALL/AML/MDS w/ IPSS>=2.5
    description
    Low-risk disease: AML or ALL in first remission, MDS with IPSS (International Prognosis Scoring System)=0; standard risk: ALL or AML in second or greater remission, MDS with IPSS 0.5-2; high risk: relapsed/refractory ALL or AML, MDS with IPSS\>=2.5.
    param Type
    NUMBER
    title
    Disease risk group
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Good
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Intermediate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          36
      title
      Poor
    description
    Good risk cytogenetics: t(8;21), t(15;17), or inversion 16 for AML, hyperdiploidy for ALL, -Y, del(5q), del(20q), or normal for MDS; poor risk: 11q23 abnormalities, monosomy 7, monosomy 5, deletion 5q, or abnormalities of 3q for AML, t(9;22) or extreme hypodiploidy for ALL, chromosome 7 abnormalities in MDS,$3 chromosome abnormalities for any disease type; Intermediate risk: all others
    param Type
    NUMBER
    title
    Cytogenetic risk group
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      1-2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          28
      title
      >=3
    description
    Risk of mortality after allograft (0 is lower risk, \>=3 is higher risk)
    param Type
    NUMBER
    title
    Hematopoietic Cell Transplantation Comorbidity Index (HCT CI)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      title
      HLA (human leukocyte antigen) -identical sibling
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      title
      HLA-matched unrelated donor
    param Type
    NUMBER
    title
    Donor type
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Bone marrow
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          53
      title
      Filgrastim-mobilized PBPC
    param Type
    NUMBER
    title
    Stem cell source
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice