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NCT00723099 · BASELINE

Baseline characteristics

Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer · Source last updated 2019-12-27

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
      72
    units
    Participants
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. ARM 1(patients at low risk for graft failure) - patients receive 200cGy TBI ARM 2 (patients at high risk for graft failure) - patients receive 300cGy TBI UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo single or double umbilical cord blood transplant
    id
    BG000
    title
    Treatment (Chemotherapy, Transplant)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          13
          upper Limit
          73
          value
          60
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    description
    Patients \> 70 may be considered if performance status \> 80% or Eastern Cooperative Oncology Group (ECOG) =\< 1 and comorbidity score \< 3; these patients must be discussed with the principal investigator (PI), Rachel Salit prior to enrollment
    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
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        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
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          54
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        100
      2. measurements
        1. group Id
          BG000
          value
          29
        title
        90
      3. measurements
        1. group Id
          BG000
          value
          18
        title
        80
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        70
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        50
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    description
    Scale from 0-100 with 100= Normal no complaints 90= Normal activity with minor signs or symptoms of disease 80= Normal activity with effort, some signs or symptoms of disease 70= Cares for self, unable to carry on normal activity 60= Requires occasional assistance 50= Requires considerable assistance 40= Disabled 30= Severely disabled 20= Very sick, hospitalized 10= Moribund 0= Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky Performance Scale
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          15
        title
        3
      5. measurements
        1. group Id
          BG000
          value
          10
        title
        4
      6. measurements
        1. group Id
          BG000
          value
          5
        title
        5
      7. measurements
        1. group Id
          BG000
          value
          8
        title
        6
      8. measurements
        1. group Id
          BG000
          value
          2
        title
        7
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        8
      10. measurements
        1. group Id
          BG000
          value
          2
        title
        unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    description
    The HCT-CI is a comorbidity index that comprises 17 different categories of organ dysfunction. Positive findings are summated into a total score. The HCT-CI provides information with regard to the overall as well as non-relapse mortality risk a patient is likely to experience after hematopoietic cell transplantation. Lower scores have been shown to be associated with lower non relapse mortality.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hematopoeitic Cell Transplant Comorbidity Index
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        title
        CMV Seropositive
      2. measurements
        1. group Id
          BG000
          value
          26
        title
        CMV Seronegative
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytomegalovirus Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        title
        AML
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        ALL
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        MDS
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Hodgkins
      5. measurements
        1. group Id
          BG000
          value
          6
        title
        Non Hodgkins Lymphoma
      6. measurements
        1. group Id
          BG000
          value
          3
        title
        Peripheral T cell Lymphoma
      7. measurements
        1. group Id
          BG000
          value
          10
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        title
        Complete Remission
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        Partial Remission
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Stable Disease
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        Progressive Disease
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Remission Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        MRD positive
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        MRD negative
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only patients in a complete remission were assessed for minimal residual disease. All others are known to have residual disease
    title
    Minimal Residual Disease
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Single Cord
      2. measurements
        1. group Id
          BG000
          value
          70
        title
        Double Cord
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of cord blood donors
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        title
        4/6 plus 4/6
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        4/6 plus 5/6
      3. measurements
        1. group Id
          BG000
          value
          19
        title
        5/6 plus 5/6
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        6/6 plus 6/6
      5. measurements
        1. group Id
          BG000
          value
          3
        title
        other
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    description
    The standard for selecting unrelated umbilical cord blood units for transplantation for non-malignant diseases relies on antigen-level (lower resolution) HLA typing for HLA-A and HLA-B, and allele-level for HLA-DRB1. A 6 of 6 cord blood in matched at A, B and DR on both Haplotypes. 5 of 6 has one mismatch and 4 of 6 has 2 mismatched. 4 of 6 is commonly the maximum number of mismatches accepted for a cord blood transplant.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Level of HLA matching
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      72
    units
    Participants
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. ARM 1(patients at low risk for graft failure) - patients receive 200cGy TBI ARM 2 (patients at high risk for graft failure) - patients receive 300cGy TBI UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo single or double umbilical cord blood transplant
    id
    BG000
    title
    Treatment (Chemotherapy, Transplant)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          13
          upper Limit
          73
          value
          60
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    description
    Patients \> 70 may be considered if performance status \> 80% or Eastern Cooperative Oncology Group (ECOG) =\< 1 and comorbidity score \< 3; these patients must be discussed with the principal investigator (PI), Rachel Salit prior to enrollment
    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
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        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
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          54
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        100
      2. measurements
        1. group Id
          BG000
          value
          29
        title
        90
      3. measurements
        1. group Id
          BG000
          value
          18
        title
        80
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        70
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        50
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    description
    Scale from 0-100 with 100= Normal no complaints 90= Normal activity with minor signs or symptoms of disease 80= Normal activity with effort, some signs or symptoms of disease 70= Cares for self, unable to carry on normal activity 60= Requires occasional assistance 50= Requires considerable assistance 40= Disabled 30= Severely disabled 20= Very sick, hospitalized 10= Moribund 0= Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky Performance Scale
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          15
        title
        3
      5. measurements
        1. group Id
          BG000
          value
          10
        title
        4
      6. measurements
        1. group Id
          BG000
          value
          5
        title
        5
      7. measurements
        1. group Id
          BG000
          value
          8
        title
        6
      8. measurements
        1. group Id
          BG000
          value
          2
        title
        7
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        8
      10. measurements
        1. group Id
          BG000
          value
          2
        title
        unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    description
    The HCT-CI is a comorbidity index that comprises 17 different categories of organ dysfunction. Positive findings are summated into a total score. The HCT-CI provides information with regard to the overall as well as non-relapse mortality risk a patient is likely to experience after hematopoietic cell transplantation. Lower scores have been shown to be associated with lower non relapse mortality.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hematopoeitic Cell Transplant Comorbidity Index
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        title
        CMV Seropositive
      2. measurements
        1. group Id
          BG000
          value
          26
        title
        CMV Seronegative
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytomegalovirus Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        title
        AML
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        ALL
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        MDS
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Hodgkins
      5. measurements
        1. group Id
          BG000
          value
          6
        title
        Non Hodgkins Lymphoma
      6. measurements
        1. group Id
          BG000
          value
          3
        title
        Peripheral T cell Lymphoma
      7. measurements
        1. group Id
          BG000
          value
          10
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        title
        Complete Remission
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        Partial Remission
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Stable Disease
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        Progressive Disease
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Remission Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        MRD positive
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        MRD negative
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only patients in a complete remission were assessed for minimal residual disease. All others are known to have residual disease
    title
    Minimal Residual Disease
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Single Cord
      2. measurements
        1. group Id
          BG000
          value
          70
        title
        Double Cord
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of cord blood donors
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        title
        4/6 plus 4/6
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        4/6 plus 5/6
      3. measurements
        1. group Id
          BG000
          value
          19
        title
        5/6 plus 5/6
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        6/6 plus 6/6
      5. measurements
        1. group Id
          BG000
          value
          3
        title
        other
      denoms
      1. counts
        1. group Id
          BG000
          value
          72
        units
        Participants
    description
    The standard for selecting unrelated umbilical cord blood units for transplantation for non-malignant diseases relies on antigen-level (lower resolution) HLA typing for HLA-A and HLA-B, and allele-level for HLA-DRB1. A 6 of 6 cord blood in matched at A, B and DR on both Haplotypes. 5 of 6 has one mismatch and 4 of 6 has 2 mismatched. 4 of 6 is commonly the maximum number of mismatches accepted for a cord blood transplant.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Level of HLA matching
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice