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NCT00789776 · BASELINE

Baseline characteristics

Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer · Source last updated 2020-01-31

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
      5
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      41
    units
    Participants
groups
  1. description
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    id
    BG000
    title
    Dose 1 (2.5 x 10^6/kg NK Cells)
  2. description
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    id
    BG001
    title
    Dose 2 (5.0 x 10^6/kg NK Cells)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          11
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          27
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        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
          lower Limit
          14.5
          upper Limit
          43.7
          value
          22.2
        2. group Id
          BG001
          lower Limit
          8.1
          upper Limit
          75.2
          value
          55.65
        3. group Id
          BG002
          lower Limit
          8.1
          upper Limit
          75.2
          value
          47.6
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          28
        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
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          35
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          32
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          41
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      41
    units
    Participants
groups
  1. description
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    id
    BG000
    title
    Dose 1 (2.5 x 10^6/kg NK Cells)
  2. description
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    id
    BG001
    title
    Dose 2 (5.0 x 10^6/kg NK Cells)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          11
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          27
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        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
          lower Limit
          14.5
          upper Limit
          43.7
          value
          22.2
        2. group Id
          BG001
          lower Limit
          8.1
          upper Limit
          75.2
          value
          55.65
        3. group Id
          BG002
          lower Limit
          8.1
          upper Limit
          75.2
          value
          47.6
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          28
        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
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          35
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          32
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          41
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.

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Preserved source evidence · Not medical advice