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NCT05350163 · BASELINE

Baseline characteristics

T-cell Receptor α/β Depleted Donor Lymphocyte Infusion · Source last updated 2024-12-10

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
      10
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      0
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      0
    6. group Id
      BG005
      value
      0
    7. group Id
      BG006
      value
      11
    units
    Participants
groups
  1. description
    5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG000
    title
    HLA Matched Cohort I
  2. description
    5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG001
    title
    HLA Matched Cohort II
  3. description
    5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG002
    title
    HLA Matched Cohort III
  4. description
    1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG003
    title
    HLA Mismatched Cohort I
  5. description
    1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG004
    title
    HLA Mismatched Cohort II
  6. description
    1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG005
    title
    HLA Mismatched Cohort III
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        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
          spread
          14.3
          value
          60.4
        2. group Id
          BG003
          spread
          0
          value
          57
        3. group Id
          BG006
          spread
          13.6
          value
          60.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG003
          value
          1
        3. group Id
          BG006
          value
          7
        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
          5
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG003
          value
          1
        3. group Id
          BG006
          value
          6
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          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
          BG003
          value
          0
        3. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          1
        3. group Id
          BG006
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          10
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          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
          10
        2. group Id
          BG003
          value
          1
        3. group Id
          BG006
          value
          11
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      10
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      0
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      0
    6. group Id
      BG005
      value
      0
    7. group Id
      BG006
      value
      11
    units
    Participants
groups
  1. description
    5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG000
    title
    HLA Matched Cohort I
  2. description
    5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG001
    title
    HLA Matched Cohort II
  3. description
    5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG002
    title
    HLA Matched Cohort III
  4. description
    1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG003
    title
    HLA Mismatched Cohort I
  5. description
    1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG004
    title
    HLA Mismatched Cohort II
  6. description
    1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    BG005
    title
    HLA Mismatched Cohort III
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        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
          spread
          14.3
          value
          60.4
        2. group Id
          BG003
          spread
          0
          value
          57
        3. group Id
          BG006
          spread
          13.6
          value
          60.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG003
          value
          1
        3. group Id
          BG006
          value
          7
        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
          5
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG003
          value
          1
        3. group Id
          BG006
          value
          6
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          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
          BG003
          value
          0
        3. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          1
        3. group Id
          BG006
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          10
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG006
          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
          10
        2. group Id
          BG003
          value
          1
        3. group Id
          BG006
          value
          11
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings.

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Preserved source evidence · Not medical advice