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NCT00074490 · BASELINE

Baseline characteristics

Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers · Source last updated 2018-12-31

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
      1
    2. group Id
      BG001
      value
      34
    3. group Id
      BG002
      value
      40
    4. group Id
      BG003
      value
      44
    5. group Id
      BG004
      value
      45
    6. group Id
      BG005
      value
      164
    units
    Participants
groups
  1. description
    Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
    id
    BG000
    title
    Arm IVDcohort 1 (Th2 DLI)
  2. description
    Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
    id
    BG001
    title
    Arm IVD Cohort 3 (Multiple Th2 DLI)
  3. description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    BG002
    title
    Arm IVA (12-day Expanded Th2 DLI)
  4. description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    BG003
    title
    Arm IVB (6-day Expanded Th2 DLI)
  5. description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    BG004
    title
    Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
  6. description
    Total of all reporting groups
    id
    BG005
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          42
        6. group Id
          BG005
          value
          153
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          11
        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
          value
          56
        2. group Id
          BG001
          spread
          12.41
          value
          45.96
        3. group Id
          BG002
          spread
          12.92
          value
          49.68
        4. group Id
          BG003
          spread
          12.45
          value
          47.66
        5. group Id
          BG004
          spread
          13.50
          value
          50.19
        6. group Id
          BG005
          spread
          13.12
          value
          49.44
    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
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          59
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          32
        6. group Id
          BG005
          value
          105
        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
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          34
        5. group Id
          BG004
          value
          41
        6. group Id
          BG005
          value
          131
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          36
        6. group Id
          BG005
          value
          115
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          33
        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
          1
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          164
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      34
    3. group Id
      BG002
      value
      40
    4. group Id
      BG003
      value
      44
    5. group Id
      BG004
      value
      45
    6. group Id
      BG005
      value
      164
    units
    Participants
groups
  1. description
    Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
    id
    BG000
    title
    Arm IVDcohort 1 (Th2 DLI)
  2. description
    Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
    id
    BG001
    title
    Arm IVD Cohort 3 (Multiple Th2 DLI)
  3. description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    BG002
    title
    Arm IVA (12-day Expanded Th2 DLI)
  4. description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    BG003
    title
    Arm IVB (6-day Expanded Th2 DLI)
  5. description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    BG004
    title
    Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
  6. description
    Total of all reporting groups
    id
    BG005
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          42
        6. group Id
          BG005
          value
          153
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          11
        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
          value
          56
        2. group Id
          BG001
          spread
          12.41
          value
          45.96
        3. group Id
          BG002
          spread
          12.92
          value
          49.68
        4. group Id
          BG003
          spread
          12.45
          value
          47.66
        5. group Id
          BG004
          spread
          13.50
          value
          50.19
        6. group Id
          BG005
          spread
          13.12
          value
          49.44
    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
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          59
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          32
        6. group Id
          BG005
          value
          105
        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
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          34
        5. group Id
          BG004
          value
          41
        6. group Id
          BG005
          value
          131
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          36
        6. group Id
          BG005
          value
          115
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          33
        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
          1
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          164
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.

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