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NCT02556931 · BASELINE

Baseline characteristics

Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies · Source last updated 2022-11-03

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
      57
    2. group Id
      BG001
      value
      60
    3. group Id
      BG002
      value
      117
    units
    Participants
groups
  1. description
    Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
    id
    BG000
    title
    PBSCT D90
  2. description
    Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
    id
    BG001
    title
    PBSCT D60
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          70
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          47
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35
          upper Limit
          78
          value
          62
        2. group Id
          BG001
          lower Limit
          22
          upper Limit
          75
          value
          63
        3. group Id
          BG002
          lower Limit
          22
          upper Limit
          78
          value
          62.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
        units
        Participants
    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
          17
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          81
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      57
    2. group Id
      BG001
      value
      60
    3. group Id
      BG002
      value
      117
    units
    Participants
groups
  1. description
    Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
    id
    BG000
    title
    PBSCT D90
  2. description
    Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
    id
    BG001
    title
    PBSCT D60
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          70
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          47
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35
          upper Limit
          78
          value
          62
        2. group Id
          BG001
          lower Limit
          22
          upper Limit
          75
          value
          63
        3. group Id
          BG002
          lower Limit
          22
          upper Limit
          78
          value
          62.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
        units
        Participants
    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
          17
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          81
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          117
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice