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NCT03192397 · BASELINE

Baseline characteristics

Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant · Source last updated 2026-04-14

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
      3
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      22
    6. group Id
      BG005
      value
      35
    units
    Participants
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG000
    title
    <=50 Years of Age Cohort A
  2. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG001
    title
    <=50 Years of Age Cohort B
  3. description
    Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG002
    title
    >50 Years of Age Cohort A -25 mg/m2 Melphalan
  4. description
    Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG003
    title
    >50 Years of Age Cohort B 50 mg/m2 Melphalan
  5. description
    Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG004
    title
    >50 Years of Age Cohort C .75 mg/m2 Melphalan
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.0
          value
          35.03
        2. group Id
          BG001
          value
          26.5
        3. group Id
          BG002
          spread
          6.2
          value
          62.5
        4. group Id
          BG003
          spread
          7.0
          value
          61.7
        5. group Id
          BG004
          spread
          13.5
          value
          62.5
        6. group Id
          BG005
          spread
          14.9
          value
          58.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          22
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. 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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          30
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All treated and evaluable patients
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      22
    6. group Id
      BG005
      value
      35
    units
    Participants
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG000
    title
    <=50 Years of Age Cohort A
  2. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG001
    title
    <=50 Years of Age Cohort B
  3. description
    Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG002
    title
    >50 Years of Age Cohort A -25 mg/m2 Melphalan
  4. description
    Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG003
    title
    >50 Years of Age Cohort B 50 mg/m2 Melphalan
  5. description
    Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
    id
    BG004
    title
    >50 Years of Age Cohort C .75 mg/m2 Melphalan
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.0
          value
          35.03
        2. group Id
          BG001
          value
          26.5
        3. group Id
          BG002
          spread
          6.2
          value
          62.5
        4. group Id
          BG003
          spread
          7.0
          value
          61.7
        5. group Id
          BG004
          spread
          13.5
          value
          62.5
        6. group Id
          BG005
          spread
          14.9
          value
          58.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          22
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. 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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          30
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All treated and evaluable patients

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

Preserved source evidence · Not medical advice