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NCT03128359 · BASELINE

Baseline characteristics

High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant · Source last updated 2024-01-09

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
      19
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      19
    4. group Id
      BG003
      value
      38
    units
    Participants
groups
  1. description
    Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV
    id
    BG000
    title
    Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
  2. description
    Patients receive fludarabine phosphate IV over 1-3 hours and busulfan IV over 3 hour on days -5 to -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Busulfan: Given IV Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV
    id
    BG001
    title
    Regimen B (Fludarabine, Busulfan, PBSC HCT, GVHD Prophylaxis)
  3. description
    Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI
    id
    BG002
    title
    Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          33
          upper Limit
          72
          value
          63
        2. group Id
          BG002
          lower Limit
          21
          upper Limit
          57
          value
          44
        3. group Id
          BG003
          lower Limit
          21
          upper Limit
          72
          value
          53
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG002
          value
          11
        3. group Id
          BG003
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG002
          value
          8
        3. group Id
          BG003
          value
          19
        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
          3
        2. group Id
          BG002
          value
          8
        3. group Id
          BG003
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG002
          value
          11
        3. group Id
          BG003
          value
          26
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          4
        3. group Id
          BG003
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG002
          value
          12
        3. group Id
          BG003
          value
          24
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG002
          value
          19
        3. group Id
          BG003
          value
          38
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
No subject enrolled onto Regimen B.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      19
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      19
    4. group Id
      BG003
      value
      38
    units
    Participants
groups
  1. description
    Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV
    id
    BG000
    title
    Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
  2. description
    Patients receive fludarabine phosphate IV over 1-3 hours and busulfan IV over 3 hour on days -5 to -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Busulfan: Given IV Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV
    id
    BG001
    title
    Regimen B (Fludarabine, Busulfan, PBSC HCT, GVHD Prophylaxis)
  3. description
    Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI
    id
    BG002
    title
    Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          33
          upper Limit
          72
          value
          63
        2. group Id
          BG002
          lower Limit
          21
          upper Limit
          57
          value
          44
        3. group Id
          BG003
          lower Limit
          21
          upper Limit
          72
          value
          53
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG002
          value
          11
        3. group Id
          BG003
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG002
          value
          8
        3. group Id
          BG003
          value
          19
        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
          3
        2. group Id
          BG002
          value
          8
        3. group Id
          BG003
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG002
          value
          11
        3. group Id
          BG003
          value
          26
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          4
        3. group Id
          BG003
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG002
          value
          12
        3. group Id
          BG003
          value
          24
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG002
          value
          19
        3. group Id
          BG003
          value
          38
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
No subject enrolled onto Regimen B.

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

Preserved source evidence · Not medical advice