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NCT00040846 · BASELINE

Baseline characteristics

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies · Source last updated 2020-01-29

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
      60
    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
      60
    units
    Participants
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO
    id
    BG000
    title
    Dose Level 1 (No Campath)
  2. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG001
    title
    Dose Level 2 (0.025 mg/kg/Day Campath)
  3. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG002
    title
    Dose Level 3 (0.050 mg/kg/Day Campath)
  4. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG003
    title
    Dose Level 4 (0.10 mg/kg/Day Campath)
  5. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG004
    title
    Dose Level 5 (0.20 mg/kg/Day Campath)
  6. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG005
    title
    Dose Level 6 (0.40 mg/kg/Day Campath)
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG006
          value
          1
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG006
          value
          52
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG006
          value
          7
        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
          lower Limit
          13
          upper Limit
          72
          value
          56.7
        2. group Id
          BG006
          lower Limit
          13
          upper Limit
          72
          value
          56.7
    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
          15
        2. group Id
          BG006
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG006
          value
          45
        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
          60
        2. group Id
          BG006
          value
          60
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      60
    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
      60
    units
    Participants
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO
    id
    BG000
    title
    Dose Level 1 (No Campath)
  2. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG001
    title
    Dose Level 2 (0.025 mg/kg/Day Campath)
  3. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG002
    title
    Dose Level 3 (0.050 mg/kg/Day Campath)
  4. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG003
    title
    Dose Level 4 (0.10 mg/kg/Day Campath)
  5. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG004
    title
    Dose Level 5 (0.20 mg/kg/Day Campath)
  6. description
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    id
    BG005
    title
    Dose Level 6 (0.40 mg/kg/Day Campath)
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG006
          value
          1
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG006
          value
          52
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG006
          value
          7
        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
          lower Limit
          13
          upper Limit
          72
          value
          56.7
        2. group Id
          BG006
          lower Limit
          13
          upper Limit
          72
          value
          56.7
    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
          15
        2. group Id
          BG006
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG006
          value
          45
        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
          60
        2. group Id
          BG006
          value
          60
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

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

Preserved source evidence · Not medical advice