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NCT00544466 · BASELINE

Baseline characteristics

Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Allo-HSCT in Hematological Malignancies · Source last updated 2026-02-19

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
      75
    units
    Participants
groups
  1. description
    PREPARATIVE REGIMEN\*: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \*Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
    id
    BG000
    title
    Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          9
          upper Limit
          70
          value
          55
    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
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          62
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Patients consented to the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      75
    units
    Participants
groups
  1. description
    PREPARATIVE REGIMEN\*: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \*Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
    id
    BG000
    title
    Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          9
          upper Limit
          70
          value
          55
    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
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          62
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Patients consented to the study.

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

Preserved source evidence · Not medical advice