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NCT00580034 · BASELINE

Baseline characteristics

Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath · Source last updated 2014-06-03

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
      88
    units
    Participants
groups
  1. description
    Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d sc or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45.
    id
    BG000
    title
    Campath Purged Non-myeloablative ASCT
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          80
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          8
        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
          spread
          24
          value
          49
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        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
          88
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Cohort of patients who actually received at least 1 donor lymphocyte infusion (DLI). DLI dosages thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      88
    units
    Participants
groups
  1. description
    Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d sc or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45.
    id
    BG000
    title
    Campath Purged Non-myeloablative ASCT
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          80
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          8
        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
          spread
          24
          value
          49
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        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
          88
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Cohort of patients who actually received at least 1 donor lymphocyte infusion (DLI). DLI dosages thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg.

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Preserved source evidence · Not medical advice