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NCT00578942 · BASELINE

Baseline characteristics

Allo Non-myeloablative SCT Utilizing Matched Family Member Stem Cells Purged Using Campath · Source last updated 2016-06-24

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
      48
    units
    Participants
groups
  1. description
    Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors 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
          1
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          41
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        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
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        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
          0
        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
          42
        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
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          47
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Cohort of subjects 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
      48
    units
    Participants
groups
  1. description
    Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors 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
          1
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          41
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        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
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        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
          0
        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
          42
        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
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          47
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Cohort of subjects 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