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NCT01518153 · BASELINE

Baseline characteristics

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT) · Source last updated 2016-03-17

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
      16
    units
    Participants
groups
  1. description
    Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10\^6 CD3+ cells/kg or 3 x 10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\*10/L for 3 consecutive days.
    id
    BG000
    title
    Stem Cell Transplant + Donor Lymphocyte Infusion
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35
          upper Limit
          65
          value
          58
    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
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        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
          16
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      16
    units
    Participants
groups
  1. description
    Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10\^6 CD3+ cells/kg or 3 x 10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\*10/L for 3 consecutive days.
    id
    BG000
    title
    Stem Cell Transplant + Donor Lymphocyte Infusion
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35
          upper Limit
          65
          value
          58
    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
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        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
          16
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice