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NCT00112723 · BASELINE

Baseline characteristics

Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma · Source last updated 2016-08-08

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
      46
    units
    Participants
groups
  1. description
    PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
    id
    BG000
    title
    Treatment (Alvocidib)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          34
          upper Limit
          84
          value
          66
    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
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        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
          45
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Canada
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    patients
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      0 (Fully active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
      title
      1 (Restricted in physically strenuous activity)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      2 (Ambulatory capable of all selfcare)
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance status
    unit Of Measure
    patients
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Indolent B-cell
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      intermediate grade B-NHL
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Mantle cell lymphoma
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      T/NK cell NHL
    param Type
    NUMBER
    title
    Diagnosis
    unit Of Measure
    patients
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      46
    units
    Participants
groups
  1. description
    PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
    id
    BG000
    title
    Treatment (Alvocidib)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          34
          upper Limit
          84
          value
          66
    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
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        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
          45
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Canada
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    patients
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      0 (Fully active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
      title
      1 (Restricted in physically strenuous activity)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      2 (Ambulatory capable of all selfcare)
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance status
    unit Of Measure
    patients
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Indolent B-cell
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      intermediate grade B-NHL
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Mantle cell lymphoma
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      T/NK cell NHL
    param Type
    NUMBER
    title
    Diagnosis
    unit Of Measure
    patients

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Preserved source evidence · Not medical advice