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NCT00012298 · BASELINE

Baseline characteristics

Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2018-08-09

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
      11
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      5
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      39
    8. group Id
      BG007
      value
      81
    units
    Participants
groups
  1. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
    id
    BG000
    title
    Treatment: Trial 1, Dose Level 1
  2. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
    id
    BG001
    title
    Treatment: Trial 1, Dose Level 2
  3. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
    id
    BG002
    title
    Treatment: Trial 2, Dose Level 3
  4. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
    id
    BG003
    title
    Treatment: Trial 2, Dose Level 4
  5. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    BG004
    title
    Treatment: Trial 3, Dose Level 5
  6. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    BG005
    title
    Treatment: Trial 3, Dose Level 6
  7. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    BG006
    title
    Treatment : Phase II (Dose Level 6)
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          39
          upper Limit
          70
          value
          60
        2. group Id
          BG001
          lower Limit
          31
          upper Limit
          65
          value
          56
        3. group Id
          BG002
          lower Limit
          37
          upper Limit
          70
          value
          52
        4. group Id
          BG003
          lower Limit
          30
          upper Limit
          67
          value
          51
        5. group Id
          BG004
          lower Limit
          42
          upper Limit
          60
          value
          46
        6. group Id
          BG005
          lower Limit
          28
          upper Limit
          62
          value
          59
        7. group Id
          BG006
          lower Limit
          36
          upper Limit
          76
          value
          58
        8. group Id
          BG007
          lower Limit
          28
          upper Limit
          76
          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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          33
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          22
        8. group Id
          BG007
          value
          48
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Saudi Arabia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Croatia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          39
        8. group Id
          BG007
          value
          79
      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
      11
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      5
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      39
    8. group Id
      BG007
      value
      81
    units
    Participants
groups
  1. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.
    id
    BG000
    title
    Treatment: Trial 1, Dose Level 1
  2. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
    id
    BG001
    title
    Treatment: Trial 1, Dose Level 2
  3. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
    id
    BG002
    title
    Treatment: Trial 2, Dose Level 3
  4. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
    id
    BG003
    title
    Treatment: Trial 2, Dose Level 4
  5. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    BG004
    title
    Treatment: Trial 3, Dose Level 5
  6. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    BG005
    title
    Treatment: Trial 3, Dose Level 6
  7. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    BG006
    title
    Treatment : Phase II (Dose Level 6)
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          39
          upper Limit
          70
          value
          60
        2. group Id
          BG001
          lower Limit
          31
          upper Limit
          65
          value
          56
        3. group Id
          BG002
          lower Limit
          37
          upper Limit
          70
          value
          52
        4. group Id
          BG003
          lower Limit
          30
          upper Limit
          67
          value
          51
        5. group Id
          BG004
          lower Limit
          42
          upper Limit
          60
          value
          46
        6. group Id
          BG005
          lower Limit
          28
          upper Limit
          62
          value
          59
        7. group Id
          BG006
          lower Limit
          36
          upper Limit
          76
          value
          58
        8. group Id
          BG007
          lower Limit
          28
          upper Limit
          76
          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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          33
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          22
        8. group Id
          BG007
          value
          48
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Saudi Arabia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Croatia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          39
        8. group Id
          BG007
          value
          79
      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