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NCT02048813 · BASELINE

Baseline characteristics

Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2026-08-28

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
      354
    2. group Id
      BG001
      value
      175
    3. group Id
      BG002
      value
      529
    units
    Participants
groups
  1. description
    Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
    id
    BG000
    title
    Arm A (Ibrutinib, Rituximab)
  2. description
    Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
    id
    BG001
    title
    Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.5
          value
          56.7
        2. group Id
          BG001
          spread
          7.2
          value
          56.7
        3. group Id
          BG002
          spread
          7.4
          value
          56.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          173
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          356
        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
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          333
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          500
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          19
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          29
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          318
        2. group Id
          BG001
          value
          160
        3. group Id
          BG002
          value
          478
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All randomized patients were included in this analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      354
    2. group Id
      BG001
      value
      175
    3. group Id
      BG002
      value
      529
    units
    Participants
groups
  1. description
    Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
    id
    BG000
    title
    Arm A (Ibrutinib, Rituximab)
  2. description
    Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
    id
    BG001
    title
    Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.5
          value
          56.7
        2. group Id
          BG001
          spread
          7.2
          value
          56.7
        3. group Id
          BG002
          spread
          7.4
          value
          56.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          173
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          356
        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
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          333
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          500
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          19
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          29
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          318
        2. group Id
          BG001
          value
          160
        3. group Id
          BG002
          value
          478
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All randomized patients were included in this analysis.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice