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NCT05023980 · BASELINE

Baseline characteristics

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) · Source last updated 2026-09-25

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
      141
    2. group Id
      BG001
      value
      141
    3. group Id
      BG002
      value
      282
    units
    Participants
groups
  1. description
    Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm A - Pirtobrutinib
  2. description
    Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
    id
    BG001
    title
    Arm B - Bendamustine Plus Rituximab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          125
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          157
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          109
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          173
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          26
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          248
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          64
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          206
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All randomized participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      141
    2. group Id
      BG001
      value
      141
    3. group Id
      BG002
      value
      282
    units
    Participants
groups
  1. description
    Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm A - Pirtobrutinib
  2. description
    Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
    id
    BG001
    title
    Arm B - Bendamustine Plus Rituximab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          125
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          157
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          109
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          173
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          26
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          248
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          64
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          206
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All randomized participants

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice