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NCT02362035 · BASELINE

Baseline characteristics

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies · Source last updated 2026-05-13

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
      161
    units
    Participants
groups
  1. description
    All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
    id
    BG000
    title
    Acalabrutinib + Pembrolizumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.6
          value
          62.4
    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
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          98
        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
          11
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          148
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          141
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          161
      title
      USA
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      161
    units
    Participants
groups
  1. description
    All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
    id
    BG000
    title
    Acalabrutinib + Pembrolizumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.6
          value
          62.4
    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
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          98
        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
          11
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          148
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          141
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          161
      title
      USA
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.

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Preserved source evidence · Not medical advice