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NCT02328014 · FLOW

Participant flow

Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies · Source last updated 2025-12-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
    id
    FG000
    title
    Part 1 Cohort 1
  2. description
    Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    FG001
    title
    Part 1 Cohort 2
  3. description
    Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
    id
    FG002
    title
    Part 1 Cohort 3
  4. description
    Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    FG003
    title
    Part 2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Study Terminated by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        12
      type
      Subject Started Another Cancer Therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        22
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All data collection and Final analysis for the study has been completed. However, as we face a unique challenge in oncology studies, some patients benefiting from the medication, continue to receive treatment beyond final analysis with NO requirement for any further data collection or additional data analysis.
Complete source fields
groups
  1. description
    Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
    id
    FG000
    title
    Part 1 Cohort 1
  2. description
    Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    FG001
    title
    Part 1 Cohort 2
  3. description
    Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
    id
    FG002
    title
    Part 1 Cohort 3
  4. description
    Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    FG003
    title
    Part 2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Study Terminated by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        12
      type
      Subject Started Another Cancer Therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        22
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All data collection and Final analysis for the study has been completed. However, as we face a unique challenge in oncology studies, some patients benefiting from the medication, continue to receive treatment beyond final analysis with NO requirement for any further data collection or additional data analysis.

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Preserved source evidence · Not medical advice