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NCT03336333 · FLOW

Participant flow

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL · Source last updated 2026-03-09

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

groups
  1. description
    Bendamustine + rituximab in participants with chronic lymphocytic leukemia (CLL) without deletion 17p \[del(17p)\]; bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)
    id
    FG000
    title
    Cohort 1: Bendamustine + Rituximab Without Del(17p)
  2. description
    Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    FG001
    title
    Cohort 1: Zanubrutinib Without Del(17p)
  3. description
    Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    FG002
    title
    Cohort 2: Zanubrutinib With Del(17p)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        202
      2. group Id
        FG001
        num Subjects
        219
      3. group Id
        FG002
        num Subjects
        102
      type
      Remained on study at time of data cut-off
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        8
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        238
      2. group Id
        FG001
        num Subjects
        241
      3. group Id
        FG002
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        227
      2. group Id
        FG001
        num Subjects
        240
      3. group Id
        FG002
        num Subjects
        111
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        238
      2. group Id
        FG001
        num Subjects
        241
      3. group Id
        FG002
        num Subjects
        111
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Available data are presented as of the primary analysis data cut-off date of 07MAY2021; as of the data cut-off date, all cohorts were ongoing.
Complete source fields
groups
  1. description
    Bendamustine + rituximab in participants with chronic lymphocytic leukemia (CLL) without deletion 17p \[del(17p)\]; bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)
    id
    FG000
    title
    Cohort 1: Bendamustine + Rituximab Without Del(17p)
  2. description
    Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    FG001
    title
    Cohort 1: Zanubrutinib Without Del(17p)
  3. description
    Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    FG002
    title
    Cohort 2: Zanubrutinib With Del(17p)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        202
      2. group Id
        FG001
        num Subjects
        219
      3. group Id
        FG002
        num Subjects
        102
      type
      Remained on study at time of data cut-off
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        8
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        238
      2. group Id
        FG001
        num Subjects
        241
      3. group Id
        FG002
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        227
      2. group Id
        FG001
        num Subjects
        240
      3. group Id
        FG002
        num Subjects
        111
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        238
      2. group Id
        FG001
        num Subjects
        241
      3. group Id
        FG002
        num Subjects
        111
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Available data are presented as of the primary analysis data cut-off date of 07MAY2021; as of the data cut-off date, all cohorts were ongoing.

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Preserved source evidence · Not medical advice