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NCT03462719 · FLOW

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A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) · Source last updated 2026-08-31

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

groups
  1. description
    Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment Arm A (Ibrutinib + Venetoclax)
  2. description
    Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
    id
    FG001
    title
    Treatment Arm B (Chlorambucil + Obinutuzumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        72
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        106
      2. group Id
        FG001
        num Subjects
        105
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        30
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        91
      2. group Id
        FG001
        num Subjects
        75
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment Arm A (Ibrutinib + Venetoclax)
  2. description
    Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
    id
    FG001
    title
    Treatment Arm B (Chlorambucil + Obinutuzumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        72
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        106
      2. group Id
        FG001
        num Subjects
        105
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        30
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        91
      2. group Id
        FG001
        num Subjects
        75
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice