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NCT02264574 · FLOW

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A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) · Source last updated 2020-09-21

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

groups
  1. description
    Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.
    id
    FG000
    title
    IBR+OB
  2. description
    Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.
    id
    FG001
    title
    CLB+OB
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        21
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Other, Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        116
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        84
      2. group Id
        FG001
        num Subjects
        86
      comment
      On-study until study termination by sponsor.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Eligible participants were required to have had a diagnosis of active CLL/SLL conformant to IWCLL 2008 criteria. All subjects were required to have measurable nodal disease. Key exclusion criteria included any previous CLL/SLL treatment; known lymphoma or leukemia of the central nervous system, history/current evidence of Richter's transformation.
recruitment Details
This study was conducted in 71 sites: 8 in the US, 36 in the EU, and 27 sites in 6 additional countries (Canada, Australia, New Zealand, Russia, Israel, Turkey). The first participant consented 06 October 2014. The last visit of the last participant was 03 September 2019, with a final database lock of 17 October 2019.
Complete source fields
groups
  1. description
    Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.
    id
    FG000
    title
    IBR+OB
  2. description
    Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.
    id
    FG001
    title
    CLB+OB
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        21
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Other, Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        116
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        84
      2. group Id
        FG001
        num Subjects
        86
      comment
      On-study until study termination by sponsor.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Eligible participants were required to have had a diagnosis of active CLL/SLL conformant to IWCLL 2008 criteria. All subjects were required to have measurable nodal disease. Key exclusion criteria included any previous CLL/SLL treatment; known lymphoma or leukemia of the central nervous system, history/current evidence of Richter's transformation.
recruitment Details
This study was conducted in 71 sites: 8 in the US, 36 in the EU, and 27 sites in 6 additional countries (Canada, Australia, New Zealand, Russia, Israel, Turkey). The first participant consented 06 October 2014. The last visit of the last participant was 03 September 2019, with a final database lock of 17 October 2019.

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Preserved source evidence · Not medical advice