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NCT03112174 · FLOW

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Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL) · Source last updated 2025-07-22

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

groups
  1. description
    Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
    id
    FG000
    title
    Safety Run-in: Increased TLS Risk at Baseline
  2. description
    Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
    id
    FG001
    title
    Safety Run-in: Low TLS Risk at Baseline
  3. description
    Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) once daily over a 5-week period for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
    id
    FG002
    title
    Randomization Phase: Ibrutinb + Venetoclax
  4. description
    Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
    id
    FG003
    title
    Randomization Phase: Ibrutinib + Placebo
  5. description
    Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
    id
    FG004
    title
    Treatment-naive Open-label Arm
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        7
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        67
      4. group Id
        FG003
        num Subjects
        73
      5. group Id
        FG004
        num Subjects
        18
      type
      Death
    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
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      Other, Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        134
      4. comment
        1 participant in this arm did not receive any dose of study drug.
        group Id
        FG003
        num Subjects
        133
      5. group Id
        FG004
        num Subjects
        78
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        31
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        26
      type
      On Study Treatment at Study Closure
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        25
      5. group Id
        FG004
        num Subjects
        25
      type
      Off Treatment and On Study Follow Up at Study Closure
    4. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        53
      4. group Id
        FG003
        num Subjects
        46
      5. group Id
        FG004
        num Subjects
        51
      comment
      Completed=Participants followed for progression (if not progressed before treatment discontinuation), subsequent anticancer therapy, and survival status until study closure. Not Completed=Already off study at study closure.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        81
      4. group Id
        FG003
        num Subjects
        87
      5. group Id
        FG004
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
    id
    FG000
    title
    Safety Run-in: Increased TLS Risk at Baseline
  2. description
    Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
    id
    FG001
    title
    Safety Run-in: Low TLS Risk at Baseline
  3. description
    Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) once daily over a 5-week period for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
    id
    FG002
    title
    Randomization Phase: Ibrutinb + Venetoclax
  4. description
    Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
    id
    FG003
    title
    Randomization Phase: Ibrutinib + Placebo
  5. description
    Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
    id
    FG004
    title
    Treatment-naive Open-label Arm
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        7
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        67
      4. group Id
        FG003
        num Subjects
        73
      5. group Id
        FG004
        num Subjects
        18
      type
      Death
    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
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      Other, Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        134
      4. comment
        1 participant in this arm did not receive any dose of study drug.
        group Id
        FG003
        num Subjects
        133
      5. group Id
        FG004
        num Subjects
        78
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        31
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        26
      type
      On Study Treatment at Study Closure
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        25
      5. group Id
        FG004
        num Subjects
        25
      type
      Off Treatment and On Study Follow Up at Study Closure
    4. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        53
      4. group Id
        FG003
        num Subjects
        46
      5. group Id
        FG004
        num Subjects
        51
      comment
      Completed=Participants followed for progression (if not progressed before treatment discontinuation), subsequent anticancer therapy, and survival status until study closure. Not Completed=Already off study at study closure.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        81
      4. group Id
        FG003
        num Subjects
        87
      5. group Id
        FG004
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice