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NCT01776840 · FLOW

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A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma · Source last updated 2025-07-08

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

groups
  1. description
    Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.
    id
    FG000
    title
    Placebo + Bendamustine and Rituximab (BR) (Treatment A)
  2. description
    Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
    id
    FG001
    title
    Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        48
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        89
      2. group Id
        FG001
        num Subjects
        87
      type
      Sponsor decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        262
      2. group Id
        FG001
        num Subjects
        261
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        260
      2. group Id
        FG001
        num Subjects
        259
      type
      Safety Analysis Set (Treated)
    3. achievements
      1. group Id
        FG000
        num Subjects
        129
      2. group Id
        FG001
        num Subjects
        119
      comment
      Participants who died were considered to have completed the study.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        142
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 523 subjects were randomized in this study.
Complete source fields
groups
  1. description
    Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.
    id
    FG000
    title
    Placebo + Bendamustine and Rituximab (BR) (Treatment A)
  2. description
    Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
    id
    FG001
    title
    Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        48
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        89
      2. group Id
        FG001
        num Subjects
        87
      type
      Sponsor decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        262
      2. group Id
        FG001
        num Subjects
        261
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        260
      2. group Id
        FG001
        num Subjects
        259
      type
      Safety Analysis Set (Treated)
    3. achievements
      1. group Id
        FG000
        num Subjects
        129
      2. group Id
        FG001
        num Subjects
        119
      comment
      Participants who died were considered to have completed the study.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        142
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 523 subjects were randomized in this study.

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Preserved source evidence · Not medical advice