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NCT01732926 · FLOW

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Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas · Source last updated 2018-11-16

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

groups
  1. description
    Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) \+ rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    FG000
    title
    Idelalisib + Bendamustine + Rituximab
  2. description
    Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    FG001
    title
    Placebo + Bendamustine + Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        168
      2. group Id
        FG001
        num Subjects
        80
      type
      Study Terminated by Sponsor
    2. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        11
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        4
      type
      Other Reason
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      type
      Initiation of Other Anti-Cancer Therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Blind Broken by Subject or Study Site
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        320
      2. group Id
        FG001
        num Subjects
        155
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        45
      comment
      Completed = reached primary efficacy endpoint of progressive disease or death
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        267
      2. group Id
        FG001
        num Subjects
        110
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
581 participants were screened.
recruitment Details
Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 02 January 2013. The last study visit occurred on 17 May 2016.
Complete source fields
groups
  1. description
    Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) \+ rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    FG000
    title
    Idelalisib + Bendamustine + Rituximab
  2. description
    Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    FG001
    title
    Placebo + Bendamustine + Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        168
      2. group Id
        FG001
        num Subjects
        80
      type
      Study Terminated by Sponsor
    2. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        11
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        4
      type
      Other Reason
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      type
      Initiation of Other Anti-Cancer Therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Blind Broken by Subject or Study Site
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        320
      2. group Id
        FG001
        num Subjects
        155
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        45
      comment
      Completed = reached primary efficacy endpoint of progressive disease or death
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        267
      2. group Id
        FG001
        num Subjects
        110
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
581 participants were screened.
recruitment Details
Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 02 January 2013. The last study visit occurred on 17 May 2016.

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Preserved source evidence · Not medical advice