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NCT01980888 · FLOW

Participant flow

Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia · Source last updated 2018-11-19

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 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at 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 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
    id
    FG001
    title
    Placebo+Bendamustine+Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        116
      2. group Id
        FG001
        num Subjects
        122
      type
      Study Terminated by Sponsor
    2. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrew Consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        3
      type
      Investigator's Discretion
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Non-Compliance with Study Drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        157
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. comment
        Completed = reached primary efficacy endpoint of progressive disease or death.
        group Id
        FG000
        num Subjects
        13
      2. comment
        Completed = reached primary efficacy endpoint of progressive disease or death.
        group Id
        FG001
        num Subjects
        21
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        144
      2. group Id
        FG001
        num Subjects
        133
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
392 participants were screened.
recruitment Details
Participants were enrolled at study sites in the North America, Australia, and Europe. The first participant was screened on 05 February 2014. The last study visit occurred on 16 June 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 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at 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 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
    id
    FG001
    title
    Placebo+Bendamustine+Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        116
      2. group Id
        FG001
        num Subjects
        122
      type
      Study Terminated by Sponsor
    2. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrew Consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        3
      type
      Investigator's Discretion
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Non-Compliance with Study Drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        157
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. comment
        Completed = reached primary efficacy endpoint of progressive disease or death.
        group Id
        FG000
        num Subjects
        13
      2. comment
        Completed = reached primary efficacy endpoint of progressive disease or death.
        group Id
        FG001
        num Subjects
        21
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        144
      2. group Id
        FG001
        num Subjects
        133
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
392 participants were screened.
recruitment Details
Participants were enrolled at study sites in the North America, Australia, and Europe. The first participant was screened on 05 February 2014. The last study visit occurred on 16 June 2016.

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Preserved source evidence · Not medical advice