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NCT01938001 · FLOW

Participant flow

Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) · Source last updated 2023-02-22

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

groups
  1. description
    Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
    id
    FG000
    title
    Rituximab + Lenalidomide (R^2)
  2. description
    Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
    id
    FG001
    title
    Rituximab + Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event unrelated to Study Drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        178
      2. group Id
        FG001
        num Subjects
        180
      comment
      Started=randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        176
      2. group Id
        FG001
        num Subjects
        180
      comment
      Completed=treated
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        8
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        54
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        176
      2. group Id
        FG001
        num Subjects
        180
      comment
      Started=treated
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        110
      comment
      Completed=completed 12 cycles of treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        70
      type
      NOT COMPLETED
    title
    Treatment
Complete source fields
groups
  1. description
    Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
    id
    FG000
    title
    Rituximab + Lenalidomide (R^2)
  2. description
    Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
    id
    FG001
    title
    Rituximab + Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event unrelated to Study Drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        178
      2. group Id
        FG001
        num Subjects
        180
      comment
      Started=randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        176
      2. group Id
        FG001
        num Subjects
        180
      comment
      Completed=treated
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        8
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        54
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        176
      2. group Id
        FG001
        num Subjects
        180
      comment
      Started=treated
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        110
      comment
      Completed=completed 12 cycles of treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        70
      type
      NOT COMPLETED
    title
    Treatment

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Preserved source evidence · Not medical advice