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NCT01996865 · FLOW

Participant flow

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. · Source last updated 2025-07-10

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

groups
  1. description
    Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
    id
    FG000
    title
    Induction Period: Lenalidomide + Rituximab
  2. description
    Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
    id
    FG001
    title
    Arm A: Lenalidomide + Rituximab
  3. description
    Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
    id
    FG002
    title
    Arm B: Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other Reasons
    5. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        111
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        503
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        500
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        284
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        219
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Induction Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        5
      type
      Other reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        23
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        4
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        7
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        135
      3. group Id
        FG002
        num Subjects
        132
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        134
      3. group Id
        FG002
        num Subjects
        132
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        78
      3. group Id
        FG002
        num Subjects
        89
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        43
      type
      NOT COMPLETED
    title
    Maintenance Period
pre Assignment Details
503 participants joined this study. All participants started in the induction period; only those who did not progress after 12 cycles of treatment were randomized to receive treatment in the maintenance period.
Complete source fields
groups
  1. description
    Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
    id
    FG000
    title
    Induction Period: Lenalidomide + Rituximab
  2. description
    Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
    id
    FG001
    title
    Arm A: Lenalidomide + Rituximab
  3. description
    Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
    id
    FG002
    title
    Arm B: Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other Reasons
    5. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        111
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        503
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        500
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        284
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        219
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Induction Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        5
      type
      Other reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        23
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        4
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        7
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        135
      3. group Id
        FG002
        num Subjects
        132
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        134
      3. group Id
        FG002
        num Subjects
        132
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        78
      3. group Id
        FG002
        num Subjects
        89
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        43
      type
      NOT COMPLETED
    title
    Maintenance Period
pre Assignment Details
503 participants joined this study. All participants started in the induction period; only those who did not progress after 12 cycles of treatment were randomized to receive treatment in the maintenance period.

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Preserved source evidence · Not medical advice