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NCT02970318 · FLOW

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A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL · Source last updated 2026-07-24

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

groups
  1. description
    Arm A- Acalabrutinib 100 mg BID- Overall Study Period
    id
    FG000
    title
    Arm A- Acala 100 mg BID- Overall Study Period
  2. description
    IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
    id
    FG001
    title
    Arm B: Investigator Choice (IR or BR)-Main Study Period
  3. description
    Arm B- Investigator Choice of IR Crossed Over to Arm A- Acala. 100 mg BID
    id
    FG002
    title
    Arm B- Inv Choice of IR Crossed Over to Arm A- Acala. 100 mg BID
  4. description
    Arm B- Investigator Choice of BR Crossed Over to Arm A- Acala. 100 mg BID
    id
    FG003
    title
    Arm B- Inv. Choice of BR Crossed Over to Arm A- Acala. 100 mg BID
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        80
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Arm B Crossed Over to Arm A Acala 100 mg Monotherapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        155
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Arm B Treatment= Idelalisib Plus Rituximab
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Arm B Treatment = Bendamustine Plus Rituximab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        This subject received 1st dose of study drug on 11Nov2011, completed study treatment on 14MAR2019, never crossed over, and and died 11 months after completing study treatment on 15Feb2020.
        group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Completed study treatment at final DCO (03Sep2021)
      type
      Completed
    5. achievements
      1. group Id
        FG000
        num Subjects
        99
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Patients ongoing treatment at final DCO (03Sep2021)
      type
      Completed
    6. achievements
      1. comment
        All 99 subjects ongoing treatment at final DCO.
        group Id
        FG000
        num Subjects
        99
      2. comment
        26 subjects ongoing treatment + 1 subject completed study treatment and died 11 months after completing study treatment on 15Feb2020.
        group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Patients Ongoing Treatment + Patients Completed Study Treatment at Final DCO (03Sep2021)
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        128
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall for Arm A & Main for Arm B
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        2
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        N/A. Note: No subjects stayed in Arm: Investigator's choice of IR/BR during cross-over period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.
        group Id
        FG002
        num Subjects
        63
      4. comment
        Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.
        group Id
        FG003
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        42
      4. group Id
        FG003
        num Subjects
        14
      comment
      Ongoing Treatment at Final DCO (03Sep2021)
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    ArmB: Inv.Choice Crossed Over to Acala
pre Assignment Details
310 patients were enrolled in this study and agreed to move forward in participating in the trial.
recruitment Details
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia. A total of 310 subjects met the eligibility criteria and were randomized to the acalabrutinib arm (N = 155) and IR/BR arm (N = 155). All but 3 subjects (1 randomized to acalabrutinib and 2 randomized to IR/BR) received study treatment.
Complete source fields
groups
  1. description
    Arm A- Acalabrutinib 100 mg BID- Overall Study Period
    id
    FG000
    title
    Arm A- Acala 100 mg BID- Overall Study Period
  2. description
    IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
    id
    FG001
    title
    Arm B: Investigator Choice (IR or BR)-Main Study Period
  3. description
    Arm B- Investigator Choice of IR Crossed Over to Arm A- Acala. 100 mg BID
    id
    FG002
    title
    Arm B- Inv Choice of IR Crossed Over to Arm A- Acala. 100 mg BID
  4. description
    Arm B- Investigator Choice of BR Crossed Over to Arm A- Acala. 100 mg BID
    id
    FG003
    title
    Arm B- Inv. Choice of BR Crossed Over to Arm A- Acala. 100 mg BID
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        80
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Arm B Crossed Over to Arm A Acala 100 mg Monotherapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        155
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Arm B Treatment= Idelalisib Plus Rituximab
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Arm B Treatment = Bendamustine Plus Rituximab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        This subject received 1st dose of study drug on 11Nov2011, completed study treatment on 14MAR2019, never crossed over, and and died 11 months after completing study treatment on 15Feb2020.
        group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Completed study treatment at final DCO (03Sep2021)
      type
      Completed
    5. achievements
      1. group Id
        FG000
        num Subjects
        99
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Patients ongoing treatment at final DCO (03Sep2021)
      type
      Completed
    6. achievements
      1. comment
        All 99 subjects ongoing treatment at final DCO.
        group Id
        FG000
        num Subjects
        99
      2. comment
        26 subjects ongoing treatment + 1 subject completed study treatment and died 11 months after completing study treatment on 15Feb2020.
        group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Patients Ongoing Treatment + Patients Completed Study Treatment at Final DCO (03Sep2021)
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        128
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall for Arm A & Main for Arm B
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        2
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        N/A. Note: No subjects stayed in Arm: Investigator's choice of IR/BR during cross-over period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.
        group Id
        FG002
        num Subjects
        63
      4. comment
        Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.
        group Id
        FG003
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        42
      4. group Id
        FG003
        num Subjects
        14
      comment
      Ongoing Treatment at Final DCO (03Sep2021)
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    ArmB: Inv.Choice Crossed Over to Acala
pre Assignment Details
310 patients were enrolled in this study and agreed to move forward in participating in the trial.
recruitment Details
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia. A total of 310 subjects met the eligibility criteria and were randomized to the acalabrutinib arm (N = 155) and IR/BR arm (N = 155). All but 3 subjects (1 randomized to acalabrutinib and 2 randomized to IR/BR) received study treatment.

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Preserved source evidence · Not medical advice