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NCT02180724 · FLOW

Participant flow

An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia · Source last updated 2026-06-16

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

groups
  1. description
    PT 100 mg BID + 200 mg QD (N = 92)
    id
    FG000
    title
    Previously Treated (PT) Total
  2. description
    TN 100 mg BID (N = 13)
    id
    FG001
    title
    Treatment Naive (TN) Cohort 1
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      type
      PI Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        8
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        14
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        1
      comment
      In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.
      type
      200 mg QD
    3. achievements
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        13
      comment
      In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.
      type
      100 mg BID
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For the ACE-WM-001 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis.
recruitment Details
In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID.
Complete source fields
groups
  1. description
    PT 100 mg BID + 200 mg QD (N = 92)
    id
    FG000
    title
    Previously Treated (PT) Total
  2. description
    TN 100 mg BID (N = 13)
    id
    FG001
    title
    Treatment Naive (TN) Cohort 1
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      type
      PI Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        8
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        14
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        1
      comment
      In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.
      type
      200 mg QD
    3. achievements
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        13
      comment
      In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.
      type
      100 mg BID
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For the ACE-WM-001 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis.
recruitment Details
In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID.

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Preserved source evidence · Not medical advice