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NCT02604511 · FLOW

Participant flow

Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing · Source last updated 2022-12-07

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

groups
  1. description
    This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated Waldenstrom's macroglobulinemia (WM) patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    id
    FG000
    title
    Ibrutinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Participant ineligible
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Intercurrent illness
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated Waldenstrom's macroglobulinemia (WM) patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    id
    FG000
    title
    Ibrutinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Participant ineligible
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Intercurrent illness
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice