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NCT01578707 · FLOW

Participant flow

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia · Source last updated 2019-12-18

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

groups
  1. description
    An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
    id
    FG000
    title
    Ofatumumab (Arm A)
  2. description
    A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
    id
    FG001
    title
    Ibrutinib (Arm B)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        196
      2. group Id
        FG001
        num Subjects
        195
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        196
      2. group Id
        FG001
        num Subjects
        195
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
    id
    FG000
    title
    Ofatumumab (Arm A)
  2. description
    A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
    id
    FG001
    title
    Ibrutinib (Arm B)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        196
      2. group Id
        FG001
        num Subjects
        195
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        196
      2. group Id
        FG001
        num Subjects
        195
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice