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NCT01578707 · OUTCOME

Progression Free Survival (PFS) by Investigator With up to 6 Years of Study Follow-up

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From study initiation to study closure, including up to 6 years of study follow-up

What was measured

Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up

Groups in this outcome

Ofatumumab (Arm A)

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)

Ibrutinib (Arm B)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ofatumumab (Arm A)196
Ibrutinib (Arm B)195

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ofatumumab (Arm A)8.1Not reported7.798.25Not reported
Ibrutinib (Arm B)44.1Not reported38.4756.18Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.79
        upper Limit
        8.25
        value
        8.1
      2. group Id
        OG001
        lower Limit
        38.47
        upper Limit
        56.18
        value
        44.1
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      195
    units
    Participants
description
Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Ibrutinib (Arm B)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From study initiation to study closure, including up to 6 years of study follow-up
title
Progression Free Survival (PFS) by Investigator With up to 6 Years of Study Follow-up
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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

Preserved source evidence · Not medical advice