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NCT01578707 · OUTCOME

Overall Response Rate (ORR) by Investigator

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From study initiation to study closure, including up to 6 years of study follow-up

What was measured

Overall response per the IWCLL 2008 criteria as assessed by 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 percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab (Arm A)22.4Not reportedNot reportedNot reportedNot reported
Ibrutinib (Arm B)87.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22.4
      2. group Id
        OG001
        value
        87.7
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      195
    units
    Participants
description
Overall response per the IWCLL 2008 criteria as assessed by Investigator with up to 6 years of study follow-up
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
NUMBER
reporting Status
POSTED
time Frame
From study initiation to study closure, including up to 6 years of study follow-up
title
Overall Response Rate (ORR) by Investigator
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice