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NCT01578707 · OUTCOME

Rate of Sustained Hemoglobin and Platelet Improvement

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

Proportion of subjects with hemoglobin (HgB) increase \>=20 g/L and platelet (PLT) increase \>=50% over baseline continuously for \>=56 days without blood transfusions or growth factors.

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

Hgb Improvement in patient with baseline anemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab (Arm A)32.6Not reportedNot reportedNot reportedNot reported
Ibrutinib (Arm B)69.7Not reportedNot reportedNot reportedNot reported
Platelet improvement in baseline thrombocytopenia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab (Arm A)9.4Not reportedNot reportedNot reportedNot reported
Ibrutinib (Arm B)78.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        32.6
      2. group Id
        OG001
        value
        69.7
    title
    Hgb Improvement in patient with baseline anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9.4
      2. group Id
        OG001
        value
        78.4
    title
    Platelet improvement in baseline thrombocytopenia
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      195
    units
    Participants
description
Proportion of subjects with hemoglobin (HgB) increase \>=20 g/L and platelet (PLT) increase \>=50% over baseline continuously for \>=56 days without blood transfusions or growth factors.
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
Rate of Sustained Hemoglobin and Platelet Improvement
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice