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NCT03734016 · OUTCOME

Time to Treatment Failure

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia · Source last updated 2025-03-30

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 randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

What was measured

Time to treatment failure is defined as the time from randomization to discontinuation of study drug due to any reason. Median time to treatment failure was estimated by the Kaplan-Meier method.

Analysis population: ITT Analysis Set

Groups in this outcome

Zanubrutinib

Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Ibrutinib

Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

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

Analysis denominator · Participants

GroupSource count
Zanubrutinib327
Ibrutinib325

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ZanubrutinibNANot reportedNANAInsufficient number of participants with events to estimate median and 95% confidence interval.
IbrutinibNANot reported34.4NAInsufficient number of participants with events to estimate median and upper 95% confidence limit.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.72
    estimate Comment
    Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
Complete source fields
analyses
  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.72
    estimate Comment
    Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events to estimate median and 95% confidence interval.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Insufficient number of participants with events to estimate median and upper 95% confidence limit.
        group Id
        OG001
        lower Limit
        34.4
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      327
    2. group Id
      OG001
      value
      325
    units
    Participants
description
Time to treatment failure is defined as the time from randomization to discontinuation of study drug due to any reason. Median time to treatment failure was estimated by the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    OG000
    title
    Zanubrutinib
  2. description
    Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    OG001
    title
    Ibrutinib
param Type
MEDIAN
population Description
ITT Analysis Set
reporting Status
POSTED
time Frame
From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
title
Time to Treatment Failure
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice