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NCT03112174 · OUTCOME

Progression-free Survival (PFS) (Randomization Phase)

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL) · Source last updated 2025-07-22

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
For an overall median time on study of 61.34 months

What was measured

PFS is defined as the time from the date of randomization to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first.

Analysis population: All randomized participants

Groups in this outcome

Randomization Phase: Ibrutinb + Venetoclax

Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.

Randomization Phase: Ibrutinib + Placebo

Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.

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

Analysis denominator · Participants

GroupSource count
Randomization Phase: Ibrutinb + Venetoclax134
Randomization Phase: Ibrutinib + Placebo133

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomization Phase: Ibrutinb + Venetoclax31.9Not reported22.854.5Not reported
Randomization Phase: Ibrutinib + Placebo22.1Not reported16.529.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.465
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.850
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0024
    p Value Comment
    P value is from stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.629
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.465
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.850
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0024
    p Value Comment
    P value is from stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.629
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.8
        upper Limit
        54.5
        value
        31.9
      2. group Id
        OG001
        lower Limit
        16.5
        upper Limit
        29.5
        value
        22.1
denoms
  1. counts
    1. group Id
      OG000
      value
      134
    2. group Id
      OG001
      value
      133
    units
    Participants
description
PFS is defined as the time from the date of randomization to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
    id
    OG000
    title
    Randomization Phase: Ibrutinb + Venetoclax
  2. description
    Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
    id
    OG001
    title
    Randomization Phase: Ibrutinib + Placebo
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
For an overall median time on study of 61.34 months
title
Progression-free Survival (PFS) (Randomization Phase)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice