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NCT03112174 · OUTCOME

Percentage of Participants With a Complete Response (CR) (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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
For an overall median time on study of 61.34 months

What was measured

Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomization Phase: Ibrutinb + Venetoclax53.7Not reported44.962.4Not reported
Randomization Phase: Ibrutinib + Placebo32.3Not reported24.541.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.240
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.218
    estimate Comment
    For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    p Value Comment
    Estimate and p-value for rate ratio are based on Cochran-Mantel-Haenszel (CMH) test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.
    param Type
    Rate Ratio
    param Value
    1.658
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.240
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.218
    estimate Comment
    For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    p Value Comment
    Estimate and p-value for rate ratio are based on Cochran-Mantel-Haenszel (CMH) test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.
    param Type
    Rate Ratio
    param Value
    1.658
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.9
        upper Limit
        62.4
        value
        53.7
      2. group Id
        OG001
        lower Limit
        24.5
        upper Limit
        41.0
        value
        32.3
denoms
  1. counts
    1. group Id
      OG000
      value
      134
    2. group Id
      OG001
      value
      133
    units
    Participants
description
Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014).
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
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
For an overall median time on study of 61.34 months
title
Percentage of Participants With a Complete Response (CR) (Randomization Phase)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice