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NCT03112174 · OUTCOME

MRD-negative Remission Rate in Participants Who Achieve CR Per Investigator Assessment (Randomization Phase and Treatment-Naive Arm)

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 (Randomization Phase) and 40.51 months (Treatment-Naïve arm)

What was measured

MRD-negative remission rate is defined as the percentage of participants with undetectable MRD at documented CR in participants who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later.

Analysis population: All enrolled treatment-naïve participants achieving CR who were evaluable for MRD (those who had positive MRD status at screening). Participants with a given post-screening sample.

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 disease progression (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.

Treatment-naive Open-label Arm

Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).

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 + Venetoclax31
Randomization Phase: Ibrutinib + Placebo8
Treatment-naive Open-label Arm34

Reported measurements

Bone marrow aspirate

Analysis denominator · Participants

GroupSource count
Randomization Phase: Ibrutinb + Venetoclax26
Randomization Phase: Ibrutinib + Placebo7
Treatment-naive Open-label Arm22
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomization Phase: Ibrutinb + Venetoclax61.5Not reported40.679.8Not reported
Randomization Phase: Ibrutinib + Placebo28.6Not reported3.771.0Not reported
Treatment-naive Open-label Arm59.1Not reported36.479.3Not reported
Peripheral blood

Analysis denominator · Participants

GroupSource count
Randomization Phase: Ibrutinb + Venetoclax31
Randomization Phase: Ibrutinib + Placebo8
Treatment-naive Open-label Arm34
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomization Phase: Ibrutinb + Venetoclax77.4Not reported58.990.4Not reported
Randomization Phase: Ibrutinib + Placebo12.5Not reported0.352.7Not reported
Treatment-naive Open-label Arm76.5Not reported58.889.3Not reported

Source statistical analyses

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

  1. group Description
    Bone marrow aspirate
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2028
    statistical Method
    Fisher Exact
  2. group Description
    Peripheral blood
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0014
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    Bone marrow aspirate
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2028
    statistical Method
    Fisher Exact
  2. group Description
    Peripheral blood
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0014
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.6
        upper Limit
        79.8
        value
        61.5
      2. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        71.0
        value
        28.6
      3. group Id
        OG002
        lower Limit
        36.4
        upper Limit
        79.3
        value
        59.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        22
      units
      Participants
    title
    Bone marrow aspirate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.9
        upper Limit
        90.4
        value
        77.4
      2. group Id
        OG001
        lower Limit
        0.3
        upper Limit
        52.7
        value
        12.5
      3. group Id
        OG002
        lower Limit
        58.8
        upper Limit
        89.3
        value
        76.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        34
      units
      Participants
    title
    Peripheral blood
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      34
    units
    Participants
description
MRD-negative remission rate is defined as the percentage of participants with undetectable MRD at documented CR in participants who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later.
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 disease progression (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
  3. description
    Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
    id
    OG002
    title
    Treatment-naive Open-label Arm
param Type
NUMBER
population Description
All enrolled treatment-naïve participants achieving CR who were evaluable for MRD (those who had positive MRD status at screening). Participants with a given post-screening sample.
reporting Status
POSTED
time Frame
For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)
title
MRD-negative Remission Rate in Participants Who Achieve CR Per Investigator Assessment (Randomization Phase and Treatment-Naive Arm)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice