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NCT03112174 · OUTCOME

Duration of CR (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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
For an overall median time on study of 40.51 months

What was measured

Duration of CR, defined for subjects who achieve CR according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014) as the time from the first occurrence of CR to disease progression or death, whichever occurs first.

Analysis population: All Enrolled Treatment-Naïve Subjects Achieving CR

Groups in this outcome

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
Treatment-naive Open-label Arm54

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment-naive Open-label Arm37.1Not reported34.0NANot estimable due to low number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to low number of events.
        group Id
        OG000
        lower Limit
        34.0
        upper Limit
        NA
        value
        37.1
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    units
    Participants
description
Duration of CR, defined for subjects who achieve CR according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014) as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Treatment-naive Open-label Arm
param Type
MEDIAN
population Description
All Enrolled Treatment-Naïve Subjects Achieving CR
reporting Status
POSTED
time Frame
For an overall median time on study of 40.51 months
title
Duration of CR (Treatment-Naive Arm)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice