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NCT03112174 · OUTCOME

Progression-free Survival (PFS) (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
Full Range
Time frame
For an overall median time on study of 40.51 months

What was measured

PFS is defined as the time from the date of the first dose of study treatment 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 enrolled treatment-naïve participants

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 Arm78

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment-naive Open-label Arm40.2Not reported29.4NANot 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
        29.4
        upper Limit
        NA
        value
        40.2
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    units
    Participants
description
PFS is defined as the time from the date of the first dose of study treatment 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
Full Range
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 participants
reporting Status
POSTED
time Frame
For an overall median time on study of 40.51 months
title
Progression-free Survival (PFS) (Treatment-Naive Arm)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice