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NCT03112174 · OUTCOME

Overall Survival (OS) (Safety Run-in)

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 74.78 months

What was measured

OS is defined as the time from the date of the first dose of study treatment to death from any cause.

Analysis population: All Enrolled Safety Run-in participants

Groups in this outcome

Safety Run-in: Increased TLS Risk at Baseline

Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

Safety Run-in: Low TLS Risk at Baseline

Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

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

Analysis denominator · Participants

GroupSource count
Safety Run-in: Increased TLS Risk at Baseline15
Safety Run-in: Low TLS Risk at Baseline6

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline52.3Not reported14.1NANot estimable due to small number of events.
Safety Run-in: Low TLS Risk at BaselineNANot reported1.5NANot estimable due to small number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to small number of events.
        group Id
        OG000
        lower Limit
        14.1
        upper Limit
        NA
        value
        52.3
      2. comment
        Not estimable due to small number of events.
        group Id
        OG001
        lower Limit
        1.5
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      6
    units
    Participants
description
OS is defined as the time from the date of the first dose of study treatment to death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
    id
    OG000
    title
    Safety Run-in: Increased TLS Risk at Baseline
  2. description
    Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
    id
    OG001
    title
    Safety Run-in: Low TLS Risk at Baseline
param Type
MEDIAN
population Description
All Enrolled Safety Run-in participants
reporting Status
POSTED
time Frame
For an overall median time on study of 74.78 months
title
Overall Survival (OS) (Safety Run-in)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice