NCT03112174 · OUTCOME

Overall Survival (OS) (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: MEDIAN
Unit: months
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

OS is defined as the time from the date of randomization (Randomization Phase) or the first dose of study treatment (Treatment-Naïve arm) to death from any cause.

Analysis population: All randomized and all enrolled treatment-naïve 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 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

Group	Source count
Randomization Phase: Ibrutinb + Venetoclax	134
Randomization Phase: Ibrutinib + Placebo	133
Treatment-naive Open-label Arm	78

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Randomization Phase: Ibrutinb + Venetoclax	44.9	Not reported	31.9	NA	Not estimable due to the small number of events.
Randomization Phase: Ibrutinib + Placebo	38.6	Not reported	25.2	52.6	Not reported
Treatment-naive Open-label Arm	NA	Not reported	44.2	NA	Not estimable due to the small number of events.

Source statistical analyses

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

ci Lower Limit
0.602
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.151
estimate Comment
Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2669
p Value Comment
P value is from stratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.832
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.602
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.151
estimate Comment
Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2669
p Value Comment
P value is from stratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.832
statistical Method
Log Rank

classes

categories
measurements
comment
Not estimable due to the small number of events.
group Id
OG000
lower Limit
31.9
upper Limit
NA
value
44.9
group Id
OG001
lower Limit
25.2
upper Limit
52.6
value
38.6
comment
Not estimable due to the small number of events.
group Id
OG002
lower Limit
44.2
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
134
group Id
OG001
value
133
group Id
OG002
value
78
units
Participants

description

OS is defined as the time from the date of randomization (Randomization Phase) or the first dose of study treatment (Treatment-Naïve arm) to death from any cause.

dispersion Type

95% Confidence Interval

groups

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
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
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

MEDIAN

population Description

All randomized and all enrolled treatment-naïve participants

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

Overall Survival (OS) (Randomization Phase and Treatment-Naive Arm)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice