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NCT02005471 · OUTCOME

Overall Survival (OS)

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) · Source last updated 2023-10-17

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
Baseline up to approximately 8 years 5 months

What was measured

OS was defined as the time from the date of randomization to the date of death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. The median OS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.

Analysis population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Groups in this outcome

Bendamustine + Rituximab Main Study

Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

Venetoclax + Rituximab Main Study

Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

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

Analysis denominator · Participants

GroupSource count
Bendamustine + Rituximab Main Study195
Venetoclax + Rituximab Main Study194

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine + Rituximab Main Study87.8Not reported70.1NAUpper limit was not estimable due to low number of participants with event.
Venetoclax + Rituximab Main StudyNANot reportedNANAMedian, lower limit and upper limit were not estimable due to low number of participants with event.

Source statistical analyses

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

  1. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.74
    estimate Comment
    Hazard ratio was estimated by Cox regression model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.76
    estimate Comment
    Hazard ratio was estimated by Cox regression model.
    group Description
    Unstratified Analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0003
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.74
    estimate Comment
    Hazard ratio was estimated by Cox regression model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.76
    estimate Comment
    Hazard ratio was estimated by Cox regression model.
    group Description
    Unstratified Analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0003
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Upper limit was not estimable due to low number of participants with event.
        group Id
        OG000
        lower Limit
        70.1
        upper Limit
        NA
        value
        87.8
      2. comment
        Median, lower limit and upper limit were not estimable due to low number of participants with event.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      195
    2. group Id
      OG001
      value
      194
    units
    Participants
description
OS was defined as the time from the date of randomization to the date of death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. The median OS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
    id
    OG000
    title
    Bendamustine + Rituximab Main Study
  2. description
    Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
    id
    OG001
    title
    Venetoclax + Rituximab Main Study
param Type
MEDIAN
population Description
ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
reporting Status
POSTED
time Frame
Baseline up to approximately 8 years 5 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice