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NCT02005471 · OUTCOME

PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test

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 PD or death, whichever occurred first (up to approximately 3 years)

What was measured

PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.

Analysis population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.

Groups in this outcome

Bendamustine + Rituximab 17p Del. Population

Participants received bendamustine at a dose of 70 mg/m\^2 via 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. Only participants with 17p deletion as identified by FISH test were included.

Venetoclax + Rituximab 17p Del. Population

Participants were initially placed on a venetoclax ramp-up period of 4 to 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet 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. Only participants with 17p deletion as identified by FISH test were included.

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 17p Del. Population46
Venetoclax + Rituximab 17p Del. Population46

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine + Rituximab 17p Del. Population16.1Not reported13.622.3Not reported
Venetoclax + Rituximab 17p Del. PopulationNANot reported27.6NAMedian and Upper Limit of 95% CI could not be estimated due to low number of participants with an event.

Source statistical analyses

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

  1. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.49
    estimate Comment
    Hazard ratio was estimated by Cox regression model.
    group Description
    Stratified Analysis; Stratification factor: geographic region.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.21
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.46
    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
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.21
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.49
    estimate Comment
    Hazard ratio was estimated by Cox regression model.
    group Description
    Stratified Analysis; Stratification factor: geographic region.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.21
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.46
    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
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.21
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.6
        upper Limit
        22.3
        value
        16.1
      2. comment
        Median and Upper Limit of 95% CI could not be estimated due to low number of participants with an event.
        group Id
        OG001
        lower Limit
        27.6
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      46
    units
    Participants
description
PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received bendamustine at a dose of 70 mg/m\^2 via 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. Only participants with 17p deletion as identified by FISH test were included.
    id
    OG000
    title
    Bendamustine + Rituximab 17p Del. Population
  2. description
    Participants were initially placed on a venetoclax ramp-up period of 4 to 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet 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. Only participants with 17p deletion as identified by FISH test were included.
    id
    OG001
    title
    Venetoclax + Rituximab 17p Del. Population
param Type
MEDIAN
population Description
Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
reporting Status
POSTED
time Frame
Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
title
PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice