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NCT02242942 · OUTCOME

Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia · Source last updated 2025-11-06

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 until disease progression or death up to approximately 3.75 years

What was measured

PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) \>/= 50% increase in the absolute number of circulating lymphocytes to at least 5\*10\^9/L, 2) Appearance of new palpable lymph nodes (\> 15 mm in longest diameter) or any new extra-nodal lesion; 3) \>/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) \>/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.

Analysis population: Intent-to-Treat (ITT) population was defined as all randomized participants.

Groups in this outcome

Obinutuzumab + Chlorambucil

Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.

Obinutuzumab + Venetoclax

Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.

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

Analysis denominator · Participants

GroupSource count
Obinutuzumab + Chlorambucil216
Obinutuzumab + Venetoclax216

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + ChlorambucilNANot reported31.1NAInsufficient number of participants with events.
Obinutuzumab + VenetoclaxNANot reportedNANAInsufficient number of participants with events.

Source statistical analyses

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

  1. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.51
    estimate Comment
    Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.33
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.51
    estimate Comment
    Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.33
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        31.1
        upper Limit
        NA
        value
        NA
      2. comment
        Insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      216
    2. group Id
      OG001
      value
      216
    units
    Participants
description
PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) \>/= 50% increase in the absolute number of circulating lymphocytes to at least 5\*10\^9/L, 2) Appearance of new palpable lymph nodes (\> 15 mm in longest diameter) or any new extra-nodal lesion; 3) \>/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) \>/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.
    id
    OG000
    title
    Obinutuzumab + Chlorambucil
  2. description
    Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.
    id
    OG001
    title
    Obinutuzumab + Venetoclax
param Type
MEDIAN
population Description
Intent-to-Treat (ITT) population was defined as all randomized participants.
reporting Status
POSTED
time Frame
Baseline until disease progression or death up to approximately 3.75 years
title
Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice