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NCT02242942 · OUTCOME

Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)

What was measured

CR: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L. PD: lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.

Analysis population: ITT population was defined as all randomized participants.

Groups in this outcome

Obinutuzumab + Chlorambucil

Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.

Obinutuzumab + Venetoclax

Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 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

CR
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil56.0Not reportedNot reportedNot reportedNot reported
Obinutuzumab + Venetoclax70.4Not reportedNot reportedNot reportedNot reported
CRi
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil5.6Not reportedNot reportedNot reportedNot reported
Obinutuzumab + Venetoclax7.9Not reportedNot reportedNot reportedNot reported
PR
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil29.2Not reportedNot reportedNot reportedNot reported
Obinutuzumab + Venetoclax13.4Not reportedNot reportedNot reportedNot reported
SD
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil1.9Not reportedNot reportedNot reportedNot reported
Obinutuzumab + Venetoclax0.5Not reportedNot reportedNot reportedNot reported
PD
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil0.5Not reportedNot reportedNot reportedNot reported
Obinutuzumab + Venetoclax0.5Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -4.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.51
    estimate Comment
    95% CI for difference in rates were constructed using Anderson-Hauck method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7169
    param Type
    Difference in Response Rates
    param Value
    0.93
    statistical Comment
    P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    -4.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.51
    estimate Comment
    95% CI for difference in rates were constructed using Anderson-Hauck method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7169
    param Type
    Difference in Response Rates
    param Value
    0.93
    statistical Comment
    P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        56.0
      2. group Id
        OG001
        value
        70.4
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5.6
      2. group Id
        OG001
        value
        7.9
    title
    CRi
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        29.2
      2. group Id
        OG001
        value
        13.4
    title
    PR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1.9
      2. group Id
        OG001
        value
        0.5
    title
    SD
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.5
      2. group Id
        OG001
        value
        0.5
    title
    PD
denoms
  1. counts
    1. group Id
      OG000
      value
      216
    2. group Id
      OG001
      value
      216
    units
    Participants
description
CR: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L. PD: lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.
groups
  1. description
    Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
    id
    OG000
    title
    Obinutuzumab + Chlorambucil
  2. description
    Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
    id
    OG001
    title
    Obinutuzumab + Venetoclax
param Type
NUMBER
population Description
ITT population was defined as all randomized participants.
reporting Status
POSTED
time Frame
Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)
title
Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice