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NCT02242942 · OUTCOME

Percentage of Participants With OR at Completion of Combination Treatment Response Assessment

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
95% Confidence Interval
Time frame
Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months

What was measured

OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination, 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. PR: two of the following features 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.

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil86.6Not reported81.2990.82Not reported
Obinutuzumab + Venetoclax88.4Not reported83.3992.37Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -4.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.33
    estimate Comment
    95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5612
    p Value Comment
    P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.
    param Type
    Difference in Response Rates
    param Value
    1.85
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    -4.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.33
    estimate Comment
    95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5612
    p Value Comment
    P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.
    param Type
    Difference in Response Rates
    param Value
    1.85
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        81.29
        upper Limit
        90.82
        value
        86.6
      2. group Id
        OG001
        lower Limit
        83.39
        upper Limit
        92.37
        value
        88.4
denoms
  1. counts
    1. group Id
      OG000
      value
      216
    2. group Id
      OG001
      value
      216
    units
    Participants
description
OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination, 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. PR: two of the following features 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.
dispersion Type
95% Confidence Interval
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
Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months
title
Percentage of Participants With OR at Completion of Combination Treatment Response Assessment
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice