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NCT02242942 · OUTCOME

Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment 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 9 or 3 months after last IV infusion, approximately 9 months

What was measured

MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood.

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 + Chlorambucil38.4Not reported31.9145.27Not reported
Obinutuzumab + Venetoclax71.3Not reported64.7777.23Not reported

Source statistical analyses

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

  1. ci Lower Limit
    23.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    41.98
    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
    <0.0001
    param Type
    Difference in MRD Negative Rates
    param Value
    32.87
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    23.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    41.98
    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
    <0.0001
    param Type
    Difference in MRD Negative Rates
    param Value
    32.87
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.91
        upper Limit
        45.27
        value
        38.4
      2. group Id
        OG001
        lower Limit
        64.77
        upper Limit
        77.23
        value
        71.3
denoms
  1. counts
    1. group Id
      OG000
      value
      216
    2. group Id
      OG001
      value
      216
    units
    Participants
description
MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood.
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 9 or 3 months after last IV infusion, approximately 9 months
title
Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice