NCT02242942 · OUTCOME

Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment

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: At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)

What was measured

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

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

Group	Source count
Obinutuzumab + Chlorambucil	216
Obinutuzumab + Venetoclax	216

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Obinutuzumab + Chlorambucil	17.1	Not reported	12.36	22.83	Not reported
Obinutuzumab + Venetoclax	56.9	Not reported	50.05	63.64	Not reported

Source statistical analyses

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

ci Lower Limit
31.27
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
48.36
estimate Comment
95% CI for difference in rates were constructed using Anderson-Hauck method.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Difference in MRD Negative Rates
param Value
39.81
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
31.27
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
48.36
estimate Comment
95% CI for difference in rates were constructed using Anderson-Hauck method.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Difference in MRD Negative Rates
param Value
39.81
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
lower Limit
12.36
upper Limit
22.83
value
17.1
group Id
OG001
lower Limit
50.05
upper Limit
63.64
value
56.9

denoms

counts
group Id
OG000
value
216
group Id
OG001
value
216
units
Participants

description

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

dispersion Type

95% Confidence Interval

groups

description
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
id
OG000
title
Obinutuzumab + Chlorambucil
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

At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)

title

Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice