NCT02475681 · OUTCOME

Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL · Source last updated 2026-08-25

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: From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first assessed up to 40 months of follow-up.

What was measured

TTNT was defined as the time from randomization to start date of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first. TTNT was analyzed in the same fashion as that for the primary efficacy analysis

Analysis population: Intent to Treat (ITT)

Groups in this outcome

Arm A: Obinutuzumab in Combination With Chlorambucil

Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.

Arm B: Acalabrutinib in Combination With Obinutuzumab

Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.

Arm C: Acalabrutinib Monotherapy

Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib

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
Arm A: Obinutuzumab in Combination With Chlorambucil	177
Arm B: Acalabrutinib in Combination With Obinutuzumab	179
Arm C: Acalabrutinib Monotherapy	179

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Obinutuzumab in Combination With Chlorambucil	NA	Not reported	28.9	NA	The median TTNT was not reached for obinutuzumab+chlorambucil (range: 0.0+ to 39.6+ months). "+" indicates a value from a censored subject.
Arm B: Acalabrutinib in Combination With Obinutuzumab	NA	Not reported	NA	NA	The median TTNT was not reached for acalabrutinib+obinutuzumab (range: 1.3-40.3+ months). "+" indicates a value from a censored subject.
Arm C: Acalabrutinib Monotherapy	NA	Not reported	NA	NA	The median TTNT was not reached for acalabrutinib monotherapy (range: 0.1+ to 40.1+ months). "+" indicates a value from a censored subject.

Source statistical analyses

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

ci Lower Limit
0.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.26
group Description
The test to compare TTNT between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.14
statistical Comment
Stratified by randomization stratification factors as recorded in IXRS
statistical Method
Log Rank
ci Lower Limit
0.15
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.40
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
P-value based on stratified by randomization stratification factors as recorded in IXRS
param Type
Hazard Ratio (HR)
param Value
0.24
statistical Comment
Stratified by randomization stratification factors as recorded in IXRS
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.26
group Description
The test to compare TTNT between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.14
statistical Comment
Stratified by randomization stratification factors as recorded in IXRS
statistical Method
Log Rank
ci Lower Limit
0.15
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.40
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
P-value based on stratified by randomization stratification factors as recorded in IXRS
param Type
Hazard Ratio (HR)
param Value
0.24
statistical Comment
Stratified by randomization stratification factors as recorded in IXRS
statistical Method
Log Rank

classes

categories
measurements
comment
The median TTNT was not reached for obinutuzumab+chlorambucil (range: 0.0+ to 39.6+ months). "+" indicates a value from a censored subject.
group Id
OG000
lower Limit
28.9
upper Limit
NA
value
NA
comment
The median TTNT was not reached for acalabrutinib+obinutuzumab (range: 1.3-40.3+ months). "+" indicates a value from a censored subject.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
comment
The median TTNT was not reached for acalabrutinib monotherapy (range: 0.1+ to 40.1+ months). "+" indicates a value from a censored subject.
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
177
group Id
OG001
value
179
group Id
OG002
value
179
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.
id
OG000
title
Arm A: Obinutuzumab in Combination With Chlorambucil
description
Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.
id
OG001
title
Arm B: Acalabrutinib in Combination With Obinutuzumab
description
Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
id
OG002
title
Arm C: Acalabrutinib Monotherapy

param Type

MEDIAN

population Description

Intent to Treat (ITT)

reporting Status

POSTED

time Frame

From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first assessed up to 40 months of follow-up.

title

Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice