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NCT02475681 · OUTCOME

IRC-assessed Objective Response Rate (ORR) 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.

What was measured

ORR was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, or PR at or before initiation of subsequent anticancer therapy. ORR including PRL was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, PR or PRL at or before initiation of subsequent anticancer therapy

Analysis population: Intent to Treat

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

GroupSource count
Arm A: Obinutuzumab in Combination With Chlorambucil177
Arm B: Acalabrutinib in Combination With Obinutuzumab179
Arm C: Acalabrutinib Monotherapy179

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Obinutuzumab in Combination With Chlorambucil78.5Not reported71.983.9Not reported
Arm B: Acalabrutinib in Combination With Obinutuzumab93.9Not reported89.396.5Not reported
Arm C: Acalabrutinib Monotherapy85.5Not reported79.689.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    8.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    22.3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Risk Difference (RD)
    param Value
    15.3
    statistical Comment
    Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Lower Limit
    -1.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    14.9
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0763
    param Type
    Risk Difference (RD)
    param Value
    6.9
    statistical Comment
    Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    8.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    22.3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Risk Difference (RD)
    param Value
    15.3
    statistical Comment
    Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Lower Limit
    -1.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    14.9
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0763
    param Type
    Risk Difference (RD)
    param Value
    6.9
    statistical Comment
    Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        71.9
        upper Limit
        83.9
        value
        78.5
      2. group Id
        OG001
        lower Limit
        89.3
        upper Limit
        96.5
        value
        93.9
      3. group Id
        OG002
        lower Limit
        79.6
        upper Limit
        89.9
        value
        85.5
denoms
  1. counts
    1. group Id
      OG000
      value
      177
    2. group Id
      OG001
      value
      179
    3. group Id
      OG002
      value
      179
    units
    Participants
description
ORR was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, or PR at or before initiation of subsequent anticancer therapy. ORR including PRL was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, PR or PRL at or before initiation of subsequent anticancer therapy
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
NUMBER
population Description
Intent to Treat
reporting Status
POSTED
time Frame
IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.
title
IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice