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NCT02328014 · OUTCOME

Best Response and Overall Response Rate

Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies · Source last updated 2025-12-09

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
from the start of the treatment to the last evaluable disease assessment, an average of 1 year

What was measured

Best response and overall response rate per the criteria investigator uses for each disease histology. Standardized response and progression criteria is based on established criteria for B-cell malignancies, including WM (Cheson 2014; Owen 2013; Hallek 2008; Bladé 1998; and Durie 2006).

Analysis population: All-Treated Population

Groups in this outcome

Part 1 Cohort 1

Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously

Part 1 Cohort 2

Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously

Part 1 Cohort 3

Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously

Part 2

Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1 Cohort 16
Part 1 Cohort 26
Part 1 Cohort 36
Part 222

Reported measurements

CR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 Cohort 133.3Not reported4.3077.7Not reported
Part 1 Cohort 20Not reported045.9Not reported
Part 1 Cohort 316.7Not reported0.464.1Not reported
Part 218.2Not reported5.240.3Not reported
VGPR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 Cohort 116.7Not reported0.464.1Not reported
Part 1 Cohort 20Not reported045.9Not reported
Part 1 Cohort 30Not reported045.9Not reported
Part 20Not reported015.4Not reported
PR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 Cohort 133.3Not reported4.377.7Not reported
Part 1 Cohort 250Not reported11.888.2Not reported
Part 1 Cohort 350Not reported11.888.2Not reported
Part 222.7Not reported7.845.4Not reported
SD
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 Cohort 116.7Not reported0.464.1Not reported
Part 1 Cohort 216.7Not reported0.464.1Not reported
Part 1 Cohort 30Not reported045.9Not reported
Part 24.5Not reported0.122.8Not reported
PD
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 Cohort 10Not reported045.9Not reported
Part 1 Cohort 233.3Not reported4.377.7Not reported
Part 1 Cohort 30Not reported045.9Not reported
Part 236.4Not reported17.259.3Not reported
Missing
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 Cohort 10Not reported045.9Not reported
Part 1 Cohort 20Not reported045.9Not reported
Part 1 Cohort 333.3Not reported4.377.7Not reported
Part 20Not reported015.4Not reported
ORR (CR+VGPR+PR)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 Cohort 183.3Not reported35.999.3Not reported
Part 1 Cohort 250Not reported11.888.2Not reported
Part 1 Cohort 366.7Not reported22.395.7Not reported
Part 240.9Not reported20.763.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.30
        upper Limit
        77.7
        value
        33.3
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        45.9
        value
        0
      3. group Id
        OG002
        lower Limit
        0.4
        upper Limit
        64.1
        value
        16.7
      4. group Id
        OG003
        lower Limit
        5.2
        upper Limit
        40.3
        value
        18.2
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        64.1
        value
        16.7
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        45.9
        value
        0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        45.9
        value
        0
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        15.4
        value
        0
    title
    VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.3
        upper Limit
        77.7
        value
        33.3
      2. group Id
        OG001
        lower Limit
        11.8
        upper Limit
        88.2
        value
        50
      3. group Id
        OG002
        lower Limit
        11.8
        upper Limit
        88.2
        value
        50
      4. group Id
        OG003
        lower Limit
        7.8
        upper Limit
        45.4
        value
        22.7
    title
    PR
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        64.1
        value
        16.7
      2. group Id
        OG001
        lower Limit
        0.4
        upper Limit
        64.1
        value
        16.7
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        45.9
        value
        0
      4. group Id
        OG003
        lower Limit
        0.1
        upper Limit
        22.8
        value
        4.5
    title
    SD
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        45.9
        value
        0
      2. group Id
        OG001
        lower Limit
        4.3
        upper Limit
        77.7
        value
        33.3
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        45.9
        value
        0
      4. group Id
        OG003
        lower Limit
        17.2
        upper Limit
        59.3
        value
        36.4
    title
    PD
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        45.9
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        45.9
        value
        0
      3. group Id
        OG002
        lower Limit
        4.3
        upper Limit
        77.7
        value
        33.3
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        15.4
        value
        0
    title
    Missing
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.9
        upper Limit
        99.3
        value
        83.3
      2. group Id
        OG001
        lower Limit
        11.8
        upper Limit
        88.2
        value
        50
      3. group Id
        OG002
        lower Limit
        22.3
        upper Limit
        95.7
        value
        66.7
      4. group Id
        OG003
        lower Limit
        20.7
        upper Limit
        63.7
        value
        40.9
    title
    ORR (CR+VGPR+PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      22
    units
    Participants
description
Best response and overall response rate per the criteria investigator uses for each disease histology. Standardized response and progression criteria is based on established criteria for B-cell malignancies, including WM (Cheson 2014; Owen 2013; Hallek 2008; Bladé 1998; and Durie 2006).
dispersion Type
95% Confidence Interval
groups
  1. description
    Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
    id
    OG000
    title
    Part 1 Cohort 1
  2. description
    Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    OG001
    title
    Part 1 Cohort 2
  3. description
    Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
    id
    OG002
    title
    Part 1 Cohort 3
  4. description
    Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    OG003
    title
    Part 2
param Type
NUMBER
population Description
All-Treated Population
reporting Status
POSTED
time Frame
from the start of the treatment to the last evaluable disease assessment, an average of 1 year
title
Best Response and Overall Response Rate
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice