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NCT02970318 · OUTCOME

IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis

A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL · Source last updated 2026-07-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up

What was measured

IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)

Analysis population: Intent-to-treat population including all randomized participants

Groups in this outcome

Arm A: Acalabrutinib Monotherapy

Acalabrutinib 100 mg orally twice a day

Arm B: Investigator's Choice

Idelalisib+Rituximab or Bendamustine + Retuximab

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: Acalabrutinib Monotherapy155
Arm B: Investigator's Choice155

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Acalabrutinib Monotherapy126Not reportedNot reportedNot reportedNot reported
Arm B: Investigator's Choice117Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -3.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    14.9
    estimate Comment
    Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.2248
    param Type
    Risk Difference (RD)
    param Value
    5.8
    statistical Comment
    Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    -3.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    14.9
    estimate Comment
    Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.2248
    param Type
    Risk Difference (RD)
    param Value
    5.8
    statistical Comment
    Based on Cochran-Mantel-Haenszel 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
        value
        126
      2. group Id
        OG001
        value
        117
denoms
  1. counts
    1. group Id
      OG000
      value
      155
    2. group Id
      OG001
      value
      155
    units
    Participants
description
IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)
groups
  1. description
    Acalabrutinib 100 mg orally twice a day
    id
    OG000
    title
    Arm A: Acalabrutinib Monotherapy
  2. description
    Idelalisib+Rituximab or Bendamustine + Retuximab
    id
    OG001
    title
    Arm B: Investigator's Choice
param Type
COUNT_OF_PARTICIPANTS
population Description
Intent-to-treat population including all randomized participants
reporting Status
POSTED
time Frame
IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
title
IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice