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NCT02970318 · OUTCOME

Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff 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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
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

Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.

Analysis population: Intent to treat (ITT) 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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Acalabrutinib MonotherapyNANot reportedNANAKaplan-Meier Estimate of median DOR and 95% CI were not reached.
Arm B: Investigator's Choice13.6Not reported11.9NAKaplan-Meier estimate of upper 95% CI for median DOR was not reached.

Source statistical analyses

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

  1. ci Lower Limit
    0.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.59
    estimate Comment
    Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    p Value Comment
    Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).
    param Type
    Hazard Ratio (HR)
    param Value
    0.33
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.59
    estimate Comment
    Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    p Value Comment
    Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).
    param Type
    Hazard Ratio (HR)
    param Value
    0.33
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Kaplan-Meier Estimate of median DOR and 95% CI were not reached.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Kaplan-Meier estimate of upper 95% CI for median DOR was not reached.
        group Id
        OG001
        lower Limit
        11.9
        upper Limit
        NA
        value
        13.6
denoms
  1. counts
    1. group Id
      OG000
      value
      155
    2. group Id
      OG001
      value
      155
    units
    Participants
description
Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Intent to treat (ITT) 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
Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice