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NCT02970318 · OUTCOME

Progression-free Survival (PFS) Per Investigator Assessment

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
From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.

What was measured

PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Acalabrutinib MonotherapyNANot reported45.8NAKaplan-Meier Estimates for median PFS and upper 95% CI were not reached for Arm A.
Arm B: Investigator's Choice16.8Not reported14.122.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.38
    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
    Stratified by randomization stratification 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
    0.28
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.38
    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
    Stratified by randomization stratification 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
    0.28
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Kaplan-Meier Estimates for median PFS and upper 95% CI were not reached for Arm A.
        group Id
        OG000
        lower Limit
        45.8
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        14.1
        upper Limit
        22.5
        value
        16.8
denoms
  1. counts
    1. group Id
      OG000
      value
      155
    2. group Id
      OG001
      value
      155
    units
    Participants
description
PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.
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 population including all randomized participants
reporting Status
POSTED
time Frame
From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.
title
Progression-free Survival (PFS) Per Investigator Assessment
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice