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NCT02970318 · OUTCOME

Overall Survival (OS)

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 death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.

What was measured

Overall Survival (OS) was based on data cutoff date of 03Sep2021

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 for median OS and 95% CIs were not reached.
Arm B: Investigator's ChoiceNANot reportedNANAKaplan-Meier estimate for median OS and 95% CIs were not reached.

Source statistical analyses

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

  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.04
    estimate Comment
    Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).
    group Description
    Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0783
    param Type
    Hazard Ratio (HR)
    param Value
    0.69
    statistical Comment
    Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.04
    estimate Comment
    Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).
    group Description
    Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0783
    param Type
    Hazard Ratio (HR)
    param Value
    0.69
    statistical Comment
    Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Kaplan-Meier estimate for median OS and 95% CIs were not reached.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Kaplan-Meier estimate for median OS and 95% CIs were not reached.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      155
    2. group Id
      OG001
      value
      155
    units
    Participants
description
Overall Survival (OS) was based on data cutoff date of 03Sep2021
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
From randomization date to date of death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice