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NCT02970318 · OUTCOME

Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff

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 start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.

What was measured

Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.

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 reported46.9NAKaplan-Meier estimate of median TTNT and upper 95% CI were not reached.
Arm B: Investigator's Choice22.5Not reported17.525.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.40
    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
    0.29
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.40
    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
    0.29
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Kaplan-Meier estimate of median TTNT and upper 95% CI were not reached.
        group Id
        OG000
        lower Limit
        46.9
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        17.5
        upper Limit
        25.9
        value
        22.5
denoms
  1. counts
    1. group Id
      OG000
      value
      155
    2. group Id
      OG001
      value
      155
    units
    Participants
description
Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.
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 start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.
title
Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice