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NCT01539512 · OUTCOME

Progression-Free Survival

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) · Source last updated 2019-05-14

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
Up to 17 months

What was measured

Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.

Analysis population: Intent-to-Treat (ITT) Analysis Set: randomized participants with treatment group designated according to initial randomization.

Groups in this outcome

Idelalisib + Rituximab

Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)

Placebo + Rituximab

Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Idelalisib + Rituximab110
Placebo + Rituximab110

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Idelalisib + RituximabNANot reported10.7NANA = Not reached due to insufficient number of events
Placebo + Rituximab5.5Not reported3.87.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.32
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    < 0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.18
    statistical Comment
    P-value is from stratified log-rank test, adjusted for randomization stratification factors.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.32
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    < 0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.18
    statistical Comment
    P-value is from stratified log-rank test, adjusted for randomization stratification factors.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = Not reached due to insufficient number of events
        group Id
        OG000
        lower Limit
        10.7
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        3.8
        upper Limit
        7.1
        value
        5.5
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    2. group Id
      OG001
      value
      110
    units
    Participants
description
Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
dispersion Type
95% Confidence Interval
groups
  1. description
    Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
    id
    OG000
    title
    Idelalisib + Rituximab
  2. description
    Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
    id
    OG001
    title
    Placebo + Rituximab
param Type
MEDIAN
population Description
Intent-to-Treat (ITT) Analysis Set: randomized participants with treatment group designated according to initial randomization.
reporting Status
POSTED
time Frame
Up to 17 months
title
Progression-Free Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice