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NCT01010061 · OUTCOME

Time to Re-Treatment/New-antileukemic Therapy

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) · Source last updated 2018-09-14

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
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)

What was measured

Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.

Analysis population: Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.

Groups in this outcome

Obinutuzumab + Chlorambucil (GClb)

Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).

Chlorambucil (Clb)

Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.

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

Analysis denominator · Participants

GroupSource count
Obinutuzumab + Chlorambucil (GClb)238
Chlorambucil (Clb)118

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)55.7Not reported47.4NAThe upper level of the 95% CI was not reached.
Chlorambucil (Clb)15.1Not reported11.718.0Not reported

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
    0.35
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Hazard Ratio (stratified)
    param Value
    0.25
    statistical Comment
    Stratified by Binet stage at Baseline.
    statistical Method
    Log Rank, Stratified
Complete source fields
analyses
  1. ci Lower Limit
    0.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.35
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Hazard Ratio (stratified)
    param Value
    0.25
    statistical Comment
    Stratified by Binet stage at Baseline.
    statistical Method
    Log Rank, Stratified
classes
  1. categories
    1. measurements
      1. comment
        The upper level of the 95% CI was not reached.
        group Id
        OG000
        lower Limit
        47.4
        upper Limit
        NA
        value
        55.7
      2. group Id
        OG001
        lower Limit
        11.7
        upper Limit
        18.0
        value
        15.1
denoms
  1. counts
    1. group Id
      OG000
      value
      238
    2. group Id
      OG001
      value
      118
    units
    Participants
description
Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
    id
    OG000
    title
    Obinutuzumab + Chlorambucil (GClb)
  2. description
    Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
    id
    OG001
    title
    Chlorambucil (Clb)
param Type
MEDIAN
population Description
Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.
reporting Status
POSTED
time Frame
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
title
Time to Re-Treatment/New-antileukemic Therapy
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice