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NCT01010061 · OUTCOME

Duration of Response

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

Duration of Response was defined as the date the response \[either Complete Response (CR) or Partial Response (PR)\] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.

Analysis population: Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response 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)191
Chlorambucil (Clb)41

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)24.8Not reported22.133.5Not reported
Chlorambucil (Clb)5.1Not reported3.36.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.28
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Hazard Ratio (stratified)
    param Value
    0.19
    statistical Comment
    Stratified by Binet stage at Baseline.
    statistical Method
    Log Rank, Stratified
Complete source fields
analyses
  1. ci Lower Limit
    0.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.28
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Hazard Ratio (stratified)
    param Value
    0.19
    statistical Comment
    Stratified by Binet stage at Baseline.
    statistical Method
    Log Rank, Stratified
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.1
        upper Limit
        33.5
        value
        24.8
      2. group Id
        OG001
        lower Limit
        3.3
        upper Limit
        6.7
        value
        5.1
denoms
  1. counts
    1. group Id
      OG000
      value
      191
    2. group Id
      OG001
      value
      41
    units
    Participants
description
Duration of Response was defined as the date the response \[either Complete Response (CR) or Partial Response (PR)\] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.
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
Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored.
reporting Status
POSTED
time Frame
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
title
Duration of Response
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice