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NCT01059630 · OUTCOME

Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN) · Source last updated 2020-01-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

What was measured

BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).

Analysis population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.

Groups in this outcome

Bendamustine Alone

Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.

Obinutuzumab + Bendamustine

Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).

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

Analysis denominator · Participants

GroupSource count
Bendamustine Alone209
Obinutuzumab + Bendamustine204

Reported measurements

CR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine Alone21.5Not reported16.1627.73Not reported
Obinutuzumab + Bendamustine23.5Not reported17.8929.96Not reported
PR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine Alone61.7Not reported54.7668.34Not reported
Obinutuzumab + Bendamustine58.8Not reported51.7465.65Not reported
SD
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine Alone6.7Not reported3.7110.98Not reported
Obinutuzumab + Bendamustine6.4Not reported3.4410.65Not reported
PD
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine Alone4.8Not reported2.328.62Not reported
Obinutuzumab + Bendamustine6.4Not reported3.4410.65Not reported
Unable to evaluate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine Alone1.4Not reported0.304.14Not reported
Obinutuzumab + Bendamustine0.5Not reported0.012.70Not reported
Missing
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine Alone3.8Not reported1.677.40Not reported
Obinutuzumab + Bendamustine4.4Not reported2.048.21Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.16
        upper Limit
        27.73
        value
        21.5
      2. group Id
        OG001
        lower Limit
        17.89
        upper Limit
        29.96
        value
        23.5
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.76
        upper Limit
        68.34
        value
        61.7
      2. group Id
        OG001
        lower Limit
        51.74
        upper Limit
        65.65
        value
        58.8
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.71
        upper Limit
        10.98
        value
        6.7
      2. group Id
        OG001
        lower Limit
        3.44
        upper Limit
        10.65
        value
        6.4
    title
    SD
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.32
        upper Limit
        8.62
        value
        4.8
      2. group Id
        OG001
        lower Limit
        3.44
        upper Limit
        10.65
        value
        6.4
    title
    PD
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.30
        upper Limit
        4.14
        value
        1.4
      2. group Id
        OG001
        lower Limit
        0.01
        upper Limit
        2.70
        value
        0.5
    title
    Unable to evaluate
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.67
        upper Limit
        7.40
        value
        3.8
      2. group Id
        OG001
        lower Limit
        2.04
        upper Limit
        8.21
        value
        4.4
    title
    Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      209
    2. group Id
      OG001
      value
      204
    units
    Participants
description
BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
    id
    OG000
    title
    Bendamustine Alone
  2. description
    Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
    id
    OG001
    title
    Obinutuzumab + Bendamustine
param Type
NUMBER
population Description
ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
reporting Status
POSTED
time Frame
Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
title
Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice