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NCT03332017 · OUTCOME

Complete Response Rate

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma · Source last updated 2026-02-18

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
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.

What was measured

CRR was defined as the percentage of participants who achieved a complete response or complete metabolic response as their best overall response, as determined by ICR and investigator assessment. Responses were assessed from randomization until the data cutoff date, the start of a new anticancer therapy, or the crossover date for participants in the monotherapy arm who switched to combination therapy.

Analysis population: ITT Analysis Set

Groups in this outcome

Obinutuzumab

Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.

Zanubrutinib + Obinutuzumab

Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.

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

Analysis denominator · Participants

GroupSource count
Obinutuzumab72
Zanubrutinib + Obinutuzumab145

Reported measurements

ICR
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab19.4Not reported11.130.5Not reported
Zanubrutinib + Obinutuzumab37.2Not reported29.445.7Not reported
Investigator
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab19.4Not reported11.130.5Not reported
Zanubrutinib + Obinutuzumab29.0Not reported21.737.1Not reported

Source statistical analyses

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

  1. group Description
    For ICR Assessment
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0083
    statistical Comment
    The p-value was from an unstratified 2-sided Fisher's exact test.
    statistical Method
    Fisher Exact
  2. group Description
    For Investigator Assessment
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.1417
    statistical Comment
    The p-value was from an unstratified 2-sided Fisher's exact test.
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    For ICR Assessment
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0083
    statistical Comment
    The p-value was from an unstratified 2-sided Fisher's exact test.
    statistical Method
    Fisher Exact
  2. group Description
    For Investigator Assessment
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.1417
    statistical Comment
    The p-value was from an unstratified 2-sided Fisher's exact test.
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        30.5
        value
        19.4
      2. group Id
        OG001
        lower Limit
        29.4
        upper Limit
        45.7
        value
        37.2
    title
    ICR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        30.5
        value
        19.4
      2. group Id
        OG001
        lower Limit
        21.7
        upper Limit
        37.1
        value
        29.0
    title
    Investigator
denoms
  1. counts
    1. group Id
      OG000
      value
      72
    2. group Id
      OG001
      value
      145
    units
    Participants
description
CRR was defined as the percentage of participants who achieved a complete response or complete metabolic response as their best overall response, as determined by ICR and investigator assessment. Responses were assessed from randomization until the data cutoff date, the start of a new anticancer therapy, or the crossover date for participants in the monotherapy arm who switched to combination therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
    id
    OG000
    title
    Obinutuzumab
  2. description
    Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
    id
    OG001
    title
    Zanubrutinib + Obinutuzumab
param Type
NUMBER
population Description
ITT Analysis Set
reporting Status
POSTED
time Frame
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
title
Complete Response Rate
type
SECONDARY
unit Of Measure
Percentage of Participants

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