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NCT03332017 · OUTCOME

Time to Response (TTR)

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
MEDIAN
Unit
Months
Interval / dispersion
Full Range
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

TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by ICR and investigator assessment. Only participants who achieved an overall response were included in the analysis. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the TRR calculation.

Analysis population: ITT Analysis Set. Only participants who achieved an overall response were included in the analysis.

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
Obinutuzumab33
Zanubrutinib + Obinutuzumab99

Reported measurements

ICR

Analysis denominator · Participants

GroupSource count
Obinutuzumab33
Zanubrutinib + Obinutuzumab99
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Obinutuzumab2.83Not reported2.56.5Not reported
Zanubrutinib + Obinutuzumab2.83Not reported2.014.0Not reported
Investigator

Analysis denominator · Participants

GroupSource count
Obinutuzumab30
Zanubrutinib + Obinutuzumab96
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Obinutuzumab2.79Not reported2.516.6Not reported
Zanubrutinib + Obinutuzumab2.79Not reported2.016.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.5
        upper Limit
        6.5
        value
        2.83
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        14.0
        value
        2.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    ICR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.5
        upper Limit
        16.6
        value
        2.79
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        16.9
        value
        2.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        96
      units
      Participants
    title
    Investigator
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      99
    units
    Participants
description
TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by ICR and investigator assessment. Only participants who achieved an overall response were included in the analysis. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the TRR calculation.
dispersion Type
Full Range
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
MEDIAN
population Description
ITT Analysis Set. Only participants who achieved an overall response were included in the analysis.
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
Time to Response (TTR)
type
SECONDARY
unit Of Measure
Months

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

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