Participant flow

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.

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. Participants who experienced progressive disease or did not respond to therapy within 12 months may have received crossover treatment with zanubrutinib plus obinutuzumab at the investigator's discretion.

   id

   FG000

   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

   FG001

   title

   Zanubrutinib + Obinutuzumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         51

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         55

      type

      Study Closed by Sponsor

   3. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         30

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Other

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Remained on Study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         145

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         71

      2. group Id

         FG001

         num Subjects

         143

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         0

      type

      Crossover to Combination Treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         145

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

After enrollment, participants were randomized 2:1 to zanubrutinib plus obinutuzumab or obinutuzumab alone, stratified by prior therapy, rituximab-refractory status, and region. Treatment began within 5 days, in 28-day cycles. At investigator discretion, those on obinutuzumab monotherapy could cross over to zanubrutinib plus obinutuzumab if progressive disease or non-response was confirmed by independent central review.

recruitment Details

Participants were enrolled in multiple study centers in Australia, Europe, Asia, and North America.

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