Participant flow

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia · Source last updated 2025-03-30

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

groups

1. description

   Participants received 160 milligrams (mg) zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

   id

   FG000

   title

   Zanubrutinib

2. description

   Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

   id

   FG001

   title

   Ibrutinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         225

      2. group Id

         FG001

         num Subjects

         200

      type

      Sponsor Ended Study

   2. reasons

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         83

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         27

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         12

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      type

      Miscellaneous

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         327

      2. group Id

         FG001

         num Subjects

         325

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         324

      2. group Id

         FG001

         num Subjects

         324

      type

      Received Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         327

      2. group Id

         FG001

         num Subjects

         325

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomly assigned to one of two treatment groups. Randomization was stratified according to age (\< 65 versus ≥ 65 years), geographic region (China vs non-China), refractory status (yes or no), and chromosome 17p deletion or TP53 mutation status (present or absent).

recruitment Details

This study was conducted at 113 study centers in 15 countries (Australia, Belgium, China, the Czech Republic, France, Germany, Italy, the Netherlands, New Zealand, Poland, Spain, Sweden, Turkey, the United Kingdom, and the United States).

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Preserved source evidence · Not medical advice