Participant flow

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL · Source last updated 2026-08-25

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

groups

1. description

   Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.

   id

   FG000

   title

   Arm A: Obinutuzumab in Combination With Chlorambucil

2. description

   Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.

   id

   FG001

   title

   Arm B: Acalabrutinib in Combination With Obinutuzumab

3. description

   Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib

   id

   FG002

   title

   Arm C: Acalabrutinib Monotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         9

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         9

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         163

      3. group Id

         FG002

         num Subjects

         157

      type

      Ongoing in Study

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Reasons other than above listed

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         177

      2. group Id

         FG001

         num Subjects

         179

      3. group Id

         FG002

         num Subjects

         179

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Crossed Over From Arm A to Arm C

   3. achievements

      1. group Id

         FG000

         num Subjects

         145

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         179

      3. group Id

         FG002

         num Subjects

         179

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A randomized, multicenter, open-label, 3 arm phase 3 study of Obinutuzumab in combination with Chlorambucil (Chlb+Obin), Acalabrutinib in combination with Obinutuzumab (Acala+Obin), and Acalabrutinib monotherapy (Acala) in subjects with previously untreated chronic lymphocytic leukemia. A total of 535 subjects recruited from 142 sites in 18 countries were randomized (1:1:1) as follows: 179/179 /177 subjects in Acla+Obin arm / Acala arm / Chlb+Obin arm respectively.

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

Preserved source evidence · Not medical advice