Participant flow

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) · Source last updated 2026-09-25

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

groups

1. description

   Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.

   id

   FG000

   title

   Arm A - Pirtobrutinib

2. description

   Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).

   id

   FG001

   title

   Arm B - Bendamustine Plus Rituximab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         130

      2. group Id

         FG001

         num Subjects

         108

      type

      On study

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         10

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         19

      type

      Withdrawal of consent

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Sponsor Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant did not agree to full active follow-up visits

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant denied doing more than one computerized axial tomography test per year

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         141

      2. group Id

         FG001

         num Subjects

         141

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         140

      2. group Id

         FG001

         num Subjects

         132

      type

      Received at Least One Dose of Study Drug (Including a Partial Dose)

   3. achievements

      1. comment

         This milestone is not applicable for Arm A.

         group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         18

      comment

      As per the planned analysis, Adverse Events were monitored separately for this group, and the data has been reported accordingly in the Adverse Events section.

      type

      Arm B Participants Who Crossed Over to Receive Pirtobrutinib

   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

         141

      2. group Id

         FG001

         num Subjects

         141

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice