A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Eligibility criteria

Qualifiers

Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.

Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.

Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)

Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2

Disqualifiers

Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation

Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months

Known central nervous system involvement

Prior exposure to any BTK protein degraders

Trial design

Treatments tested in this trial

  • BGB-16673
  • Bendamustine
  • Idelalisib
  • Rituximab
  • Venetoclax

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators