The purpose of this study is to investigate the efficacy and safety of tacabrutideg 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).
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
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
Parallel
Tacabrutideg
DrugAdministered orally
Bendamustine
DrugAdministered intravenously
Idelalisib
DrugAdministered orally
Rituximab
DrugAdministered intravenously
Venetoclax
DrugAdministered orally
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
Overall Survival (OS)
OS is defined as time from the date of randomization to the date of death due to any cause.
Progression-Free Survival (PFS) in Participants with Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 iwCLL for participants with prior exposure to ncBTKi.
PFS by the Investigator Assessment
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by the investigator using modified 2018 iwCLL criteria for participants with CLL and Lugano classification for participants with SLL
Overall Response Rate (ORR) by IRC and Investigator Assessment
ORR is defined as the percentage of participants with best overall response of complete response (CR), complete response with incomplete bone marrow recovery (Cri), nodular partial remission (nPR), or partial response (PR) as assessed by the IRC or by the investigator.
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