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A Study of Tacabrutideg (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

RecruitingPhase 3Ages 18 Years - anyAllBeOne Medicines
NCT06846671 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i. 3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 5. Adequate liver function 6. Adequate blood clotting function Exclusion Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months 3. Known central nervous system involvement 4. Prior exposure to any BTK protein degraders 5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy 6. Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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What it tests

  • Tacabrutideg
  • Bendamustine
  • Idelalisib
  • Rituximab
  • Venetoclax
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Where

132 sites
St Bernards Medical Center
Jonesboro, United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, United States
Scripps Prebys Cancer Center
San Diego, United States
Pih Health Whittier Hospital
Whittier, United States
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, United States
Intermountain Health Lutheran Hospital Cancer Center of Colorado
Golden, United States
Florida Oncology and Hematology
Fort Myers, United States
Baptist Md Anderson Cancer Center
Jacksonville, United States

…and 124 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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