A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT ID: NCT06973187
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2025-09-04
2028-04-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: BGB-16673
Participants will receive BGB-16673 orally.
BGB-16673
BGB-16673 will be administered orally
Arm B: Pirtobrutinib
Participants will receive pirtobrutinib orally.
Pirtobrutinib
Pirtobrutinib will be administered orally
Interventions
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BGB-16673
BGB-16673 will be administered orally
Pirtobrutinib
Pirtobrutinib will be administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
* Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
Exclusion Criteria
* History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
* History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
* Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
* Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Cancer Specialists of North Florida
Jacksonville, Florida, United States
Dayton Physician Network
Dayton, Ohio, United States
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
Roanoke, Virginia, United States
Summit Cancer Centers
Spokane, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
North Shore Hospital
Auckland, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital Haematology
Singapore, , Singapore
Countries
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Central Contacts
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Other Identifiers
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2025-522860-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-16673-304
Identifier Type: -
Identifier Source: org_study_id