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
A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2 other identifiers
interventional
500
21 countries
146
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2025
Typical duration for phase_3
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2025
CompletedFirst Posted
Study publicly available on registry
May 15, 2025
CompletedStudy Start
First participant enrolled
September 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 17, 2028
June 3, 2026
June 1, 2026
2.6 years
May 7, 2025
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) per 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).
Up to approximately 3 years
Secondary Outcomes (8)
Overall Survival (OS)
Up to approximately 3 years
PFS per Investigator (INV)
Up to approximately 3 years
Overall Response Rate (ORR) per IRC and INV
Up to approximately 3 years
Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV
Up to approximately 3 years
Duration of Response (DOR) per IRC and INV
Up to approximately 3 years
- +3 more secondary outcomes
Study Arms (2)
Arm A: BGB-16673
EXPERIMENTALParticipants will receive BGB-16673 orally.
Arm B: Pirtobrutinib
ACTIVE COMPARATORParticipants will receive pirtobrutinib orally.
Interventions
Pirtobrutinib will be administered orally
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL 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.
You may not qualify if:
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (156)
Mayo Clinic Phoenix
Phoenix, Arizona, 85054-4502, United States
Kaiser Permanente Southern California
Irvine, California, 92618-3734, United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, 92093-1503, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720-3302, United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, 90095-3075, United States
Stanford Cancer Institute
Palo Alto, California, 94304-2205, United States
Christiana Care
Newark, Delaware, 19713-2055, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 001625, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224-1865, United States
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida, 33140, United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1443, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205-2003, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808-4365, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809-3738, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2429, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201-2013, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
Titan Health Partners Llc Dba Astera Cancer Care
East Brunswick, New Jersey, 08816-4096, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800, United States
University of Rochester
Rochester, New York, 14642-0001, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514-4220, United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204-2990, United States
Duke University Medical Center
Durham, North Carolina, 27705-3976, United States
Dayton Physician Network
Dayton, Ohio, 45415, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2434, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203, United States
Md Anderson Cancer Center
Houston, Texas, 77030-3907, United States
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
Roanoke, Virginia, 24014, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433, United States
Summit Cancer Centers
Spokane, Washington, 99208-1129, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Gunderson Health System
La Crosse, Wisconsin, 54601-5467, United States
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, QLD 4575, Australia
Flinders Medical Centre
Bedford PK, South Australia, SA 5042, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065, Australia
Peninsula Private Hospital
Frankston, Victoria, VIC 3199, Australia
Austin Health
Heidelberg, Victoria, VIC 3084, Australia
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
Linear Clinical Research
Nedlands, Western Australia, WA 6009, Australia
Medical University Graz
Graz, 8036, Austria
Medizinische Universitatsklinik Innsbruck
Innsbruck, 6020, Austria
Ordensklinikum Linz Gmbh Elisabethinen
Linz, 4020, Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Uk St Poelten
Sankt Pölten, 3100, Austria
Institut Jules Bordet
Anderlecht, 1070, Belgium
UZ GENT
Ghent, 9000, Belgium
Az Groeninge Campus Loofstraat
Kortrijk, 8500, Belgium
Chc Montlegia
Liège, 4000, Belgium
Chu de Liege
Liège, 4000, Belgium
Az Sint Maarten
Mechelen, 2800, Belgium
Chu Ucl Namur
Yvoir, 5530, Belgium
Centro de Pesquisa Clinica Dom Bosco Ltda
Araçatuba, 16015-150, Brazil
Ictr Instituto Do Cancer E Transplante de Curitiba
Curitiba, 80510-130, Brazil
Hospital de Clinicas de Goiania Ufg
Goiânia, 74605-020, Brazil
Inca Instituto Nacional de Cancer
Rio de Janeiro, 20231-050, Brazil
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador, 41950-640, Brazil
Hospital Nove de Julho Dasa
São Paulo, 01409-001, Brazil
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
São Paulo, 05403-010, Brazil
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33000, France
Hopital Estaing
ClermontFerrand, 63100, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44000, France
Hopital Saint Louis
Paris, 75010, France
Centre Henri Becquerel
Rouen, 76038, France
Iuc Toulouse Oncopole
Toulouse, 31100, France
Chu Tours Hopital Bretonneau
Tours, 37000, France
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, 54511, France
Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund
Dortmund, 44309, Germany
Stadtisches Klinikum Karlsruhe
Karlsruhe, 76133, Germany
Luebecker Onkologische Schwerpunktpraxis Dres Med Kisroweber
Lübeck, 23562, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede
Westerstede, 26655, Germany
Bnai Zion Medical Center
Haifa, 31048, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
Meir Medical Center
KfarSava, 4428164, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Sourasky Tel Aviv Medical Center
Tel Aviv, 6423906, Israel
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera Di Padova
Padova, 35128, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nakamuraku, Aichi-ken, 453-8511, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, 790 8524, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, 730-8619, Japan
Aiiku Hospital
Sapporo, Hokkaido, 064-0804, Japan
Kochi Medical School Hospital
Nankoku, Kochi, 783-8505, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyotoshi, Kyoto, 602-8026, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, 503-8502, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Tokyo, 113-8677, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550, Japan
National Hospital Organization (Nho) Disaster Medical Center
Tachikawashi, Tokyo, 190-0014, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Oita Prefectural Hospital
Ōita, 870-8511, Japan
Centro de Investigacion Clinica Gramel
México, 3720, Mexico
Christus Latam Hub Center of Excellence and Innovation Sc
Monterrey, 64000, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020, Mexico
Centro Hemato Oncologico Privado de Toluca
Toluca, 50120, Mexico
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Catharina Hospital
EJ Eindhoven, 5623, Netherlands
Groene Hart Hospital
Gouda, 2803, Netherlands
University of Medical Center Groningen (Umcg)
Groningen, 9713 GZ, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
North Shore Hospital
Auckland, 0622, New Zealand
Tauranga Hospital
Tauranga, 3112, New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, 6021, New Zealand
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdansk, 80-219, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Kielce, 25-734, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-513, Poland
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie Uniwersytet Medyczny W Lublinie
Lublin, 20-400, Poland
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii
Olsztyn, 10-228, Poland
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
Torun, 87-100, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw, 02-781, Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, 50-367, Poland
Auxilio Mutuo Cancer Center
San Juan, 00917, Puerto Rico
Coltea Clinical Hospital
Bucharest, 30171, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca, 400015, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Singapore General Hospital
Singapore, 168582, Singapore
Tan Tock Seng Hospital Haematology
Singapore, 308433, Singapore
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, 49241, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Ico Badalona
Badalona, 08916, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas de Gran Canaria, 35010, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Universitari Son Espases
Palma de Mallorca, 07120, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 46, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Inselspital Bern (Inselspital, Universitatsspital Bern)
Bern, 3010, Switzerland
Universitatsspital Zurich
Zurich, 8091, Switzerland
University Hospitals Sussex Nhs Foundation Trust
Brighton, BN2 5BE, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY, United Kingdom
Spire Leeds Healthcare Spire Leeds Hospital
Roundhay, LS8 1NT, United Kingdom
Salisbury Foundation Trust
Salisbury, SP2 8BJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2025
First Posted
May 15, 2025
Study Start
September 4, 2025
Primary Completion (Estimated)
April 17, 2028
Study Completion (Estimated)
April 17, 2028
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.