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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: BGB-16673; Drug: Pirtobrutinib

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1-877-828-5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, NSW 2139
      • Recruiting
      • Concord Repatriation General Hospital
  • Queensland
    • Birtinya, Queensland, Australia, QLD 4575
      • Recruiting
      • Sunshine Coast Hospital and Health Service
  • South Australia
    • Bedford PK, South Australia, Australia, SA 5042
      • Recruiting
      • Flinders Medical Centre
  • Victoria
    • Fitzroy, Victoria, Australia, VIC 3065
      • Recruiting
      • St Vincents Hospital Melbourne
    • Frankston, Victoria, Australia, VIC 3199
      • Recruiting
      • Peninsula Private Hospital
    • Heidelberg, Victoria, Australia, VIC 3084
      • Recruiting
      • Austin Health
    • Malvern, Victoria, Australia, VIC 3144
      • Recruiting
      • Cabrini Hospital Malvern
    • Melbourne, Victoria, Australia, VIC 3004
      • Recruiting
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, VIC 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • Linear Clinical Research
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University Graz
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medizinische Universitatsklinik Innsbruck
  • Linz, Austria, 4020
    • Recruiting
    • Ordensklinikum Linz GmbH Elisabethinen
  • Salzburg, Austria, 5020
    • Recruiting
    • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
  • Sankt Pölten, Austria, 3100
    • Recruiting
    • Uk St Poelten
• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • Institut Jules Bordet
  • Ghent, Belgium, 9000
    • Recruiting
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • Recruiting
    • Az Groeninge Campus Loofstraat
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liège
  • Liège, Belgium, 4000
    • Recruiting
    • CHC MontLegia
  • Mechelen, Belgium, 2800
    • Recruiting
    • Az Sint Maarten
  • Yvoir, Belgium, 5530
    • Recruiting
    • CHU UCL Namur
• Brazil
  • Araçatuba, Brazil, 16015-150
    • Recruiting
    • Centro de Pesquisa Clinica Dom Bosco Ltda
  • Curitiba, Brazil, 80510-130
    • Recruiting
    • Ictr Instituto Do Cancer E Transplante de Curitiba
  • Goiânia, Brazil, 74605-020
    • Recruiting
    • Hospital de Clinicas de Goiania Ufg
  • Rio de Janeiro, Brazil, 20231-050
    • Recruiting
    • Inca Instituto Nacional de Cancer
  • Salvador, Brazil, 41950-640
    • Recruiting
    • Ensino E Terapia de Inovacao Clinica Amo Etica
  • São Paulo, Brazil, 01409-001
    • Recruiting
    • Hospital Nove de Julho Dasa
  • São Paulo, Brazil, 05403-010
    • Recruiting
    • Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
• France
  • Bordeaux, France, 33000
    • Recruiting
    • Centre de Lutte Contre Le Cancer Institut Bergonie
  • ClermontFerrand, France, 63100
    • Recruiting
    • Hopital Estaing
  • Nantes, France, 44000
    • Recruiting
    • Centre Hospitalier Universitaire Nantes Hotel Dieu
  • Paris, France, 75010
    • Recruiting
    • Hopital Saint Louis
  • Rouen, France, 76038
    • Recruiting
    • Centre Henri Becquerel
  • Toulouse, France, 31100
    • Recruiting
    • Iuc Toulouse Oncopole
  • Tours, France, 37000
    • Recruiting
    • Chu Tours Hopital Bretonneau
  • VandoeuvrelesNancy, France, 54511
    • Recruiting
    • Chu Nancy Hopital Brabois
• Germany
  • Dortmund, Germany, 44309
    • Recruiting
    • Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund
  • Karlsruhe, Germany, 76133
    • Recruiting
    • Stadtisches Klinikum Karlsruhe
  • Lübeck, Germany, 23562
    • Recruiting
    • Luebecker Onkologische Schwerpunktpraxis Dres Med Kisroweber
  • Ulm, Germany, 89081
    • Recruiting
    • Universitaetsklinikum Ulm
  • Westerstede, Germany, 26655
    • Recruiting
    • Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede
• Israel
  • Haifa, Israel, 31048
    • Recruiting
    • Bnai Zion Medical Center
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah University Hospital Ein Kerem
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center
  • KfarSava, Israel, 4428164
    • Recruiting
    • Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • Recruiting
    • Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Sourasky Tel Aviv Medical Center
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico Sorsola Malpighi, Aou Di Bologna
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Milan, Italy, 20162
    • Recruiting
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Padova, Italy, 35128
    • Recruiting
    • Azienda Ospedaliera Di Padova
• Japan
  • Kumamoto, Japan, 860-8556
    • Recruiting
    • Kumamoto University Hospital
  • Osaka, Japan, 545-8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Ōita, Japan, 870-8511
    • Recruiting
    • Oita Prefectural Hospital
  • Aichi-ken
    • Nakamuraku, Aichi-ken, Japan, 453-8511
      • Recruiting
      • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 790 8524
      • Recruiting
      • Matsuyama Red Cross Hospital
  • Fukushima
    • Fukushima, Fukushima, Japan, 960-1295
      • Recruiting
      • Fukushima Medical University Hospital
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 730-8619
      • Recruiting
      • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-0804
      • Recruiting
      • Aiiku Hospital
  • Kochi
    • Nankoku, Kochi, Japan, 783-8505
      • Recruiting
      • Kochi Medical School Hospital
  • Kyoto
    • Kyotoshi, Kyoto, Japan, 602-8026
      • Recruiting
      • Japanese Red Cross Kyoto Daini Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Recruiting
      • Okayama University Hospital
  • Osaka
    • Sakai, Osaka, Japan, 590-0197
      • Recruiting
      • Kindai University Hospital
  • Saitama
    • Koshigaya, Saitama, Japan, 503-8502
      • Recruiting
      • Dokkyo Medical University Saitama Medical Center
  • Tokyo
    • Bunkyoku, Tokyo, Japan, 113-8677
      • Recruiting
      • Tokyo Metropolitan Komagome Hospital
    • Kotoku, Tokyo, Japan, 135-8550
      • Recruiting
      • Cancer Institute Hospital Of JFCR
    • Tachikawashi, Tokyo, Japan, 190-0014
      • Recruiting
      • National Hospital Organization (Nho) Disaster Medical Center
  • Yamagata
    • Yamagata, Yamagata, Japan, 990-9585
      • Recruiting
      • Yamagata University Hospital
• Mexico
  • Monterrey, Mexico, 64000
    • Recruiting
    • Christus Latam Hub Center of Excellence and Innovation Sc
  • México, Mexico, 3720
    • Recruiting
    • Centro de Investigacion Clinica Gramel
  • Oaxaca City, Mexico, 68020
    • Recruiting
    • Centro de Investigacion Clinica de Oaxaca
  • Toluca, Mexico, 50120
    • Recruiting
    • Centro Hemato Oncologico Privado de Toluca
• Netherlands
  • Dordrecht, Netherlands, 3318 AT
    • Recruiting
    • Albert Schweitzer Ziekenhuis
  • EJ Eindhoven, Netherlands, 5623
    • Recruiting
    • Catharina Hospital
  • Gouda, Netherlands, 2803
    • Recruiting
    • Groene Hart Hospital
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • University of Medical Center Groningen (Umcg)
  • Nijmegen, Netherlands, 6532 SZ
    • Recruiting
    • Canisius Wilhelmina Ziekenhuis
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • Universitair Medisch Centrum Utrecht
• New Zealand
  • Auckland, New Zealand, 0622
    • Recruiting
    • North Shore Hospital
  • Tauranga, New Zealand, 3112
    • Recruiting
    • Tauranga Hospital
  • Wellington, New Zealand, 6021
    • Recruiting
    • Wellington Regional Hospital (Ccdhb)
• Poland
  • Gdansk, Poland, 80-219
    • Recruiting
    • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
  • Kielce, Poland, 25-734
    • Recruiting
    • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
  • Lodz, Poland, 93-513
    • Recruiting
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
  • Lublin, Poland, 20-400
    • Recruiting
    • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie Uniwersytet Medyczny W Lublinie
  • Olsztyn, Poland, 10-228
    • Recruiting
    • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii
  • Torun, Poland, 87-100
    • Recruiting
    • Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
  • Warsaw, Poland, 02-781
    • Recruiting
    • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
  • Wroclaw, Poland, 50-367
    • Recruiting
    • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Recruiting
    • Auxilio Mutuo Cancer Center
• Romania
  • Bucharest, Romania, 30171
    • Recruiting
    • Coltea Clinical Hospital
  • ClujNapoca, Romania, 400015
    • Recruiting
    • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
  • Iași, Romania, 700483
    • Recruiting
    • Institutul Regional de Oncologie Iasi
• Singapore
  • Singapore, Singapore, 168582
    • Recruiting
    • Singapore General Hospital
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital Haematology
• South Korea
  • Busan Gwang'yeogsi
    • Seogu, Busan Gwang'yeogsi, South Korea, 49241
      • Recruiting
      • Pusan National University Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Gyeongsangnam-do
    • Jinju, Gyeongsangnam-do, South Korea, 52727
      • Recruiting
      • Gyeongsang National University Hospital
  • Seoul Teugbyeolsi
    • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
      • Recruiting
      • The Catholic University of Korea, Seoul St Marys Hospital
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
• Spain
  • Badalona, Spain, 08916
    • Recruiting
    • Ico Badalona
  • Burgos, Spain, 09006
    • Recruiting
    • Hospital Universitario de Burgos
  • Las Palmas de Gran Canaria, Spain, 35010
    • Recruiting
    • Hospital Universitario de Gran Canaria Dr Negrin
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundación Jimenez Díaz
  • Majadahonda, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Palma de Mallorca, Spain, 07120
    • Recruiting
    • Hospital Universitari Son Espases
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocío
• Sweden
  • Gothenburg, Sweden, 413 46
    • Recruiting
    • Sahlgrenska Universitetssjukhuset
  • Stockholm, Sweden, 171 76
    • Recruiting
    • Karolinska Universitetssjukhuset Solna
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital Bern (Inselspital, Universitatsspital Bern)
  • Zurich, Switzerland, 8091
    • Recruiting
    • Universitatsspital Zurich
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Recruiting
    • University Hospitals Sussex NHS Foundation Trust
  • Canterbury, United Kingdom, CT1 3NG
    • Recruiting
    • Kent and Canterbury Hospital
  • Hull, United Kingdom, HU3 2JZ
    • Recruiting
    • Hull Royal Infirmary
  • Norwich, United Kingdom, NR4 7UY
    • Recruiting
    • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Roundhay, United Kingdom, LS8 1NT
    • Recruiting
    • Spire Leeds Healthcare Spire Leeds Hospital
  • Salisbury, United Kingdom, SP2 8BJ
    • Recruiting
    • Salisbury Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054-4502
      • Recruiting
      • Mayo Clinic Phoenix
  • California
    • Irvine, California, United States, 92618-3734
      • Recruiting
      • Kaiser Permanente Southern California
    • La Jolla, California, United States, 92093-1503
      • Recruiting
      • University of California San Diego (Ucsd) Moores Cancer Center
    • Los Alamitos, California, United States, 90720-3302
      • Recruiting
      • Cancer and Blood Specialty Clinic
    • Los Angeles, California, United States, 90095-3075
      • Recruiting
      • UCLA Department of Medicine Hematologyoncology
    • Palo Alto, California, United States, 94304-2205
      • Recruiting
      • Stanford Cancer Institute
  • Delaware
    • Newark, Delaware, United States, 19713-2055
      • Recruiting
      • Christiana Care
  • Florida
    • Jacksonville, Florida, United States, 32224-1865
      • Recruiting
      • Mayo Clinic Jacksonville
    • Jacksonville, Florida, United States, 001625
      • Recruiting
      • Cancer Specialists of North Florida
    • Miami, Florida, United States, 33140
      • Recruiting
      • Mount Sinai Medical Center Braman Comprehensive Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637-1443
      • Recruiting
      • University of Chicago Medical Center
  • Kansas
    • Westwood, Kansas, United States, 66205-2003
      • Recruiting
      • The University of Kansas Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809-3738
      • Recruiting
      • Mary Bird Perkins Cancer Center
    • Baton Rouge, Louisiana, United States, 70808-4365
      • Recruiting
      • Our Lady of the Lake Hospital
    • New Orleans, Louisiana, United States, 70121-2429
      • Recruiting
      • Ochsner Clinic Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5418
      • Recruiting
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201-2013
      • Recruiting
      • Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Recruiting
      • Mayo Clinic Rochester
  • Missouri
    • St Louis, Missouri, United States, 63110-1010
      • Recruiting
      • Washington University School of Medicine
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816-4096
      • Recruiting
      • Titan Health Partners Llc Dba Astera Cancer Care
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • John Theurer Cancer Center Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
    • New York, New York, United States, 10065-6800
      • Recruiting
      • Memorial Sloan Kettering Cancer Center Mskcc
    • Rochester, New York, United States, 14642-0001
      • Recruiting
      • University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Recruiting
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28204-2990
      • Recruiting
      • Atrium Health Levine Cancer Institute (Lci)
    • Durham, North Carolina, United States, 27705-3976
      • Recruiting
      • Duke University Medical Center
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Recruiting
      • Dayton Physician Network
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111-2434
      • Recruiting
      • Fox Chase Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology, Pllc Nashville
  • Texas
    • Houston, Texas, United States, 77030-3907
      • Recruiting
      • Md Anderson Cancer Center
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
  • Washington
    • Seattle, Washington, United States, 98109-4433
      • Recruiting
      • Fred Hutchinson Cancer Research Center
    • Spokane, Washington, United States, 99208-1129
      • Recruiting
      • Summit Cancer Centers
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601-5467
      • Recruiting
      • Gunderson Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: BGB-16673; Participants will receive BGB-16673 orally.	Drug: BGB-16673; BGB-16673 will be administered orally
Active Comparator: Arm B: Pirtobrutinib; Participants will receive pirtobrutinib orally.	Drug: Pirtobrutinib; Pirtobrutinib will be administered orally; Other Names: Jaypirca

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause.	Up to approximately 3 years
PFS per Investigator (INV)	PFS per INV is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by investigator using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with CLL and Lugano classification for participants with SLL.	Up to approximately 3 years
Overall Response Rate (ORR) per IRC and INV	ORR is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, or partial response, as assessed by the investigator and IRC using modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL.	Up to approximately 3 years
Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV	The rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, partial response, or PR-L.	Up to approximately 3 years
Duration of Response (DOR) per IRC and INV	DOR is defined as the time from initial response to disease progression or death, whichever occurs first.	Up to approximately 3 years
Time to Next Anti-CLL/SLL Treatment (TTNT)	TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment.	Up to approximately 3 years
Number of Participants with Adverse Events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities.	Up to approximately 3 years
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409	EORTC IL409 consists of a set of 19 questions derived from the EORTC quality of life questionnaire core 30 (QLQ-C30) and its CLL module CLL17. The EORTC IL409 includes questions on global health status (GHS)/quality of life, physical functioning, role functioning, physical condition/fatigue, and symptom burden.Higher scores in GHS and functional scales and lower scores in symptom scales indicate better health-related quality of life.	Baseline and up to approximately 3 years

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Estimated): April 17, 2028
• Study Completion (Estimated): April 17, 2028

Study Registration Dates

• First Submitted: May 7, 2025
• First Submitted That Met QC Criteria: May 7, 2025
• First Posted (Actual): May 15, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Noncovalent Bruton tyrosine kinase inhibitor; Bruton tyrosine kinase-targeted protein degrader
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; pirtobrutinib
• Other Study ID Numbers: BGB-16673-304; 2025-522860-34-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No