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NCT06973187PHASE3Recruiting

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

BeOne Medicines

Start Date

9/4/2025

Completion Date

4/17/2028

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).

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BGB-16673

DRUG

Pirtobrutinib

Interested in This Trial?

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Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Locations

University of Alabama At Birmingham Hospital

Birmingham, Alabama 35294-0004

United States

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

Kaiser Permanente Roseville Medical Center

Roseville, California 95661

United States

Kaiser Permanente Northern California

Vallejo, California 94589-2441

United States

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California 94596

United States

Christiana Care

Newark, Delaware 19713-2055

United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia 20007-2113

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224-1865

United States

Cancer Specialists of North Florida

Jacksonville, Florida 32256

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

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina 27157

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

FUNDALEU

Caba, CP1114

Argentina

Centro Oncologico de Integracion Regional (Coir)

Mendoza, M5500

Argentina

Concord Repatriation General Hospital

Concord, New South Wales NSW 2139

Australia

St George Private Hospital

Kogarah, New South Wales 2217

Australia

Westmead Private Hospital

Westmead, New South Wales 2145

Australia

Pindara Private Hospital

Benowa, Queensland QLD 4217

Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland QLD 4575

Australia

John Flynn Private Hospital

Tugun, Queensland QLD 4224

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

Peking Union Medical College Hospital

Beijing, Beijing Municipality 100730

China

Fujian Medical University Union Hospital

Fuzhou, Fujian 350001

China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong 510060

China

Jiangmen Central Hospital

Jiangmen, Guangdong 529030

China

The Fourth Hospital of Hebei Medical University East Branch

Shijiazhuang, Hebei 050035

China

Xuchang Central Hospitalluminghu Branch

Xuchang, Henan 461000

China

Henan Cancer Hospital

Zhengzhou, Henan 450000

China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technologychegu Branch

Wuhan, Hubei 430056

China

Affiliated Hospital of Nantong University

Nantong, Jiangsu 201203

China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu 215006

China

Wuxi Peoples Hospital

Wuxi, Jiangsu 214023

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu 221000

China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

Qinghai University Affiliated Hospital

Xining, Qinghai 810001

China

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi 710004

China

Binzhou Medical University Hospital

Binzhou, Shandong 256603

China

Taian City Central Hospital

Taian, Shandong 271099

China

Renji Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality 200000

China

Shanxi Bethune Hospital

Taiyuan, Shanxi 030032

China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan 610071

China

Dazhou Central Hospital

Dazhou, Sichuan 635099

China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan 646099

China

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality 300020

China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan 650032

China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang 315010

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

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

St Josef Hospital Klinikum Der Ruhr Universitat Bochum

Bochum, 44791

Germany

Universitatsklinikum Bonn

Bonn, 53127

Germany

Uniklinik Koeln (Aoer)

Cologne, 50937

Germany

Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund

Dortmund, 44309

Germany

Stadtisches Klinikum Karlsruhe

Karlsruhe, 76133

Germany

Mvz Fur Hamatologie Und Onkologie Lubeckgmbh

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

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken 464-8681

Japan

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 Klinika Hematoonkologii

Lublin, 20-081

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 W Warszawie

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

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