RecruitingPhase 3NCT06973187

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

Sponsor

BeOne Medicines

Enrollment

500 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new targeted drug called BGB-16673 against pirtobrutinib in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose cancer has come back or stopped responding to a type of treatment called BTK inhibitors. **You may be eligible if...** - You have confirmed CLL or SLL that requires treatment - You have previously been treated with a covalent BTK inhibitor (such as ibrutinib or acalabrutinib) and your disease relapsed or did not respond - If you have SLL, your lymph nodes must be measurable on a CT or MRI scan **You may NOT be eligible if...** - You have a type of leukemia called prolymphocytic leukemia, or your CLL has transformed into a more aggressive lymphoma (Richter's transformation) - You have a serious bleeding disorder like hemophilia - You have uncontrolled infections or other conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-16673

BGB-16673 will be administered orally

DRUGPirtobrutinib

Pirtobrutinib will be administered orally

Locations(145)

Mayo Clinic Phoenix

Phoenix, Arizona, United States

Kaiser Permanente Southern California

Irvine, California, United States

University of California San Diego (Ucsd) Moores Cancer Center

La Jolla, California, United States

UCLA Department of Medicine Hematologyoncology

Los Angeles, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Christiana Care

Newark, Delaware, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Titan Health Partners Llc Dba Astera Cancer Care

East Brunswick, New Jersey, United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

University of Rochester

Rochester, New York, United States

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Levine Cancer Institute (Lci)

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Dayton Physician Network

Dayton, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States

Md Anderson Cancer Center

Houston, Texas, United States

Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)

Roanoke, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Summit Cancer Centers

Spokane, Washington, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Gunderson Health System

La Crosse, Wisconsin, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia

Flinders Medical Centre

Bedford PK, South Australia, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Peninsula Private Hospital

Frankston, Victoria, Australia

Austin Health

Heidelberg, 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

Medizinische Universitatsklinik Innsbruck

Innsbruck, Austria

Ordensklinikum Linz Gmbh Elisabethinen

Linz, Austria

Uk St Poelten

Sankt Pölten, Austria

Institut Jules Bordet

Anderlecht, Belgium

UZ GENT

Ghent, Belgium

Az Groeninge Campus Loofstraat

Kortrijk, Belgium

Chc Montlegia

Liège, Belgium

Chu de Liege

Liège, Belgium

Chu Ucl Namur

Yvoir, Belgium

Centro de Pesquisa Clinica Dom Bosco Ltda

Araçatuba, Brazil

Ictr Instituto Do Cancer E Transplante de Curitiba

Curitiba, Brazil

Hospital de Clinicas de Goiania Ufg

Goiânia, Brazil

Inca Instituto Nacional de Cancer

Rio de Janeiro, Brazil

Ensino E Terapia de Inovacao Clinica Amo Etica

Salvador, Brazil

Hospital Nove de Julho Dasa

São Paulo, Brazil

Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo

São Paulo, Brazil

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France

Hopital Estaing

Clermontferrand, France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France

Hopital Saint Louis

Paris, France

Centre Henri Becquerel

Rouen, France

Iuc Toulouse Oncopole

Toulouse, France

Chu Tours Hopital Bretonneau

Tours, France

Chu Nancy Hopital Brabois

VandoeuvrelesNancy, France

Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund

Dortmund, Germany

Luebecker Onkologische Schwerpunktpraxis Dres Med Kisroweber

Lübeck, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede

Westerstede, Germany

Bnai Zion Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Meir Medical Center

KfarSava, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Sourasky Tel Aviv Medical Center

Tel Aviv, Israel

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy

Ospedale San Raffaele

Milan, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliera Di Padova

Padova, Italy

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

Nakamuraku, Aichi-ken, Japan

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Aiiku Hospital

Sapporo, Hokkaido, Japan

Kochi Medical School Hospital

Nankoku, Kochi, Japan

Japanese Red Cross Kyoto Daini Hospital

Kyotoshi, Kyoto, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Kindai University Hospital

Sakai, Osaka, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyoku, Tokyo, Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, Japan

National Hospital Organization (Nho) Disaster Medical Center

Tachikawashi, Tokyo, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan

Kumamoto University Hospital

Kumamoto, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Oita Prefectural Hospital

Ōita, Japan

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Catharina Hospital

EJ Eindhoven, Netherlands

Groene Hart Hospital

Gouda, Netherlands

University of Medical Center Groningen (Umcg)

Groningen, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

North Shore Hospital

Auckland, New Zealand

Tauranga Hospital

Tauranga, New Zealand

Wellington Regional Hospital (Ccdhb)

Wellington, New Zealand

Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

Gdansk, Poland

Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach

Kielce, Poland

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, Poland

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie Uniwersytet Medyczny W Lublinie

Lublin, Poland

Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

Olsztyn, Poland

Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu

Torun, Poland

Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit

Warsaw, Poland

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, Poland

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico

Coltea Clinical Hospital

Bucharest, Romania

Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca

ClujNapoca, Romania

Institutul Regional de Oncologie Iasi

Iași, Romania

Singapore General Hospital

Singapore, Singapore

Tan Tock Seng Hospital Haematology

Singapore, Singapore

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Ico Badalona

Badalona, Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital Universitario de Gran Canaria Dr Negrin

Las Palmas de Gran Canaria, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Inselspital Bern (Inselspital, Universitatsspital Bern)

Bern, Switzerland

Universitatsspital Zurich

Zurich, Switzerland

University Hospitals Sussex Nhs Foundation Trust

Brighton, United Kingdom

Kent and Canterbury Hospital

Canterbury, United Kingdom

Hull Royal Infirmary

Hull, United Kingdom

Salisbury Foundation Trust

Salisbury, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06973187

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