RecruitingPhase 3NCT06846671

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

Sponsor

BeOne Medicines

Enrollment

250 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia CLL

Summary

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
Adequate liver function
Adequate blood clotting function

Exclusion Criteria6

Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
Known central nervous system involvement
Prior exposure to any BTK protein degraders
Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
Clinically significant cardiovascular disease

Interventions

DRUGBGB-16673

Administered orally

DRUGBendamustine

Administered intravenously

DRUGIdelalisib

Administered orally

DRUGRituximab

Administered intravenously

DRUGVenetoclax

Administered orally

Locations(112)

St Bernards Medical Center

Jonesboro, Arkansas, United States

UCLA Department of Medicine Hematologyoncology

Los Angeles, California, United States

Pih Health Whittier Hospital

Whittier, California, United States

Rocky Mountain Cancer Centers (Williams) Usor

Aurora, Colorado, United States

Florida Oncology and Hematology

Fort Myers, Florida, United States

Baptist Md Anderson Cancer Center

Jacksonville, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, United States

American Oncology Partners of Maryland Pa

Bethesda, Maryland, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

Clinical Research Alliance, Inc

Westbury, New York, United States

University Hospitals

Cleveland, Ohio, United States

Dayton Physician Network

Dayton, Ohio, United States

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Cancer Care Associates of York

York, Pennsylvania, United States

Texas Oncology Tyler

Tyler, Texas, United States

FUNDALEU

Caba, Argentina

Instituto Alexander Fleming (Iaf)

Ciudad Autonoma Buenos Aires, Argentina

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Gosford Hospital

Gosford, New South Wales, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

Toowoomba Hospital

Toowoomba, Queensland, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Perth Blood Institute

West Perth, Western Australia, Australia

CETUS

Belo Horizonte, Brazil

Hospital Sirio Libanes Brasilia

Brasília, Brazil

Hospital Erasto Gaertner

Curitiba, Brazil

Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)

Florianópolis, Brazil

Instituto Joinvilense de Hematologia E Oncologia

Joinville, Brazil

Complexo Hospitalar de Niteroi

Niterói, Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Sao Lucas Dasa Oncologia

Rio de Janeiro, Brazil

Oncoclinicas Rio de Janeiro Sa

Rio de Janeiro, Brazil

Hospital Sao Rafael (Rede Dor)

Salvador, Brazil

Instituto Brasileiro de Controle Do Cancer

São Paulo, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, Brazil

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre

Greenfield Park, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Fakultni Nemocnice Brno

Brno, Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni Nemocnice Ostrava

Ostrava, Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia

Universitatsklinikum Augsburg

Augsburg, Germany

Praxis Am Volkspark

Berlin, Germany

Klinikum Chemnitz Ggmbh

Chemnitz, Germany

Universitatsklinikum Essen (Aor)

Essen, Germany

Centrum Fur Haematologie Und Onkologie Bethanien

Frankfurt am Main, Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitatsklinikum Heidelberg

Heidelberg, Germany

Saarland University Medical Center

Homburg, Germany

Invo Institut Fur Versorgungsforschung in Der Onkologie

Koblenz, Germany

Universitaetsklinikum Leipzig Aor

Leipzig, Germany

Universitatsklinikum Munster Medizinische Klinik A

Münster, Germany

Irccs Istituto Tumori Giovanni Paolo Ii

Bari, Italy

Aou Careggi, Servizio Sanitario Toscana

Florence, Italy

Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliera Universitaria Federico Ii

Napoli, Italy

Aou Maggiore Della Carita

Novara, Italy

Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

Pavia, Italy

Ospedale Santa Maria Della Misericordia

Perugia, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken, Japan

Nho Shikoku Cancer Center

Matsuyama, Ehime, Japan

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Aiiku Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Amagasaki General Medical Center

AmagasakiCity, Hyōgo, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

University Hospital, Kyoto Prefectural Univ of Medicine

KyotoShi, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

Kurashiki Central Hospital

Kurashikishi, Okayama-ken, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Kindai University Hospital

Sakai, Osaka, Japan

Saitama Medical Center

Kawagoeshi, Saitama, Japan

Ntt Medical Center Tokyo

Shinagawaku, Tokyo, Japan

Kumamoto University Hospital

Kumamoto, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Amsterdam Umc Vu Mc

Amsterdam, Netherlands

Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

Brzozów, Poland

Pratia Onkologia Katowice

Katowice, Poland

Pratia McM Krakow

Krakow, Poland

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, Poland

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, Poland

Dong A University Hospital

Seogu, Busan Gwang'yeogsi, South Korea

Kyungpook National University Hospital

Junggu, Daegu Gwang'yeogsi, South Korea

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

HwasunGun, Jeollanam-do, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Gazi University

Ankara, Turkey (Türkiye)

Dokuz Eylul University

Balçova, Turkey (Türkiye)

Antalya Memorial Hospital

Dokuma, Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Birmingham Heartlands Hospital

Birmingham, United Kingdom

The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

Bournemouth, United Kingdom

University College Hospital

London, United Kingdom

Royal Marsden Hospital

London, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

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