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NCT06846671PHASE3Recruiting

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

BeOne Medicines

Start Date

4/10/2025

Completion Date

2/14/2030

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).

Detailed Description

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms. In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab). Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment. "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: 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i. 3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 5. Adequate liver function 6. Adequate blood clotting function Exclusion Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months 3. Known central nervous system involvement 4. Prior exposure to any BTK protein degraders 5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy 6. Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

BGB-16673

DRUG

Bendamustine

DRUG

Idelalisib

DRUG

Rituximab

DRUG

Venetoclax

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Conditions

CLLChronic Lymphocytic Leukemia

Locations

St Bernards Medical Center

Jonesboro, Arkansas 72401

United States

UCLA Department of Medicine Hematologyoncology

Los Angeles, California 90095-3075

United States

Pih Health Whittier Hospital

Whittier, California 90602

United States

Rocky Mountain Cancer Centers (Williams) Usor

Aurora, Colorado 80012-5405

United States

Florida Oncology and Hematology

Fort Myers, Florida 33912

United States

Baptist Md Anderson Cancer Center

Jacksonville, Florida 32207-8432

United States

Cleveland Clinic Florida

Weston, Florida 33331-3609

United States

Emory University Winship Cancer Institute

Atlanta, Georgia 30322-1013

United States

Northside Cancer Center

Atlanta, Georgia 30342

United States

Our Lady of the Lake Hospital

Baton Rouge, Louisiana 70808-4365

United States

American Oncology Partners of Maryland Pa

Bethesda, Maryland 20817-7847

United States

Oncology Hematology Associates

Springfield, Missouri 65807-5288

United States

Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

Omaha, Nebraska 68130-2042

United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York 10065-6800

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Optum Medical Care, Pc

Westbury, New York 11590-5119

United States

University Hospitals

Cleveland, Ohio 44106-1716

United States

Dayton Physician Network

Dayton, Ohio 45415

United States

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon 97401

United States

West Penn Hospital

Pittsburgh, Pennsylvania 15224

United States

Cancer Care Associates of York

York, Pennsylvania 17403-5049

United States

Texas Oncology Tyler

Tyler, Texas 75702-7522

United States

Hospital Aleman

CABA, 1425

Argentina

CEMIC

Caba, C1431

Argentina

FUNDALEU

Caba, CP1114

Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, 1413

Argentina

Instituto Alexander Fleming (Iaf)

Ciudad Autonoma Buenos Aires, 1426

Argentina

Cice 9 de Julio Sanatorio 9 de Julio

San Miguel de Tucumán, 4000

Argentina

Concord Repatriation General Hospital

Concord, New South Wales NSW 2139

Australia

Gosford Hospital

Gosford, New South Wales NSW 2250

Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales NSW 2444

Australia

Prince of Wales Hospital

Randwick, New South Wales NSW 2031

Australia

Toowoomba Hospital

Toowoomba, Queensland QLD 4350

Australia

Flinders Medical Centre

Bedford PK, South Australia SA 5042

Australia

The Alfred Hospital

Melbourne, Victoria VIC 3004

Australia

Perth Blood Institute

West Perth, Western Australia WA 6005

Australia

CETUS

Belo Horizonte, 30110-022

Brazil

Hospital Sirio Libanes Brasilia

Brasília, 70200-730

Brazil

Hospital Erasto Gaertner

Curitiba, 81520-060

Brazil

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

Florianópolis, 88020-210

Brazil

Instituto Joinvilense de Hematologia E Oncologia

Joinville, 89201-260

Brazil

Complexo Hospitalar de Niteroi

Niterói, 24020-096

Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, 90110-270

Brazil

Hospital Santa Joana Recife

Recife, 52011-906

Brazil

Hospital Sao Lucas Dasa Oncologia

Rio de Janeiro, 22061-080

Brazil

Oncoclinicas Rio de Janeiro Sa

Rio de Janeiro, 22250-040

Brazil

Hospital Sao Rafael (Rede Dor)

Salvador, 41253-190

Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, 01401-004

Brazil

Instituto Brasileiro de Controle Do Cancer

São Paulo, 04014-002

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900

Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, 29043-260

Brazil

London Health Sciences Centre

London, Ontario N6A 5W9

Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario K1H 8L6

Canada

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

Greenfield Park, Quebec J4V 2H1

Canada

Jewish General Hospital

Montreal, Quebec QC H3t 1E2

Canada

Unite de Recherche Clinique Du Cisss Des Laurentides

SaintJerome, Quebec J7Z 5T3

Canada

Fakultni Nemocnice Brno

Brno, 625 00

Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 03

Czechia

Fakultni Nemocnice Ostrava

Ostrava, 708 00

Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, 10000

Czechia

Universitatsklinikum Augsburg

Augsburg, 86156

Germany

Praxis Am Volkspark

Berlin, 10715

Germany

Klinikum Chemnitz Ggmbh

Chemnitz, 09116

Germany

Universitatsklinikum Essen (Aor)

Essen, 45122

Germany

Centrum Fur Haematologie Und Onkologie Bethanien

Frankfurt am Main, 60389

Germany

Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I

Freiburg im Breisgau, 79106

Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, 20251

Germany

Universitatsklinikum Heidelberg

Heidelberg, 69120

Germany

Saarland University Medical Center

Homburg, 66421

Germany

Invo Institut Fur Versorgungsforschung in Der Onkologie

Koblenz, 56068

Germany

Universitaetsklinikum Leipzig Aor

Leipzig, 04103

Germany

Universitatsklinikum Munster Medizinische Klinik A

Münster, 48149

Germany

Irccs Istituto Tumori Giovanni Paolo Ii

Bari, 70124

Italy

Aou Careggi, Servizio Sanitario Toscana

Florence, 50134

Italy

Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Azienda Ospedaliera Universitaria Federico Ii

Naples, 80131

Italy

Aou Maggiore Della Carita

Novara, 28100

Italy

Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

Pavia, 27100

Italy

Ospedale Santa Maria Della Misericordia

Perugia, 6129

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken 464-8681

Japan

Nho Shikoku Cancer Center

Matsuyama, Ehime 791-0280

Japan

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima 730-8619

Japan

Aiiku Hospital

Sapporo, Hokkaido 064-0804

Japan

Hyogo Prefectural Amagasaki General Medical Center

AmagasakiCity, Hyōgo 660-8550

Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken 890-8520

Japan

University Hospital, Kyoto Prefectural Univ of Medicine

KyotoShi, Kyoto 602-8566

Japan

Tohoku University Hospital

Sendai, Miyagi 980-8574

Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata 951-8520

Japan

Kurashiki Central Hospital

Kurashikishi, Okayama-ken 710-8602

Japan

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan

Kindai University Hospital

Sakai, Osaka 590-0197

Japan

Saitama Medical Center

Kawagoeshi, Saitama 350-8550

Japan

Tokyo Metropolitan Komagome Hospital

Bunkyoku, Tokyo 113-8677

Japan

Ntt Medical Center Tokyo

Shinagawaku, Tokyo 141-0022

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Osaka Metropolitan University Hospital

Osaka, 545-8586

Japan

Amsterdam Umc Vu Mc

Amsterdam, 1081 HV

Netherlands

Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

Brzozów, 36-200

Poland

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Pratia McM Krakow

Krakow, 30-727

Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, 93-513

Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, 20-090

Poland

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, 50-367

Poland

Dong A University Hospital

Seogu, Busan Gwang'yeogsi 49201

South Korea

Kyungpook National University Hospital

Junggu, Daegu Gwang'yeogsi 41944

South Korea

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do 10408

South Korea

Chonnam National University Hwasun Hospital

HwasunGun, Jeollanam-do 58128

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi 06591

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, 06200

Turkey (Türkiye)

Gazi University

Ankara, 6500

Turkey (Türkiye)

Dokuz Eylul University

Balçova, 35330

Turkey (Türkiye)

Antalya Memorial Hospital

Dokuma, 07025

Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, 54100

Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN

United Kingdom

Birmingham Heartlands Hospital

Birmingham, B9 5SS

United Kingdom

The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

Bournemouth, BH7 7DW

United Kingdom

University College Hospital

London, NW1 2PG

United Kingdom

Royal Marsden Hospital

London, SW3 6JJ

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom