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NCT06943872PHASE3Recruiting

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

BeOne Medicines

Start Date

6/11/2025

Completion Date

12/1/2031

Summary

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

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/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria * Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy * Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 * Adequate organ function Exclusion Criteria: * Known active prolymphocytic leukemia or currently suspected Richter's transformation * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug * Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent * Known central nervous system involvement by CLL/SLL * Severe or debilitating pulmonary disease * Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Sonrotoclax

DRUG

Obinutuzumab

DRUG

Rituximab

DRUG

Venetoclax

Interested in This Trial?

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Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Locations

Uci Health Laguna Hills

Laguna Hills, California 92653

United States

Chao Family Comprehensive Cancer Center

Orange, California 92868-3201

United States

Stanford Cancer Institute

Palo Alto, California 94304-2205

United States

Scripps Prebys Cancer Center

San Diego, California 92103-2106

United States

Rocky Mountain Cancer Centers (Williams) Usor

Aurora, Colorado 80012-5405

United States

Yale University Yale Cancer Center

New Haven, Connecticut 06520-8028

United States

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut 06360-2700

United States

Cleveland Clinic Florida

Weston, Florida 33331-3609

United States

Northwestern University

Chicago, Illinois 60611

United States

Illinois Cancer Specialists (Niles) Usor

Niles, Illinois 60714-5905

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242-1009

United States

Mission Cancer and Blood

Waukee, Iowa 50263

United States

University of Louisville, Brown Cancer Center

Louisville, Kentucky 40202

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana 70809-3738

United States

The University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

Beth Israel Deaconess Medical Center (Bidmc)

Boston, Massachusetts 02215-5400

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215-5418

United States

The Cancer and Hematology Centers

Grand Rapids, Michigan 49503-2563

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905-0001

United States

Sidney Kimmel Comprehensive Cancer Center Washington Twp

Sewell, New Jersey 08080

United States

Christus St Vincent Regional Cancer Center

Santa Fe, New Mexico 87505

United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York 10065-6800

United States

Optum Medical Care, Pc

Westbury, New York 11590-5119

United States

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina 27514-4220

United States

Levine Cancer Center

Charlotte, North Carolina 28204-2990

United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

Oncology Hematology Care Clinical Trials, Llc

Cincinnati, Ohio 45245-1995

United States

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon 97401

United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107-4216

United States

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania 15232-1309

United States

Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga

Chattanooga, Tennessee 37404

United States

Tennessee Oncology

Nashville, Tennessee 37205

United States

Texas Oncology Baylorcharles A Sammons Cancer Center

Dallas, Texas 75246-2003

United States

Texas Oncology San Antonio Medical Center Usor

San Antonio, Texas 78240-5251

United States

Texas Oncology Tyler

Tyler, Texas 75702-7522

United States

Swedish Medical Center Swedish Cancer Institute First Hill Campus

Seattle, Washington 98104

United States

Northwest Cancer Specialist, Pc(Us Oncology Research)

Vancouver, Washington 98684-6930

United States

Hospital Aleman

CABA, 1425

Argentina

FUNDALEU

Caba, CP1114

Argentina

Instituto Alexander Fleming (Iaf)

Ciudad Autonoma Buenos Aires, 1426

Argentina

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

St George Hospital

Kogarah, New South Wales NSW 2217

Australia

Northern Nsw Health District

Lismore, New South Wales NSW 2480

Australia

Macquarie University

North Ryde, New South Wales NSW 2109

Australia

Genesiscare North Shore

St Leonards, New South Wales NSW 2065

Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland QLD 4575

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland QLD 4102

Australia

Monash Health

Clayton, Victoria VIC 3168

Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria VIC 3065

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria VIC 3000

Australia

The Alfred Hospital

Melbourne, Victoria VIC 3004

Australia

Rockingham Hospital

Cooloongup, Western Australia WA 6168

Australia

Perth Blood Institute

West Perth, Western Australia WA 6005

Australia

Medizinische Universitatsklinik Innsbruck

Innsbruck, 6020

Austria

Medical University Vienna Oncology

Vienna, 1090

Austria

Hanusch Krankenhaus

Vienna, 1140

Austria

Cliniques Universitaires Saint Luc

Brussels, 1200

Belgium

Uz Antwerpen

Edegem, 2650

Belgium

University Hospitals Leuven

Leuven, 3000

Belgium

CETUS

Belo Horizonte, 30110-022

Brazil

Universidade de Campinas Centro de Hematologia E Hemoterapia

Campinas, 13083-878

Brazil

Hospital Erasto Gaertner

Curitiba, 81520-060

Brazil

Complexo Hospitalar de Niteroi

Niterói, 24020-096

Brazil

Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre

Porto Alegre, 90020-090

Brazil

Hospital Sao Lucas

Rio de Janeiro, 22061-080

Brazil

Instituto Dor de Pesquisa E Ensino Rio de Janeiro

Rio de Janeiro, 22281-100

Brazil

Hospital Santa Izabel

Salvador, 40050-410

Brazil

Hospital Samaritano Sao Paulo

São Paulo, 01232-010

Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, 01401-004

Brazil

Hospital Nove de Julho Dasa

São Paulo, 01409-001

Brazil

Instituto Brasileiro de Controle Do Cancer

São Paulo, 04014-002

Brazil

Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

São Paulo, 05402-000

Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, 29043-260

Brazil

Arthur Je Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia V5Z 4E6

Canada

Cancercare Manitoba

Winnipeg, Manitoba R3E 0V9

Canada

Newfoundland and Labrador Health Services

St. John's, Newfoundland and Labrador A1B 3V6

Canada

The Ottawa Hospital

Ottawa, Ontario K1H 8L6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Ciusss Nim Hscm

Montreal, Quebec H4J 1C5

Canada

Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

Québec, G1J 1Z4

Canada

China Japan Friendship Hospital

Beijing, Beijing Municipality 100029

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality 630014

China

Fujian Provincial Hospital

Fuzhou, Fujian 350001

China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian 350005

China

Fujian Medical University Union Hospitalqishan Branch

Fuzhou, Fujian 350108

China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian 361003

China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong 510000

China

Guangzhou First Peoples Hospital

Guangzhou, Guangdong 510013

China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong 510515

China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi 530201

China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei 050000

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan 453100

China

Taihe Hospital

Shiyan, Hubei 442000

China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430030

China

Xiangya Hospital of Central South University

Changsha, Hunan 410008

China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia 010050

China

Zhongda Hospital Southeast University

Nanjing, Jiangsu 210009

China

Suzhou Municipal Hospitalbaita Branch

Suzhou, Jiangsu 215001

China

Affiliated Hospital of Jiangnan University South Campus

Wuxi, Jiangsu 214122

China

Northern Jiangsu Peoples Hospital

Yangzhou, Jiangsu 225001

China

Jiangxi Cancer Hospital

Nanchang, Jiangxi 330029

China

The First Hospital of China Medical University

Shenyang, Liaoning 110001

China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning 110042

China

Shaanxi Provincial Peoples Hospital

Xi'an, Shaanxi 710068

China

Shandong Provincial Hospital

Jinan, Shandong 250000

China

Jining No1 Peoples Hospital West Branch

Jining, Shandong 272000

China

The Affiliated Hospital of Qingdao University Branch West Coast

Qingdao, Shandong 266555

China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 200000

China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality 200032

China

West China Hospital, Sichuan University

Chengdu, Sichuan 610041

China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

Tianjin, Tianjin Municipality 301617

China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicinegrand Canal Branch

Hangzhou, Zhejiang 310000

China

The Affiliated Peoples Hospital of Ningbo University

Ningbo, Zhejiang 315040

China

Taizhou Hospital of Zhejiang Province (East)

Taizhou, Zhejiang 317004

China

Fakultni Nemocnice Brno

Brno, 625 00

Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 03

Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, 10000

Czechia

Ustav Hematologie A Krevni Transfuze (Uhkt)

Prague, 128 00

Czechia

University Hospital of Aalborg

Aalborg, 9000

Denmark

Rigshospitalet

Copenhagen, 2100

Denmark

Odense University Hospital

Odense C, 5000

Denmark

Zealand University Hospital, Roskilde

Roskilde, 4000

Denmark

Chu Clermont Ferrand Therapie Cellulaire and Hematolo

ClermontFerrand, 63100

France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, 44000

France

Hopital de La Pitie Salpetriere

Paris, 75013

France

Chu Hopital Lyon Sud

PierreBenite, 69495

France

Hopital Robert Debre

Reims, 51100

France

Chu Rennes

Rennes Cedes, 35000

France

Centre Henri Becquerel

Rouen, 76038

France

Iuct Oncopole

Toulouse, 31100

France

Chu Nancy Hopital Brabois

VandoeuvrelesNancy, 54511

France

Osp Kurfuerstendamm

Berlin, 10707

Germany

Uniklinik Koeln (Aoer)

Cologne, 50937

Germany

Gokos Gmbh

Dresden, 01307

Germany

Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

Jena, 07747

Germany

Universitatsklinikum Schleswig Holstein Campus Kiel

Kiel, 24105

Germany

Stauferklinikum Schwabisch Gmund Kliniken Ostalb

Mutlangen, 73557

Germany

Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii

München, 81377

Germany

Dietrich Bonhoeffer Klinikum Neubrandenburg

Neubrandenburg, 17036

Germany

Medizinische Universitaetsklinik

Tübingen, 72076

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Haematologisch Onkologische Schwerpunktpraxis

Würzburg, 97080

Germany

St Jamess Hospital

Dublin, D08 NHY1

Ireland

Mater Misericordiae University Hospital

Dublin, D7

Ireland

University Hospital Galway

Galway, H91 YR71

Ireland

University Hospital Limerick

Limerick, V94F858

Ireland

Azienda Ospedaliera Policlinico Di Bari

Bari, 70124

Italy

Ao Brotzu Ospedale Oncologico Armando Businco

Cagliari, 09121

Italy

Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania

Catania, 95123

Italy

Azienda Ospedaliero Universitaria Di Ferrara

Ferrara, 44124

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

Modena, 41124

Italy

Asl Salerno Andrea Tortora

Pagani, 84014

Italy

Flevoziekenhuis

Almere Stad, 1315 RA

Netherlands

Rijnstate

Arnhem, 6815 AD

Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, 3318 AT

Netherlands

Tergooi Mc

Hilversum, 1212 VG

Netherlands

North Shore Hospital

Auckland, 0622

New Zealand

Auckland City Hospital

Auckland, 1023

New Zealand

Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu

Torun, 87-100

Poland

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, 50-367

Poland

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi 49241

South Korea

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do 10408

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

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

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Vall D Hebron Institute of Oncology Vhio

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Ico Lhospitalet Hospital Duran I Reynals

LHospitalet de Llobregat, 08908

Spain

Hospital de La Princesa

Madrid, 28006

Spain

Hospital Universitario Infanta Leonor

Madrid, 28031

Spain

Costa Del Sol (Marbella, Malaga)

Marbella, 29603

Spain

Hospital Universitario de Salamanca

Salamanca, 37007

Spain

Hospital Universitario Marques de Valdecilla

Santander, 39008

Spain

Hospital Virgen de Valme (Sevilla)

Seville, 41014

Spain

Sahlgrenska University Hospital Hematology

Gothenburg, 413 46

Sweden

Skanes Universitetssjukhus I Lund

Lund, 221 85

Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, 171 76

Sweden

Uppsala Akademiska Sjukhus

Uppsala, 751 85

Sweden

University Hospitals Dorset Royal Bournemouth Hospital

Bournemouth, BH7 7DW

United Kingdom

Oxford University Hospitals Nhs Trust Churchill Hospital

Headington, OX3 7LE

United Kingdom

St Jamess University Hospital

Leeds, LS9 7TF

United Kingdom

Kings College Hospital

London, SE5 9RS

United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, CH63 4JY

United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

Royal Cornwall Hospitalsnhs Trust

Truro, TR1 3LJ

United Kingdom