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RECRUITING
NCT06943872
PHASE3

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)

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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.

Official title: A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

630

Start Date

2025-06-11

Completion Date

2031-12

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

Sonrotoclax

Administered orally

DRUG

Obinutuzumab

Administered intravenously

DRUG

Rituximab

Administered intravenously

DRUG

Venetoclax

Administered Orally

Locations (195)

Uci Health Laguna Hills

Laguna Hills, California, United States

Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Scripps Prebys Cancer Center

San Diego, California, United States

Rocky Mountain Cancer Centers (Williams) Usor

Aurora, Colorado, United States

Yale University Yale Cancer Center

New Haven, Connecticut, United States

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut, United States

Cleveland Clinic Florida

Weston, Florida, United States

Northwestern University

Chicago, Illinois, United States

Illinois Cancer Specialists (Niles) Usor

Niles, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Mission Cancer and Blood

Waukee, Iowa, United States

University of Louisville, Brown Cancer Center

Louisville, Kentucky, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

The University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center (Bidmc)

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

The Cancer and Hematology Centers

Grand Rapids, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Sidney Kimmel Comprehensive Cancer Center Washington Twp

Sewell, New Jersey, United States

Christus St Vincent Regional Cancer Center

Santa Fe, New Mexico, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

Optum Medical Care, Pc

Westbury, New York, United States

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Levine Cancer Center

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Oncology Hematology Care Clinical Trials, Llc

Cincinnati, Ohio, United States

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania, United States

Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology Baylor Charles A Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology San Antonio Medical Center Usor

San Antonio, Texas, United States

Texas Oncology Tyler

Tyler, Texas, United States

Swedish Medical Center Swedish Cancer Institute First Hill Campus

Seattle, Washington, United States

Northwest Cancer Specialist, Pc(Us Oncology Research)

Vancouver, Washington, United States

Hospital Aleman

Caba, Argentina

FUNDALEU

Caba, Argentina

Instituto Alexander Fleming (Iaf)

Ciudad Autonoma Buenos Aires, Argentina

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Northern Nsw Health District

Lismore, New South Wales, Australia

Macquarie University

North Ryde, New South Wales, Australia

Genesiscare North Shore

St Leonards, New South Wales, Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Rockingham Hospital

Cooloongup, Western Australia, Australia

Perth Blood Institute

West Perth, Western Australia, Australia

Medizinische Universitatsklinik Innsbruck

Innsbruck, Austria

Medical University Vienna Oncology

Vienna, Austria

Hanusch Krankenhaus

Vienna, Austria

Cliniques Universitaires Saint Luc

Brussels, Belgium

Uz Antwerpen

Edegem, Belgium

University Hospitals Leuven

Leuven, Belgium

CETUS

Belo Horizonte, Brazil

Universidade de Campinas Centro de Hematologia E Hemoterapia

Campinas, Brazil

Hospital Erasto Gaertner

Curitiba, Brazil

Complexo Hospitalar de Niteroi

Niterói, Brazil

Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre

Porto Alegre, Brazil

Hospital Sao Lucas

Rio de Janeiro, Brazil

Instituto Dor de Pesquisa E Ensino Rio de Janeiro

Rio de Janeiro, Brazil

Hospital Santa Izabel

Salvador, Brazil

Hospital Samaritano Sao Paulo

São Paulo, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Hospital Nove de Julho Dasa

São Paulo, Brazil

Instituto Brasileiro de Controle Do Cancer

São Paulo, Brazil

Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular

São Paulo, Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, Brazil

Arthur Je Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia, Canada

Cancercare Manitoba

Winnipeg, Manitoba, Canada

Newfoundland and Labrador Health Services

St. John's, Newfoundland and Labrador, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Ciusss Nim Hscm

Montreal, Quebec, Canada

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

Québec, Canada

China Japan Friendship Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Fujian Medical University Union Hospitalqishan Branch

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangzhou First Peoples Hospital

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Taihe Hospital

Shiyan, Hubei, China

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

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

And 95 more locations on ClinicalTrials.gov