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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
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
Sonrotoclax
Administered orally
Obinutuzumab
Administered intravenously
Rituximab
Administered intravenously
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