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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
2026-03-19
Healthy Volunteers
No
Interventions
Sonrotoclax
Administered orally
Obinutuzumab
Administered intravenously
Rituximab
Administered intravenously
Venetoclax
Administered Orally
Locations (155)
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
Northwestern University
Chicago, Illinois, United States
Illinois Cancer Specialists (Niles) Usor
Niles, Illinois, United States
University of Louisville, Brown Cancer Center
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 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
Sidney Kimmel Comprehensive Cancer Center Washington Twp
Sewell, New Jersey, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Clinical Research Alliance, Inc
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 Baylorcharles 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
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, United States
FUNDALEU
Caba, 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
Hospital Nove de Julho Dasa
São Paulo, Brazil
Instituto Brasileiro de Controle Do Cancer
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
China Japan Friendship Hospital
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospitalqishan Branch
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 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 Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Suzhou Municipal Hospitalbaita Branch
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, China
Northern Jiangsu Peoples Hospital
Yangzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Jining No1 Peoples Hospital West Branch
Jining, Shandong, China
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The Affiliated Peoples Hospital of Ningbo University
Ningbo, Zhejiang, China
Taizhou Hospital of Zhejiang Province (East)
Taizhou, Zhejiang, China
Fakultni Nemocnice Brno
Brno, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
University Hospital of Aalborg
Aalborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense C, Denmark
Zealand University Hospital, Roskilde
Roskilde, Denmark
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Clermontferrand, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, France
Hopital de La Pitie Salpetriere
Paris, France
Chu Hopital Lyon Sud
PierreBenite, France
Hopital Robert Debre
Reims, France
Chu Rennes
Rennes Cedes, France
Centre Henri Becquerel
Rouen, France
Iuct Oncopole
Toulouse, France
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, France
Osp Kurfuerstendamm
Berlin, Germany
Uniklinik Koeln (Aoer)
Cologne, Germany
Gokos Gmbh
Dresden, Germany
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
Jena, Germany
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
Mutlangen, Germany
Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
München, Germany
Dietrich Bonhoeffer Klinikum Neubrandenburg
Neubrandenburg, Germany
Medizinische Universitaetsklinik
Tübingen, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Haematologisch Onkologische Schwerpunktpraxis
Würzburg, Germany
St Jamess Hospital
Dublin, Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
University Hospital Limerick
Limerick, Ireland
Ao Brotzu Ospedale Oncologico Armando Businco
Cagliari, Italy
Ospedale San Raffaele
Milan, Italy
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, Italy
Asl Salerno Andrea Tortora
Pagani, Italy
Flevoziekenhuis
Almere Stad, Netherlands
Rijnstate
Arnhem, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Tergooi Mc
Hilversum, Netherlands
North Shore Hospital
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
Torun, Poland
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-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
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Vall D Hebron Institute of Oncology Vhio
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Ico Lhospitalet Hospital Duran I Reynals
Lhospitalet de Llobregat, Spain
Hospital de La Princesa
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Costa Del Sol (Marbella, Malaga)
Marbella, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital Virgen de Valme (Sevilla)
Seville, Spain
Sahlgrenska University Hospital Hematology
Gothenburg, Sweden
Skanes Universitetssjukhus I Lund
Lund, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden
Uppsala Akademiska Sjukhus
Uppsala, Sweden
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth, United Kingdom
Kings College Hospital
London, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Royal Cornwall Hospitalsnhs Trust
Truro, United Kingdom