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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)
NCT06943872 · BeOne Medicines
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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
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.
Study design
Enrollment target: 630 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-11
Estimated completion: 2031-12
Last updated: 2026-04-15
Interventions
Drug: SonrotoclaxDrug: ObinutuzumabDrug: RituximabDrug: Venetoclax
Primary outcomes
- • Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D (Up to approximately 51 months)
Sponsor
BeOne Medicines · industry
With: German CLL Study Group
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 1-877-828-5568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (164)
Uci Health Laguna HillsRecruiting
Laguna Hills, California, United States
Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
Stanford Cancer InstituteRecruiting
Palo Alto, California, United States
Scripps Prebys Cancer CenterRecruiting
San Diego, California, United States
Rocky Mountain Cancer Centers (Williams) UsorRecruiting
Aurora, Colorado, United States
Yale University, Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Eastern Connecticut Hematology and OncologyRecruiting
Norwich, Connecticut, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Illinois Cancer Specialists (Niles) UsorRecruiting
Niles, Illinois, United States
University of Louisville, Brown Cancer CenterRecruiting
Louisville, Kentucky, United States
Mary Bird Perkins Cancer CenterRecruiting
Baton Rouge, Louisiana, United States
University of Maryland Greenebaum Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
The Cancer and Hematology CentersRecruiting
Grand Rapids, Michigan, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
Sidney Kimmel Comprehensive Cancer Center Washington TwpRecruiting
Sewell, New Jersey, United States
Memorial Sloan Kettering Cancer Center MskccRecruiting
New York, New York, United States
Clinical Research Alliance, IncRecruiting
Westbury, New York, United States
University of North Carolina At Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Levine Cancer CenterRecruiting
Charlotte, North Carolina, United States
Atrium Health Wake Forest BaptistRecruiting
Winston-Salem, North Carolina, United States
Oncology Hematology Care Clinical Trials, LlcRecruiting
Cincinnati, Ohio, United States
Oncology Associates of Oregon Willamette Valley Cancer CenterRecruiting
Eugene, Oregon, United States
Penn State Milton S Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)Recruiting
Pittsburgh, Pennsylvania, United States
Tennessee Oncology Greco Hainsworth Centers For Research ChattanoogaRecruiting
Chattanooga, Tennessee, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
Texas Oncology Baylorcharles A Sammons Cancer CenterRecruiting
Dallas, Texas, United States
Texas Oncology San Antonio Medical Center UsorRecruiting
San Antonio, Texas, United States
Texas Oncology TylerRecruiting
Tyler, Texas, United States
Northwest Cancer Specialist, Pc(Us Oncology Research)Recruiting
Vancouver, Washington, United States
FUNDALEURecruiting
Caba, Argentina
Blacktown Cancer and Haematology CentreRecruiting
Blacktown, New South Wales, Australia
St George HospitalRecruiting
Kogarah, New South Wales, Australia
Northern Nsw Health DistrictRecruiting
Lismore, New South Wales, Australia
Macquarie UniversityRecruiting
North Ryde, New South Wales, Australia
Genesiscare North ShoreRecruiting
St Leonards, New South Wales, Australia
Sunshine Coast Hospital and Health ServiceRecruiting
Birtinya, Queensland, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
St Vincents Hospital MelbourneRecruiting
Fitzroy, Victoria, Australia
Peter Maccallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Rockingham HospitalRecruiting
Cooloongup, Western Australia, Australia
Perth Blood InstituteRecruiting
West Perth, Western Australia, Australia
Medizinische Universitatsklinik InnsbruckRecruiting
Innsbruck, Austria
Medical University Vienna OncologyRecruiting
Vienna, Austria
Hanusch KrankenhausRecruiting
Vienna, Austria
Cliniques Universitaires Saint LucRecruiting
Brussels, Belgium
Uz AntwerpenRecruiting
Edegem, Belgium
University Hospitals LeuvenRecruiting
Leuven, Belgium
CETUSActive Not Recruiting
Belo Horizonte, Brazil
Universidade de Campinas Centro de Hematologia E HemoterapiaActive Not Recruiting
Campinas, Brazil
Hospital Erasto GaertnerActive Not Recruiting
Curitiba, Brazil
Complexo Hospitalar de NiteroiActive Not Recruiting
Niterói, Brazil
Irmandade Da Santa Casa de Misericordia Hospital Porto AlegreActive Not Recruiting
Porto Alegre, Brazil
Hospital Sao LucasActive Not Recruiting
Rio de Janeiro, Brazil
Instituto Dor de Pesquisa E Ensino Rio de JaneiroActive Not Recruiting
Rio de Janeiro, Brazil
Hospital Santa IzabelActive Not Recruiting
Salvador, Brazil
Hospital Samaritano Sao PauloActive Not Recruiting
São Paulo, Brazil
Hospital Nove de Julho DasaActive Not Recruiting
São Paulo, Brazil
Instituto Brasileiro de Controle Do CancerActive Not Recruiting
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao PauloActive Not Recruiting
São Paulo, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia CelularActive Not Recruiting
São Paulo, Brazil
Hospital Santa Rita de Cassia AfeccActive Not Recruiting
Vitória, Brazil
Arthur Je Child Comprehensive Cancer CentreRecruiting
Calgary, Alberta, Canada
The Ottawa HospitalRecruiting
Ottawa, Ontario, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)Recruiting
Québec, Canada
China Japan Friendship HospitalRecruiting
Beijing, Beijing Municipality, China
Fujian Provincial HospitalRecruiting
Fuzhou, Fujian, China
Fujian Medical University Union Hospitalqishan BranchRecruiting
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen UniversityRecruiting
Xiamen, Fujian, China
Guangzhou First Peoples HospitalRecruiting
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical UniversityRecruiting
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital Wuxiang BranchRecruiting
Nanning, Guangxi, China
The Second Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, Hebei, China
Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical UniversityRecruiting
Hohhot, Inner Mongolia, China
Zhongda Hospital Southeast UniversityRecruiting
Nanjing, Jiangsu, China
Suzhou Municipal Hospitalbaita BranchRecruiting
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University South CampusRecruiting
Wuxi, Jiangsu, China
Northern Jiangsu Peoples HospitalRecruiting
Yangzhou, Jiangsu, China
Jiangxi Cancer HospitalRecruiting
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and InstituteRecruiting
Shenyang, Liaoning, China
Shaanxi Provincial Peoples HospitalRecruiting
Xi'an, Shaanxi, China
Shandong Provincial HospitalRecruiting
Jinan, Shandong, China
Jining No1 Peoples Hospital West BranchRecruiting
Jining, Shandong, China
The Affiliated Hospital of Qingdao University Branch West CoastRecruiting
Qingdao, Shandong, China
Affiliated Zhongshan Hospital of Fudan UniversityRecruiting
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, Sichuan, China
The Affiliated Peoples Hospital of Ningbo UniversityRecruiting
Ningbo, Zhejiang, China
Taizhou Hospital of Zhejiang Province (East)Recruiting
Taizhou, Zhejiang, China
Fakultni Nemocnice BrnoRecruiting
Brno, Czechia
Fakultni Nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
Vseobecna Fakultni Nemocnice V PrazeRecruiting
Prague, Czechia
Ustav Hematologie A Krevni Transfuze (Uhkt)Recruiting
Prague, Czechia
University Hospital of AalborgRecruiting
Aalborg, Denmark
RigshospitaletRecruiting
Copenhagen, Denmark
Odense University HospitalRecruiting
Odense C, Denmark
Zealand University Hospital, RoskildeRecruiting
Roskilde, Denmark
Chu Clermont Ferrand Therapie Cellulaire and HematoloRecruiting
Clermontferrand, France
Centre Hospitalier Universitaire Nantes Hotel DieuRecruiting
Nantes, France
Hopital de La Pitie SalpetriereRecruiting
Paris, France
Chu Hopital Lyon SudRecruiting
PierreBenite, France
Hopital Robert DebreRecruiting
Reims, France
Chu RennesRecruiting
Rennes Cedes, France
Centre Henri BecquerelRecruiting
Rouen, France
Iuct OncopoleRecruiting
Toulouse, France
Chu Nancy Hopital BraboisRecruiting
VandoeuvrelesNancy, France
Osp KurfuerstendammRecruiting
Berlin, Germany
Uniklinik Koeln (Aoer)Recruiting
Cologne, Germany
Gokos GmbhRecruiting
Dresden, Germany
Universitatsklinikum Jena Klinik Fur Innere Medizin IiRecruiting
Jena, Germany
Universitatsklinikum Schleswig Holstein, Campus KielRecruiting
Kiel, Germany
Stauferklinikum Schwabisch Gmund Kliniken OstalbRecruiting
Mutlangen, Germany
Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik IiiRecruiting
München, Germany
Dietrich Bonhoeffer Klinikum NeubrandenburgRecruiting
Neubrandenburg, Germany
Medizinische UniversitaetsklinikRecruiting
Tübingen, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
Haematologisch Onkologische SchwerpunktpraxisRecruiting
Würzburg, Germany
St Jamess HospitalRecruiting
Dublin, Ireland
Mater Misericordiae University HospitalRecruiting
Dublin, Ireland
University Hospital GalwayRecruiting
Galway, Ireland
University Hospital LimerickRecruiting
Limerick, Ireland
Azienda Ospedaliera Policlinico Di BariRecruiting
Bari, Italy
Ao Brotzu Ospedale Oncologico Armando BusincoRecruiting
Cagliari, Italy
Po Grodolico, Aou Policlinico Vittorio Emanuele Di CataniaRecruiting
Catania, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Universita Degli Studi Di Modena Azienda Ospedaliere PoliclincoRecruiting
Modena, Italy
Asl Salerno Andrea TortoraRecruiting
Pagani, Italy
FlevoziekenhuisRecruiting
Almere Stad, Netherlands
RijnstateRecruiting
Arnhem, Netherlands
Albert Schweitzer ZiekenhuisRecruiting
Dordrecht, Netherlands
Tergooi McRecruiting
Hilversum, Netherlands
North Shore HospitalRecruiting
Auckland, New Zealand
Auckland City HospitalRecruiting
Auckland, New Zealand
Wojewodzki Szpital Zespolony Im L Rydygiera W ToruniuRecruiting
Torun, Poland
Pusan National University HospitalRecruiting
Seogu, Busan Gwang'yeogsi, South Korea
National Cancer Center (Korea)Recruiting
IlsandongGu GoyangSi, Gyeonggi-do, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical CenterRecruiting
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys HospitalRecruiting
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Vall D Hebron Institute of Oncology VhioRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Ico Lhospitalet Hospital Duran I ReynalsRecruiting
Lhospitalet de Llobregat, Spain
Hospital de La PrincesaRecruiting
Madrid, Spain
Hospital Universitario Infanta LeonorRecruiting
Madrid, Spain
Costa Del Sol (Marbella, Malaga)Recruiting
Marbella, Spain
Hospital Universitario de SalamancaRecruiting
Salamanca, Spain
Hospital Universitario Marques de ValdecillaRecruiting
Santander, Spain
Hospital Virgen de Valme (Sevilla)Recruiting
Seville, Spain
Sahlgrenska University Hospital HematologyRecruiting
Gothenburg, Sweden
Skanes Universitetssjukhus I LundRecruiting
Lund, Sweden
Karolinska Universitetssjukhuset SolnaRecruiting
Stockholm, Sweden
Uppsala Akademiska SjukhusRecruiting
Uppsala, Sweden
University Hospitals Dorset Royal Bournemouth HospitalRecruiting
Bournemouth, United Kingdom
Kings College HospitalRecruiting
London, United Kingdom
Clatterbridge Cancer CentreRecruiting
Metropolitan Borough of Wirral, United Kingdom
Freeman HospitalRecruiting
Newcastle upon Tyne, United Kingdom
Royal Cornwall Hospitalsnhs TrustRecruiting
Truro, United Kingdom