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)
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
3 other identifiers
interventional
630
20 countries
164
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2025
Longer than P75 for phase_3
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
June 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
April 23, 2026
March 1, 2026
4.3 years
April 17, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Up to approximately 51 months
Secondary Outcomes (27)
Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D
Up to approximately 69 months
Rate of uMRD4 for Arm A versus Arm D
Up to approximately 12 months
Complete Response Rate as assessed by BIRC for Arm A versus Arm D
Up to approximately 25 months
Overall Survival for Arm A versus Arm D
Up to approximately 84 months
PFS per Investigator Assessment (INV) for Arm B versus Arm D
Up to approximately 69 months
- +22 more secondary outcomes
Study Arms (4)
Arm A: Sonrotoclax plus Obinutuzumab
EXPERIMENTALSonrotoclax and obinutuzumab will be administered in combination.
Arm B: Sonrotoclax plus Rituximab
EXPERIMENTALSonrotoclax and rituximab will be administered in combination.
Arm C: Sonrotoclax plus Obinutuzumab (MRD)
EXPERIMENTALSonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).
Arm D: Venetoclax plus Rituximab
ACTIVE COMPARATORVenetoclax and rituximab will be administered in combination.
Interventions
Administered intravenously
Administered orally
Administered intravenously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
- German CLL Study Groupcollaborator
Study Sites (167)
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 Louisville, Brown Cancer Center
Louisville, Kentucky, 40202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809-3738, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201-1544, 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
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800, United States
Clinical Research Alliance, Inc
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
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, 98684-6930, United States
FUNDALEU
Caba, CP1114, 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
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, 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
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Fujian Medical University Union Hospitalqishan Branch
Fuzhou, Fujian, 350108, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, 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
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
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, 710068, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000, China
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, 266555, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, 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
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2025
First Posted
April 24, 2025
Study Start
June 11, 2025
Primary Completion (Estimated)
September 30, 2029
Study Completion (Estimated)
December 1, 2031
Last Updated
April 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.