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)
Launched by BEIGENE · Apr 17, 2025
Trial Information
Current as of November 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called CELESTIAL-RRCLL, is looking at how effective two new treatment combinations are for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study will compare the effectiveness of sonrotoclax combined with either obinutuzumab or rituximab against another treatment option, venetoclax plus rituximab. The main goal is to see which combination helps patients live longer without their cancer getting worse. Safety is also an important part of this study.
To participate in this trial, adults aged 65 to 74 must have a confirmed diagnosis of CLL or SLL and have previously received at least two cycles of treatment for their cancer. Certain health conditions like severe lung disease or active heart problems may disqualify someone from joining. Participants will receive one of the treatment combinations and will be monitored closely for how well the treatment works and any side effects. It’s important to note that this trial is not yet recruiting participants, but it represents a significant step in finding better treatments for CLL and SLL.
Gender
ALL
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.
About Beigene
BeiGene is a global biotechnology company focused on discovering, developing, and commercializing innovative medicines for the treatment of cancer. With a robust pipeline of targeted therapies and immuno-oncology agents, BeiGene is dedicated to advancing precision medicine to improve patient outcomes. The company integrates cutting-edge research, clinical development, and manufacturing capabilities to deliver transformative therapies across diverse oncology indications. Committed to addressing unmet medical needs, BeiGene collaborates with healthcare professionals and institutions worldwide to accelerate the development of its product candidates and enhance the lives of patients battling cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Copenhagen, Denmark
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Madrid, Spain
Santander, Spain
Miami, Florida, United States
Chapel Hill, North Carolina, United States
Melbourne, Victoria, Australia
Salamanca, Spain
Woolloongabba, Queensland, Australia
Hershey, Pennsylvania, United States
Curitiba, Brazil
Uppsala, Sweden
Ottawa, Ontario, Canada
Kogarah, New South Wales, Australia
Odense C, Denmark
Brussels, Belgium
Leuven, Belgium
Milano, Italy
London, United Kingdom
Seoul, Korea, Republic Of
Reims, France
Nashville, Tennessee, United States
Edegem, Belgium
Stockholm, Sweden
Auckland, New Zealand
Melbourne, Victoria, Australia
Salvador, Brazil
Vienna, Austria
Gdansk, Poland
Guangzhou, Guangdong, China
Jinan, Shandong, China
Ulm, Germany
Newcastle Upon Tyne, United Kingdom
Rouen Cedex, France
Chengdu, Sichuan, China
Toronto, Ontario, Canada
Fuzhou, Fujian, China
Brno, Czechia
Dordrecht, Netherlands
Bari, Italy
Auckland, New Zealand
Lund, Sweden
Almere, Netherlands
Madrid, Spain
Barcelona, Spain
Wien, Austria
Nanjing, Jiangsu, China
Xiamen, Fujian, China
Weston, Florida, United States
Fitzroy, Victoria, Australia
Orange, California, United States
North Ryde, New South Wales, Australia
Clayton, Victoria, Australia
Catania, Italy
Boston, Massachusetts, United States
Paris, France
Melbourne, Victoria, Australia
Hohhot, Inner Mongolia, China
Nanchang, Jiangxi, China
Wirral, United Kingdom
Galway, Ireland
Baltimore, Maryland, United States
Arnhem, Netherlands
Milano, Italy
Blacktown, New South Wales, Australia
West Perth, Western Australia, Australia
Toulouse, France
Limerick, Ireland
Shenyang, Liaoning, China
Wollongong, New South Wales, Australia
Dresden, Germany
Shanghai, Shanghai, China
Ferrara, Italy
St Leonards, New South Wales, Australia
Roskilde, Denmark
Strasbourg, France
Niteroi, Brazil
Innsbruck, Austria
Beijing, Beijing, China
Rio De Janeiro, Brazil
Birtinya, Queensland, Australia
Barcelona, Spain
Caba, Argentina
Caba, Argentina
Campinas, Brazil
Sao Paulo, Brazil
Montreal, Quebec, Canada
Dublin, Ireland
Warszawa, Poland
Vancouver, British Columbia, Canada
Wuxi, Jiangsu, China
Praha, Czechia
Taizhou, Zhejiang, China
Eugene, Oregon, United States
Pierrebenite, France
Yangzhou, Jiangsu, China
Qingdao, Shandong, China
Xian, Shaanxi, China
Woolloongabba, Queensland, Australia
Headington, United Kingdom
Modena, Italy
Sao Paulo, Brazil
San Diego, California, United States
Porto Alegre, Brazil
Louisville, Kentucky, United States
Rio De Janeiro, Brazil
Niterói, Brazil
Torun, Poland
Kiel, Germany
Vandoeuvrelesnancy, France
Leeds, United Kingdom
Bournemouth, United Kingdom
Hilversum, Netherlands
St Johns, Newfoundland And Labrador, Canada
Jining, Shandong, China
Calgary, Canada
Rennes Cedes, France
Wroclaw, Poland
Neubrandenburg, Germany
Jena, Germany
Cooloongup, Western Australia, Australia
Dublin, Leinster, Ireland
Sao Paulo, Brazil
Mutlangen, Germany
Westbury, New York, United States
Niles, Illinois, United States
Tyler, Texas, United States
Vancouver, Washington, United States
Wrocaw, Poland
Aurora, Colorado, United States
New York, New York, United States
Nantes, France
Bundanggu Seongnamsi, Gyeonggi Do, Korea, Republic Of
Ilsandonggu Goyangsi, Gyeonggi Do, Korea, Republic Of
Gangnamgu, Seoul Teugbyeolsi, Korea, Republic Of
Seochogu, Seoul Teugbyeolsi, Korea, Republic Of
Seodaemungu, Seoul Teugbyeolsi, Korea, Republic Of
Baton Rouge, Louisiana, United States
Rochester, Minnesota, United States
Sao Paulo, Brazil
Vitoria, Brazil
Goteborg, Sweden
Waukee, Iowa, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
Hradec Kralove, Czechia
Dallas, Texas, United States
Clermontferrand, France
New Haven, Connecticut, United States
Tubingen, Germany
Gdask, Poland
Pittsburgh, Pennsylvania, United States
Ciudad Autonoma Buenos Aires, Argentina
Od, Poland
Grand Rapids, Michigan, United States
Wien, Austria
Seogu, Busan Gwang'yeogsi, Korea, Republic Of
Chapel Hill, North Carolina, United States
Koln, Germany
Belo Horizonte, Brazil
Melbourne, Victoria, Australia
Palo Alto, California, United States
Norwich, Connecticut, United States
Charlotte, North Carolina, United States
San Antonio, Texas, United States
Lismore, New South Wales, Australia
Innsbruck, Austria
Sao Paulo, Brazil
Praha, Czechia
Aalborg, Denmark
Berlin, Germany
Munchen, Germany
Wurzburg, Germany
Cagliari, Italy
Pagani, Italy
Lhospitalet De Llobregat, Spain
Marbella, Spain
Sevilla, Spain
Tianjin, Tianjin, China
Birtinya, Australia
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
West Perth, Western Australia, Australia
Kogarah, New South Wales, Australia
Birtinya, Queensland, Australia
Blacktown, New South Wales, Australia
St Leonards, New South Wales, Australia
Lodz, Poland
North Ryde, New South Wales, Australia
Cooloongup, Western Australia, Australia
Lismore, New South Wales, Australia
Wollongong, New South Wales, Australia
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Suzhou, Jiangsu, China
Ningbo, Zhejiang, China
São Paulo, Brazil
São Paulo, Brazil
Vitória, Brazil
Ilsandonggu Goyangsi, Gyeonggi Do, South Korea
Gangnamgu, Seoul Teugbyeolsi, South Korea
Seochogu, Seoul Teugbyeolsi, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Bundanggu Seongnamsi, Gyeonggi Do, South Korea
Seodaemungu, Seoul Teugbyeolsi, South Korea
São Paulo, Brazil
Seogu, Busan Gwang'yeogsi, South Korea
São Paulo, Brazil
Patients applied
Trial Officials
Study Director
Study Director
BeiGene
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported