Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
Launched by BEIGENE · Oct 3, 2023
Trial Information
Current as of May 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of two different treatment combinations for people with chronic lymphocytic leukemia (CLL), a type of cancer that affects the blood and bone marrow. The trial is comparing sonrotoclax combined with zanubrutinib to another combination of venetoclax and obinutuzumab. The goal is to see which treatment works better for patients who have just been diagnosed and need treatment for their CLL.
To participate in this trial, individuals must be adults between the ages of 65 and 74 who have a confirmed diagnosis of CLL that requires treatment. They should not have received any previous treatments for CLL and must meet certain health conditions, such as having good liver and kidney function. Participants will have regular check-ups during the trial to monitor their health and response to the treatments. This trial is currently recruiting participants, and it’s a great opportunity to contribute to important research that could help improve CLL treatment in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
- • Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- • Measurable disease by Computer Tomography/Magnetic Resonance Imaging
- • Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN
- • Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute
- Exclusion Criteria:
- • Previous systemic treatment for CLL
- • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- • Known central nervous system involvement
- • History of confirmed progressive multifocal leukoencephalopathy (PML)
- • Uncontrolled hypertension
- • Note: Other protocol defined 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
Minneapolis, Minnesota, United States
Durham, North Carolina, United States
New York, New York, United States
Milwaukee, Wisconsin, United States
Cleveland, Ohio, United States
Seattle, Washington, United States
Orange, California, United States
Iowa City, Iowa, United States
Saint Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
Milano, , Italy
Saskatoon, Saskatchewan, Canada
Winnipeg, Manitoba, Canada
New Orleans, Louisiana, United States
Salt Lake City, Utah, United States
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
Miami Beach, Florida, United States
Padova, , Italy
Madrid, , Spain
Duarte, California, United States
Concord, New South Wales, Australia
Rochester, New York, United States
Tampa, Florida, United States
Washington, District Of Columbia, United States
Chapel Hill, North Carolina, United States
Edmonton, Alberta, Canada
Calgary, Alberta, Canada
Melbourne, Victoria, Australia
Curitiba, , Brazil
Hamilton, Ontario, Canada
Madrid, , Spain
Southampton, , United Kingdom
Heidelberg, Victoria, Australia
Kashiwa, Chiba, Japan
Auckland, , New Zealand
Madrid, , Spain
Milano, , Italy
Rotterdam, , Netherlands
Jerusalem, , Israel
Aomori, , Japan
Kumamoto, , Japan
Richmond, Virginia, United States
Stockholm, , Sweden
Auckland, , New Zealand
Melbourne, Victoria, Australia
Nanjing, Jiangsu, China
Hradec Kralove, , Czechia
New Haven, Connecticut, United States
Vienna, , Austria
London, , United Kingdom
Warszawa, , Poland
Chattanooga, Tennessee, United States
Osakasayama, Osaka, Japan
Jinan, Shandong, China
New Brunswick, New Jersey, United States
Okayama, , Japan
Nedlands, Western Australia, Australia
Concord, California, United States
Rouen Cedex, , France
Aurora, Colorado, United States
Jerusalem, , Israel
Shenyang, Liaoning, China
Newnan, Georgia, United States
Nanning, Guangxi, China
Nanchang, Jiangxi, China
Brno, , Czechia
Westwood, Kansas, United States
Murdoch, Western Australia, Australia
Dunedin, , New Zealand
Chengdu, Sichuan, China
Beijing, Beijing, China
Den Haag, , Netherlands
Norwich, , United Kingdom
Fuzhou, Fujian, China
Takapuna, , New Zealand
Zhengzhou, Henan, China
Le Mans, , France
Peoria, Illinois, United States
Burgos, , Spain
Hackensack, New Jersey, United States
London, , United Kingdom
Delft, , Netherlands
Almere, , Netherlands
Malvern, Victoria, Australia
Nanyang, Henan, China
Amersfoort, , Netherlands
Yantai, Shandong, China
Canterbury, , United Kingdom
Kayseri, , Turkey
Guangzhou, Guangdong, China
Wenzhou, Zhejiang, China
Fort Wayne, Indiana, United States
Haifa, , Israel
Fitzroy, Victoria, Australia
Tel Aviv, , Israel
Groningen, , Netherlands
Tilburg, , Netherlands
Toronto, Ontario, Canada
La Crosse, Wisconsin, United States
Tauranga, , New Zealand
Olomouc, , Czechia
Clayton, Victoria, Australia
Wuhan, Hubei, China
Stanford, California, United States
Oshawa, Ontario, Canada
Kocaeli, , Turkey
Dartford, , United Kingdom
Paris, , France
Hirakata, Osaka, Japan
Billings, Montana, United States
Rotterdam, , Netherlands
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Goyangsi, Gyeonggi Do, Korea, Republic Of
Tours, , France
Osaka, , Japan
Quebec, , Canada
New York, New York, United States
Columbus, Ohio, United States
Hefei, Anhui, China
Xuzhou, Jiangsu, China
Milano, , Italy
Benowa, Queensland, Australia
Novara, , Italy
Glasgow, , United Kingdom
Nantes, , France
Chongqing, Chongqing, China
Sapporo, Hokkaido, Japan
Los Angeles, California, United States
Cona, , Italy
Westbury, New York, United States
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Ankara, , Turkey
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
St Leonards, New South Wales, Australia
Lyon Cedex, , France
Ashdod, , Israel
Anchorage, Alaska, United States
Changzhou, Jiangsu, China
Innsbruck, , Austria
Kingwood, Texas, United States
Des Moines, Iowa, United States
Birtinya, Queensland, Australia
Columbus, Ohio, United States
Bedford Pk, South Australia, Australia
Perugia, , Italy
Wellington, , New Zealand
Botucatu, , Brazil
Greenfiled Park, Quebec, Canada
Nantong, Jiangsu, China
Tel Aviv, , Israel
Busan, Busan Gwang'yeogsi, Korea, Republic Of
Seongnamsi, Gyeonggido, Korea, Republic Of
Hwasungun, Jeonranamdo, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Warszawa, , Poland
Hospitalet De Llobregat, , Spain
Atakum Samsun, , Turkey
Xian, Shaanxi, China
Chengdu, Sichuan, China
Sutton, , United Kingdom
Vancouver, British Columbia, Canada
Jieyang, Guangdong, China
Anchorage, Alaska, United States
Praha, , Czechia
Bologna, , Italy
Wroclaw, , Poland
Eugene, Oregon, United States
Salzburg, , Austria
Sherbrooke, Quebec, Canada
Bordeaux, , France
Nantes Cedex, , France
Pierrebenite, , France
Chibashi, Chiba, Japan
Yokohamashi, Kanagawa, Japan
Sendaishi, Miyagi, Japan
Kurashikishi, Okayama, Japan
Chuoku, Tokyo, Japan
Nijmegen, , Netherlands
Lodz, , Poland
Madrid, , Spain
Ankara, , Turkey
Goyangsi, Gyeonggido, Korea, Republic Of
Matsuyamashi, Ehime, Japan
Amagasakicity, Hyogo, Japan
La Jolla, California, United States
Louisville, Kentucky, United States
San Juan, , Puerto Rico
Berlin, , Germany
Headington, , United Kingdom
Ostrava, , Czechia
Ribeirao Preto, , Brazil
Sao Paulo, , Brazil
Lille, , France
Madrid, , Spain
Porto Alegre, , Brazil
Sao Paulo, , Brazil
Clermont Ferrand, , France
Christchurch, , New Zealand
Yichang, Hubei, China
Vandoeuvrelesnancy, , France
Luebeck, , Germany
Leeds, , United Kingdom
Lublin, , Poland
Las Palmas Gran Canarias, , Spain
Columbus, Georgia, United States
Montreal Saintjerome, Quebec, Canada
Bournemouth, , United Kingdom
Seongnamsi, Gyeonggi Do, Korea, Republic Of
St Johns, Newfoundland And Labrador, Canada
Hwasungun, Jeollanam Do, Korea, Republic Of
Charlotte, North Carolina, United States
Manchester, , United Kingdom
Plzen, , Czechia
Jd Alkmaar, , Netherlands
Poznan, , Poland
Tenerife, , Spain
Montreal Saintjerome, Quebec, Canada
Amsterdam, , Netherlands
Schiedam, , Netherlands
Liverpool, , United Kingdom
Jining, Shandong, China
Los Angeles, California, United States
Richmond, Virginia, United States
Frankfurt, , Germany
Beer Sheva, , Israel
Lublin, , Poland
Quebec, , Canada
Montreal, Quebec, Canada
Calgary, , Canada
Esseylesnancy, , France
Rennes Cedes, , France
Nagoya, Aichi, Japan
Yokohamashi, , Japan
Regine, Saskatchewan, Canada
Luebeck, , Germany
Iseharashi, Kanagawa, Japan
Niigatashi, Niigata, Japan
Yamagatashi, Yamagata, Japan
Goyangsi, Gyeonggi Do, Korea, Republic Of
Kagoshimashi, Kagoshima, Japan
Groznyy, Chechenskaya Respublika, Russian Federation
Yichang, Hubei, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported