Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
Launched by BEIGENE · Nov 19, 2019
Trial Information
Current as of July 22, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • 1. Currently participating or participated recently in a BeiGene parent study
- 2. Intent to continue or start zanubrutinib treatment after any of the following:
- • 1. At time of final analysis or study closure of the eligible BeiGene parent study
- • 2. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
- • 3. At an alternative timepoint for an alternative reason
- 3. Patient who is currently on zanubrutinib treatment:
- • Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment
- 4. Zanubrutinib-naive patient:
- Must meet the following criteria ≤ 15 days before first dose of study drug:
- • 1. Platelets ≥ 50,000/mm3
- • 2. Absolute neutrophil count ≥ 750/mm3
- • 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
- • 4. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
- • 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
- • 6. No known New York Heart Association (NYHA) Class III or IV congestive heart failure
- • 7. Creatinine clearance ≥ 30 mL/min
- • 5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.
- Key Exclusion Criteria:
- • 1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent
- • 2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
- • 3. Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
- • 4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
- • 5. Pregnant or lactating woman
- • 6. Inability to comply with study procedures
- • 7. Concurrent participation in another therapeutic clinical study
- • 8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
- • 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
Rochester, Minnesota, United States
Rochester, Minnesota, United States
Bordeaux, , France
Adelaide, South Australia, Australia
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
Perth, Western Australia, Australia
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Concord, New South Wales, Australia
Hobart, Tasmania, Australia
Box Hill, Victoria, Australia
Barcelona, , Spain
Omaha, Nebraska, United States
Portland, Oregon, United States
Houston, Texas, United States
Christchurch, , New Zealand
Ann Arbor, Michigan, United States
Nedlands, Western Australia, Australia
Barcelona, , Spain
Melbourne, Victoria, Australia
Salamanca, , Spain
Malvern, Victoria, Australia
Bedford Park, South Australia, Australia
Houston, Texas, United States
Paris, , France
Denver, Colorado, United States
Houston, Texas, United States
Pavia, , Italy
St Leonards, New South Wales, Australia
Southampton, , United Kingdom
Westmead, New South Wales, Australia
Melbourne, , Australia
Heidelberg, Victoria, Australia
Kogarah, New South Wales, Australia
Birmingham, , United Kingdom
Sapporo, Hokkaido, Japan
Madrid, , Spain
Salamanca, , Spain
Waratah, New South Wales, Australia
Woolloongabba, Queensland, Australia
Nashville, Tennessee, United States
Tugun, Queensland, Australia
Adelaide, , Australia
Kogarah, New South Wales, Australia
Perth, Western Australia, Australia
Nashville, Tennessee, United States
Kurume, Fukuoka, Japan
Beijing, Beijing, China
Sydney, New South Wales, Australia
Hobart, Tasmania, Australia
Glasgow, , United Kingdom
Barcelona, , Spain
Paris, , France
Stockholm, , Sweden
Seoul, , Korea, Republic Of
Auckland, , New Zealand
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Melbourne, Victoria, Australia
Toyohashi, Aichi, Japan
Nanjing, Jiangsu, China
Hradec Kralove, , Czechia
Busan, , Korea, Republic Of
Beijing, , China
Concord, New South Wales, Australia
Heidelberg, Victoria, Australia
Chattanooga, Tennessee, United States
Gdansk, , Poland
Changchun, Jilin, China
Krakow, , Poland
Utrecht, , Netherlands
Durham, North Carolina, United States
Goyang Si, , Korea, Republic Of
Beijing, Beijing, China
Hangzhou, Zhejiang, China
Shenyang, Liaoning, China
Brno, , Czechia
Morristown, New Jersey, United States
Chengdu, Sichuan, China
Ostrava, , Czechia
Beijing, Beijing, China
Nottingham, , United Kingdom
Beijing, Beijing, China
Manchester, , United Kingdom
Plymouth, , United Kingdom
Fuzhou, Fujian, China
Zhengzhou, Henan, China
Shanghai, , China
Torino, , Italy
Takapuna, , New Zealand
Zhengzhou, Henan, China
Le Mans, , France
Busan, , Korea, Republic Of
Beijing, Beijing, China
Spokane, Washington, United States
Tianjin, Tianjin, China
Gilbert, Arizona, United States
Shanghai, Shanghai, China
Lund, , Sweden
Frankston, Victoria, Australia
Valencia, , Spain
London, , United Kingdom
Valencia, , Spain
Harbin, Heilongjiang, China
Wuhan, Hubei, China
Changchun, Jilin, China
Malvern, Victoria, Australia
Barcelona, , Spain
Roanoke, Virginia, United States
Canterbury, , United Kingdom
Wodonga, , Australia
Guangzhou, Guangdong, China
London, , United Kingdom
Terni, , Italy
Seoul, , Korea, Republic Of
Barcelona, , Spain
Fitzroy, Victoria, Australia
Athens, , Greece
Harbin, Heilongjiang, China
Geelong, Victoria, Australia
Novara, , Italy
Plymouth, , United Kingdom
Bologna, , Italy
Shanghai, Shanghai, China
Tauranga, , New Zealand
Olomouc, , Czechia
Clayton, Victoria, Australia
Wuhan, Hubei, China
Terni, , Italy
Geelong, , Australia
Clayton, Victoria, Australia
Roma, , Italy
Girona, , Spain
Kraków, , Poland
Changchun, , China
Udine, , Italy
Fitzroy, , Australia
Greenslopes, Queensland, Australia
Tekirdag, , Turkey
Goyangsi, Gyeonggi Do, Korea, Republic Of
Tours, , France
Florham Park, New Jersey, United States
Tianjin, Tianjin, China
Little Rock, Arkansas, United States
Saint Petersburg, Florida, United States
Phillip, Australian Capital Territory, Australia
Torino, , Italy
Roma, , Italy
Beijing, Beijing, China
Xuzhou, Jiangsu, China
Praha, , Czechia
Bournemouth, , United Kingdom
Nottingham, , United Kingdom
Milano, , Italy
Novara, , Italy
Auchenflower, Queensland, Australia
Melbourne, Victoria, Australia
Frankston, Victoria, Australia
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
La Roche Sur Yon, , France
London, Greater London, United Kingdom
Sapporo, Hokkaido, Japan
Hradec Králové, , Czechia
Chorzów, Slaskie, Poland
East Albury, New South Wales, Australia
Glasgow, Scotland, United Kingdom
Westbury, New York, United States
Box Hill, Victoria, Australia
Tianjin, Tianjin, China
Auckland, , New Zealand
Barcelona, , Spain
Hangzhou, Zhejiang, China
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Bydgoszcz, , Poland
Gilbert, Arizona, United States
Fort Myers, Florida, United States
Saint Petersburg, Florida, United States
Ann Arbor, Michigan, United States
Seattle, Washington, United States
Kurralta Park, South Australia, Australia
Beijing, Beijing, China
Guangzhou, Guandong, China
Guangzhou, Guandong, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Shanghai, Shanghai, China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Shanghai, , China
Prague, , Czechia
Sigmaringen, , Germany
Milan, , Italy
Amsterdam, , Netherlands
Barcelona, , Spain
Leeds, , United Kingdom
London, , United Kingdom
Oxford, , United Kingdom
Roma, , Italy
Auckland, , New Zealand
Bedford Pk, South Australia, Australia
Wellington, , New Zealand
Pavia, , Italy
Ravenna, , Italy
Udine, , Italy
Busan, Busan Gwang'yeogsi, Korea, Republic Of
Bydgoszcz, , Poland
Skorzewo Poznan, , Poland
Greater Manchester, , United Kingdom
Meldola, , Italy
Quanzhou, Fujian, China
Praha, , Czechia
Eugene, Oregon, United States
Geelong, Victoria, Australia
Bordeaux, , France
Pierrebenite, , France
Bologna, , Italy
Nijmegen, , Netherlands
Gdask, , Poland
Lodz, , Poland
Barcelona, , Spain
Goyangsi, Gyeonggido, Korea, Republic Of
Bialystok, , Poland
Brzozow, , Poland
Chorzow, , Poland
Headington, , United Kingdom
Busan, Busan Gwang'yeogsi, Korea, Republic Of
Fort Myers, Florida, United States
Seattle, Washington, United States
Ostrava, , Czechia
Prague, , Czechia
Modena, , Italy
Amsterdam, , Netherlands
Leeds, , United Kingdom
Centennial, Colorado, United States
Hattiesburg, Mississippi, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Toledo, , Spain
Aberdeen, , United Kingdom
Kurralta Park, South Australia, Australia
Hamilton Waikato, , New Zealand
Canberra, Australian Capital Territory, Australia
Greenslopes, Queensland, Australia
Patients applied
Trial Officials
Study Director
Study Director
BeiGene
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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