Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

B-cell Malignancies Clinical Trial

Official title:

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170283
• Other study ID #: BGB-3111-LTE1
• Status: Recruiting
• Phase: Phase 3
• Start date: January 21, 2020
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: BeiGene
• Contact: BeiGene
• Phone: +1-877-828-5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2028
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• B-cell Malignancies
• Neoplasms

Intervention

Drug:
• Zanubrutinib
Participants will receive zanubrutinib at a dose of 160 mg twice daily (for a total daily dose of 320 mg), or the last dose level received in the BeiGene parent study.
• Tislelizumab
Patients in Australia who participated in a parent study that involved combination therapy of zanubrutinib and tislelizumab will receive tislelizumab at a dose of 200mg every 3 weeks..

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Peoples Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong Provincial Peoples Hospital	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Quanzhou First Affliated Hospital of Fujian Medical University	Quanzhou	Fujian
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Institute of Hematology and Hospital of Blood Disease	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
Czechia	Fakultni Nemocnice Brno	Brno
Czechia	Fakultni Nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni Nemocnice Olomouc	Olomouc
Czechia	Fakultni Nemocnice Ostrava	Ostrava
Czechia	University Hospital Vinohrady Hematology Department	Prague
Czechia	Vseobecna Fakultni Nemocnice V Praze	Praha
France	Centre Hospitalier Departemental de Vendee	La Roche sur Yon
France	Centre Hospitalier Le Mans	Le Mans
France	Chu Tours Hopital Bretonneau	Tours
Greece	General Hospital of Athens Alexandra	Athens
Italy	Policlinico Sorsola Malpighi, Aou Di Bologna	Bologna
Italy	Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst	Meldola
Italy	Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda	Milano
Italy	Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco	Modena
Italy	Aou Maggiore Della Carita	Novara
Italy	Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia	Ravenna
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma
Italy	Azienda Ospedaliera S Maria Di Terni	Terni
Italy	Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino	Torino
Italy	Aou Santa Maria Della Misericordia Di Udine	Udine
Korea, Republic of	Dong A University Hospital	Busan	Busan Gwang'yeogsi
Korea, Republic of	Inje University Busan Paik Hospital	Busan	Busan Gwang'yeogsi
Korea, Republic of	National Cancer Center	Goyangsi	Gyeonggido
Korea, Republic of	Samsung Medical Center Hematology Oncology	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Seoul Teugbyeolsi
Netherlands	Amsterdam Umc Amc	Amsterdam
Netherlands	Albert Schweitzer Ziekenhuis	Nijmegen
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	Interhem Opieka Szpitalna	Bialystok
Poland	Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny	Brzozow
Poland	Szpital Uniwersytecki Nr Im Dr Jana Biziela	Bydgoszcz
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich	Chorzow
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii	Gdask
Poland	Malopolskie Centrum Medyczne Sc	Krakow
Poland	Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi	Lodz
Poland	Centrum Medyczne Pratia Poznan	Skorzewo Poznan
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitario Vall Dhebron	Barcelona
Spain	Ico Hug Trias I Pujol	Barcelona
Spain	Ico Girona	Girona
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario de Toledo	Toledo
Spain	Hospital Universitari I Politecnic La Fe	Valencia
Sweden	Skanes Universitetssjukhus I Lund	Lund
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm
Turkey	Namik Kemal University	Tekirdag
United Kingdom	Nhs Grampian Ppds	Aberdeen
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	The Royal Bournemouth and Christchurch Hospitals Nhs Foundation	Bournemouth
United Kingdom	Kent and Canterbury Hospital	Canterbury
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	The Christie Hospital	Greater Manchester
United Kingdom	Churchill Hospital Oxford University Hospital Nhs Trust	Headington
United Kingdom	St Jamess Institute of Oncology	Leeds
United Kingdom	Barts Health Nhs Trust	London
United Kingdom	University College Hospital	London
United Kingdom	Nottingham University Hospitals Nhs Trust	Nottingham
United Kingdom	Plymouth Hospitals Nhs Trust	Plymouth
United Kingdom	Southampton General Hospital	Southampton
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers Centennial	Centennial	Colorado
United States	Scri Tennessee Oncology Chattanooga	Chattanooga	Tennessee
United States	Duke University Hospital	Durham	North Carolina
United States	Oncology Associates of Oregon Willamette Valley Cancer Center	Eugene	Oregon
United States	Summit Medical Group	Florham Park	New Jersey
United States	Florida Cancer Specialists Fort Myers	Fort Myers	Florida
United States	Texas Oncology Fort Worth Cancer Center	Fort Worth	Texas
United States	Forrest General Hospital Cancer Center	Hattiesburg	Mississippi
United States	The University of Texas Md Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Carti Cancer Center	Little Rock	Arkansas
United States	Atlantic Health System	Morristown	New Jersey
United States	Tennessee Oncology	Nashville	Tennessee
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Oregon Health and Science University	Portland	Oregon
United States	Oncology and Hematology Associates of Southwest Virginia, Inc	Roanoke	Virginia
United States	Scri Florida Cancer Specialists North	Saint Petersburg	Florida
United States	Texas Oncology San Antonio Medical Center Usor	San Antonio	Texas
United States	University of Washington Seattle Cancer Alliance	Seattle	Washington
United States	Medical Oncology Associates	Spokane	Washington
United States	Clinical Research Alliance, Inc	Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  China,  Czechia,  France,  Greece,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)	Up to 5 years
Secondary	Progression-Free Survival (PFS) per investigator assessment	Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of first documentation of disease progression or death, whichever occurs first	Up to 5 years
Secondary	Duration of Response (DOR) per investigator assessment	Time from the date that response criteria are first met after the start of zanubrutinib in the eligible BeiGene study to the date that progressive disease (PD) is objectively documented or death, whichever occurs first	Up to 5 years
Secondary	Overall Survival (OS)	Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of death due to any reason	Up to 5 years