Clinical trial NCT04170283: Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
Official title: An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: B-cell Malignancies
Keywords: Zanubrutinib
Bruton's tyrosine kinase (BTK) inhibitor
long-term extension
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-Free Survival (PFS) per investigator assessment
timeFrame: Up to 5 years
measure: Duration of Response (DOR) per investigator assessment
timeFrame: Up to 5 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Md Anderson Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: Carti Cancer Center
state: Arkansas
city: Centennial
country: United States
facility: Rocky Mountain Cancer Centers Centennial
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists Fort Myers
state: Florida
city: Saint Petersburg
country: United States
facility: Scri Florida Cancer Specialists North
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Hattiesburg
country: United States
facility: Forrest General Hospital Cancer Center
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Westbury
country: United States
facility: Clinical Research Alliance, Inc
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Eugene
country: United States
facility: Oncology Associates of Oregon Willamette Valley Cancer Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Chattanooga
country: United States
facility: Scri Tennessee Oncology Chattanooga
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Fort Worth
country: United States
facility: Texas Oncology Fort Worth Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Md Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology San Antonio Medical Center Usor
state: Texas
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc
state: Virginia
city: Seattle
country: United States
facility: University of Washington Seattle Cancer Alliance
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
city: Canberra
country: Australia
facility: Paratus Clinical Research Woden
state: Australian Capital Territory
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: East Albury
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Centre Wesley
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Brisbane Clinic For Lymphoma
state: Queensland
city: Tugun
country: Australia
facility: John Flynn Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford PK
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: Icon Cancer Centre Kurralta Park
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Private Hospital
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health the Geelong Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Peoples Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Affliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Hospital of Blood Disease
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Prague
country: Czechia
facility: University Hospital Vinohrady Hematology Department
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice V Praze
city: Bordeaux
country: France
facility: Centre de Lutte Contre Le Cancer Institut Bergonie
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental de Vendee
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Paris
country: France
facility: Hopital Saint Louis
city: PierreBenite
country: France
facility: Chu Hopital Lyon Sud
city: Tours
country: France
facility: Chu Tours Hopital Bretonneau
city: Sigmaringen
country: Germany
facility: Srh Kliniken Landkreis Sigmaringen
city: Athens
country: Greece
facility: General Hospital of Athens Alexandra
city: Bologna
country: Italy
facility: Policlinico Sorsola Malpighi, Aou Di Bologna
city: Meldola
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Modena
country: Italy
facility: Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
city: Novara
country: Italy
facility: Aou Maggiore Della Carita
city: Pavia
country: Italy
facility: Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
city: Ravenna
country: Italy
facility: Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Terni
country: Italy
facility: Azienda Ospedaliera S Maria Di Terni
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
city: Udine
country: Italy
facility: Aou Santa Maria Della Misericordia Di Udine
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Aiiku Hospital
state: Hokkaido
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
state: Busan Gwang'yeogsi
city: Busan
country: Korea, Republic of
facility: Dong A University Hospital
state: Busan Gwang'yeogsi
city: Goyangsi
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center Hematology Oncology
state: Seoul Teugbyeolsi
city: Amsterdam
country: Netherlands
facility: Amsterdam Umc Amc
city: Nijmegen
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton Waikato
country: New Zealand
facility: Waikato Hospital
city: Takapuna
country: New Zealand
facility: North Shore Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Wellington
country: New Zealand
facility: Wellington Regional Hospital (Ccdhb)
city: Bialystok
country: Poland
facility: Interhem Opieka Szpitalna
city: Brzozow
country: Poland
facility: Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr Im Dr Jana Biziela
city: Chorzow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdask
country: Poland
facility: Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne Sc
city: Lodz
country: Poland
facility: Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
city: Skorzewo Poznan
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall Dhebron
city: Barcelona
country: Spain
facility: Ico Hug Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Girona
country: Spain
facility: Ico Girona
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus I Lund
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Tekirdag
country: Turkey
facility: Namik Kemal University
city: Aberdeen
country: United Kingdom
facility: Nhs Grampian Ppds
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Greater Manchester
country: United Kingdom
facility: The Christie Hospital
city: Headington
country: United Kingdom
facility: Churchill Hospital Oxford University Hospital Nhs Trust
city: Leeds
country: United Kingdom
facility: St Jamess Institute of Oncology
city: London
country: United Kingdom
facility: Barts Health Nhs Trust
city: London
country: United Kingdom
facility: University College Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Nhs Trust
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals Nhs Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: