Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
NCT ID: NCT03846427
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2019-02-19
2022-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zanubrutinib
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
Zanubrutinib
Zanubrutinib at a dose of 160 mg orally twice a day (BID)
Interventions
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Zanubrutinib
Zanubrutinib at a dose of 160 mg orally twice a day (BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
3. Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (PD) after, the most recent systemic treatment
4. Current need for systemic therapy for MZL
5. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
6. Eastern Cooperative Oncology Group (ECOG) of 0-2
7. Life expectancy ≥ 6 months
8. Adequate bone marrow function
9. Adequate organ function
10. Male and female participants must use highly effective methods of contraception
Exclusion Criteria
2. Clinically significant cardiovascular disease
3. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
5. History of stroke or intracranial hemorrhage
6. Severe or debilitating pulmonary disease
7. Active fungal, bacterial and/or viral infection requiring systemic therapy
8. Known central nervous system involvement by lymphoma
9. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
10. Major surgery within 4 weeks of the first dose of study drug
11. Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
12. Pregnant or lactating women
13. Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
14. Concurrent participation in another therapeutic clinical trial
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: PRINCIPAL_INVESTIGATOR
BeiGene
Locations
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Clinical Research Alliance, Inc
Westbury, New York, United States
The Charlotte Mecklenburg Hospital Authority
Charlotte, North Carolina, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
The Saint George Hospital Kogarah
Kogarah, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
Peking University Third Hospital
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
University Hospital Vinohrady Hematology Department
Prague, , Czechia
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, , France
Hopital de La Conception Aphm
Marseille, , France
Hopital Saint Louis
Paris, , France
Chu Hopital Lyon Sud
PierreBenite, , France
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, , Italy
Azienda Ospedaliera S Maria Di Terni
Terni, , Italy
Ao Citta Della Salute E Della Scienza Di Torino Presidio O
Torino, , Italy
Auckland City Hospital
Auckland, , New Zealand
North Shore Hospital
Takapuna, , New Zealand
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Christie Hospital
Greater Manchester, , United Kingdom
University College Hospital
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Countries
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References
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Stephen Opat, Robert Marcus, MA, FRCP, FRCPath, Craig A. Portell, MD, William Reed, MD, Chris Tankersley, Jane Huang, MD, Judith Trotman, MBChB, FRACP, FRCPA. Phase 2 Study of Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Marginal Zone Lymphoma. Blood. 2019; 134(1):5256. https://doi.org/10.1182/blood-2019-122629
Stephen Opat, et al. Efficacy and Safety of Zanubrutinib in Patients with Relapsed/Refractory Marginal Zone Lymphoma: Initial Results of the MAGNOLIA (BGB-3111-214) Trial. Presented at the 62nd American Society of Hematology (ASH) Annual Meeting, December 5-8, 2020. Abstract 339.
Opat S, Tedeschi A, Linton K, McKay P, Hu B, Chan H, Jin J, Sobieraj-Teague M, Zinzani PL, Coleman M, Thieblemont C, Browett P, Ke X, Sun M, Marcus R, Portell CA, Ardeshna K, Bijou F, Walker P, Hawkes EA, Mapp S, Ho SJ, Talaulikar D, Zhou KS, Co M, Li X, Zhou W, Cappellini M, Tankersley C, Huang J, Trotman J. The MAGNOLIA Trial: Zanubrutinib, a Next-Generation Bruton Tyrosine Kinase Inhibitor, Demonstrates Safety and Efficacy in Relapsed/Refractory Marginal Zone Lymphoma. Clin Cancer Res. 2021 Dec 1;27(23):6323-6332. doi: 10.1158/1078-0432.CCR-21-1704. Epub 2021 Sep 15.
Opat S, Tedeschi A, Hu B, et al: Long-term efficacy and safety of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma. 2022 ASH Annual Meeting and Exposition. Abstract 234. Presented December 10, 2022.
Moslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641.
Opat S, Tedeschi A, Hu B, Linton KM, McKay P, Leitch S, Coleman M, Zinzani PL, Jin J, Sun M, Sobieraj-Teague M, Browett P, Ke X, Thieblemont C, Ardeshna K, Bijou F, Walker P, Hawkes EA, Ho SJ, Zhou K, Liang Z, Xu J, Tankersley C, Delarue R, Co M, Trotman J. Safety and efficacy of zanubrutinib in relapsed/refractory marginal zone lymphoma: final analysis of the MAGNOLIA study. Blood Adv. 2023 Nov 28;7(22):6801-6811. doi: 10.1182/bloodadvances.2023010668.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001284-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20180823
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-3111-214
Identifier Type: -
Identifier Source: org_study_id
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