Marginal Zone LymphomaPhase 2MAGNOLIANCT03846427
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
A Phase 2 study testing Zanubrutinib in people with Marginal Zone Lymphoma and MZL, run by BeiGene at 31 sites in 9 countries.
Trial summary
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma, MZL
- What is being tested?
- Zanubrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 31 sitesin 9 countries
- Study dates
- 19 Feb 2019to 4 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
- 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
- Current need for systemic therapy for MZL
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) of 0-2
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- Life expectancy ≥ 6 months
- Adequate bone marrow function
- Adequate organ function
- Male and female participants must use highly effective methods of contraception
Who cannot join
- Known transformation to aggressive lymphoma, eg, large cell lymphoma
- Clinically significant cardiovascular disease
- 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
- 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
- History of stroke or intracranial hemorrhage
- Severe or debilitating pulmonary disease
Show all 15Show fewer
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Known central nervous system involvement by lymphoma
- Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
- Major surgery within 4 weeks of the first dose of study drug
- Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
- Pregnant or lactating women
- Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
- Concurrent participation in another therapeutic clinical trial
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
31 sites in 9 countries.
31 sites in 9 countries
Australia8 sites
Flinders Medical Centre
Bedford PK, South Australia, 5042
Box Hill Hospital
Box Hill, Victoria, 3128
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Monash Health
Clayton, Victoria, 3168
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Peninsula Private Hospital
Frankston, Victoria, 3199
Canberra Hospital
Garran, Australian Capital Territory, 2605
The Saint George Hospital Kogarah
Kogarah, New South Wales, 2217
Italy5 sites
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, 41124
Azienda Ospedaliera S Maria Di Terni
Terni, 05100
Ao Citta Della Salute E Della Scienza Di Torino Presidio O
Torino, 10126
China4 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020
Henan Cancer Hospital
Zhengzhou, Henan, 450000
France4 sites
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
Hopital de La Conception Aphm
Marseille, 13005
Hopital Saint Louis
Paris, 75010
Chu Hopital Lyon Sud
PierreBenite, 69495
United Kingdom4 sites
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
The Christie Hospital
Greater Manchester, M20 4BX
University College Hospital
London, NW1 2PG
Royal Marsden Hospital
London, SW3 6JJ
United States2 sites
The Charlotte Mecklenburg Hospital Authority
Charlotte, North Carolina, 28203
Clinical Research Alliance, Inc
Westbury, New York, 11590
New Zealand2 sites
Auckland City Hospital
Auckland, 1023
North Shore Hospital
Takapuna, 0622
Czechia1 site
University Hospital Vinohrady Hematology Department
Prague, 10034
South Korea1 site
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
About this study
Official title: A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
- Conditions
- Marginal Zone Lymphoma, MZL
- Being tested
- Zanubrutinib
- Keywords
- BGB-3111, Zanubrutinib
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called BGB-3111, Brukinsa
Zanubrutinib at a dose of 160 mg orally twice a day (BID)
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib | Experimental | Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent Receives: Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by an IRC using the Lugano Classification
Measured: Up to approximately 3 years and 2.5 months
Secondary outcomes (25)
ORR by Investigator Assessment
ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by the investigator using the Lugano Classification.
Measured: Up to approximately 3 years and 2.5 months
ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)
ORR is defined as the percentage of participants with complete and partial response as the best overall response, as determined by an IRC using PET-CT assessment data for participants with fluorodeoxyglucose (FDG)-avid disease
Measured: Up to approximately 3 years and 2.5 months
Progression-free Survival (PFS) by Investigator Assessment
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using Lugano Classification
Measured: Up to approximately 3 years and 2.5 months
PFS Event-Free Rate by Investigator Assessment
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for PFS at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
PFS by IRC Assessment
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by an IRC using Lugano Classification
Measured: Up to approximately 3 years and 2.5 months
PFS Event-Free Rate by IRC Assessment
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for PFS at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Overall Survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause
Measured: Up to approximately 3 years and 2.5 months
OS Event-Free Rate
OS is defined as the time from first study drug administration to the date of death due to any cause. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for OS at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Duration of Response (DOR) by Investigator Assessment
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using Lugano Classification.
Measured: Up to approximately 3 years and 2.5 months
DOR Event-Free Rate by Investigator Assessment
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
DOR by IRC Assessment
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using Lugano Classification.
Measured: Up to approximately 3 years and 2.5 months
DOR Event-Free Rate by IRC Assessment
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Time to Treatment Failure (TTF)
TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason.
Measured: Up to approximately 3 years and 2.5 months
TTF Event-Free Rate
TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for TTF at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Time to Next Line of Therapy
Time to next line of therapy is defined as the time from study treatment start to the start of the first subsequent therapy for MZL
Measured: Up to approximately 3 years and 2.5 months
Time to Next Line of Therapy Event-Free Rate
Time to next line of therapy is defined as the time from study treatment start to the start of the first subsequent therapy for MZL. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for time to next line of therapy at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Measured: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Time to Response (TTR) by Investigator Assessment
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as assessed by the investigator using Lugano Classification
Measured: Up to approximately 3 years and 2.5 months
TTR by IRC Assessment
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by the IRC using Lugano Classification.
Measured: Up to approximately 3 years and 2.5 months
Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS)
Mean change from baseline in EQ-5D-5L VAS. The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' Positive change from baseline indicates improved health.
Measured: Baseline to Cycle 30 (28 days per cycle)
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a positive score from baseline indicating improved health.
Measured: Baseline to Cycle 30 (28 days per cycle)
Number of Participants With Adverse Events
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, physical exams, and vital signs
Measured: From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Area Under the Curve From Time 0 to 6 Hours (AUC0-6)
Measured: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Apparent Oral Clearance (CL/F) of Zanubrutinib
Measured: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Maximum Observed Concentration (Cmax)
Measured: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Elimination Half Life (t1/2)
Measured: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start19 Feb 2019
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Principal investigator, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846427
- Sponsor's protocol ID
- BGB-3111-214
- Other IDs
- 2018-001284-24, CTR20180823, 2018
- Acronym
- MAGNOLIA
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2018
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34526366Opat 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.
PubMed 38502198Opat 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.
PubMed 37682792
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT03846427
- Acronym / sponsor ID
- MAGNOLIA / BGB-3111-214
- Conditions
- Marginal Zone Lymphoma, MZL
- Keywords
- BGB-3111, Zanubrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 3 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib | Experimental | Drug: ZanubrutinibZanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 years or older
- Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
- 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
- Current need for systemic therapy for MZL
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
Key exclusion criteria (15 listed)
- Known transformation to aggressive lymphoma, eg, large cell lymphoma
- Clinically significant cardiovascular disease
- 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
- 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
- History of stroke or intracranial hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibAlso: BGB-3111, BrukinsaZanubrutinib at a dose of 160 mg orally twice a day (BID) | Drug | Zanubrutinib |
Primary outcome
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
Time frame: Up to approximately 3 years and 2.5 months
ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by an IRC using the Lugano Classification
25 secondary outcomes
ORR by Investigator Assessment
Time frame: Up to approximately 3 years and 2.5 months
ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)
Time frame: Up to approximately 3 years and 2.5 months
Progression-free Survival (PFS) by Investigator Assessment
Time frame: Up to approximately 3 years and 2.5 months
PFS Event-Free Rate by Investigator Assessment
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
PFS by IRC Assessment
Time frame: Up to approximately 3 years and 2.5 months
PFS Event-Free Rate by IRC Assessment
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Overall Survival (OS)
Time frame: Up to approximately 3 years and 2.5 months
OS Event-Free Rate
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Duration of Response (DOR) by Investigator Assessment
Time frame: Up to approximately 3 years and 2.5 months
DOR Event-Free Rate by Investigator Assessment
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
DOR by IRC Assessment
Time frame: Up to approximately 3 years and 2.5 months
DOR Event-Free Rate by IRC Assessment
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Time to Treatment Failure (TTF)
Time frame: Up to approximately 3 years and 2.5 months
TTF Event-Free Rate
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Time to Next Line of Therapy
Time frame: Up to approximately 3 years and 2.5 months
Time to Next Line of Therapy Event-Free Rate
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Time to Response (TTR) by Investigator Assessment
Time frame: Up to approximately 3 years and 2.5 months
TTR by IRC Assessment
Time frame: Up to approximately 3 years and 2.5 months
Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS)
Time frame: Baseline to Cycle 30 (28 days per cycle)
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
Time frame: Baseline to Cycle 30 (28 days per cycle)
Number of Participants With Adverse Events
Time frame: From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Area Under the Curve From Time 0 to 6 Hours (AUC0-6)
Time frame: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Apparent Oral Clearance (CL/F) of Zanubrutinib
Time frame: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Maximum Observed Concentration (Cmax)
Time frame: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Elimination Half Life (t1/2)
Time frame: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundStephen 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
- BackgroundStephen 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.
- Background: PubMed 34526366Opat 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.
- BackgroundOpat 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.
- Derived from this study: PubMed 38502198Moslehi 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.
- Derived from this study: PubMed 37682792Opat 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.
- Individual participant dataSharing planned: Yes
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DLBCL, High-grade B-cell Lymphoma (HGBCL)
Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director principal investigator
BeiGene
31 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib in people with Marginal Zone Lymphoma and MZL, run by BeiGene at 31 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Australia, Italy, China, France, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment (time frame: Up to approximately 3 years and 2.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03846427, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.