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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001284-24 | EudraCT Number | ||
| CTR20180823 | Registry Identifier | Center for drug evaluation, CFDA |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Zanubrutinib at a dose of 160 mg orally twice a day (BID) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to approximately 3 years and 2.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 3 years and 2.5 months |
| ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Alliance, Inc | Westbury | New York | 11590 | United States | ||
| The Charlotte Mecklenburg Hospital Authority |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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. | ||
| 34526366 | Background | 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. |
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The study was composed of an initial screening phase (up to 35 days), a single-arm treatment phase, and a follow-up phase. A total of 38 participants rolled over to BGB-3111-LTE1 (NCT04170283) after study completion.
This study was conducted at 31 study centers in 9 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zanubrutinib | Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2020 | Jan 14, 2022 |
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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 |
| 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 | 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. | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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 | 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. | 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. | 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. | 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 | 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) | 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 | 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) | 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) | 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) |
| Charlotte |
| North Carolina |
| 28203 |
| United States |
| Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| The Saint George Hospital Kogarah | Kogarah | New South Wales | 2217 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Flinders Medical Centre | Bedford PK | South Australia | 5042 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Peninsula Private Hospital | Frankston | Victoria | 3199 | Australia |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Institute of Hematology and Hospital of Blood Disease | Tianjin | Tianjin Municipality | 300020 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| University Hospital Vinohrady Hematology Department | Prague | 10034 | Czechia |
| Centre de Lutte Contre Le Cancer Institut Bergonie | Bordeaux | 33076 | France |
| Hopital de La Conception Aphm | Marseille | 13005 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Chu Hopital Lyon Sud | PierreBenite | 69495 | France |
| Policlinico Sorsola Malpighi, Aou Di Bologna | Bologna | 40138 | Italy |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco | Modena | 41124 | Italy |
| Azienda Ospedaliera S Maria Di Terni | Terni | 05100 | Italy |
| Ao Citta Della Salute E Della Scienza Di Torino Presidio O | Torino | 10126 | Italy |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| North Shore Hospital | Takapuna | 0622 | New Zealand |
| Severance Hospital Yonsei University Health System | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| The Christie Hospital | Greater Manchester | M20 4BX | United Kingdom |
| University College Hospital | London | NW1 2PG | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Background | 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. |
| 38502198 | Derived | 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. |
| 37682792 | Derived | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zanubrutinib | Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 2.5 months |
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| Secondary | 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 | Efficacy analysis set consisted of evaluable participants with FDG-avid disease at baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 2.5 months |
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| Secondary | 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 | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported |
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| Secondary | 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 | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported |
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| Secondary | Overall Survival (OS) | OS is defined as the time from first study drug administration to the date of death due to any cause | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above. | Posted | Median | Full Range | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above. | Posted | Median | Full Range | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported |
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| Secondary | 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 | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported |
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| Secondary | 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 | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; TTR was summarized for responders only, defined as participants with a best overall response of partial response or above. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; TTR was summarized for responders only, defined as participants with a best overall response of partial response or above. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 2.5 months |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Cycle 30 (28 days per cycle) |
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| Secondary | 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. | Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Cycle 30 (28 days per cycle) |
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| Secondary | 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 | Safety analysis set is all participants who were enrolled and received at least 1 dose of study drug | Posted | Count of Participants | Participants | No | From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months) |
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| Secondary | Area Under the Curve From Time 0 to 6 Hours (AUC0-6) | Pharmacokinetic analysis set included all participants who had at least 1 postdose zanubrutinib plasma concentration | Posted | Mean | Standard Deviation | Hour*ng/mL | 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) |
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| Secondary | Apparent Oral Clearance (CL/F) of Zanubrutinib | Pharmacokinetic analysis set included all participants who had at least 1 postdose zanubrutinib plasma concentration | Posted | Mean | Standard Deviation | Liters/hour | 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) |
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| Secondary | Maximum Observed Concentration (Cmax) | Pharmacokinetic analysis set included all participants who had at least 1 postdose zanubrutinib plasma concentration | Posted | Mean | Standard Deviation | nanograms/milliliter | 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) |
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| Secondary | Elimination Half Life (t1/2) | Pharmacokinetic analysis set included all participants who had at least 1 postdose zanubrutinib plasma concentration | Posted | Median | Full Range | Hours | 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) |
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From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zanubrutinib | Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent | 13 | 68 | 30 | 68 | 61 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Septic encephalopathy | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra 24.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2020 | Jan 14, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Multiple |
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| Other |
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| Unknown |
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| Not Reported |
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