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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03846427
Registration number
NCT03846427
Ethics application status
Date submitted
11/10/2018
Date registered
19/02/2019
Date last updated
6/06/2023
Titles & IDs
Public title
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
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Scientific title
A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma
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Secondary ID [1]
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2018-001284-24
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Secondary ID [2]
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BGB-3111-214
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Universal Trial Number (UTN)
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Trial acronym
MAGNOLIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Marginal Zone Lymphoma
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MZL
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Zanubrutinib
Experimental: Zanubrutinib - Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
Treatment: Drugs: Zanubrutinib
Zanubrutinib at a dose of 160 mg orally twice a day (BID)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
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Assessment method [1]
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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
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Timepoint [1]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [1]
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ORR by Investigator Assessment
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [2]
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ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)
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Assessment method [2]
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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
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Timepoint [2]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [3]
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Progression-free Survival (PFS) by Investigator Assessment
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Assessment method [3]
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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
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Timepoint [3]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [4]
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PFS Event-Free Rate by Investigator Assessment
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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Secondary outcome [5]
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PFS by IRC Assessment
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Assessment method [5]
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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
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Timepoint [5]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [6]
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PFS Event-Free Rate by IRC Assessment
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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OS is defined as the time from first study drug administration to the date of death due to any cause
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Timepoint [7]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [8]
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OS Event-Free Rate
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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Secondary outcome [9]
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Duration of Response (DOR) by Investigator Assessment
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Assessment method [9]
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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.
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Timepoint [9]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [10]
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DOR Event-Free Rate by Investigator Assessment
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Assessment method [10]
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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.
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Timepoint [10]
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Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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Secondary outcome [11]
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DOR by IRC Assessment
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Assessment method [11]
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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.
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Timepoint [11]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [12]
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DOR Event-Free Rate by IRC Assessment
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Assessment method [12]
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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.
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Timepoint [12]
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Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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Secondary outcome [13]
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Time to Treatment Failure (TTF)
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Assessment method [13]
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TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason.
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Timepoint [13]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [14]
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TTF Event-Free Rate
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Assessment method [14]
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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.
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Timepoint [14]
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Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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Secondary outcome [15]
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Time to Next Line of Therapy
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Assessment method [15]
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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
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Timepoint [15]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [16]
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Time to Next Line of Therapy Event-Free Rate
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Assessment method [16]
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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.
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Timepoint [16]
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Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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Secondary outcome [17]
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Time to Response (TTR) by Investigator Assessment
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Assessment method [17]
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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
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Timepoint [17]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [18]
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TTR by IRC Assessment
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Assessment method [18]
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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.
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Timepoint [18]
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Up to approximately 3 years and 2.5 months
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Secondary outcome [19]
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Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS)
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline to Cycle 30 (28 days per cycle)
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Secondary outcome [20]
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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline to Cycle 30 (28 days per cycle)
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Secondary outcome [21]
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Number of Participants With Adverse Events
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Assessment method [21]
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, physical exams, and vital signs
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Timepoint [21]
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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)
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Secondary outcome [22]
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Area Under the Curve From Time 0 to 6 Hours (AUC0-6)
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Assessment method [22]
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Timepoint [22]
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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 outcome [23]
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Apparent Oral Clearance (CL/F) of Zanubrutinib
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Assessment method [23]
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Timepoint [23]
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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 outcome [24]
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Maximum Observed Concentration (Cmax)
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Assessment method [24]
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Timepoint [24]
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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 outcome [25]
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Elimination Half Life (t1/2)
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Assessment method [25]
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Timepoint [25]
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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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Eligibility
Key inclusion criteria
Key
1. Age 18 years or older
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known transformation to aggressive lymphoma, eg, large cell lymphoma
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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/05/2022
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Sample size
Target
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Accrual to date
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Final
68
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
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St George Hospital - Kogarah
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Recruitment hospital [4]
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Princess Alexandra Hospital (AUS) - Woolloongabba
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Recruitment hospital [5]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [6]
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Box Hill Hospital (AUS) - Box Hill
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Recruitment hospital [7]
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Monash Medical Centre - Clayton
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Recruitment hospital [8]
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Peninsula Private Hospital - Frankston
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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- Concord
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Recruitment postcode(s) [3]
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- Kogarah
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Recruitment postcode(s) [4]
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- Woolloongabba
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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- Box Hill
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Recruitment postcode(s) [7]
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3168 - Clayton
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Recruitment postcode(s) [8]
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- Frankston
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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Country [3]
0
0
China
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State/province [3]
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Henan
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Country [4]
0
0
China
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State/province [4]
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0
Tianjin
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Country [5]
0
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China
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State/province [5]
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Zhejiang
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Country [6]
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China
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State/province [6]
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Beijing
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Country [7]
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Czechia
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State/province [7]
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Praha 10
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Country [8]
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France
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State/province [8]
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Bouches-du-Rhône
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Country [9]
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France
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State/province [9]
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Bordeaux
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Country [10]
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France
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State/province [10]
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Paris
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Country [11]
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France
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State/province [11]
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Pierre-Bénite
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Country [12]
0
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Italy
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State/province [12]
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Bologna
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Country [13]
0
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Italy
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State/province [13]
0
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Milano
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Country [14]
0
0
Italy
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State/province [14]
0
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Modena
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Country [15]
0
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Italy
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State/province [15]
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Novara
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Country [16]
0
0
Italy
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State/province [16]
0
0
Terni
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Country [17]
0
0
Korea, Republic of
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State/province [17]
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Seoul
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Country [18]
0
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New Zealand
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State/province [18]
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Auckland
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Country [19]
0
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United Kingdom
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State/province [19]
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Greater London
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Country [20]
0
0
United Kingdom
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State/province [20]
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0
Greater Longon
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Country [21]
0
0
United Kingdom
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State/province [21]
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0
Greater Manchester
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Country [22]
0
0
United Kingdom
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State/province [22]
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0
Strathclyde
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03846427
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Trial related presentations / 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.
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.
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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BeiGene
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Country
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Phone
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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Address
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Country
0
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03846427
Download to PDF