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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03846427
Other study ID # BGB-3111-214
Secondary ID 2018-001284-24CT
Status Completed
Phase Phase 2
First received
Last updated
Start date February 19, 2019
Est. completion date May 4, 2022

Study information

Verified date June 2023
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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Study Design


Intervention

Drug:
Zanubrutinib
Zanubrutinib at a dose of 160 mg orally twice a day (BID)

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Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Australia,  China,  Czechia,  France,  Italy,  Korea, Republic of,  New Zealand,  United Kingdom, 

References & Publications (4)

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.

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. — View Citation

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.

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

Outcome

Type Measure Description Time frame Safety issue
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 Up to approximately 3 years and 2.5 months
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. Up to approximately 3 years and 2.5 months
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 Up to approximately 3 years and 2.5 months
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 Up to approximately 3 years and 2.5 months
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. Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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 Up to approximately 3 years and 2.5 months
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. Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Secondary 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
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. Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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. Up to approximately 3 years and 2.5 months
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. Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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. Up to approximately 3 years and 2.5 months
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. Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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. Up to approximately 3 years and 2.5 months
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. Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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 Up to approximately 3 years and 2.5 months
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. Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
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 Up to approximately 3 years and 2.5 months
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. Up to approximately 3 years and 2.5 months
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. Baseline to Cycle 30 (28 days per cycle)
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. Baseline to Cycle 30 (28 days per cycle)
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 From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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