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Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma (MAGNOLIA)

Primary Purpose

Marginal Zone Lymphoma, MZL

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zanubrutinib
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marginal Zone Lymphoma focused on measuring BGB-3111, Zanubrutinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  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

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 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.

Sites / Locations

  • Clinical Research Alliance, Inc.
  • The Charlotte-Mecklenburg Hospital Authority
  • Canberra Hospital
  • Concord Repatriation General Hospital
  • St George Hospital
  • Princess Alexandra Hospital (AUS)
  • Flinders Medical Centre
  • Box Hill Hospital (AUS)
  • Monash Medical Centre
  • Peninsula Private Hospital
  • Henan Cancer Hospital
  • Institute of Hematology and Hospital of Blood Disease
  • The First Affiliated Hospital, College of Medicine, Zhejiang University
  • Peking University Third Hospital
  • Fakultni nemocnice Kralovske Vinohrady
  • Hopital de la Conception - APHM
  • Centre de Lutte Contre Le Cancer - Institut Bergonie
  • Hôpital Saint-Louis
  • Centre Hospitalier Lyon Sud
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
  • A.O.U. Policlinico di Modena
  • Azienda Ospedaliero - Universitaria Maggiore delle Carità
  • Azienda Ospedaliera S. Maria Di Terni
  • Severence Hospital
  • North Shore Hospital (NZ)
  • Auckland City Hospital
  • University College London Hospitals
  • Royal Marsden Hospital- London
  • The Christie
  • Beatson West of Scotland Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zanubrutinib

Arm Description

Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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
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.
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
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.
Overall Survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause
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.
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.
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.
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.
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.
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.
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.
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
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.
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
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.
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.
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.
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
Area Under the Curve From Time 0 to 6 Hours (AUC0-6)
Apparent Oral Clearance (CL/F) of Zanubrutinib
Maximum Observed Concentration (Cmax)
Elimination Half Life (t1/2)

Full Information

First Posted
October 11, 2018
Last Updated
June 2, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03846427
Brief Title
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
Acronym
MAGNOLIA
Official Title
A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Zone Lymphoma, MZL
Keywords
BGB-3111, Zanubrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zanubrutinib
Arm Type
Experimental
Arm Description
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Other Intervention Name(s)
BGB-3111, Brukinsa
Intervention Description
Zanubrutinib at a dose of 160 mg orally twice a day (BID)
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
Description
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
Time Frame
Up to approximately 3 years and 2.5 months
Secondary Outcome Measure Information:
Title
ORR by Investigator Assessment
Description
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.
Time Frame
Up to approximately 3 years and 2.5 months
Title
ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)
Description
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
Time Frame
Up to approximately 3 years and 2.5 months
Title
Progression-free Survival (PFS) by Investigator Assessment
Description
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
Time Frame
Up to approximately 3 years and 2.5 months
Title
PFS Event-Free Rate by Investigator Assessment
Description
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.
Time Frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Title
PFS by IRC Assessment
Description
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
Time Frame
Up to approximately 3 years and 2.5 months
Title
PFS Event-Free Rate by IRC Assessment
Description
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.
Time Frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Title
Overall Survival (OS)
Description
OS is defined as the time from first study drug administration to the date of death due to any cause
Time Frame
Up to approximately 3 years and 2.5 months
Title
OS Event-Free Rate
Description
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.
Time Frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Title
Duration of Response (DOR) by Investigator Assessment
Description
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.
Time Frame
Up to approximately 3 years and 2.5 months
Title
DOR Event-Free Rate by Investigator Assessment
Description
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.
Time Frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Title
DOR by IRC Assessment
Description
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.
Time Frame
Up to approximately 3 years and 2.5 months
Title
DOR Event-Free Rate by IRC Assessment
Description
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.
Time Frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Title
Time to Treatment Failure (TTF)
Description
TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason.
Time Frame
Up to approximately 3 years and 2.5 months
Title
TTF Event-Free Rate
Description
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.
Time Frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Title
Time to Next Line of Therapy
Description
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
Time Frame
Up to approximately 3 years and 2.5 months
Title
Time to Next Line of Therapy Event-Free Rate
Description
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.
Time Frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Title
Time to Response (TTR) by Investigator Assessment
Description
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
Time Frame
Up to approximately 3 years and 2.5 months
Title
TTR by IRC Assessment
Description
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.
Time Frame
Up to approximately 3 years and 2.5 months
Title
Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS)
Description
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.
Time Frame
Baseline to Cycle 30 (28 days per cycle)
Title
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
Description
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.
Time Frame
Baseline to Cycle 30 (28 days per cycle)
Title
Number of Participants With Adverse Events
Description
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, physical exams, and vital signs
Time Frame
From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Title
Area Under the Curve From Time 0 to 6 Hours (AUC0-6)
Time Frame
Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Title
Apparent Oral Clearance (CL/F) of Zanubrutinib
Time Frame
Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Title
Maximum Observed Concentration (Cmax)
Time Frame
Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Title
Elimination Half Life (t1/2)
Time Frame
Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Age 18 years or older Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (PD) after, the most recent systemic treatment Current need for systemic therapy for MZL Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) Eastern Cooperative Oncology Group (ECOG) of 0-2 Life expectancy ≥ 6 months Adequate bone marrow function Adequate organ function Male and female participants must use highly effective methods of contraception Key Exclusion Criteria: Known transformation to aggressive lymphoma, eg, large cell lymphoma Clinically significant cardiovascular disease Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention History of stroke or intracranial hemorrhage Severe or debilitating pulmonary disease Active fungal, bacterial and/or viral infection requiring systemic therapy Known central nervous system involvement by lymphoma Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection Major surgery within 4 weeks of the first dose of study drug Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor Pregnant or lactating women Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer Concurrent participation in another therapeutic clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Alliance, Inc.
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
Facility Name
The Charlotte-Mecklenburg Hospital Authority
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
Princess Alexandra Hospital (AUS)
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Box Hill Hospital (AUS)
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peninsula Private Hospital
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Institute of Hematology and Hospital of Blood Disease
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Hopital de la Conception - APHM
City
Marseille Cedex 05
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13005
Country
France
Facility Name
Centre de Lutte Contre Le Cancer - Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Maggiore delle Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria Di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Severence Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
North Shore Hospital (NZ)
City
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
University College London Hospitals
City
London
State/Province
Greater London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Royal Marsden Hospital- London
City
London
State/Province
Greater Longon
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G12 OYN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
Citation
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
Results Reference
background
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.
Results Reference
background
PubMed Identifier
34526366
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background

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Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma

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