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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03846427




Registration number
NCT03846427
Ethics application status
Date submitted
11/10/2018
Date registered
19/02/2019
Date last updated
14/08/2019

Titles & IDs
Public title
Study of Zanubrutinib (BGB-3111) in Patients With Marginal Zone Lymphoma
Scientific title
A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Secondary ID [1] 0 0
2018-001284-24
Secondary ID [2] 0 0
BGB-3111-214
Universal Trial Number (UTN)
Trial acronym
MAGNOLIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Marginal Zone Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zanubrutinib

Experimental: Zanubrutinib -


Treatment: Drugs: Zanubrutinib
Zanubrutinib at a dose of 160 mg PO BID

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate (ORR) determined by independent central review
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
ORR by investigator assessment
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Time to response (TTR)
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Patient-reported outcomes (PROs) as measured by the EQ-5D-5L questionnaire
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
PROs as measured by the EORTC QLQ-C30 questionnaire
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
Occurrence and severity of treatment-emergent adverse events (safety and tolerability)
Timepoint [8] 0 0
Up to 3 years

Eligibility
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 PR or documented PD after, the most recent systemic treatment

4. Current need for systemic therapy for MZL

5. Measurable disease by CT or MRI

6. ECOG of 0-2

7. Life expectancy = 6 months

8. Adequate bone marrow function

9. Adequate organ function

10. Male and female patients must use highly effective methods of contraception
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 BTK inhibitor

12. Pregnant or lactating women

13. Requires ongoing treatment with a strong CYP3A inhibitor or inducer

14. Concurrent participation in another therapeutic clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [4] 0 0
Princess Alexandra Hospital (AUS) - Woolloongabba
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Box Hill Hospital (AUS) - Box Hill
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre-East Melbourne - Melbourne
Recruitment hospital [10] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
- Box Hill
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
- Frankston
Recruitment postcode(s) [9] 0 0
3000 - Melbourne
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
China
State/province [7] 0 0
Henan
Country [8] 0 0
China
State/province [8] 0 0
Tianjin
Country [9] 0 0
China
State/province [9] 0 0
Zhejiang
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
France
State/province [11] 0 0
Bouches-du-Rhône
Country [12] 0 0
Italy
State/province [12] 0 0
Milano
Country [13] 0 0
Italy
State/province [13] 0 0
Novara
Country [14] 0 0
Italy
State/province [14] 0 0
Terni
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Greater London
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Greater Manchester
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Strathclyde

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib
(BGB-3111) in patients with relapsed/refractory marginal zone lymphoma (R/R MZL).
Trial website
https://clinicaltrials.gov/show/NCT03846427
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
William Reed, MD
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03846427