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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/NCT04002297




Registration number
NCT04002297
Ethics application status
Date submitted
27/06/2019
Date registered
28/06/2019
Date last updated
24/08/2023

Titles & IDs
Public title
Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma
Scientific title
A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
Secondary ID [1] 0 0
2019-000413-36
Secondary ID [2] 0 0
BGB-3111-306
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mantle Cell Lymphoma; Non-Hodgkin 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
Treatment: Drugs - bendamustine
Treatment: Drugs - rituximab

Experimental: zanubrutinib plus rituximab -

Active Comparator: bendamustine plus rituximab -


Treatment: Drugs: zanubrutinib
Administered as two 80 mg capsules by mouth twice a day

Treatment: Drugs: bendamustine
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

Treatment: Drugs: rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
Key

1. =70 years of age at the time of informed consent, OR =60 and <70 years of age with
comorbidities precluding autologous stem cell transplantation

2. Histologically confirmed diagnosis of MCL

3. No prior systemic treatments for MCL

4. Measurable disease by CT/MRI

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

6. Adequate marrow and organ function

Key
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known central nervous system involvement by lymphoma

2. Participants for whom the goal of therapy is tumor debulking prior to stem cell
transplant

3. Clinically significant cardiovascular disease

4. History of severe bleeding disorder

5. Unable to swallow capsules or disease significantly affecting gastrointestinal
function

6. Active fungal, bacterial and/or viral infection requiring systemic therapy

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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
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
21/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Aichi
Country [2] 0 0
Japan
State/province [2] 0 0
Chiba
Country [3] 0 0
Japan
State/province [3] 0 0
Fukuoka
Country [4] 0 0
Japan
State/province [4] 0 0
Hiroshima
Country [5] 0 0
Japan
State/province [5] 0 0
Kanagawa
Country [6] 0 0
Japan
State/province [6] 0 0
Kumamoto
Country [7] 0 0
Japan
State/province [7] 0 0
Miyagi
Country [8] 0 0
Japan
State/province [8] 0 0
Okayama
Country [9] 0 0
Japan
State/province [9] 0 0
Osaka
Country [10] 0 0
Japan
State/province [10] 0 0
Tokyo
Country [11] 0 0
Japan
State/province [11] 0 0
Kyoto

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab
versus bendamustine plus rituximab in previously untreated participants with mantle cell
lymphoma (MCL) who are not eligible for stem cell transplantation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04002297
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
BeiGene
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/ct2/show/NCT04002297