Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06742996




Registration number
NCT06742996
Ethics application status
Date submitted
16/12/2024
Date registered
19/12/2024

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma
Scientific title
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Secondary ID [1] 0 0
2024-515593-27-00
Secondary ID [2] 0 0
BGB-11417-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mantle Cell Lymphoma 0 0
B Cell 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 - Sonrotoclax
Treatment: Drugs - Zanubrutinib
Treatment: Drugs - Placebo

Experimental: Arm A: sonrotoclax plus zanubrutinib - Sonrotoclax and zanubrutinib will be administered in combination.

Placebo comparator: Arm B: placebo plus zanubrutinib - Placebo and zanubrutinib will be administered in combination.


Treatment: Drugs: Sonrotoclax
Administered orally

Treatment: Drugs: Zanubrutinib
Administered orally

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
Timepoint [1] 0 0
Approximately 49 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately 92 months
Secondary outcome [2] 0 0
PFS as assessed by investigator (INV)
Timepoint [2] 0 0
Approximately 66 months
Secondary outcome [3] 0 0
Overall Response Rate (ORR) as assessed by BIRC and by INV
Timepoint [3] 0 0
Approximately 66 months
Secondary outcome [4] 0 0
Duration of Response (DOR) as assessed by BIRC and by INV
Timepoint [4] 0 0
Approximately 66 months
Secondary outcome [5] 0 0
Complete Response Rate (CRR) as assessed by BIRC and by INV
Timepoint [5] 0 0
Approximately 66 months
Secondary outcome [6] 0 0
Time to first response as assessed by BIRC and by INV
Timepoint [6] 0 0
Approximately 66 months
Secondary outcome [7] 0 0
Time to initiation of new anticancer therapy
Timepoint [7] 0 0
Approximately 66 months
Secondary outcome [8] 0 0
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29)
Timepoint [8] 0 0
Approximately 66 months
Secondary outcome [9] 0 0
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Timepoint [9] 0 0
Approximately 66 months
Secondary outcome [10] 0 0
Number of participants with treatment-emergent adverse events (TEAEs)
Timepoint [10] 0 0
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 66 months

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
* Relapsed or refractory disease after the last line of therapy
* Measurable disease defined as = 1 nodal lesion that is > 1.5 cm in longest diameter, or = 1 extranodal lesion that is > 1 cm in longest diameter
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy with B-cell lymphoma-2 inhibitor
* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
* Known central nervous system involvement by lymphoma
* Clinically significant cardiovascular disease
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
25/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2032
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Genesiscare North Shore - St Leonards
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Sunshine Coast Hospital and Health Service - Birtinya
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Monash Health - Clayton
Recruitment hospital [7] 0 0
Rockingham Hospital - Cooloongup
Recruitment hospital [8] 0 0
Linear Clinical Research - Nedlands
Recruitment hospital [9] 0 0
One Clinical Research - Nedlands
Recruitment hospital [10] 0 0
Perth Blood Institute - West Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
6168 - Cooloongup
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
6005 - West 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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Caba
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autonoma Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Cordoba
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Austria
State/province [26] 0 0
Salzburg
Country [27] 0 0
Austria
State/province [27] 0 0
St Polten
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Brazil
State/province [29] 0 0
Barretos
Country [30] 0 0
Brazil
State/province [30] 0 0
Belo Horizonte
Country [31] 0 0
Brazil
State/province [31] 0 0
Campinas
Country [32] 0 0
Brazil
State/province [32] 0 0
Curitiba
Country [33] 0 0
Brazil
State/province [33] 0 0
Joinville
Country [34] 0 0
Brazil
State/province [34] 0 0
Petropolis
Country [35] 0 0
Brazil
State/province [35] 0 0
Porto AlegreRS
Country [36] 0 0
Brazil
State/province [36] 0 0
Recife
Country [37] 0 0
Brazil
State/province [37] 0 0
Sao Paulo
Country [38] 0 0
Brazil
State/province [38] 0 0
Vitoria
Country [39] 0 0
China
State/province [39] 0 0
Beijing
Country [40] 0 0
China
State/province [40] 0 0
Chongqing
Country [41] 0 0
China
State/province [41] 0 0
Fujian
Country [42] 0 0
China
State/province [42] 0 0
Guangdong
Country [43] 0 0
China
State/province [43] 0 0
Heilongjiang
Country [44] 0 0
China
State/province [44] 0 0
Henan
Country [45] 0 0
China
State/province [45] 0 0
Hubei
Country [46] 0 0
China
State/province [46] 0 0
Jiangsu
Country [47] 0 0
China
State/province [47] 0 0
Jiangxi
Country [48] 0 0
China
State/province [48] 0 0
Liaoning
Country [49] 0 0
China
State/province [49] 0 0
Shaanxi
Country [50] 0 0
China
State/province [50] 0 0
Shandong
Country [51] 0 0
China
State/province [51] 0 0
Shanghai
Country [52] 0 0
China
State/province [52] 0 0
Sichuan
Country [53] 0 0
China
State/province [53] 0 0
Zhejiang
Country [54] 0 0
France
State/province [54] 0 0
Montpellier
Country [55] 0 0
France
State/province [55] 0 0
Nantes
Country [56] 0 0
France
State/province [56] 0 0
PierreBenite
Country [57] 0 0
France
State/province [57] 0 0
Tours
Country [58] 0 0
Germany
State/province [58] 0 0
Chemnitz
Country [59] 0 0
Germany
State/province [59] 0 0
Frankfurt am Main
Country [60] 0 0
Germany
State/province [60] 0 0
Halle Saale
Country [61] 0 0
Germany
State/province [61] 0 0
Hamburg
Country [62] 0 0
Germany
State/province [62] 0 0
Munchen
Country [63] 0 0
Germany
State/province [63] 0 0
Mutlangen
Country [64] 0 0
Italy
State/province [64] 0 0
Bologna
Country [65] 0 0
Italy
State/province [65] 0 0
Leece
Country [66] 0 0
Italy
State/province [66] 0 0
Meldola
Country [67] 0 0
Italy
State/province [67] 0 0
Trieste
Country [68] 0 0
Italy
State/province [68] 0 0
Verona
Country [69] 0 0
Japan
State/province [69] 0 0
Aichi
Country [70] 0 0
Japan
State/province [70] 0 0
Chiba
Country [71] 0 0
Japan
State/province [71] 0 0
Ehime
Country [72] 0 0
Japan
State/province [72] 0 0
Gifu
Country [73] 0 0
Japan
State/province [73] 0 0
Hiroshima
Country [74] 0 0
Japan
State/province [74] 0 0
Hyogo
Country [75] 0 0
Japan
State/province [75] 0 0
Kagoshima
Country [76] 0 0
Japan
State/province [76] 0 0
Kanagawa
Country [77] 0 0
Japan
State/province [77] 0 0
Miyagi
Country [78] 0 0
Japan
State/province [78] 0 0
Okayama
Country [79] 0 0
Japan
State/province [79] 0 0
Osaka
Country [80] 0 0
Japan
State/province [80] 0 0
Saitama
Country [81] 0 0
Japan
State/province [81] 0 0
Tokyo
Country [82] 0 0
Japan
State/province [82] 0 0
YokohamaShi
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Busan Gwang'yeogsi
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Gyeonggi-do
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Seoul Teugbyeolsi
Country [86] 0 0
New Zealand
State/province [86] 0 0
Auckland
Country [87] 0 0
New Zealand
State/province [87] 0 0
Christchurch
Country [88] 0 0
New Zealand
State/province [88] 0 0
Dunedin
Country [89] 0 0
New Zealand
State/province [89] 0 0
Tauranga
Country [90] 0 0
Poland
State/province [90] 0 0
Dopiewo
Country [91] 0 0
Poland
State/province [91] 0 0
Krakow
Country [92] 0 0
Poland
State/province [92] 0 0
Lublin
Country [93] 0 0
Poland
State/province [93] 0 0
OD
Country [94] 0 0
Poland
State/province [94] 0 0
Wrocaw
Country [95] 0 0
Puerto Rico
State/province [95] 0 0
San Juan
Country [96] 0 0
Spain
State/province [96] 0 0
Barcelona
Country [97] 0 0
Spain
State/province [97] 0 0
Madrid
Country [98] 0 0
Spain
State/province [98] 0 0
Majadahonda
Country [99] 0 0
Turkey
State/province [99] 0 0
Ankara
Country [100] 0 0
Turkey
State/province [100] 0 0
Dokuma
Country [101] 0 0
Turkey
State/province [101] 0 0
Edirne
Country [102] 0 0
Turkey
State/province [102] 0 0
Kocaeli
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Birmingham
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Bournemouth
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Glasgow
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Headington
Country [107] 0 0
United Kingdom
State/province [107] 0 0
London
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Plymouth
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Wirral

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06742996