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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05952037




Registration number
NCT05952037
Ethics application status
Date submitted
11/07/2023
Date registered
19/07/2023

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Sonrotoclax in Participants With Waldenström's Macroglobulinemia
Scientific title
An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination With Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia
Secondary ID [1] 0 0
U1111-1291-4524
Secondary ID [2] 0 0
BGB-11417-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Waldenstrom Macroglobulinemia 0 0
Waldenstrom's Macroglobulinemia Recurrent 0 0
Waldenstrom's Macroglobulinemia Refractory 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
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-11417
Treatment: Drugs - Zanubrutinib

Experimental: Cohort 1 - Participants with R/R disease to both Bruton tyrosine kinase (BTK) inhibitor and anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor will receive sonrotoclax at a standard dose, given orally once daily.

Experimental: Cohort 2 - Participants with R/R disease to anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor and were intolerant to BTK inhibitor will receive sonrotoclax at a standard dose, given orally once daily.

Experimental: Cohort 3 - Participants with R/R disease to a BTK inhibitor treatment and are unsuitable for chemoimmunotherapy will receive sonrotoclax at a standard dose, given orally once daily.

Experimental: Cohort 4 - Participants with previously untreated WM will receive sonrotoclax and zanubrutinib combination therapy with fixed duration.


Treatment: Drugs: BGB-11417
Administered orally as a tablet.

Treatment: Drugs: Zanubrutinib
Administered orally as a tablet.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1: Major Response Rate (MRR)
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [1] 0 0
Cohorts 2 and 3: MRR as assessed by the IRC
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
All Cohorts: MRR as assessed by the Investigator
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Cohorts 1, 2, and 3: Duration of Major Response (DoMR) as assessed by the IRC
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
All Cohorts: DoMR as assessed by the Investigator
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Cohorts 1, 2, and 3: Complete Response (CR) + Very Good Partial Response (VGPR) as assessed by the IRC
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
All Cohorts: CR + VGPR as assessed by the Investigator
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Cohorts 1, 2, and 3: Overall Response Rate (ORR) as assessed by the IRC
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
All cohorts: ORR as assessed by the investigator
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Cohorts 1, 2, and 3: Duration of Response (DOR) as assessed by the IRC
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
All Cohorts: DOR as assessed by the investigator
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
Cohorts 1, 2, and 3: Progression-Free Survival (PFS)
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Cohorts 1, 2, and 3: Time to major response as assessed by the IRC
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
All Cohorts: Time to major response as assessed by the investigator
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Cohorts 1, 2, and 3: Overall Survival (OS)
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Time to next treatment in cohort 4
Timepoint [15] 0 0
Up to approximately 5 years
Secondary outcome [16] 0 0
Number of participants reporting adverse events
Timepoint [16] 0 0
Up to approximately 5 years
Secondary outcome [17] 0 0
Health-Related Quality of Life (HRQoL): NFLymSI-18
Timepoint [17] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
* Clinical and definitive histologic diagnosis of WM.
* Meeting = 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
* For Cohorts 1-3, refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
* For Cohort 4, patients must not have received prior therapy for WM.
* Adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Central nervous system (CNS) involvement by WM.
* Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
* History of other malignancies = 2 years before study entry.
* Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed = 14 days before the first dose of the study drug.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 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
28/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
105
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
Genesiscare North Shore - St Leonards
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford PK
Recruitment hospital [5] 0 0
Monash Health - Clayton
Recruitment hospital [6] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Linear Clinical Research - Nedlands
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5042 - Bedford PK
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
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
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
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Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
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Utah
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United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
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Canada
State/province [21] 0 0
Ontario
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China
State/province [22] 0 0
Fujian
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China
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Guangdong
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China
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Henan
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China
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Hubei
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China
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China
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Liaoning
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China
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Shanghai
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China
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Shanxi
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China
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Tianjin
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China
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Zhejiang
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France
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Amiens Cedex
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France
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Clermont Ferrand
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France
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Marseille
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France
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Paris
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France
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PierreBenite
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France
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Reims Cedex
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Greece
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Athens
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Milano
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Italy
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Pavia
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Italy
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Roma
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Italy
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Udine
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Terassa
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United Kingdom
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Bournemouth
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United Kingdom
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Glasgow
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United Kingdom
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Headington
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United Kingdom
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Inverness
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United Kingdom
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Leeds
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London
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United Kingdom
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Manchester
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Plymouth
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United Kingdom
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Sutton

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
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT05952037