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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
Date last updated
8/11/2024

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,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford PK
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5042 - Bedford PK
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
China
State/province [5] 0 0
Henan
Country [6] 0 0
China
State/province [6] 0 0
Tianjin
Country [7] 0 0
France
State/province [7] 0 0
Clermont Ferrand
Country [8] 0 0
Italy
State/province [8] 0 0
Milano
Country [9] 0 0
Italy
State/province [9] 0 0
Pavia
Country [10] 0 0
Spain
State/province [10] 0 0
Madrid
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Headington
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Leeds

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 (sonrotoclax) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
Trial website
https://clinicaltrials.gov/study/NCT05952037
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05952037