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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06073821




Registration number
NCT06073821
Ethics application status
Date submitted
3/10/2023
Date registered
10/10/2023

Titles & IDs
Public title
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
Scientific title
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
CTR20241195
Secondary ID [2] 0 0
BGB-11417-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CLL 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

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

Experimental: Sonrotoclax Plus Zanubrutinib - Participants will receive from start of Cycle 1 a standard dose of zanubrutinib once or twice daily orally and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses until target dose is reached and continuing until end of Cycle 15 (each cycle is 28 days)

Active comparator: Venetoclax Plus Obinutuzumab - Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900 mg on Day 2 Cycle 1 (or alternatively receive 1000 mg intravenously on Day 1), followed by 1000 mg on Days 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 through 6 (each cycle is 28 days) in combination with venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12 (each cycles is 28 days)


Treatment: Drugs: Sonrotoclax
Administered orally

Treatment: Drugs: Zanubrutinib
Administered orally

Treatment: Drugs: Venetoclax
Administered orally

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

Outcomes
Primary outcome [1] 0 0
Cohort 1: Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 9 years
Primary outcome [2] 0 0
Cohort 1: Rate of Undetectable Measurable Residual Disease
Timepoint [2] 0 0
Up to one and a half years
Secondary outcome [1] 0 0
Cohort 1: Complete Response Rate (CRR ) by IRC
Timepoint [1] 0 0
Up to approximately 9 years
Secondary outcome [2] 0 0
Cohort 1: Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 9 years
Secondary outcome [3] 0 0
Cohort 1: PFS by Investigator Assessment
Timepoint [3] 0 0
Up to approximately 9 years
Secondary outcome [4] 0 0
Cohort 1: CRR by Investigator Assessment
Timepoint [4] 0 0
Up to approximately 9 years
Secondary outcome [5] 0 0
Cohort 1: Rate of Undetectable Measurable Residual Disease
Timepoint [5] 0 0
Up to approximately 9 years
Secondary outcome [6] 0 0
Cohort 1: Overall Response Rate (ORR) by IRC and Investigator Assessment
Timepoint [6] 0 0
Up to approximately 9 years
Secondary outcome [7] 0 0
Cohort 1: Duration of Response (DOR) by IRC and Investigator Assessment
Timepoint [7] 0 0
Up to approximately 9 years
Secondary outcome [8] 0 0
Pooled Cohorts: PFS by IRC and Investigator Assessment
Timepoint [8] 0 0
Up to approximately 9 years
Secondary outcome [9] 0 0
Pooled Cohorts: ORR by IRC and Investigator Assessment
Timepoint [9] 0 0
Up to approximately 9 years
Secondary outcome [10] 0 0
Pooled Cohorts: DOR by IRC and Investigator Assessment
Timepoint [10] 0 0
Up to approximately 9 years
Secondary outcome [11] 0 0
Pooled Cohorts: Rate of Undetectable Measurable Residual Disease
Timepoint [11] 0 0
Up to approximately 9 years
Secondary outcome [12] 0 0
Pooled Cohorts: CRR by IRC and Investigator Assessment
Timepoint [12] 0 0
Up to approximately 9 years
Secondary outcome [13] 0 0
Cohort 1 and Pooled Cohorts: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [13] 0 0
Up to one and a half years for Sonrotoclax Plus Zanubrutinib group and 13 months for Venetoclax Plus Obinutuzumab group]
Secondary outcome [14] 0 0
Cohort 1 and Pooled Cohorts: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire -Core 30 (EORTC QLQ-C30) Global Health Status/QoL (GHS) and Physical Functioning Scales
Timepoint [14] 0 0
Every three cycles during the treatment period
Secondary outcome [15] 0 0
Cohort 1 and Pooled Cohorts: Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales
Timepoint [15] 0 0
Every three cycles during the treatment period
Secondary outcome [16] 0 0
Cohort 1 and Pooled Cohorts: Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS).
Timepoint [16] 0 0
Every three cycles during the treatment period

Eligibility
Key inclusion criteria
* Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
* Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
* Measurable disease by Computer Tomography/Magnetic Resonance Imaging
* Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN
* Adequate renal function as defined as creatinine clearance = 50 milliliters per minute
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous systemic treatment for CLL
* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
* Known central nervous system involvement
* History of confirmed progressive multifocal leukoencephalopathy (PML)
* Uncontrolled hypertension

Note: Other protocol defined 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
11/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2032
Actual
Sample size
Target
652
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
Pindara Private Hospital - Benowa
Recruitment hospital [4] 0 0
Sunshine Coast Hospital and Health Service - Birtinya
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford PK
Recruitment hospital [7] 0 0
Monash Health - Clayton
Recruitment hospital [8] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [9] 0 0
Austin Health - Heidelberg
Recruitment hospital [10] 0 0
Cabrini Hospital Malvern - Malvern East
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5042 - Bedford PK
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3144 - Malvern East
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alaska
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California
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District of Columbia
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Florida
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Georgia
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Wien
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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
Address 0 0
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/NCT06073821