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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
Date last updated
26/10/2024

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
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
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 9 years
Secondary outcome [1] 0 0
Complete Response Rate (CRR)
Timepoint [1] 0 0
Up to approximately 9 years
Secondary outcome [2] 0 0
Rates of Undetectable Measurable Residual Disease
Timepoint [2] 0 0
Up to approximately 9 years
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 9 years
Secondary outcome [4] 0 0
PFS by Investigator Assessment
Timepoint [4] 0 0
Up to approximately 9 years
Secondary outcome [5] 0 0
CRR by Investigator Assessment
Timepoint [5] 0 0
Up to approximately 9 years
Secondary outcome [6] 0 0
Rates of uMRD4 Based on Flow-Cytometry
Timepoint [6] 0 0
Up to approximately 9 years
Secondary outcome [7] 0 0
Overall Response Rate (ORR) Determined by IRC and Investigator Assessment
Timepoint [7] 0 0
Up to approximately 9 years
Secondary outcome [8] 0 0
Duration of Response (DOR) by IRC and Investigator Assessment
Timepoint [8] 0 0
Up to approximately 9 years
Secondary outcome [9] 0 0
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [9] 0 0
Up to approximately 9 years
Secondary outcome [10] 0 0
The Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [10] 0 0
Up to approximately 9 years
Secondary outcome [11] 0 0
HRQoL) as Assessed by EORTC QLQ-C30 CLL Module Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17)
Timepoint [11] 0 0
Up to approximately 9 years
Secondary outcome [12] 0 0
European Quality of Life 5-Dimensions 5-Levels Health Questionnaire (EQ-5D-5L)
Timepoint [12] 0 0
Up to approximately 9 years

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
640
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
Pindara Private Hospital - Benowa
Recruitment hospital [4] 0 0
Sunshine Coast Hospital and Health Service - Birtinya
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [6] 0 0
Monash Health - Clayton
Recruitment hospital [7] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Austin Health - Heidelberg
Recruitment hospital [9] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 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 - Brisbane
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alaska
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California
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Kansas
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Kentucky
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Missouri
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New York
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North Carolina
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Ohio
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Washington
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Wisconsin
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Austria
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Innsbruck
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Austria
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Salzburg
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Liaoning
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Zhejiang
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Amsterdam
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JD Alkmaar
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Tauranga
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Ankara
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Kocaeli
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United Kingdom
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Bournemouth
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Headington
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Liverpool
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London
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United Kingdom
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Norwich

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

Ethics approval
Ethics application status

Summary
Brief summary
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
Trial website
https://clinicaltrials.gov/study/NCT06073821
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06073821