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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06846671




Registration number
NCT06846671
Ethics application status
Date submitted
21/02/2025
Date registered
25/03/2025

Titles & IDs
Public title
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
Scientific title
A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia Previously Exposed to Both BTK and BCL2 Inhibitors
Secondary ID [1] 0 0
2024-518893-15-00
Secondary ID [2] 0 0
BGB-16673-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CLL 0 0
Chronic Lymphocytic Leukemia 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 - BGB-16673
Treatment: Drugs - Bendamustine
Treatment: Drugs - Idelalisib
Treatment: Drugs - Rituximab
Treatment: Drugs - Venetoclax

Experimental: Arm A: BGB-16673 monotherapy - Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met

Active comparator: Arm B: Investigator's Choice - Participants will receive investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.


Treatment: Drugs: BGB-16673
Administered orally

Treatment: Drugs: Bendamustine
Administered intravenously

Treatment: Drugs: Idelalisib
Administered orally

Treatment: Drugs: Rituximab
Administered intravenously

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
Timepoint [1] 0 0
Approximately 36 Months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately 36 Months
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) in Participants With Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC
Timepoint [2] 0 0
Approximately 36 Months
Secondary outcome [3] 0 0
PFS as Assessed by the Investigator
Timepoint [3] 0 0
Approximately 36 Months
Secondary outcome [4] 0 0
Overall Response Rate (ORR) by IRC and Investigator Assessment
Timepoint [4] 0 0
Approximately 36 Months
Secondary outcome [5] 0 0
Rate of PR with Lymphocytosis or Higher Determined by IRC and by investigator assessment
Timepoint [5] 0 0
Approximately 36 Months
Secondary outcome [6] 0 0
Duration of Response (DOR) by IRC and Investigator Assessment
Timepoint [6] 0 0
Approximately 36 Months
Secondary outcome [7] 0 0
Time to Next Anti-CLL Treatment (TTNT)
Timepoint [7] 0 0
Approximately 36 Months
Secondary outcome [8] 0 0
Number of Participants with Adverse Events
Timepoint [8] 0 0
Approximately 36 Months
Secondary outcome [9] 0 0
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 [9] 0 0
Approximately 24 Months
Secondary outcome [10] 0 0
Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales
Timepoint [10] 0 0
Approximately 24 Months

Eligibility
Key inclusion criteria
1. Confirmed diagnosis of CLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
2. Previously received treatment for CLL with a BTKi and BCL2i.
3. Measurable disease by computer tomography/magnetic resonance imaging
4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
5. Adequate liver function
6. Adequate blood clotting function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
3. Known central nervous system involvement
4. Prior exposure to any BTK protein degraders
5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
6. Clinically significant cardiovascular disease

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
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
11/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/02/2030
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Darling Downs Hospital and Health Service - Toowoomba
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Perth Blood Institute - West Perth
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
4350 - Toowoomba
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Caba
Country [2] 0 0
Brazil
State/province [2] 0 0
Belo Horizonte
Country [3] 0 0
Brazil
State/province [3] 0 0
Brasilia
Country [4] 0 0
Brazil
State/province [4] 0 0
Curitiba
Country [5] 0 0
Brazil
State/province [5] 0 0
Florianopolis
Country [6] 0 0
Brazil
State/province [6] 0 0
Joinville
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio de Janeiro
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
Vitoria
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Czechia
State/province [11] 0 0
Brno
Country [12] 0 0
Czechia
State/province [12] 0 0
Hradec Kralove
Country [13] 0 0
Czechia
State/province [13] 0 0
Praha
Country [14] 0 0
Germany
State/province [14] 0 0
Augsburg
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Chemnitz
Country [17] 0 0
Germany
State/province [17] 0 0
Dortmund
Country [18] 0 0
Germany
State/province [18] 0 0
Frankfurt
Country [19] 0 0
Germany
State/province [19] 0 0
Hamburg
Country [20] 0 0
Germany
State/province [20] 0 0
Homburg
Country [21] 0 0
Germany
State/province [21] 0 0
Koblenz
Country [22] 0 0
Germany
State/province [22] 0 0
Leipzig
Country [23] 0 0
Germany
State/province [23] 0 0
Munster
Country [24] 0 0
Italy
State/province [24] 0 0
Bari
Country [25] 0 0
Italy
State/province [25] 0 0
Firenze
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Novara
Country [28] 0 0
Italy
State/province [28] 0 0
Perugia
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Japan
State/province [30] 0 0
Aichi
Country [31] 0 0
Japan
State/province [31] 0 0
Chiba
Country [32] 0 0
Japan
State/province [32] 0 0
Ehime
Country [33] 0 0
Japan
State/province [33] 0 0
Hiroshima
Country [34] 0 0
Japan
State/province [34] 0 0
Hokkaido
Country [35] 0 0
Japan
State/province [35] 0 0
Hyogo
Country [36] 0 0
Japan
State/province [36] 0 0
Kagoshima
Country [37] 0 0
Japan
State/province [37] 0 0
Miyagi
Country [38] 0 0
Japan
State/province [38] 0 0
Niigata
Country [39] 0 0
Japan
State/province [39] 0 0
Okayama
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka
Country [41] 0 0
Japan
State/province [41] 0 0
Saitama
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Japan
State/province [43] 0 0
Kumamoto
Country [44] 0 0
Japan
State/province [44] 0 0
Kyoto
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Busan Gwang'yeogsi
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Daegu Gwang'yeogsi
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Gyeonggi-do
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Jeollanam-do
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul Teugbyeolsi
Country [50] 0 0
Mexico
State/province [50] 0 0
Mexico
Country [51] 0 0
Mexico
State/province [51] 0 0
Oaxaca
Country [52] 0 0
New Zealand
State/province [52] 0 0
Takapuna
Country [53] 0 0
Poland
State/province [53] 0 0
Brzozow
Country [54] 0 0
Poland
State/province [54] 0 0
Katowice
Country [55] 0 0
Poland
State/province [55] 0 0
Krakow
Country [56] 0 0
Poland
State/province [56] 0 0
Lodz
Country [57] 0 0
Poland
State/province [57] 0 0
Lublin
Country [58] 0 0
Poland
State/province [58] 0 0
Wroclaw
Country [59] 0 0
Sweden
State/province [59] 0 0
Goteborg
Country [60] 0 0
Turkey
State/province [60] 0 0
Ankara
Country [61] 0 0
Turkey
State/province [61] 0 0
Antalya Memorial Hospital
Country [62] 0 0
Turkey
State/province [62] 0 0
Izmir
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Aberdeen
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Birmingham
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Bournemouth
Country [66] 0 0
United Kingdom
State/province [66] 0 0
London
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Nottingham
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Southampton

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/NCT06846671