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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06073821
Registration number
NCT06073821
Ethics application status
Date submitted
3/10/2023
Date registered
10/10/2023
Date last updated
6/06/2024
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)
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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
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Secondary ID [1]
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BGB-11417-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
CLL
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by independent review committee (IRC)
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Timepoint [1]
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Up to approximately 9 years
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Secondary outcome [1]
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Complete Response Rate (CRR)
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Assessment method [1]
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CRR is defined as the percentage of participants that achieved best response of complete response (CR)/ complete response with incomplete hematopoietic recovery (CRi), determined by IRC.
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Timepoint [1]
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Up to approximately 9 years
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Secondary outcome [2]
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Rates of Undetectable Measurable Residual Disease
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Assessment method [2]
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Undetectable measurable residual disease uMRD4 rate at the first Post- Treatment Follow-up (PTFU 1) Visit will be based on next-generation sequencing.
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Timepoint [2]
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Up to approximately 9 years
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS is defined as time from the date of enrollment to the date of death because of any cause
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Timepoint [3]
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Up to approximately 9 years
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Secondary outcome [4]
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PFS by Investigator Assessment
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Assessment method [4]
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FS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by investigator assessment
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Timepoint [4]
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Up to approximately 9 years
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Secondary outcome [5]
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CRR by Investigator Assessment
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Assessment method [5]
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CRR is defined as the percentage of participants that achieved best response of complete response (CR)/ complete response with incomplete hematopoietic recovery (CRi), determined by Investigator Assessment
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Timepoint [5]
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Up to approximately 9 years
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Secondary outcome [6]
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Rates of uMRD4 Based on Flow-Cytometry
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Assessment method [6]
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The overall uMRD4 rate is defined as the proportion of participants who achieve uMRD status in peripheral blood before disease progression or start of new anti-CLL treatment (whichever is earlier), based on flow cytometry.
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Timepoint [6]
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Up to approximately 9 years
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Secondary outcome [7]
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Overall Response Rate (ORR) Determined by IRC and Investigator Assessment
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Assessment method [7]
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ORR is defined as the percentage of participants who achieve a response (CR, CRi, nodular partial remission (nPR), partial response (PR), and partial response with lymphocytosis [PR-L]), before disease progression or start of new anti-CLL treatment (whichever is earlier).
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Timepoint [7]
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Up to approximately 9 years
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Secondary outcome [8]
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Duration of Response (DOR) by IRC and Investigator Assessment
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Assessment method [8]
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Duration of response (DOR) is defined as the time from first qualifying response PR, PR-L, CR, or CRi) until CLL progression or death.
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Timepoint [8]
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Up to approximately 9 years
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Secondary outcome [9]
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [9]
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Timepoint [9]
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Up to approximately 9 years
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Secondary outcome [10]
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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)
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Assessment method [10]
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Global health status (GHS)/qualify of life (QoL) and physical functioning measured by EORTC QLQ-C30 The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
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Timepoint [10]
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Up to approximately 9 years
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Secondary outcome [11]
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HRQoL) as Assessed by EORTC QLQ-C30 CLL Module Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17)
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Assessment method [11]
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The symptom burden and physical condition/fatigue will be measured by QLQ-CLL17.
EORTC QLQ-CLL17 comprises 17 items grouped into 3 multi-item scales: 1) symptom burden, 2) physical condition/fatigue, and 3) worries/fears about health and functioning.
The EORTC QLQ-CLL17 will be scored according to the EORTC QLQ-C30 Scoring Manual. An outcome variable consisting of a score from 0 to 100 will be derived for each of the symptom scales, each of the functional scales, and the global measure of health status scale. Higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity
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Timepoint [11]
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Up to approximately 9 years
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Secondary outcome [12]
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European Quality of Life 5-Dimensions 5-Levels Health Questionnaire (EQ-5D-5L)
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Assessment method [12]
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Mean change from baseline in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
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Timepoint [12]
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Up to approximately 9 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2032
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Actual
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Sample size
Target
640
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Genesiscare North Shore - St Leonards
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Westmead Hospital - Westmead
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Pindara Private Hospital - Benowa
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Recruitment hospital [5]
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Sunshine Coast Hospital and Health Service - Birtinya
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Recruitment hospital [6]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [7]
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Monash Health - Clayton
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Recruitment hospital [8]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [9]
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Austin Health - Heidelberg
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Recruitment hospital [10]
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Cabrini Hospital Malvern - Malvern
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Recruitment hospital [11]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [12]
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The Alfred Hospital - Melbourne
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Recruitment hospital [13]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [14]
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Hollywood Private Hospital - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4217 - Benowa
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Recruitment postcode(s) [5]
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4575 - Birtinya
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Recruitment postcode(s) [6]
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4102 - Brisbane
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Recruitment postcode(s) [7]
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3168 - Clayton
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Recruitment postcode(s) [8]
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3065 - Fitzroy
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Recruitment postcode(s) [9]
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3084 - Heidelberg
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Recruitment postcode(s) [10]
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3144 - Malvern
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Recruitment postcode(s) [11]
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3000 - Melbourne
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Recruitment postcode(s) [12]
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3004 - Melbourne
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Recruitment postcode(s) [13]
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6150 - Murdoch
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Recruitment postcode(s) [14]
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6009 - Nedlands
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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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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Missouri
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Montana
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Curitiba
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China
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Sichuan
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Korea, Republic of
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Busan Gwang'yeogsi
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Gyeonggido
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Seoul Teugbyeolsi
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Nijmegen
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Rotterdam
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Auckland
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Christchurch
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Takapuna
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Tauranga
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Wellington
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Poland
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San Juan
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Burgos
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Las Palmas Gran Canarias
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Spain
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Madrid
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Bournemouth
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Glasgow
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Headington
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United Kingdom
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London
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United Kingdom
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Norwich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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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)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06073821
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Contact person for public queries
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Study Director
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Address
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Phone
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1-877-828-5568
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06073821
Download to PDF