ClinTrial Refer

Trial Acronym
BGB-11417-301(Celestial)

Registration Number
NCT06073821

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

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)

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

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

Trial Location Name

Address

Status

Alfred Health (Haematology)

The Alfred, Commercial Road, Melbourne VIC, Australia

Closed

Primary Contact : John Nguyen, john.nguyen@alfred.org.au , 03 9076 7135

Auckland City Hospital (Haematology)

2 Park Rd, Grafton, Auckland 1023, New Zealand

Closed

Primary Contact : Charlie Stratton, clinicaltrialrefer@tewhatuora.govt.nz , N/A

Christchurch Hospital (Haematology)

2 Riccarton Ave, Christchurch Central, Christchurch 8011, New Zealand

Closed

Primary Contact : Haematology trials coordinator, HaemClinTrials@cdhb.health.nz , 03 364 0386

Concord Repatriation General Hospital (Haematology)

Hospital Rd, Concord NSW 2139, Australia

Closed

Primary Contact : Jennifer Harman, SLHD-ConcordHaematologyClinicalResearch@health.nsw.gov.au , 02 9767 6348

Fiona Stanley Hospital (Haematology)

11 Robin Warren Dr, Murdoch WA 6150, Australia

Closed

Primary Contact : Wendy Angelatos, wendy.angelatos@health.wa.gov.au , 08 6152 6540

Hollywood Private Hospital (Haematology)

Monash Ave, Nedlands WA 6009, Australia

Closed

Primary Contact : HPH Haematology Team, haematologyctu.hph@ramsayhealth.com.au , 08 9346 6637

North Shore Hospital (Haematology)

North Shore Hospital 124 Shakespeare Road, Takapuna, Auckland, New Zealand

Closed

Primary Contact : Haematology trials coordinator, haematology.research@waitematadhb.govt.nz , N/A

Peter MacCallum - Parkville Cancer Clinical Trials Unit (PCCTU) (Haematology)

Peter MacCallum Cancer Centre, Grattan Street, Melbourne VIC, Australia

Closed

Primary Contact : Enquiry Line Coordinator, clinicaltrials.enquiries@petermac.org , +613 8559 7456

Pindara Private Hospital

Allchurch St, Benowa QLD 4217, Australia

Closed

Primary Contact : Emma Langshaw, LangshawE@ramsayhealth.com.au , 0755889093

Princess Alexandra Hospital (Haematology)

199 Ipswich Rd, Woolloongabba QLD 4102, Australia

Closed

Primary Contact : David Barnes, david.barnes2@health.qld.gov.au , +617 3176 6827

Secondary Contact : Steven Ivanhoe, steven.ivanhoe@health.qld.gov.au , (07) 3176 6826

Tauranga Hospital (Haematology)

Tauranga Hospital 829 Cameron Road, Tauranga South, Tauranga, New Zealand

Closed

Primary Contact : Dr Marie Hughes, marie.hughes@bopdhb.govt.nz , N/A

Wellington Hospital (Haematology)

Wellington Regional Hospital 49 Riddiford Street, Newtown, Wellington, New Zealand

Closed

Primary Contact : Cancer and blood trials coordinator, WBCC-ClinicalTrials@ccdhb.org.nz , N/A

Westmead Hospital (Haematology)

Hawkesbury Rd, Westmead NSW 2145, Australia

Closed

Primary Contact : Gillian Huang, Gillian.Huang@health.nsw.gov.au , (02) 8890 5448

BeiGene

Website URL

Link Name

Link URL

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT06073821

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT06073821

Secondary IDs
N/A

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 3

Minimum Age
18

Maximum Age
100

Date Registered
14/11/2023

Date Closed
N/A

Status
Closed

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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