Clinical Trials in France / NCT07277231
Recruiting
Phase 3
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT07277231 · tracked via the Priya Life Science France tracker
Condition(s) studied
Chronic Lymphocytic Leukemia
Investigational drug(s) / intervention(s)
Sonrotoclax: Administered orally.
Zanubrutinib: Administered orally.
Acalabrutinib: Administered orally.
Venetoclax: Administered orally.
Study summary
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Eligibility
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 bone marrow and organ function
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 or clinically significant cardiovascular disease
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
- Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC) — Up to approximately 70 months
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first. - Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4) — Up to approximately 16 months
Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS).
Trial sites (115)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | Recruiting |
| Chao Family Comprehensive Cancer Center | Orange | California | Recruiting |
| Stanford Cancer Institute | Palo Alto | California | Recruiting |
| Rocky Mountain Cancer Centers (Williams) Usor | Aurora | Colorado | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | Recruiting |
| Mount Sinai Medical Center Braman Comprehensive Cancer Center | Miami | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| Midwestern Regional Medical Center | Zion | Illinois | Recruiting |
| Ochsner Clinic Foundation | New Orleans | Louisiana | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| Atrium Health Levine Cancer Institute (Lci) | Charlotte | North Carolina | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Oncology Associates of Oregon Willamette Valley Cancer Center | Eugene | Oregon | Recruiting |
| Upmc Hillman Cancer Center(Univ of Pittsburgh) | Pittsburgh | Pennsylvania | Recruiting |
| Texas Oncology Tyler | Tyler | Texas | Recruiting |
| Huntsman Cancer Institute | Salt Lake City | Utah | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Blacktown Cancer and Haematology Centre | Blacktown | New South Wales | Recruiting |
| Concord Repatriation General Hospital | Concord | New South Wales | Recruiting |
| Genesiscare North Shore | St Leonards | New South Wales | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Recruiting |
| Monash Health | Clayton | Victoria | Recruiting |
| Austin Health | Heidelberg | Victoria | Recruiting |
| Cabrini Hospital Malvern | Malvern | Victoria | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Instituto Dor de Pesquisa E Ensino Distrito Federal | Brasília | Brazil | Recruiting |
| Centro Gaucho Integrado de Oncologia Hospital Mae de Deus | Porto Alegre | Brazil | Recruiting |
| Ensino E Terapia de Inovacao Clinica Amo Etica | Salvador | Brazil | Recruiting |
| Instituto Dor de Pesquisa E Ensino Sao Paulo | São Paulo | Brazil | Recruiting |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | Brazil | Recruiting |
| Bc Cancer Victoria | Victoria | British Columbia | Recruiting |
| Juravinski Cancer Centre | Hamilton | Ontario | Recruiting |
| Ciusss Nim Hscm | Montreal | Quebec | Recruiting |
| Jewish General Hospital | Montreal | Quebec | Recruiting |
| Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) | Québec | Quebec | Recruiting |
+ 75 more sites — see the full list on the official registry below.
On this site
📄 Brukinsa (zanubrutinib) drug profile → 📄 Calquence (acalabrutinib) drug profile → 📄 Venclexta (venetoclax) drug profile →More BeOne Medicines trials in France
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
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Other trials for the same condition
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
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A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
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Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
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National Acalabrutinib Observational Study
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07277231 on ClinicalTrials.gov ↗ ← All trials in France