Clinical Trials in Italy / NCT06073821
Active, not recruiting
Phase 3
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
NCT06073821 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
CLL
Investigational drug(s) / intervention(s)
Sonrotoclax: Administered orally
Zanubrutinib: Administered orally
Venetoclax: Administered orally
Obinutuzumab: Administered intravenously
Study 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)
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 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
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
Primary outcome measure(s)
- Cohort 1: Progression Free Survival (PFS） — Up to approximately 9 years
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) - Cohort 1: Rate of Undetectable Measurable Residual Disease — Up to one and a half years
Undetectable measurable residual disease uMRD4 rate at the first Post- Treatment Follow-up (PTFU 1) Visit will be based on next-generation sequencing.
Trial sites (201)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Oncology and Hematology, Llc | Anchorage | Alaska | |
| City of Hope National Medical Center | Duarte | California | |
| University of California San Diego (Ucsd) Moores Cancer Center | La Jolla | California | |
| Valkyrie Clinical Trials | Los Angeles | California | |
| UCLA Department of Medicine Hematologyoncology | Los Angeles | California | |
| Chao Family Comprehensive Cancer Center | Orange | California | |
| Stanford Medicine | Palo Alto | California | |
| University of Colorado Cancer Center | Aurora | Colorado | |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | |
| Mount Sinai Medical Center Braman Comprehensive Cancer Center | Miami | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Southeastern Regional Medical Center | Newnan | Georgia | |
| Northwestern University | Chicago | Illinois | |
| Illinois Cancercare, Pc | Peoria | Illinois | |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | |
| Mission Cancer and Blood | Waukee | Iowa | |
| The University of Kansas Cancer Center | Westwood | Kansas | |
| Norton Cancer Institute Pavilion | Louisville | Kentucky | |
| Ochsner Clinic Foundation | New Orleans | Louisiana | |
| University of Minnesota | Minneapolis | Minnesota | |
| Washington University School of Medicine | St Louis | Missouri | |
| John Theurer Cancer Center Hackensack University Medical Center | Hackensack | New Jersey | |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | |
| Columbia University Medical Center | New York | New York | |
| Optum Medical Care, Pc | Westbury | New York | |
| University of North Carolina At Chapel Hill | Chapel Hill | North Carolina | |
| Atrium Health Levine Cancer Institute (Lci) | Charlotte | North Carolina | |
| Duke University Medical Center | Durham | North Carolina | |
| Cleveland Clinic Foundation | Cleveland | Ohio | |
| The James Cancer Hospital and Solove Research Institute At Ohio State University | Columbus | Ohio | |
| Oncology Associates of Oregon Willamette Valley Cancer Center | Eugene | Oregon | |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | |
| Scri Tennessee Oncology Chattanooga | Chattanooga | Tennessee | |
| Huntsman Cancer Institute | Salt Lake City | Utah | |
| Virginia Cancer Institute | Richmond | Virginia | |
| Vcu Health System Massey Comprehensive Cancer Center | Richmond | Virginia | |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | |
| Gunderson Health System | La Crosse | Wisconsin | |
| Medical College of Wisconsin | Milwaukee | Wisconsin |
+ 161 more sites — see the full list on the official registry below.
More BeOne Medicines trials in Italy
Other trials for the same condition
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 NCT06073821 on ClinicalTrials.gov ↗ ← All trials in Italy