Previously untreated chronic lymphocytic leukemia
Conditions
Interventions
Patients will be randomized in a 1:1 ratio to one of the following:
- Experimental: Sonrotoclax Plus Zanubrutinib
Participants will receive from start of Cycle 1 a standard dose of zanubrutinib once o
Sponsors
Tanaka Koichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Treatment-naive (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) = 50 milliliters per minute
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as time from the date of randomization to the date of first confirmed disease progression as determined by IRC or death due to any cause, whichever occurs first. | — |
Countries
Australia, Austria, Brazil, Canada, China, Czech Republic, France, Germany, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Spain, Sweden, Turkey, UK, US
Contacts
Public ContactFumiaki Hamano
BeOne Medicines Japan
Outcome results
None listed