previously untreated chronic lymphocytic leukemia (CLL)
Conditions
Brief summary
Incidence and severity of TLS (both laboratory and clinical TLS) as defined by Howard criteria during the SLT evaluation window
Detailed description
Safety via incidence and severity of treatment-emergent adverse events, serious adverse events, and adverse events according to NCI-CTCAE v5.0; Tolerability as determined by protocol-defined SLTs during the SLT evaluation window, Incidence of dose modifications (dose modified, held, or discontinued), during the SLT evaluation window
Interventions
DRUGBGB-11417
DRUGZanubrutinib
Sponsors
BeOne Medicines AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of TLS (both laboratory and clinical TLS) as defined by Howard criteria during the SLT evaluation window | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety via incidence and severity of treatment-emergent adverse events, serious adverse events, and adverse events according to NCI-CTCAE v5.0; Tolerability as determined by protocol-defined SLTs during the SLT evaluation window, Incidence of dose modifications (dose modified, held, or discontinued), during the SLT evaluation window | — |
Countries
France
Outcome results
None listed