Chronic lymphotic leukemia and Small Lymphocytic lymphoma
Conditions
Brief summary
PFS, defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for patients with chronic lymphocytic leukemia (CLL) and Lugano classification for patients with small lymphocytic lymphoma (SLL).
Detailed description
OS, defined as time from the date of randomization to the date of death due to any cause, PFS in patients who were exposed to ncBTKi, determined by IRC, PFS determined by investigator assessment, Overall response rate (partial response [PR] or better) determined by IRC and by investigator assessment, per modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL, Rate of PR with lymphocytosis or higher determined by IRC and by investigator assessment, Duration of response determined by IRC and by investigator assessment, Time to next anti-CLL/SLL treatment (TTNT), Incidence and severity of treatment-emergent adverse events (TEAEs), serious TEAEs, and laboratory abnormalities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Patient-reported symptom burden and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnairechronic lymphocytic leukemia module 17 items (QLQ-CLL17) and global health status (GHS) and physical functioning measured by EORTC quality of life questionnaire core 30 (QLQ-C30)
Interventions
Sponsors
BeOne Medicines AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for patients with chronic lymphocytic leukemia (CLL) and Lugano classification for patients with small lymphocytic lymphoma (SLL). | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, defined as time from the date of randomization to the date of death due to any cause, PFS in patients who were exposed to ncBTKi, determined by IRC, PFS determined by investigator assessment, Overall response rate (partial response [PR] or better) determined by IRC and by investigator assessment, per modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL, Rate of PR with lymphocytosis or higher determined by IRC and by investigator assessment, Duration of response determined by IRC and by investigator assessment, Time to next anti-CLL/SLL treatment (TTNT), Incidence and severity of treatment-emergent adverse events (TEAEs), serious TEAEs, and laboratory abnormalities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Patient-reported symptom burden and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questio | — |
Countries
Czechia, Germany, Italy, Netherlands, Poland
Outcome results
None listed