Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Conditions
Brief summary
Overall response rate (ORR) (complete Response [CR]/ CR with incomplete marrow recovery [CRi] + partial response [PR] + nodular PR) as assessed by an Independent Review Committee (IRC)
Detailed description
ORR as assessed by investigator, Duration of response as assessed by IRC and by investigator, Progression-free survival as assessed by IRC and by investigator, Complete response rate (CR + CRi) as assessed by IRC and by investigator, Time to response as assessed by IRC and by investigator, Overall survival, Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation, Changes from baseline in laboratory parameters and vital signs, NX-5948 plasma concentrations
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) (complete Response [CR]/ CR with incomplete marrow recovery [CRi] + partial response [PR] + nodular PR) as assessed by an Independent Review Committee (IRC) | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR as assessed by investigator, Duration of response as assessed by IRC and by investigator, Progression-free survival as assessed by IRC and by investigator, Complete response rate (CR + CRi) as assessed by IRC and by investigator, Time to response as assessed by IRC and by investigator, Overall survival, Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation, Changes from baseline in laboratory parameters and vital signs, NX-5948 plasma concentrations | — |
Countries
France, Hungary, Italy, Poland