A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)
Phase 2 – studying effectiveness and dosage
Conditions:
Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Sponsor: Nurix Therapeutics Inc.
trial.available_in:
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Overview
Trial status: Authorised
ORR with PR-L as assessed by IRC, DOR as assessed by IRC and by investigator, PFS as assessed by IRC and by investigator, Complete response rate as assessed by IRC and by investigator, TTR as assessed by IRC and by investigator, OS, Including, but not limited to, incidence and severity of TEAEs, SAEs and TEAEs leading to study drug discontinuation, Changes from baseline in laboratory parameters and vital signs, Summary measures of PK trough concentrations, ORR (with and without PR-L) as assessed by investigator, PROs measured by EORTC QLQ-C30 and EQ-5D-5L questionnaires
ORR (without PR-L) as assessed by IRC
Description
ORR with PR-L as assessed by IRC, DOR as assessed by IRC and by investigator, PFS as assessed by IRC and by investigator, Complete response rate as assessed by IRC and by investigator, TTR as assessed by IRC and by investigator, OS, Including, but not limited to, incidence and severity of TEAEs, SAEs and TEAEs leading to study drug discontinuation, Changes from baseline in laboratory parameters and vital signs, Summary measures of PK trough concentrations, ORR (with and without PR-L) as assessed by investigator, PROs measured by EORTC QLQ-C30 and EQ-5D-5L questionnaires
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 41 participants