The study will evaluate the efficacy and safety of NX-5948 (bexobrutideg) versus pirtobrutinib in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who are relapsed or refractory to prior covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
620
Administered orally once daily
Administered orally once daily per prescribing information
Central Georgia Cancer Care
Macon, Georgia, United States
RECRUITINGFort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
RECRUITINGHematology Oncology of Indiana
Indianapolis, Indiana, United States
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
Time from randomization to disease progression per 2018 International Workshop on CLL (iwCLL) or death due to any cause, whichever is earlier
Time frame: Up to approximately 3.5 years
Objective response rate (ORR) without partial response with lymphocytosis (PR-L) as assessed by IRC
Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), or nodular PR, as assessed per 2018 iwCLL guidelines
Time frame: Up to approximately 2.5 years
Overall survival
Time from randomization to death from any cause
Time frame: Up to approximately 7 years
PFS as assessed by the investigator
Time from randomization to disease progression or death due to any cause, whichever is earlier
Time frame: Up to approximately 3.5 years
Objective response rate (ORR) with and without partial response with lymphocytosis (PR-L) as assessed by IRC and investigator
Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR) or nodular PR, or PR-L (for ORR with PR-L), as assessed per 2018 International Workshop on CLL (iwCLL) guidelines
Time frame: Up to approximately 3.5 years
Duration of response with and without PR-L as assessed by IRC and investigator
Time from the date of the first response to documented disease progression or death due to any cause, whichever is earlier
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SCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGTexas Oncology - West Texas
Midland, Texas, United States
RECRUITINGVirginia Cancer Specialists
Fairfax, Virginia, United States
RECRUITINGTime frame: Up to approximately 3.5 years
Time to next anti-CLL/SLL treatment as assessed by IRC and by investigator
Time from randomization to the date of next anti-CLL/SLL treatment
Time frame: Up to approximately 3.5 years
Change from baseline in global health status/quality of life on the European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire C30 with CLL module (EORTC QLQ-C30-CLL17)
Percentage of participants with a clinically meaningful change from baseline using the EORTC QLQ-C30-CLL17 questionnaire to assess global health and overall quality of life
Time frame: Baseline and up to approximately 3.5 years
Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)
Percentage of participants with a clinically meaningful change from baseline using the EQ-5D-5L questionnaire to assess health outcomes
Time frame: Baseline and up to approximately 3.5 years
Number of participants with treatment-emergent adverse events
Time frame: Up to approximately 3.5 years
Pharmacokinetic profile of NX-5948
NX-5948 concentrations in blood samples
Time frame: Up to Cycle 13 Day 1 (each cycle is 28 days)
Number of participants with clinically significant changes from baseline in laboratory parameters
Laboratory parameters may include hematology, clinical chemistry, and urinalysis
Time frame: Up to approximately 3.5 years
Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure, heart and respiratory rates, pulse oximetry, and temperature
Time frame: Up to approximately 3.5 years