A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: D'Angelo, Christopher
Contact Information:
Katie Bourret
kbourret@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06637501?term=NCT06637501&rank=1#participation-criteria
Summary
Primary
To compare efficacy between Arm A (sonrotoclax plus zanubrutinib) versus Arm B (zanubrutinib) measured by the proportion of patients that achieve a complete response (CR) or complete response with incomplete bone marrow recovery (CRi)
Key Secondary
To compare efficacy between Arm A (sonrotoclax plus zanubrutinib) versus Arm B (zanubrutinib) by rate of undetectable minimal residual disease at < 10-4 sensitivity (uMRD4)
Secondary
To compare the efficacy between Arm A versus Arm B through CR/CRi per investigator response assessment; overall response rate (ORR), duration of response (DOR), and time to response (TTR) per IRC and investigator assessment; progression-free survival (PFS) per investigator assessment, and overall survival (OS).
To compare the safety and tolerability of Arm A (sonrotoclax plus zanubrutinib) versus Arm B (zanubrutinib)
Exploratory
To evaluate the prognostic biomarkers and biomarkers of relapse and correlation with clinical outcomes
To assess undetectable MRD (uMRD) rate at various timepoints by flow cytometry and delta MRD by ClonoSEQ® in Arm A
To evaluate the pharmacokinetics of sonrotoclax when co-administered with zanubrutinib in Arm A
To evaluate the patient-reported outcomes (PROs)