A Phase III, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared with Venetoclax Plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Lymphoma/CLL (ONC)
Current Status: Not open
Phase: III
Principal Investigator: Vose, Julie
Contact Information:
Lidia Boghean
lidia.boghean@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07277231?term=NCT07277231&viewType=Card&rank=1#participation-criteria
Summary
Primary:
- To compare efficacy between Arm A (SZ) vs Arm B (AV), as measured by PFS determined by the Independent Review Committee (IRC) in all enrolled patients.
- To compare the rate of undetectable MRD at < 10-4 sensitivity (uMRD4) in both PB and BMA among patients enrolled to Arm A vs Arm B.
Secondary:
- To compare PFS determined by IRC among high risk patients enrolled to Arm A vs Arm B.
- To compare overall survival (OS) among patients enrolled to Arm A vs Arm B.
- To compare overall response rate (ORR) among patients enrolled to Arm A vs Arm B determined by IRC.
- To compare the rate of undetectable MRD at < 10-5 sensitivity (uMRD5) in both PB and BMA among patients enrolled to Arm A vs Arm B.
- Safety.
- To further compare the outcomes of Arms A and Arm B.
- To evaluate the patient-reported disease and treatment specific symptoms and functioning in patients receiving SZ compared with patients receiving AV; and compare changes in the key patient-reported outcomes (PRO) endpoints in patients receiving SZ vs AV.