Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL

This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL/SLL.

NCT Number	NCT07321652
Lead Sponsor	Alliance for Clinical Trials in Oncology Collaborators: National Cancer Institute (NCI)
Conditions	Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Enrollment	466 participants
Start Date	2026-04-30
Primary Completion	2028-09-30 (estimated)
Study Completion	2038-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-05