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

StatusRecruiting
PhasePhase 3
Started2026-04-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v4
Trial sites expanded: 182 → 210 locations
2026-08-04
minor
Study Status, Contacts/Locations v3
Trial sites expanded: 152 → 182 locations
2026-07-01
minor
Study Status, Contacts/Locations v2
Trial sites expanded: 141 → 152 locations
2026-06-15
notable
Study Identification, Study Status, Contacts/Locations v1
Recruitment opened
Trial sites expanded: 0 → 141 locations
Start dateestimated 2026-01-15→confirmed 2026-04-30
2026-01-05
minor
Original filing
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.
Trial Details
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 2026-09-02