Zanubrutinib Induction Followed by Delayed Fixed-Duration Combination With Sonrotoclax for CLL/SLL：Stop Trial 2.0

Summary

The goal of this clinical trial is to learn if zanubrutinib induction followed by delayed fixed-duration combination with sonrotoclax works to treat previously untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). It will also learn about the safety of this combination regimen. The main questions it aims to answer are:Does this combination therapy achieve undetectable minimal residual disease (uMRD) in participants?What medical problems (adverse events) do participants have when taking zanubrutinib and sonrotoclax?Researchers will conduct a single-arm study to systematically evaluate the MRD clearance, efficacy, safety, and immune-related functions of this specific treatment sequence.Participants will:Low-risk group (without 17p deletion/TP53 mutation): Take zanubrutinib monotherapy for 12 cycles, followed by combination zanubrutinib + sonrotoclax for 12 cycles, then discontinue treatment for observation.High-risk group (with 17p deletion/TP53 mutation): Follow the same initial regimen (12 cycles monotherapy + 12 cycles combination), followed by zanubrutinib monotherapy maintenance until disease progression.Visit the clinic periodically for MRD assessment (via flow cytometry), efficacy evaluation (CT/PET-CT, lab tests), and safety checks (physical exam, blood tests, ECG).Undergo immune function evaluation via peripheral blood samples to assess changes in T-cell counts and subsets.

Timeline

Start

2026-06-08

Primary completion

2029-12-31

Completion

2034-08-01

Publications

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• Background Laurencin CT, Walker JM. A Pandemic on a Pandemic: Racism and COVID-19 in Blacks. Cell Syst. 2020 Jul 22;11(1):9-10. doi: 10.1016/j.cels.2020.07.002. Epub 2020 Jul 22.
• Background Jana A, Baruah M, Munan S, Samanta A. ICT based water-soluble fluorescent probe for discriminating mono and dicarbonyl species and analysis in foods. Chem Commun (Camb). 2021 Jun 29;57(52):6380-6383. doi: 10.1039/d1cc02600c.
• Background Zakir M, Thomas D, Adams R, Farnell D, Claydon N. A Systematic Review and Meta-Analysis of the Clinical Outcomes for Adjunctive Physical, Chemical, and Biological Treatment of Dental Implants With Peri-Implantitis. J Oral Implantol. 2023 Apr 1;49(2):168-178. doi: 10.1563/aaid-joi-D-21-00204.
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