Safety Evaluation of Sonrotoclax Dose Ramp-up Combined with Zanubrutinib in Adults with Blood Cancers Including CLL and MCL

What this Trial Is About

Researchers are evaluating the safety of new dosing and ramp-up schedules for sonrotoclax in adults with blood cancers, including chronic lymphocytic leukemia CLL and mantle cell lymphoma MCL. This study aims to focus on tumor lysis syndrome TLS and related toxicities caused by the drug. Sonrotoclax works by blocking a protein called BCL-2, which helps slow or stop tumor growth and promote tumor cell death. Zanubrutinib, another drug blocking Brutons tyrosine kinase BTK, is also included and is approved for treating these B-cell malignancies worldwide. Participants will first receive zanubrutinib alone, followed by a combination with sonrotoclax using a gradual dose ramp-up based on specific schedules defined in the study protocol. Treatment lasts 15 cycles of 28 days for treatment-naefve CLL participants or 27 cycles for relapsedrefractory MCL participants, with some continuing zanubrutinib alone afterward. The study takes place at multiple centers worldwide and aims to optimize the ramp-up schedule to potentially benefit patients and caregivers. Participants will be monitored for safety during treatment, focusing on the occurrence of tumor lysis syndrome within approximately four months. Adverse events and dose modifications will also be recorded during this period. The total participation duration is about 17 months for treatment-naefve CLL and about 32 months for relapsedrefractory MCL participants, including treatment and follow-up assessments.

A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.