Study on Sonrotoclax, Rituximab, and Zanubrutinib for Treating Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma

Program Overview

The purpose of this study is to test the safety of a new treatment approach for patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). The treatment involves using a combination of drugs: sonrotoclax, which helps kill cancer cells by blocking a protein that helps them survive; rituximab, which targets a protein on cancer cells; and zanubrutinib, which blocks a protein needed for cancer cell growth. The study aims to see if increasing the dose of sonrotoclax over a shorter period, along with rituximab or zanubrutinib, is safe and tolerable for patients.

Description

This study involves two groups of patients receiving different treatments based on their previous response to certain drugs.

Group 1: Patients who have not previously been resistant to Bruton's tyrosine kinase inhibitors (BTKi) will start with zanubrutinib taken by mouth daily for the first 15 cycles. From the fourth cycle, they will gradually increase the dose of sonrotoclax until the target dose is reached, continuing both drugs through 15 cycles. Each cycle lasts 28 days, and patients will have regular CT scans and blood tests. Some may also have bone marrow biopsies and endoscopies.

Group 2: Patients who are resistant to BTKi will start with rituximab taken by mouth on specific days of the first cycle. From the second cycle, they will gradually increase the dose of sonrotoclax until the target dose is reached, continuing sonrotoclax through 13 cycles. Rituximab will also be taken on specific days of cycles 3 to 6. Each cycle lasts 28 days, and patients will have regular CT scans and blood tests. Some may also have bone marrow biopsies and endoscopies.

After finishing the treatment, patients will have follow-up visits 14 days later and then periodically for up to 5 years.

Eligibility Criteria

Locations