Study on Adding Sonrotoclax to Standard Treatment Zanubrutinib for Untreated Chronic Lymphoblastic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Program Overview

This study aims to find out if combining sonrotoclax with zanubrutinib is more effective than using zanubrutinib alone for treating patients with untreated chronic lymphoblastic leukemia (CLL) or small lymphocytic lymphoma (SLL). Sonrotoclax works by blocking a protein that cancer cells need to survive, while zanubrutinib targets another protein that helps cancer cells grow. The study will compare how well patients do on the combination treatment versus zanubrutinib alone.

Description

The main goal of this study is to compare how long patients live without their cancer getting worse when treated with either the combination of zanubrutinib and sonrotoclax or zanubrutinib alone. The study will also look at how long patients live overall, how many patients achieve complete remission, and how long it takes before they need another treatment. Researchers will also monitor the side effects of the treatments, focusing on infections, heart problems, and other serious conditions.

Patients will be randomly assigned to one of two groups:

• Group 1: Patients will take zanubrutinib twice daily in 28-day cycles. They will continue this treatment as long as it is effective and not causing unacceptable side effects. Regular scans and tests will be done to monitor their progress.

• Group 2: Patients will take zanubrutinib twice daily and start taking sonrotoclax daily from the fourth cycle. They will continue this treatment as long as it is effective and not causing unacceptable side effects. Regular scans and tests will be done to monitor their progress. If patients achieve certain responses, they may stop treatment after 15 cycles and be monitored.

After completing the study treatment, patients will have follow-up visits every 3 months for 3 years, then every 6 months for up to 10 years.

Eligibility Criteria

Locations