Short-term Combined Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection and/or Early Treatment Who Do Not Meet IWCLL Treatment Criteria

What this Trial Is About

This research aims to evaluate whether a combination of two cancer drugs, acalabrutinib and venetoclax, can reduce the risk of serious infections and death in patients newly diagnosed with chronic lymphocytic leukemia (CLL) who have a weakened immune system. These infections are a major cause of death among CLL patients, even those who do not yet need chemotherapy. The study uses a computer model called CLL-TIM to identify patients at high risk for infections or early treatment needs. Participants are randomly assigned to receive either three months of combined venetoclax and acalabrutinib treatment or observation without treatment. Venetoclax is gradually increased in dose over five weeks and then given daily, while acalabrutinib is taken twice daily for three cycles of 28 days each. Treatment starts within 14 days after randomization, and the study is conducted at select sites capable of detailed immune system analysis. During the study, patients undergo extensive monitoring of their immune function, infection rates, and overall health before, during, and after treatment. Researchers measure outcomes such as survival without severe infection 12 weeks after treatment, and event-free survival up to two years after enrollment. The study also tracks infections, treatment-free survival, and overall survival at several timepoints to understand the impact of the preventive treatment. Participants are followed for safety and health outcomes throughout the study period.

Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment