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

Many patients with CLL have a weakened immune system due to their disease. It increases their risk of developing serious, treatment-requiring infections such as blood poisoning or pneumonia, which in the worst case may end with fatal outcomes. Serious infections due to CLL are responsible for one third of all deaths among CLL patients. PreVent-ACaLL study will investigate whether a combination of two known types of cancer drugs can reduce the risk of infection and thus mortality when given preventively to newly diagnosed CLL patients. A newly developed register-based computer model can predict which patients are at high risk in order to develop infections as a result of their CLL. A preventive treatment might be initiated before patients need chemotherapy. In this way, the cancer disease might be "reset" so that the immune system, which is inhibited by CLL, is restored and the risk of fatal infections is minimized.

NCT Number	NCT03868722
Lead Sponsor	Rigshospitalet, Denmark Collaborators: Stichting Hemato-Oncologie voor Volwassenen Nederland, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Karolinska Institutet
Conditions	CLL
Enrollment	212 participants
Start Date	2019-10-11
Primary Completion	2029-07-31 (estimated)
Study Completion	2030-07-31 (estimated)
Updated on ClinicalTrials.gov	2023-12-04