Fixed-duration ibrutinib-venetoclax for first-line treatment of patients with chronic lymphocytic leukemia: the REALITY-WW prospective real-world study cohort

The fixed-duration combination of ibrutinib and venetoclax has shown significant benefits in the first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) through clinical studies with follow-up extending up to 5.5 years. However, there remains an important gap in real-world data regarding efficacy and tolerability outcomes of this regimen outside of clinical trial settings. The REALITY-Worldwide study has been initiated as a prospective observational study aimed at understanding the usage, factors for therapy decision, and clinical response of first-line fixed-duration ibrutinib-venetoclax in routine clinical practice. The primary endpoint is physician-assessed overall response rate according to 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Secondary endpoints and outcomes of interest include duration of response, progression-free survival, overall survival, time to next treatment, tumor lysis syndrome risk, adverse events, patient-reported outcomes, factors associated with physician decision to initiate fixed-duration ibrutinib-venetoclax in clinical practice, medical resource utilization, and patient-reported outcomes. The study aims to enroll approximately 200 patients across Europe, the Middle East, and Latin America. A pooled analysis will include subsets of data collected from REALITY-WW and the ongoing multicenter REALITY-2 study in Germany.