Fixed-duration ibrutinib-venetoclax for first-line treatment of patients with chronic lymphocytic leukemia: the REALITY-WW prospective real-world study cohort.
No Thumbnail Available
All Authors
Munir, T.
Leao, D.
Messahel, B.
Srikanthan, S.
Xu, P.
Fouad, M.
Kavanagh, C.
Tapprich, C.
Miles, O.
Scheliga, A.
LTHT Author
Munir, Talha
LTHT Department
Oncology
Haematology
Haematology
Non Medic
Publication Date
2025
Item Type
Journal Article
Observational Study
Observational Study
Language
Subject
Subject Headings
Abstract
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.
Journal
Future Oncology