Hemato · Published 2026-05-15 · DOI 10.3390/hemato7020016
Asli Odabasi Giden, Duzgun Ozatli, Mehmet Ali Erkurt, Abdullah Karakus, Gulden Sincan, Fehmi Hindilerden, Yusuf Bilen, Ugur Hatipoglu, Gulsum Akgun Cagliyan, Tuba Hacibekiroglu, Sinan Demircioglu, Didar Yanardag Acik, Cengiz Demir, Yavuz Katircilar, Anil Tombak, Seda Yilmaz, Irfan Kuku, Fuat Erdem, Asli Yuksel Ozturkmen, Mehmet Sinan Dal, Semih Basci, Serdal Korkmaz, Turgay Ulas, Fevzi Altuntas
Background: Chronic lymphocytic leukemia (CLL) is a biologically heterogeneous disease characterized by variable clinical outcomes. The introduction of targeted therapies, particularly the BCL-2 inhibitor venetoclax, has significantly improved treatment outcomes in patients with relapsed/refractory (R/R) CLL. However, real-world data on the safety and effectiveness of venetoclax-based regimens remain limited. Methods: In this multicenter retrospective study, 147 adult patients with R/R CLL treated with venetoclax between April 2019 and August 2025 were analyzed. Venetoclax was administered as monotherapy or in combination with rituximab, obinutuzumab, or ibrutinib. Adverse events were graded according to CTCAE v4.0, and treatment responses were assessed based on IWCLL criteria. Survival outcomes, including overall survival (OS) and progression-free survival (PFS), were evaluated using Kaplan–Meier analysis. Results: The median age at venetoclax initiation was 64 years, and patients had received a median of two prior lines of therapy. Combination therapy was administered in 78.9% of patients. The overall response rate was 83.0%, including complete remission in 65.3% of patients. Grade ≥ 3 hematologic adverse events included neutropenia (18.4%), thrombocytopenia (14.3%), and anemia (7.5%). Tumor lysis syndrome (TLS) occurred in 28.6% of patients, predominantly during the dose ramp-up phase. At a median follow-up of 61 months, median OS and PFS were both 60 months. Bulky disease was associated with inferior survival outcomes. Conclusions: Venetoclax-based therapy is effective and well tolerated in patients with R/R CLL in a real-world setting. High response rates and durable survival outcomes were observed despite the inclusion of patients with high-risk clinical and biological features. These findings support the use of venetoclax as a key component of modern CLL treatment strategies and highlight the importance of real-world evidence in optimizing patient management.
Abstract from DOAJ. Public domain (CC0 1.0).
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Giden, A., Ozatli, D., Erkurt, M., et al. (2026). Real-World Outcomes of Venetoclax in Relapsed/Refractory Chronic Lymphocytic Leukemia. Hemato. https://doi.org/10.3390/hemato7020016