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Low-Dose Azacitidine Plus Venetoclax Is Effective Maintenance for AML

By Patrick Daly - Last Updated: April 26, 2024 

Low-dose azacitidine plus venetoclax appeared to be a feasible maintenance strategy in acute myeloid leukemia (AML) after intensive and low-intensity induction therapy, according to researchers led by Alexandre Bazinet, MD, of the University of Texas MD Anderson Cancer Center in Houston.

The data, published in Lancet Haematology, were based on a single-center, single-arm, phase II study at the authors’ center. Eligible patients had a World Health Organization 2016 criteria-based diagnosis of AML in complete remission (CR) or CR with incomplete blood count recovery after intensive or low-intensity induction and were not immediately eligible for hematopoietic stem cell transplantation.

The study enrolled a total of 35 patients, of whom 25 (71%) received intensive induction and 10 (29%) received low-intensity induction. The median age of the cohort was 55 years (interquartile range [IQR], 41-62), and 51% of the patients were male. The median number of treatment cycles completed was nine (IQR, 2-22). The median follow-up was 23.3 months (IQR, 9.0-30.0).

The authors reported the median relapse-free survival (RFS) was not reached in the full cohort (95% CI, 20.1 to not calculable) or the intensive induction cohort (95% CI, 29.1 to not calculable). It was 30.3 months (95% CI, 16.5 to not calculable) in the low-intensity cohort.

Two-year RFS was 65% (95% CI, 50-85) in the full cohort, 71% (95% CI, 53-94) in the intensive cohort, and 52% (95% CI, 27-100) in the low-intensity cohort.

For safety, the most common grade 3 or 4 treatment-emergent adverse events were thrombocytopenia in six patients, lung infection in four, leukopenia in four, and neutropenia in three.

“Low-dose azacitidine plus venetoclax is a feasible maintenance strategy in AML following intensive and low-intensity induction,” Dr. Bazinet and colleagues summarized.



Bazinet A, Kantarjian H, Bataller A, et al. Reduced dose azacitidine plus venetoclax as maintenance therapy in acute myeloid leukaemia following intensive or low-intensity induction: a single-centre, single-arm, phase 2 trial. Lancet Haematol. 2024. doi:10.1016/S2352-3026(24)00034-6


Original Source: Low-Dose Azacitidine Plus Venetoclax Is Effective Maintenance for AML | Blood Cancers Today

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