Patients with higher-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) often experience temporary responses to current treatments, such as hypomethylating agents, which leads to an increased risk of the disease evolving to acute myeloid leukemia. In a phase II study, which is being presented at the 2025 ASCO Annual Meeting (Abstract 6503), Guillermo Montalban-Bravo, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues evaluated the safety and efficacy of cladribine plus low-dose cytarabine and venetoclax, alternating with azacitidine and venetoclax, in patients with newly diagnosed and relapsed or refractory higher-risk MDS or CMML.
The combination was reported to be well tolerated overall, with the most common adverse events being thrombocytopenia (35%), febrile neutropenia (13%), and neutropenia (10%). Among the 48 evaluable patients, overall response rates were 43% (complete response in four patients) and 72% (complete response in seven patients) in relapsed or refractory and newly diagnosed patients, respectively. With a median follow-up of 15.1 months, median overall survival was not yet reached for newly diagnosed patients and 5.8 months for relapsed or refractory patients. The trial is ongoing, and researchers continue to evaluate and enroll patients.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
