Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
Mendel Goldfinger
MDMontefiore Medical Center
Project Term: October 1, 2023 - September 30, 2024
Dr. Mendel Goldfinger and collaborators of Einstein have shown in a preliminary trial that weekly low dose decitabine plus one a week venetoclax is highly effective in newly diagnosed patients with MDS or AML. The regimen has reduced toxicity compared to the current dose and schedule of azacitidine plus venetoclax. The proposed new work is attempting to demonstrate in a prospective trial at 3 sites that this data can be replicated and expanded.
The combination of venetoclax plus azacitidine (Ven/Aza) has been widely adopted as new standard of care for elderly patients with AML and is increasingly being used for patients with MDS. While this regimen has transformed the treatment of AML, challenges remain with hematologic toxicities. The majority of patients receiving standard dosing of Aza/Ven require dose interruptions, treatment delays and dose reductions.
Dr. Mendel Goldfinger and collaborators of Einstein have shown in a preliminary trial that weekly low dose decitabine plus one a week venetoclax is highly effective in newly diagnosed patients with MDS or AML. The regimen has reduced toxicity compared to the current dose and schedule of azacitidine plus venetoclax.
The trial is already underway. The goal is to obtain 75 patients by the end of 2024. To date, 22 patients have been enrolled (all at Montefiore Hospital) and 17 have reached an evaluable point. 95% of the patients have achieved the primary endpoint of not requiring a dose interruption or dose reduction, with promising response rates.