Study design
AML
DISEASE, AML
This study was a single-arm, open-label, multicenter, EAS of venetoclax in combination with LDAC in newly diagnosed patients with AML who were ineligible for intensive induction therapy in Japan. The primary objective was to provide a treatment option with venetoclax plus LDAC to eligible patients in the EAS prior to the approval of venetoclax by the Ministry of Health, Labour and Welfare in Japan. There were no efficacy endpoints and only safety was assessed, but bone marrow and disease assessment were conducted at the investigator’s discretion to evaluate the disease condition based on patients’ physical findings, peripheral blood counts and/or bone marrow examination during study treatment. The protocol and informed consent form were reviewed and approved by an independent ethics committee/institutional review board at each site before initiation. All patients provided written informed consent before participating. The study was conducted in accordance with the International Council for Harmonization requirements, Good Clinical Practice guidelines and the Declaration of Helsinki.