Venetoclax With Hypomethylating Agents in Newly Diagnosed AML Unfit for Intensive Chemotherapy

This single-arm interventional study evaluated the short-term outcome of one 28-day cycle of venetoclax combined with a hypomethylating agent (azacitidine or decitabine) in adults with newly diagnosed acute myeloid leukemia who could not receive intensive induction chemotherapy. Twenty-four patients were enrolled at the Department of Haematology, Dhaka Medical College Hospital, Dhaka, Bangladesh. In addition to older and comorbid patients, the cohort included younger patients for whom intensive chemotherapy was financially inaccessible - a population under-represented in existing trial and registry data. The primary endpoint was the composite remission rate (complete remission plus complete remission with incomplete haematologic recovery) assessed by bone marrow examination on Day 28. Secondary endpoints included change in complete blood count parameters, treatment-emergent adverse events, and 28-day mortality.

Inclusion Criteria: Newly diagnosed acute myeloid leukemia Age 18 years or older Deemed ineligible for intensive chemotherapy by the treating physician on the basis of age (≥60 years), performance status, or comorbidity; or unable to receive intensive chemotherapy for financial reasons; or unwilling to receive intensive chemotherapy Written informed consent Exclusion Criteria: Acute promyelocytic leukemia Previous treatment with a hypomethylating agent