Phase 1 results
AML, pneumonia, death, DLTs
CHRONIC PULMONARY FIBROSIS, SECONDARY, PNEUMONIA, AML
Ten patients with newly diagnosed secondary or therapy-related AML were enrolled into the phase 1 portion of the study (3 at dose level 0 with venetoclax 200 mg and 7 at dose level 1 with venetoclax 400 mg). One patient who received the 400 mg dose of venetoclax died on cycle 1, day 14 from pneumonia in the setting of underlying chronic pulmonary fibrosis; this death was considered unrelated to the study drugs so was not considered to be a DLT. Overall, no DLTs were observed at the 2 venetoclax doses evaluated, and a daily dose of 400 mg of venetoclax was chosen as the recommended phase 2 dose for further study.