Treatment
pneumocystis infections, TLS
ACUTE MYELOID LEUKEMIA, TUMOR LYSIS SYNDROME, AML, ADVERSE EVENT, ONCOLOGY, PNEUMOCYSTIS INFECTIONS
All patients received venetoclax 600 mg orally once a day or daily (QD) on Days 1–28 in combination with LDAC 20 mg/mDesign of the expanded access study. AE, adverse event; ECG, electrocardiogram; LDAC, low-dose cytarabine; AML, acute myeloid leukemia; ECOG, Eastern Cooperative Oncology Group; PS, performance status.Tumor lysis syndrome (TLS) prophylaxis and monitoring were implemented for all patients during the study as TLS risk mitigation measures. Specifically, all patients (i) were hospitalized prior to the initial dose of study treatment for at least 24 hours after reaching the target dose of venetoclax in Cycle 1 to monitor for TLS; (ii) received a uric acid reducing agent and hydration prior to and during the ramp-up period and (iii) underwent blood sampling for TLS chemistry tests, including calcium, inorganic phosphorus, potassium, uric acid and creatinine on Day 1 of each cycle and each day during the ramp-up period within 4 hours prior to dosing and 6–8 hours post-dosing of the study drug. Anti-infective prophylaxis for viral, fungal, bacterial or pneumocystis infections was required for patients with an absolute neutrophil count of <500/μl.