Final analysis of the phase 1b Chemotherapy and Venetoclax in Elderly Acute Myeloid Leukemia Trial (CAVEAT)

Abstract

Venetoclax plus azacitidine represents a key advance for older, unfit patients with acute myeloid leukemia (AML). The Chemotherapy and Venetoclax in Elderly AML Trial (CAVEAT) was first to combine venetoclax with intensive chemotherapy in newly diagnosed patients aged ≥65 years. In this final analysis, 85 patients (median age, 71 years) were followed up for a median of 41.8 months. The CAVEAT induction combined cytarabine and idarubicin with 5 dose levels of venetoclax (50-600 mg) for up to 14 days. Two additional cohorts explored adjusted-dose venetoclax (50 mg and 100 mg) with posaconazole. CAVEAT induction was well tolerated, with low mortality (4%) and limited high-grade gastrointestinal..