Chemotherapy and Venetoclax in Elderly Acute Myeloid Leukemia Trial (CAVEAT): A Phase Ib Dose-Escalation Study of Venetoclax Combined With Modified Intensive Chemotherapy
Chong Chyn Chua, Andrew W Roberts, John Reynolds, Chun Yew Fong, Stephen B Ting, Jessica M Salmon, Sarah MacRaild, Adam Ivey, Ing Soo Tiong, Shaun Fleming, Fiona C Brown, Sun Loo, Ian J Majewski, Stefan K Bohlander, Andrew H Wei
JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2020
PURPOSE: The B-cell lymphoma 2 (BCL-2) inhibitor venetoclax has an emerging role in acute myeloid leukemia (AML), with promising response rates in combination with hypomethylating agents or low-dose cytarabine in older patients. The tolerability and efficacy of venetoclax in combination with intensive chemotherapy in AML is unknown. PATIENTS AND METHODS: Patients with AML who were ≥ 65 years (≥ 60 years if monosomal karyotype) and fit for intensive chemotherapy were allocated to venetoclax dose-escalation cohorts (range, 50-600 mg). Venetoclax was administered orally for 14 days each cycle. During induction, a 7-day prephase/dose ramp-up (days -6 to 0) was followed by an additional 7 days of..View full abstract
Awarded by National Health and Medical Research Council of Australia
Awarded by Medical Research Future Fund
Supported by a grant from the Victorian Cancer Agency; by Abbvie (which provided venetoclax); and in part by grants and fellowships from National Health and Medical Research Council of Australia (Nos. 1079560, 1162809, 1126843, 1174902), Leukemia and Lymphoma Society Specialized Centre of Research (to A. Strasser.), the Australian Cancer Research Foundation (for equipment), the Medical Research Future Fund (fellowship support, to A.H.W., No. 1141460), and the Victorian Cancer Agency (to I.J.M.); and by Leukaemia and Blood Cancer New Zealand (S.K.B.) and the family of Marijana Kumerich (S.K.B.).