A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML

Summary

The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.

Timeline

Start

2024-01-17

Primary completion

2028-12

Completion

2028-12

Outcome

Met primary endpoint

paper GMRs were 2.0 (90% CI, 1.4-2.8) for AUC0-24h and 1.4 (90% CI, 1.0-2.0) for Cmax. PMID 42007248 ↗

Publications

• Westra N, Cerro ER, Schilder E, Lub-de Hooge MN, Touw DJ, Kosterink JGW, Chitu DA, Ammatuna E, Klein SK, Westerweel PE, Cuijpers M, Cruijsen M, Corsten MMF, Alhan C, Tick L, Schuringa JJ, Huls G, Woolthuis CM, Oude Munnink TH. Pharmacological boosting of azacitidine/venetoclax in acute myeloid leukemia. Blood Neoplasia. 2026 Mar 12;3(2):100218. doi: 10.1016/j.bneo.2026.100218. eCollection 2026 May.

Drugs

Indications