Venetoclax and Azacitidine for the Management of Molecular Relapse/Progression in Adult NPM1-mutated Acute Myeloid Leukemia

Summary

This is a phase 2, non-randomized, interventional, open-label, multicenter trial evaluating the efficacy of VEN-AZA as a bridge-to-transplant therapy in chemotherapy-treated adult NPM1mut AML patients who experience molecular relapse or progression during treatment or follow-up. Subjects will receive cycles of venetoclax plus azacitidine. After each cycle, MRD will be evaluated and at any time of MRD-negativity, AlloSCT will be performed.

Timeline

Start

2022-03-01

Primary completion

2025-01

Completion

2025-01

Publications

• Sartor C, Brunetti L, Audisio E, Cignetti A, Zannoni L, Cristiano G, Nanni J, Ciruolo R, Zingarelli F, Ottaviani E, Patuelli A, Bandini L, Forte D, Sciabolacci S, Cardinali V, Papayannidis C, Cavo M, Martelli MP, Curti A. A venetoclax and azacitidine bridge-to-transplant strategy for NPM1-mutated acute myeloid leukaemia in molecular failure. Br J Haematol. 2023 Aug;202(3):599-607. doi: 10.1111/bjh.18887. Epub 2023 May 24.

Drugs

Indications