Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT

Summary

This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the safety and efficacy of the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) as "bridge" to allo-SCT in elderly (≥ 60 - \< 75 years) AML patients. The primary objective is to evaluate the proportion of elderly (≥60 - \<75 years) patients with newly diagnosed AML, eligible for allo-SCT, treated with the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/Cri/MLFS.

Timeline

Start

2019-12-09

Primary completion

2023-02-03

Completion

2025-06-30

Publications

• Russo D, Polverelli N, Bernardi S, Santarone S, Farina M, Borlenghi E, Onida F, Castagna L, Bramanti S, Carella AM, Sorasio R, Martino M, Alati C, Olivieri A, Beltrami G, Curti A, Vetro C, Leotta S, Mancini V, Terruzzi E, Bernardi M, Galieni P, Musto P, Cerretti R, Giaccone L, Skert C, Radici V, Vezzoli M, Calza S, Leoni A, Garuffo L, Bonvicini C, Pellizzeri S, Malagola M, Ciceri F. Venetoclax plus decitabine as a bridge to allogeneic haematopoietic stem-cell transplantation in older patients with acute myeloid leukaemia (VEN-DEC GITMO): final report of a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2024 Nov;11(11):e830-e838. doi: 10.1016/S2352-3026(24)00241-2. Epub 2024 Sep 20.

Drugs

Indications