Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia

Summary

Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as IGVH unmutated and patients with a particular characteristic known as 'disrupted TP53' show an inferior outcome after FCR in terms of survival. Venetoclax as a single agent or combined with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated CLL and/or del(17p) and is associated with a high rate of clinical responses.

Timeline

Start

2018-10-31

Primary completion

2021-09-05

Completion

2023-05-11

Publications

• Mauro FR, Starza ID, Messina M, Reda G, Trentin L, Coscia M, Sportoletti P, Orsucci L, Arena V, Casaluci GM, Marasca R, Murru R, Laurenti L, Ilariucci F, Stelitano C, Mannina D, Massaia M, Rigolin GM, Scarfo L, Marchetti M, Levato L, Tani M, Arcari A, Musuraca G, Deodato M, Galieni P, Patrizi VB, Gottardi D, Liberati AM, Giordano A, Molinari MC, Pietrasanta D, Mattiello V, Visentin A, Vitale C, Albano F, Neri A, De Novi LA, De Propris MS, Nanni M, Del Giudice I, Guarini A, Fazi P, Vignetti M, Piciocchi A, Cuneo A, Foa R. High rate of durable responses with undetectable minimal residual disease with front-line venetoclax and rituximab in young, fit patients with chronic lymphocytic leukemia and an adverse biological profile: results of the GIMEMA phase II LLC1518 - VERITAS study. Haematologica. 2023 Aug 1;108(8):2091-2100. doi: 10.3324/haematol.2022.282116.

Drugs

Indications