TY - JOUR AU - Mauro, Francesca R. AU - Starza, Irene Della AU - Messina, Monica AU - Reda, Gianluigi AU - Trentin, Livio AU - Coscia, Marta AU - Sportoletti, Paolo AU - Orsucci, Lorella AU - Arena, Valentina AU - Casaluci, Gloria Margiotta AU - Marasca, Roberto AU - Murru, Roberta AU - Laurenti, Luca AU - Ilariucci, Fiorella AU - Stelitano, Caterina AU - Mannina, Donato AU - Massaia, Massimo AU - Rigolin, Gian Matteo AU - Scarfò, Lydia AU - Marchetti, Monia AU - Levato, Luciano AU - Tani, Monica AU - Arcari, Annalisa AU - Musuraca, Gerardo AU - Deodato, Marina AU - Galieni, Piero AU - Patrizi, Valeria Belsito AU - Gottardi, Daniela AU - Liberati, Anna Marina AU - Giordano, Annamaria AU - Molinari, Maria Chiara AU - Pietrasanta, Daniela AU - Mattiello, Veronica AU - Visentin, Andrea AU - Vitale, Candida AU - Albano, Francesco AU - Neri, Antonino AU - De Novi, Lucia Anna AU - De Propris, Maria Stefania AU - Nanni, Mauro AU - Del Giudice, Ilaria AU - Guarini, Anna AU - Fazi, Paola AU - Vignetti, Marco AU - Piciocchi, Alfonso AU - Cuneo, Antonio AU - Foà, Robin PY - 2023/08/01 Y2 - 2024/03/28 TI - 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 JF - Haematologica JA - haematol VL - 108 IS - 8 SE - Articles DO - 10.3324/haematol.2022.282116 UR - https://haematologica.org/article/view/haematol.2022.282116 SP - 2091-2100 AB - The GIMEMA phase II LLC1518 VERITAS trial investigated the efficacy and safety of front-line, fixed-duration venetoclax and rituximab (VenR) in combination in young (≤65 years), fit patients with chronic lymphocytic leukemia and unmutated IGHV and/or TP53 disruption. Treatment consisted of the venetoclax ramp-up, six monthly courses of the VenR combination, followed by six monthly courses of venetoclax as a single agent. A centralized assessment of minimal residual disease (MRD) was performed by allele-specific oligonucleotide polymerase chain reaction assay on the peripheral blood and bone marrow at the end of treatment (EOT) and during the follow-up. The primary endpoint was the complete remission rate at the EOT. Seventy-five patients were enrolled; the median age was 54 years (range, 38-65), 96% had unmutated IGHV, 12% had TP53 disruption, and 4% had mutated IGHV with TP53 disruption. The overall response rate at the EOT was 94.7%, with a complete remission rate of 76%. MRD was undetectable in the peripheral blood of 69.3% of patients and in the bone marrow of 58.7% of patients. The 12-month MRD-free survival in the 52 patients with undetectable MRD in the peripheral blood at the EOT was 73.1%. After a median follow-up of 20.8 months, no cases of disease progression were observed. Three patients had died, two due to COVID-19 and one due to tumor lysis syndrome. The first report of the VERITAS study shows that front-line VenR was associated with a high rate of complete remissions and durable response with undetectable MRD in young patients with chronic lymphocytic leukemia and unfavorable genetic characteristics. ClinicalTrials.gov identifier: NCT03455517. ER -