@article{Mauro_Starza_Messina_Reda_Trentin_Coscia_Sportoletti_Orsucci_Arena_Casaluci_Marasca_Murru_Laurenti_Ilariucci_Stelitano_Mannina_Massaia_Rigolin_Scarfò_Marchetti_Levato_Tani_Arcari_Musuraca_Deodato_Galieni_Patrizi_Gottardi_Liberati_Giordano_Molinari_Pietrasanta_Mattiello_Visentin_Vitale_Albano_Neri_De Novi_De Propris_Nanni_Del Giudice_Guarini_Fazi_Vignetti_Piciocchi_Cuneo_Foà_2023, place={Pavia, Italy}, title={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}, volume={108}, url={https://haematologica.org/article/view/haematol.2022.282116}, DOI={10.3324/haematol.2022.282116}, abstractNote={<p>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.</p&gt;}, number={8}, journal={Haematologica}, author={Mauro, Francesca R. and Starza, Irene Della and Messina, Monica and Reda, Gianluigi and Trentin, Livio and Coscia, Marta and Sportoletti, Paolo and Orsucci, Lorella and Arena, Valentina and Casaluci, Gloria Margiotta and Marasca, Roberto and Murru, Roberta and Laurenti, Luca and Ilariucci, Fiorella and Stelitano, Caterina and Mannina, Donato and Massaia, Massimo and Rigolin, Gian Matteo and Scarfò, Lydia and Marchetti, Monia and Levato, Luciano and Tani, Monica and Arcari, Annalisa and Musuraca, Gerardo and Deodato, Marina and Galieni, Piero and Patrizi, Valeria Belsito and Gottardi, Daniela and Liberati, Anna Marina and Giordano, Annamaria and Molinari, Maria Chiara and Pietrasanta, Daniela and Mattiello, Veronica and Visentin, Andrea and Vitale, Candida and Albano, Francesco and Neri, Antonino and De Novi, Lucia Anna and De Propris, Maria Stefania and Nanni, Mauro and Del Giudice, Ilaria and Guarini, Anna and Fazi, Paola and Vignetti, Marco and Piciocchi, Alfonso and Cuneo, Antonio and Foà, Robin}, year={2023}, month={Aug.}, pages={2091-2100} }