1. 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
- Author
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Francesca R. Mauro, Irene Della Starza, Monica Messina, Gianluigi Reda, Livio Trentin, Marta Coscia, Paolo Sportoletti, Lorella Orsucci, Valentina Arena, Gloria Margiotta Casaluci, Roberto Marasca, Roberta Murru, Luca Laurenti, Fiorella Ilariucci, Caterina Stelitano, Donato Mannina, Massimo Massaia, Gian Matteo Rigolin, Lydia Scarfò, Monia Marchetti, Luciano Levato, Monica Tani, Annalisa Arcari, Gerardo Musuraca, Marina Deodato, Piero Galieni, Valeria Belsito Patrizi, Daniela Gottardi, Anna Marina Liberati, Annamaria Giordano, Maria Chiara Molinari, Daniela Pietrasanta, Veronica Mattiello, Andrea Visentin, Candida Vitale, Francesco Albano, Antonino Neri, Lucia Anna De Novi, Maria Stefania De Propris, Mauro Nanni, Ilaria Del Giudice, Anna Guarini, Paola Fazi, Marco Vignetti, Alfonso Piciocchi, Antonio Cuneo, and Robin Foà
- Subjects
Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
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.
- Published
- 2023
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