: The GIMEMA phase II LLC1518 VERITAS trial investigated the efficacy and safety of frontline, fixed-duration venetoclax and rituximab (VenR) combination in young (≤65 years) and fit patients with chronic lymphocytic leukemia (CLL) and unmutated IGHV and/or TP53 disruption. Treatment consisted of the Ven ramp-up, six-monthly courses of the VenR combination, followed by six monthly courses of Ven single agent. A centralized assessment of measurable minimal residual disease (MRD) was performed on the peripheral blood (PB) and bone marrow (BM) by ASO-PCR at the end of treatment (EOT) and during the follow-up. The primary endpoint was the complete remission (CR) rate at the EOT. Seventy-five patients were enrolled; the median age was 54 years (range 38-65), 96% had unmutated IGHV, 9 (12%) had TP53 disruption, and 4% were IGHV mutated with TP53 disruption. The overall response rate (ORR) at the EOT was 94.7%, with a CR rate of 76%. An undetectable (u) MRD was recorded in 69.3% of patients in the PB and 58.7% in the BM. The 12-month MRD-free survival in the 52 patients with uMRD in the PB at the EOT was 73.1%. After a median follow-up of 20.8 months, no disease progressions were observed. Three patients have died, two due to Covid-19 and 1 to tumor lysis syndrome. The first report of the VERITAS study shows that frontline VenR was associated with a high rate of CRs and durable responses with uMRD in young patients with CLL and unfavorable genetic characteristics.

High rate of durable responses with undetectable minimal residual disease with frontline venetoclax and rituximab in young and fit patients with chronic lymphocytic leukemia and an adverse biologic profile: results of the gimema phase II LLC1518 - 'Veritas' study

Coscia, Marta;Massaia, Massimo;Vitale, Candida;
2023-01-01

Abstract

: The GIMEMA phase II LLC1518 VERITAS trial investigated the efficacy and safety of frontline, fixed-duration venetoclax and rituximab (VenR) combination in young (≤65 years) and fit patients with chronic lymphocytic leukemia (CLL) and unmutated IGHV and/or TP53 disruption. Treatment consisted of the Ven ramp-up, six-monthly courses of the VenR combination, followed by six monthly courses of Ven single agent. A centralized assessment of measurable minimal residual disease (MRD) was performed on the peripheral blood (PB) and bone marrow (BM) by ASO-PCR at the end of treatment (EOT) and during the follow-up. The primary endpoint was the complete remission (CR) rate at the EOT. Seventy-five patients were enrolled; the median age was 54 years (range 38-65), 96% had unmutated IGHV, 9 (12%) had TP53 disruption, and 4% were IGHV mutated with TP53 disruption. The overall response rate (ORR) at the EOT was 94.7%, with a CR rate of 76%. An undetectable (u) MRD was recorded in 69.3% of patients in the PB and 58.7% in the BM. The 12-month MRD-free survival in the 52 patients with uMRD in the PB at the EOT was 73.1%. After a median follow-up of 20.8 months, no disease progressions were observed. Three patients have died, two due to Covid-19 and 1 to tumor lysis syndrome. The first report of the VERITAS study shows that frontline VenR was associated with a high rate of CRs and durable responses with uMRD in young patients with CLL and unfavorable genetic characteristics.
2023
1
32
Mauro, Francesca R; Starza, Irene Della; Messina, Monica; Reda, Gianluigi; Trentin, Livio; Coscia, Marta; Sportoletti, Paolo; Orsucci, Lorella; Arena, Valentina; Casaluci, Gloria Margiotta; Marasca, Roberto; Murru, Roberta; Laurenti, Luca; Ilariucci, Fiorella; Stelitano, Caterina; Mannina, Donato; Massaia, Massimo; Rigolin, Gian Matteo; Scarfò, Lydia; Marchetti, Monia; Levato, Luciano; Tani, Monica; Arcari, Annalisa; Musuraca, Gerardo; Deodato, Marina; Galieni, Piero; Patrizi, Valeria Belsito; Gottardi, Daniela; Liberati, Anna Marina; Giordano, Annamaria; Molinari, Maria Chiara; Pietrasanta, Daniela; Mattiello, Veronica; Visentin, Andrea; Vitale, Candida; Albano, Francesco; Neri, Antonino; De Novi, Lucia Anna; De Propris, Maria Stefania; Nanni, Mauro; Del Giudice, Ilaria; Guarini, Anna; Fazi, Paola; Vignetti, Marco; Piciocchi, Alfonso; Cuneo, Antonio; Foà, Robin
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1890215
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