TY - JOUR
T1 - 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 biological profile: results of the GIMEMA phase II LLC1518 - 'Veritas' study
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
Y1 - 2023
N2 - : 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.
AB - : 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.
KW - Rituximab
KW - Venetoclax
KW - chronic lymphocytic leukemia
KW - Rituximab
KW - Venetoclax
KW - chronic lymphocytic leukemia
UR - https://publicatt.unicatt.it/handle/10807/235644
UR - https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85166388643&origin=inward
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85166388643&origin=inward
U2 - 10.3324/haematol.2022.282116
DO - 10.3324/haematol.2022.282116
M3 - Article
SN - 0390-6078
SP - N/A-N/A
JO - Haematologica
JF - Haematologica
IS - January
ER -