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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
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 venet...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Fondazione Ferrata Storti
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10388270/ https://www.ncbi.nlm.nih.gov/pubmed/36632738 http://dx.doi.org/10.3324/haematol.2022.282116 |
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author | 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 |
author_facet | 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 |
author_sort | Mauro, Francesca R. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10388270 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Fondazione Ferrata Storti |
record_format | MEDLINE/PubMed |
spelling | pubmed-103882702023-08-01 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 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 Haematologica Article - Chronic Lymphocytic Leukemia 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. Fondazione Ferrata Storti 2023-01-12 /pmc/articles/PMC10388270/ /pubmed/36632738 http://dx.doi.org/10.3324/haematol.2022.282116 Text en Copyright© 2023 Ferrata Storti Foundation https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Noncommercial License (by-nc 4.0) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. |
spellingShingle | Article - Chronic Lymphocytic Leukemia 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 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Article - Chronic Lymphocytic Leukemia |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10388270/ https://www.ncbi.nlm.nih.gov/pubmed/36632738 http://dx.doi.org/10.3324/haematol.2022.282116 |
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