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1. Busulfan or Treosulfan Conditioning Platform for Allogeneic Stem Cell Transplantation in Patients Aged >60 y with Acute Myeloid Leukemia/Myelodysplastic Syndrome: A Subanalysis of the GITMO AlloEld Study

Author

Malagola, M., Polverelli, N., Martino, Michelangelo, Patriarca, Fabrizio, Bruno, Brunella, Giaccone, L., Grillo, G., Bramanti, S., Bernasconi, P., De Gobbi, M., Natale, A., Terruzzi, E., Olivieri, Alessandra, Chiusolo, Patrizia, Carella, A. M., Casini, Marina, Maffini, E., Nozzoli, C., Mazza, P., Bassi, S., Onida, F., Vacca, Alessandro, Falcioni, S., Luppi, M., Iori, A. P., Pavone, V., Skert, C., Carluccio, P., Borghero, C., Proia, A., Selleri, C., Rubini, V., Sacchi, N., Oldani, E., Bonifazi, F., Ciceri, F., Russo, Daniele, Bernardi, S., Farina, M., Fiore, M., Lupo Stanghellini, M. T., Fanin, R., Faraci, D. G., Castagna, Luigi, Colombo, A. A., Nicoli, P., Santarone, S., Scortechini, I., Metafuni, Elisabetta, Merla, E., Cavattoni, I., Cutini, I., Mazzone, A., Saporiti, G., Canale, F. A., Piras, Edoardo, Galieni, P., Debbia, G., La Rocca, U., Mele, Dario Antonio, Carobolante, F., Elice, F., Fanelli, F., Martino M., Patriarca F., Bruno B., Olivieri A., Chiusolo P. (ORCID:0000-0002-1355-1587), Casini M. (ORCID:0000-0002-3209-7770), Vacca A., Russo D., Castagna L., Metafuni E., Piras E., Mele A., Malagola, M., Polverelli, N., Martino, Michelangelo, Patriarca, Fabrizio, Bruno, Brunella, Giaccone, L., Grillo, G., Bramanti, S., Bernasconi, P., De Gobbi, M., Natale, A., Terruzzi, E., Olivieri, Alessandra, Chiusolo, Patrizia, Carella, A. M., Casini, Marina, Maffini, E., Nozzoli, C., Mazza, P., Bassi, S., Onida, F., Vacca, Alessandro, Falcioni, S., Luppi, M., Iori, A. P., Pavone, V., Skert, C., Carluccio, P., Borghero, C., Proia, A., Selleri, C., Rubini, V., Sacchi, N., Oldani, E., Bonifazi, F., Ciceri, F., Russo, Daniele, Bernardi, S., Farina, M., Fiore, M., Lupo Stanghellini, M. T., Fanin, R., Faraci, D. G., Castagna, Luigi, Colombo, A. A., Nicoli, P., Santarone, S., Scortechini, I., Metafuni, Elisabetta, Merla, E., Cavattoni, I., Cutini, I., Mazzone, A., Saporiti, G., Canale, F. A., Piras, Edoardo, Galieni, P., Debbia, G., La Rocca, U., Mele, Dario Antonio, Carobolante, F., Elice, F., Fanelli, F., Martino M., Patriarca F., Bruno B., Olivieri A., Chiusolo P. (ORCID:0000-0002-1355-1587), Casini M. (ORCID:0000-0002-3209-7770), Vacca A., Russo D., Castagna L., Metafuni E., Piras E., and Mele A.

Abstract

Background. The conditioning regimens with different alkylators at different doses can influence the outcome of allogeneic stem cell transplantation (SCT), but conclusive data are missing. Methods. With the aim to analyze real-life allogeneic SCTs performed in Italy between 2006 and 2017 in elderly patients (aged >60 y) with acute myeloid leukemia or myelodysplastic syndrome, we collected 780 first transplants data. For analysis purposes, patients were grouped according to the type of alkylator included in the conditioning (busulfan [BU]-based; n = 618; 79%; treosulfan [TREO]-based; n=162; 21%). Results. No significant differences were observed in nonrelapse mortality, cumulative incidence of relapse, and overall survival, although in the TREO-based group, we observed a greater proportion of elderly patients (P < 0.001); more active diseases at the time of SCT (P < 0.001); a higher prevalence of patients with either hematopoietic cell transplantation-comorbidity index ≥3 (P < 0.001) or a good Karnofsky performance status (P = 0.025); increased use of peripheral blood stem cells as graft sources (P < 0.001); and greater use of reduced intensity conditioning regimens (P = 0.013) and of haploidentical donors (P < 0.001). Moreover, the 2-y cumulative incidence of relapse with myeloablative doses of BU was significantly lower than that registered with reduced intensity conditioning (21% versus 31%; P = 0.0003). This was not observed in the TREO-based group. Conclusions. Despite a higher number of risk factors in the TREO group, no significant differences were observed in nonrelapse mortality, cumulative incidence of relapse, and overall survival according to the type of alkylator, suggesting that TREO has no advantage over BU in terms of efficacy and toxicity in acute myeloid leukemia and myelodysplastic syndrome.

Published
2023

2. ‘Real-life’ report on the management of chronic GvHD in the Gruppo Italiano Trapianto Midollo Osseo (GITMO)

Author

Giaccone, L, Mancini, G, Mordini, N, Gargiulo, G, De Cecco, V, Angelini, S, Arpinati, M, Baronciani, D, Bozzoli, V, Bramanti, S, Calore, E, Cavattoni, I M, Cimminiello, M, Colombo, A A, Facchini, L, Falcioni, S, Faraci, M, Fedele, R, Guidi, S, Iori, A P, Marotta, S, Micò, M C, Milone, G, Onida, F, Pastore, D, Patriarca, F, Pini, M, Raimondi, R, Rovelli, A, Santarone, S, Severino, A, Skert, C, Stanghellini, M T L, Tecchio, C, Vassallo, E, Chiarucci, M, Bruno, B, Bonifazi, F, and Olivieri, A

Published
2018
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4. Changes in Stem Cell Transplant activity and procedures during SARS-CoV2 pandemic in Italy: an Italian Bone Marrow Transplant Group (GITMO) nationwide analysis (TransCOVID-19 Survey)

Author

Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., Elice F., Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., and Elice F.

Abstract

The Transplant Centers belonging to Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO) conducted a survey with the aim of evaluating the effect of SARS-CoV2 pandemic on the allogeneic transplant activity in Italy. The pandemic period from 1/3/2020 to 31/7/2020 was compared with the same period in 2019. Overall, in 2020 there was a 2.4% reduction in the number of allo-HCT cases compared to 2019. Interestingly, this deflection did not affect the acute leukemia cases (+5.7% in 2020). The use of peripheral blood-derived stem cells (+10.7%) and cryopreservation (97.4% of the centers) was highly adopted in 2020. Despite the sanitary emergency, almost all of the surveyed centers declared no impact of SARS-CoV2 pandemic on the transplant timing and outcomes, and the sanitary policy was positively evaluated by the majority of centers. The emergency measures ensured that only a minority of the allo-HCT patients had been infected by SARS-CoV2; however, a mortality of 42.1% among the allo-HCT patients hospitalized for COVID-19 was recorded. This survey gives us the information that the GITMO Group reacted positively to the pandemic. Thanks to the emergency strategies, the Italian allo-HCT activity continued safely, showing only a minor deflection and offering the same probability of cure to the transplanted patients.

Published
2021

5. Changes in Stem Cell Transplant activity and procedures during SARS-CoV2 pandemic in Italy: an Italian Bone Marrow Transplant Group (GITMO) nationwide analysis (TransCOVID-19 Survey)

Author

Russo D., Polverelli N., Malagola M., Farina M., Leoni A., Bernardi S., Mammoliti S., Sacchi N., Martino M., Ciceri F., Zallio F., Olivieri A., Falcioni S., Storti G., Michieli M., Carluccio P., Grassi A., Oldani E., Bonifazi F., Prete A., Cavattoni I. M., Maffeis M., Pastore D., Vacca A., Caravelli D., Mirabile M., Mordini N., Nozzoli C., Faraci M., Federico V., Ronconi S., Skert C., Onida F., Marcatti M., Piemontese S., Narni F., Balduzzi A., De Simone G., Picardi A., De Gobbi M., Calore E., Tringali S., Zecca M., Secondino S., Guiducci B., Pelosini M., Zuffa E., Facchini L., Imola M., Iori A. P., Proia A., Sica S., Armiento D., Carella A. M., Dellacasa C. M., Fagioli F., Rabusin M., Ferrario A., Elice F., Russo, D, Polverelli, N, Malagola, M, Farina, M, Leoni, A, Bernardi, S, Mammoliti, S, Sacchi, N, Martino, M, Ciceri, F, Zallio, F, Olivieri, A, Falcioni, S, Storti, G, Michieli, M, Carluccio, P, Grassi, A, Oldani, E, Bonifazi, F, Prete, A, Cavattoni, I, Maffeis, M, Pastore, D, Vacca, A, Caravelli, D, Mirabile, M, Mordini, N, Nozzoli, C, Faraci, M, Federico, V, Ronconi, S, Skert, C, Onida, F, Marcatti, M, Piemontese, S, Narni, F, Balduzzi, A, De Simone, G, Picardi, A, De Gobbi, M, Calore, E, Tringali, S, Zecca, M, Secondino, S, Guiducci, B, Pelosini, M, Zuffa, E, Facchini, L, Imola, M, Iori, A, Proia, A, Sica, S, Armiento, D, Carella, A, Dellacasa, C, Fagioli, F, Rabusin, M, Ferrario, A, Elice, F, Russo, D., Polverelli, N., Malagola, M., Farina, M., Leoni, A., Bernardi, S., Mammoliti, S., Sacchi, N., Martino, M., Ciceri, F., Zallio, F., Olivieri, A., Falcioni, S., Storti, G., Michieli, M., Carluccio, P., Grassi, A., Oldani, E., Bonifazi, F., Prete, A., Cavattoni, I. M., Maffeis, M., Pastore, D., Vacca, A., Caravelli, D., Mirabile, M., Mordini, N., Nozzoli, C., Faraci, M., Federico, V., Ronconi, S., Skert, C., Onida, F., Marcatti, M., Piemontese, S., Narni, F., Balduzzi, A., De Simone, G., Picardi, A., De Gobbi, M., Calore, E., Tringali, S., Zecca, M., Secondino, S., Guiducci, B., Pelosini, M., Zuffa, E., Facchini, L., Imola, M., Iori, A. P., Proia, A., Sica, S., Armiento, D., Carella, A. M., Dellacasa, C. M., Fagioli, F., Rabusin, M., Ferrario, A., and Elice, F.

Subjects
Homologous, Myeloid, medicine.medical_specialty, 2019-20 coronavirus outbreak, Bone marrow transplant, Coronavirus disease 2019 (COVID-19), Epidemiology, medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Hematopoietic stem cell transplantation, Acute, Humans, Italy, Pandemics, RNA, Viral, SARS-CoV-2, Stem Cell Transplantation, Transplantation, Homologous, COVID-19, Hematopoietic Stem Cell Transplantation, Leukemia, Myeloid, Acute, Article, hematopoietic stem cell transplantation, covid-19, pandemic, Internal medicine, Pandemic, medicine, Viral, Acute leukemia, Transplantation, Leukemia, business.industry, Hematology, Stem-cell research, RNA, Stem cell, business
Abstract

The Transplant Centers belonging to Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO) conducted a survey with the aim of evaluating the effect of SARS-CoV2 pandemic on the allogeneic transplant activity in Italy. The pandemic period from 1/3/2020 to 31/7/2020 was compared with the same period in 2019. Overall, in 2020 there was a 2.4% reduction in the number of allo-HCT cases compared to 2019. Interestingly, this deflection did not affect the acute leukemia cases (+5.7% in 2020). The use of peripheral blood-derived stem cells (+10.7%) and cryopreservation (97.4% of the centers) was highly adopted in 2020. Despite the sanitary emergency, almost all of the surveyed centers declared no impact of SARS-CoV2 pandemic on the transplant timing and outcomes, and the sanitary policy was positively evaluated by the majority of centers. The emergency measures ensured that only a minority of the allo-HCT patients had been infected by SARS-CoV2; however, a mortality of 42.1% among the allo-HCT patients hospitalized for COVID-19 was recorded. This survey gives us the information that the GITMO Group reacted positively to the pandemic. Thanks to the emergency strategies, the Italian allo-HCT activity continued safely, showing only a minor deflection and offering the same probability of cure to the transplanted patients.

Published
2021

9. Clinical significance of chromatin-spliceosome acute myeloid leukemia: a report from the Northern Italy Leukemia Group (NILG) randomized trial 02/06

Author

Caprioli, C, Lussana, F, Salmoiraghi, S, Cavagna, R, Buklijas, K, Elidi, L, Zanghi', P, Michelato, A, Delaini, F, Oldani, E, Intermesoli, T, Grassi, A, Gianfaldoni, G, Mannelli, F, Ferrero, D, Audisio, E, Terruzzi, E, De Paoli, L, Cattaneo, C, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, A, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Falini, B, Pavoni, C, Bassan, R, Spinelli, O, Rambaldi, A, Caprioli, Chiara, Lussana, Federico, Salmoiraghi, Silvia, Cavagna, Roberta, Buklijas, Ksenija, Elidi, Lara, Zanghi', Pamela, Michelato, Anna, Delaini, Federica, Oldani, Elena, Intermesoli, Tamara, Grassi, Anna, Gianfaldoni, Giacomo, Mannelli, Francesco, Ferrero, Dario, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Cattaneo, Chiara, Borlenghi, Erika, Cavattoni, Irene, Tajana, Monica, Scattolin, Anna Maria, Mattei, Daniele, Corradini, Paolo, Campiotti, Leonardo, Ciceri, Fabio, Bernardi, Massimo, Todisco, Elisabetta, Cortelezzi, Agostino, Falini, Brunangelo, Pavoni, Chiara, Bassan, Renato, Spinelli, Orietta, Rambaldi, Alessandro, Caprioli, C, Lussana, F, Salmoiraghi, S, Cavagna, R, Buklijas, K, Elidi, L, Zanghi', P, Michelato, A, Delaini, F, Oldani, E, Intermesoli, T, Grassi, A, Gianfaldoni, G, Mannelli, F, Ferrero, D, Audisio, E, Terruzzi, E, De Paoli, L, Cattaneo, C, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, A, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Falini, B, Pavoni, C, Bassan, R, Spinelli, O, Rambaldi, A, Caprioli, Chiara, Lussana, Federico, Salmoiraghi, Silvia, Cavagna, Roberta, Buklijas, Ksenija, Elidi, Lara, Zanghi', Pamela, Michelato, Anna, Delaini, Federica, Oldani, Elena, Intermesoli, Tamara, Grassi, Anna, Gianfaldoni, Giacomo, Mannelli, Francesco, Ferrero, Dario, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Cattaneo, Chiara, Borlenghi, Erika, Cavattoni, Irene, Tajana, Monica, Scattolin, Anna Maria, Mattei, Daniele, Corradini, Paolo, Campiotti, Leonardo, Ciceri, Fabio, Bernardi, Massimo, Todisco, Elisabetta, Cortelezzi, Agostino, Falini, Brunangelo, Pavoni, Chiara, Bassan, Renato, Spinelli, Orietta, and Rambaldi, Alessandro

Abstract

Secondary acute myeloid leukemia (sAML) after myelodysplastic or myeloproliferative disorders is a high-risk category currently identified by clinical history or specific morphological and cytogenetic abnormalities. However, in the absence of these features, uncertainties remain to identify the secondary nature of some cases otherwise defined as de novo AML. To test whether a chromatin-spliceosome (CS) mutational signature might better inform the definition of the de novo AML group, we analyzed a prospective cohort of 413 newly diagnosed AML patients enrolled into a randomized clinical trial (NILG AML 02/06) and provided with accurate cytogenetic and molecular characterization. Among clinically defined de novo AML, 17.6% carried CS mutations (CS-AML) and showed clinical characteristics closer to sAML (older age, lower white blood cell counts and higher rate of multilineage dysplasia). Outcomes in this group were adverse, more similar to those of sAML as compared to de novo AML (overall survival, 30% in CS-AML and 17% in sAML vs 61% in de novo AML, P<0.0001; disease free survival, 26% in CS-AML and 22% in sAML vs 54% of de novo AML, P<0.001) and independently confirmed by multivariable analysis. Allogeneic transplant in first complete remission improved survival in both sAML and CS-AML patients. In conclusion, these findings highlight the clinical significance of identifying CS-AML for improved prognostic prediction and potential therapeutic implications. (NILG AML 02/06: ClinicalTrials.gov Identifier: NCT00495287).

Published
2021

12. High throughput molecular characterization of normal karyotype acute myeloid leukemia in the context of the prospective trial 02/06 of the northern italy leukemia group (NILG)

Author

Salmoiraghi, S, Cavagna, R, Zanghì, P, Pavoni, C, Michelato, A, Buklijas, K, Elidi, L, Intermesoli, T, Lussana, F, Oldani, E, Caprioli, C, Stefanoni, P, Gianfaldoni, G, Audisio, E, Terruzzi, E, De Paoli, L, Borlenghi, E, Cavattoni, I, Mattei, D, Scattolin, A, Tajana, M, Ciceri, F, Todisco, E, Campiotti, L, Corradini, P, Fracchiolla, N, Bassan, R, Rambaldi, A, Spinelli, O, Salmoiraghi, Silvia, Cavagna, Roberta, Zanghì, Pamela, Pavoni, Chiara, Michelato, Anna, Buklijas, Ksenija, Elidi, Lara, Intermesoli, Tamara, Lussana, Federico, Oldani, Elena, Caprioli, Chiara, Stefanoni, Paola, Gianfaldoni, Giacomo, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Borlenghi, Erika, Cavattoni, Irene, Mattei, Daniele, Scattolin, Annamaria, Tajana, Monica, Ciceri, Fabio, Todisco, Elisabetta, Campiotti, Leonardo, Corradini, Paolo, Fracchiolla, Nicola, Bassan, Renato, Rambaldi, Alessandro, Spinelli, Orietta, Salmoiraghi, S, Cavagna, R, Zanghì, P, Pavoni, C, Michelato, A, Buklijas, K, Elidi, L, Intermesoli, T, Lussana, F, Oldani, E, Caprioli, C, Stefanoni, P, Gianfaldoni, G, Audisio, E, Terruzzi, E, De Paoli, L, Borlenghi, E, Cavattoni, I, Mattei, D, Scattolin, A, Tajana, M, Ciceri, F, Todisco, E, Campiotti, L, Corradini, P, Fracchiolla, N, Bassan, R, Rambaldi, A, Spinelli, O, Salmoiraghi, Silvia, Cavagna, Roberta, Zanghì, Pamela, Pavoni, Chiara, Michelato, Anna, Buklijas, Ksenija, Elidi, Lara, Intermesoli, Tamara, Lussana, Federico, Oldani, Elena, Caprioli, Chiara, Stefanoni, Paola, Gianfaldoni, Giacomo, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Borlenghi, Erika, Cavattoni, Irene, Mattei, Daniele, Scattolin, Annamaria, Tajana, Monica, Ciceri, Fabio, Todisco, Elisabetta, Campiotti, Leonardo, Corradini, Paolo, Fracchiolla, Nicola, Bassan, Renato, Rambaldi, Alessandro, and Spinelli, Orietta

Abstract

By way of a Next-Generation Sequencing NGS high throughput approach, we defined the mutational profile in a cohort of 221 normal karyotype acute myeloid leukemia (NK-AML) enrolled into a prospective randomized clinical trial, designed to evaluate an intensified chemotherapy program for remission induction. NPM1, DNMT3A, and FLT3-ITD were the most frequently mutated genes while DNMT3A, FLT3, IDH1, PTPN11, and RAD21 mutations were more common in the NPM1 mutated patients (p < 0.05). IDH1 R132H mutation was strictly associated with NPM1 mutation and mutually exclusive with RUNX1 and ASXL1. In the whole cohort of NK-AML, no matter the induction chemotherapy used, by multivariate analysis, the achievement of complete remission was negatively affected by the SRSF2 mutation. Alterations of FLT3 (FLT3-ITD) and U2AF1 were associated with a worse overall and disease-free survival (p < 0.05). FLT3-ITD positive patients who proceeded to alloHSCT had a survival probability similar to FLT3-ITD negative patients and the transplant outcome was no different when comparing high and low-AR-FLT3-ITD subgroups in terms of both OS and DFS. In conclusion, a comprehensive molecular profile for NK-AML allows for the identification of genetic lesions associated to different clinical outcomes and the selection of the most appropriate and effective treatment strategies, including stem cell transplantation and targeted therapies.

Published
2020

13. PROGNOSTIC VALUE OF CLONAL HEMATOPOIESIS-MUTATIONS DETECTED AT DIAGNOSIS IN ACUTE MYELOID LEUKEMIA PATIENTS WITH NORMAL KARYOTYPE

Author

Caprioli, C, Spinelli, O, Salmoiraghi, S, Intermesoli, T, Zanghi, P, Cavagna, R, Michelato, A, Buklijas, K, Elidi, L, Delaini, F, Oldani, E, Gianfaldoni, G, Bosi, A, Marmont, F, Audisio, E, Ferrero, D, Terruzzi, E, De Paoli, L, Rossi, G, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, Am, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Cortelazzo, S, Falini, B, Pavoni, C, Bassan, R, Rambaldi, A, and Lussana, F

Published
2019

14. PF227 PROGNOSTIC VALUE OF CLONAL HEMATOPOIESIS-MUTATIONS DETECTED AT DIAGNOSIS IN ACUTE MYELOID LEUKEMIA PATIENTS WITH NORMAL KARYOTYPE

Author

Caprioli, C., primary, Spinelli, O., additional, Salmoiraghi, S., additional, Intermesoli, T., additional, Zanghì, P., additional, Cavagna, R., additional, Michelato, A., additional, Buklijas, K., additional, Elidi, L., additional, Delaini, F., additional, Oldani, E., additional, Gianfaldoni, G., additional, Bosi, A., additional, Marmont, F., additional, Audisio, E., additional, Ferrero, D., additional, Terruzzi, E., additional, De Paoli, L., additional, Rossi, G., additional, Borlenghi, E., additional, Cavattoni, I., additional, Tajana, M., additional, Scattolin, A.M., additional, Mattei, D., additional, Corradini, P., additional, Campiotti, L., additional, Ciceri, F., additional, Bernardi, M., additional, Todisco, E., additional, Cortelezzi, A., additional, Cortelazzo, S., additional, Falini, B., additional, Pavoni, C., additional, Bassan, R., additional, Rambaldi, A., additional, and Lussana, F., additional

Published
2019
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15. S1624 A DAY 100 LAB-SCORE PREDICTS EXTENSIVE CGVHD, OVERALL SURVIVAL AND TRANSPLANT-RELATED MORTALITY AFTER HEMATOPOIETIC STEM CELL TRANSPLANTATION: FINAL ANALYSIS

Author

Metafuni, E., primary, Cavattoni, I., additional, Lamparellli, T., additional, Raiola, A.M., additional, Ghiso, A., additional, Galaverna, F., additional, Gualandi, F., additional, Di Grazia, C., additional, Dominietto, A., additional, Varaldo, R., additional, Van Lint, M.T., additional, Angelucci, E., additional, and Bacigalupo, A., additional

Published
2019
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16. MOLECULAR PROLIFE BY NEXT GENERATION SEQUENCING OF ACUTE MYELOID LEUKEMIA WITH NORMAL KARYOTYPE: CLINICAL RESULTS FROM THE PROSPECTIVE TRIAL 02/06 OF THE NORTHERN ITALY LEUKEMIA GROUP (NILG)

Author

Spinelli, O, Salmoiraghi, S, Zanghi, P, Cavagna, R, Michelato, A, Buklijas, K, Zannino, L, Intermesoli, T, Lussana, F, Delaini, F, Oldani, E, Caprioli, C, Stefanoni, P, Gianfaldoni, G, Marmont, F, Ferrero, D, Terruzzi, E, De Paoli, L, Rossi, G, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, Am, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Cortelazzo, S, Audisio, E, Bosi, A, Falini, B, Pavoni, C, Bassan, R, and Rambaldi, A

Published
2018

17. NEXT GENERATION SEQUENCING (NGS) CONFIRMED THE ADVERSE CLINICAL IMPACT OF RUNX1 MUTATIONS IN A SUBSET OF ACUTE MYELOID LEUKEMIA NORMAL KARYOTYPE PATIENTS NEGATIVE FOR RISK DEFINING GENES MUTATIONS AND HOMOGENOUSLY TREATED WITHIN A CLINICAL TRIAL (NILG AML 02/06)

Author

Salmoiraghi, S, Zanghi, P, Pavoni, C, Montalvo, Mlg, Ubiali, G, Intermesoli, T, Oldani, E, Marmont, F, Cavattoni, I, Mattei, D, Terruzzi, E, De Paoli, L, Rossi, G, Borlenghi, E, Ciceri, F, Campiotti, L, Corradini, P, Cortelezzi, A, Ferrero, D, Audisio, E, Bosi, A, Bassan, R, Rambaldi, A, and Spinelli, O

Published
2017

18. ‘Real-life’ report on the management of chronic GvHD in the Gruppo Italiano Trapianto Midollo Osseo (GITMO)

Author

Giaccone, L, primary, Mancini, G, additional, Mordini, N, additional, Gargiulo, G, additional, De Cecco, V, additional, Angelini, S, additional, Arpinati, M, additional, Baronciani, D, additional, Bozzoli, V, additional, Bramanti, S, additional, Calore, E, additional, Cavattoni, I M, additional, Cimminiello, M, additional, Colombo, A A, additional, Facchini, L, additional, Falcioni, S, additional, Faraci, M, additional, Fedele, R, additional, Guidi, S, additional, Iori, A P, additional, Marotta, S, additional, Micò, M C, additional, Milone, G, additional, Onida, F, additional, Pastore, D, additional, Patriarca, F, additional, Pini, M, additional, Raimondi, R, additional, Rovelli, A, additional, Santarone, S, additional, Severino, A, additional, Skert, C, additional, Stanghellini, M T L, additional, Tecchio, C, additional, Vassallo, E, additional, Chiarucci, M, additional, Bruno, B, additional, Bonifazi, F, additional, and Olivieri, A, additional

Published
2017
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19. Phase II Study of Sequential Infusion of Donor Lymphocyte Infusion and Cytokine-Induced Killer Cells for Patients Relapsed after Allogeneic Hematopoietic Stem Cell Transplantation

Author

Introna, M, Lussana, F, Algarotti, A, Gotti, E, Valgardsdottir, R, Micò, C, Grassi, A, Pavoni, C, Ferrari, M, Delaini, F, Todisco, E, Cavattoni, I, Deola, S, Biagi, E, Balduzzi, A, Rovelli, A, Parma, M, Napolitano, S, Sgroi, G, Marrocco, E, Perseghin, P, Belotti, D, Cabiati, B, Gaipa, G, Golay, J, Biondi, A, Rambaldi, A, Introna, Martino, Lussana, Federico, Algarotti, Alessandra, Gotti, Elisa, Valgardsdottir, Rut, Micò, Caterina, Grassi, Anna, Pavoni, Chiara, Ferrari, Maria Luisa, Delaini, Federica, Todisco, Elisabetta, Cavattoni, Irene, Deola, Sara, Biagi, Ettore, Balduzzi, Adriana, Rovelli, Attilio, Parma, Matteo, Napolitano, Sara, Sgroi, Giusy, Marrocco, Emanuela, Perseghin, Paolo, Belotti, Daniela, Cabiati, Benedetta, Gaipa, Giuseppe, Golay, Josée, Biondi, Andrea, Rambaldi, Alessandro, Introna, M, Lussana, F, Algarotti, A, Gotti, E, Valgardsdottir, R, Micò, C, Grassi, A, Pavoni, C, Ferrari, M, Delaini, F, Todisco, E, Cavattoni, I, Deola, S, Biagi, E, Balduzzi, A, Rovelli, A, Parma, M, Napolitano, S, Sgroi, G, Marrocco, E, Perseghin, P, Belotti, D, Cabiati, B, Gaipa, G, Golay, J, Biondi, A, Rambaldi, A, Introna, Martino, Lussana, Federico, Algarotti, Alessandra, Gotti, Elisa, Valgardsdottir, Rut, Micò, Caterina, Grassi, Anna, Pavoni, Chiara, Ferrari, Maria Luisa, Delaini, Federica, Todisco, Elisabetta, Cavattoni, Irene, Deola, Sara, Biagi, Ettore, Balduzzi, Adriana, Rovelli, Attilio, Parma, Matteo, Napolitano, Sara, Sgroi, Giusy, Marrocco, Emanuela, Perseghin, Paolo, Belotti, Daniela, Cabiati, Benedetta, Gaipa, Giuseppe, Golay, Josée, Biondi, Andrea, and Rambaldi, Alessandro

Abstract

Seventy-four patients who relapsed after allogeneic stem cell transplantation were enrolled in a phase IIA study and treated with the sequential infusion of donor lymphocyte infusion (DLI) followed by cytokine-induced killer (CIK) cells. Seventy-three patients were available for the intention to treat analysis. At least 1 infusion of CIK cells was given to 59 patients, whereas 43 patients received the complete cell therapy planned (58%). Overall, 12 patients (16%) developed acute graft-versus-host disease (aGVHD) of grades I to II in 7 cases and grades III to IV in 5). In 8 of 12 cases, aGVHD developed during DLI treatment, leading to interruption of the cellular program in 3 patients, whereas in the remaining 5 cases aGVHD was controlled by steroids treatment, thus allowing the subsequent planned administration of CIK cells. Chronic GVHD (cGVHD) was observed in 11 patients (15%). A complete response was observed in 19 (26%), partial response in 3 (4%), stable disease in 8 (11%), early death in 2 (3%), and disease progression in 41 (56%). At 1 and 3 years, rates of progression-free survival were 31% and 29%, whereas rates of overall survival were 51% and 40%, respectively. By multivariate analysis, the type of relapse, the presence of cGVHD, and a short (<6 months) time from allogeneic hematopoietic stem cell transplantation to relapse were the significant predictors of survival. In conclusion, a low incidence of GVHD is observed after the sequential administration of DLI and CIK cells, and disease control can be achieved mostly after a cytogenetic or molecular relapse.

Published
2017

20. Factors predicting outcome after allogeneic transplant in refractory acute myeloid leukemia: A retrospective analysis of Gruppo Italiano Trapianto di Midollo Osseo (GITMO)

Author

Todisco, E., Ciceri, F., Boschini, C., Giglio, F., Bacigalupo, A., Patriarca, F., Donnini, I., Alessandrino, E. P., Arcese, W., Iori, A. P., Marenco, P., Cavattoni, I., Chiusolo, P., Terruzzi, E., Castagna, L., Santoro, A., Bosi, A., Oldani, E., Bruno, B., Bonifazi, F., Rambaldi, A., Bacigalupo, A. (ORCID:0000-0002-9119-567X), Chiusolo, P. (ORCID:0000-0002-1355-1587), Todisco, E., Ciceri, F., Boschini, C., Giglio, F., Bacigalupo, A., Patriarca, F., Donnini, I., Alessandrino, E. P., Arcese, W., Iori, A. P., Marenco, P., Cavattoni, I., Chiusolo, P., Terruzzi, E., Castagna, L., Santoro, A., Bosi, A., Oldani, E., Bruno, B., Bonifazi, F., Rambaldi, A., Bacigalupo, A. (ORCID:0000-0002-9119-567X), and Chiusolo, P. (ORCID:0000-0002-1355-1587)

Abstract

The clinical outcome of primary refractory (PRF) AML patients is poor and only a minor proportion of patients is rescued by allogenic hematopoietic stem cell transplantation (HSCT). The identification of pre-HSCT variables may help to determine PRF AML patients who can most likely benefit from HSCT. We analyzed PRF AML patients transplanted between 1999 and 2012 from a sibling, unrelated donor or a cord blood unit. Overall, 227 patients from 26 Gruppo Italiano Trapianto di Midollo Osseo e Terapia cellulare centers were included in the analysis. At 3 years, the overall survival was 14%. By multivariate analysis, the number of chemotherapy cycles, (hazard ratio (HR): 1.87; 95% confidence interval (CI): 1.24-2.85; P=0.0028), the percentage of bone marrow or peripheral blood blasts (HR: 1.75; 95% CI: 1.16-2.64; P=0.0078), the adverse cytogenetic (HR: 1.44; 95% CI: 1.00-2.07; P=0.0508) and the age of patients (HR: 1.77; 95% CI: 1.08-2.88; P=0.0223) remained significantly associated with survival. Thus, we set up a new score predicting at 3 years after transplantation, an overall survival probability of 32% for patients with score 0 (no or 1 prognostic factor), 10% for patients with score 1 (2 prognostic factors) and 3% for patients with score 2 (3 or 4 prognostic factors).

Published
2017

21. Multi-center experience using total lymphoid irradiation and anti-thymocyte globulin as conditioning for allografting in hematological malignancies

Author

Messina G, Giaccone L, Festuccia M, Irrera G, Scortechini I, Sorasio R, Gigli F, Passera R, Cavattoni I, Filippi AR, Schianca FC, Pini M, Selleri C, Levis A, Mordini N, Gallamini A, Pastano R, Casini M, Aglietta M, Montanari M, Console G, Boccadoro M, Ricardi U, Bruno B., RISITANO, ANTONIO MARIA, Messina, G, Giaccone, L, Festuccia, M, Irrera, G, Scortechini, I, Sorasio, R, Gigli, F, Passera, R, Cavattoni, I, Filippi, Ar, Schianca, Fc, Pini, M, Risitano, ANTONIO MARIA, Selleri, C, Levis, A, Mordini, N, Gallamini, A, Pastano, R, Casini, M, Aglietta, M, Montanari, M, Console, G, Boccadoro, M, Ricardi, U, and Bruno, B.

Published
2012

23. ALLOGENEIC STEM CELL TRANSPLANTATION FOLLOWING A REDUCED INTENSITY CONDITIONING REGIMEN IN RELAPSED PERIPHERAL T-CELL LYMPHOMAS (PTCL): RESULTS AFTER A MEDIAN FOLLOW-UP OF 67 MONTHS

Author

Dodero A, Spina F, Narni F, Patriarca F, Cavattoni I, Benedetti F, Baronciani D, Scime R, Pogliani E, Rambaldi A, Bonifazi F, Dalto S, Bruno B, Corradini P., CICERI , FABIO, Dodero, A, Spina, F, Narni, F, Patriarca, F, Cavattoni, I, Benedetti, F, Ciceri, Fabio, Baronciani, D, Scime, R, Pogliani, E, Rambaldi, A, Bonifazi, F, Dalto, S, Bruno, B, and Corradini, P.

Published
2011

24. TWO-STEP RESPONSE-ORIENTED INDUCTION PREDICTS LONG-TERM OUTCOME OF ADULT PATIENTS WITH STANDARD- AND HIGH-RISK ACUTE MYELOID LEUKAEMIA (AML): A NORTHERN ITALY LEUKAEMIA GROUP (NILG) STUDY

Author

Intermesoli, T, Oldani, E, Rossi, G, Pogliani, E, Marmont, F, Cavattoni, I, Cassibba, V, Scattolin, A, Musso, M, Mattei, D, Minotto, C, Ciceri, F, Campiotti, L, Corradini, P, Borlenghi, E, Ruggeri, G, Terruzzi, E, Fumagalli, M, Audisio, E, Fabris, P, Chisesi, T, Spinelli, O, Tosi, M, Giussani, U, Barbui, T, Rambaldi, A, Bassan, R, Intermesoli, T, Oldani, E, Rossi, G, Pogliani, E, Marmont, F, Cavattoni, I, Cassibba, V, Scattolin, A, Musso, M, Mattei, D, Minotto, C, Ciceri, Fabio, Campiotti, L, Corradini, P, Borlenghi, E, Ruggeri, G, Terruzzi, E, Fumagalli, M, Audisio, E, Fabris, P, Chisesi, T, Spinelli, O, Tosi, M, Giussani, U, Barbui, T, Rambaldi, A, and Bassan, R.

Published
2010

25. IN ADULT ACUTE MYELOID LEUKAEMIA (AML) ALL RISK SUBSETS BENEFIT FROM A SEQUENTIAL HIGH-DOSE PROGRAMME AS EARLY RESCUE OF FIRST INDUCTION FAILURE: A REPORT FROM NORTHERN ITALY LEUKAEMIA GROUP (NILG)

Author

Intermesoli, T, Rossi, G, Pogliani, E, Marmont, F, Cavattoni, I, Cassibba, V, Scattolin, A, Musso, M, Mattei, D, Minotto, C, Ciceri, F, Campiotti, L, Corradini, P, Borlenghi, E, Ruggeri, G, Terruzzi, E, Verga, L, Audisio, E, Fabris, P, Chisesi, T, Giussani, U, Spinelli, O, Zanghi, P, Oldani, E, Barbui, T, Rambaldi, A, Bassan, R, Intermesoli, T, Rossi, G, Pogliani, E, Marmont, F, Cavattoni, I, Cassibba, V, Scattolin, A, Musso, M, Mattei, D, Minotto, C, Ciceri, Fabio, Campiotti, L, Corradini, P, Borlenghi, E, Ruggeri, G, Terruzzi, E, Verga, L, Audisio, E, Fabris, P, Chisesi, T, Giussani, U, Spinelli, O, Zanghi, P, Oldani, E, Barbui, T, Rambaldi, A, and Bassan, R.

Published
2010

26. Improved Clinical Outcome of Adult Patients with Ph plus ALL After a Combined Imatinib-Chemotherapy Induction/Consolidation Program Followed by Allogeneic Hematopoietic Stem Cell Transplantation: Results From a Prospective Study of the Northern Italy Leukemia Group

Author

Rambaldi A, Spinelli O, Oldani E, Grassi A, Rossi G, Pogliani EM, Di Bona E, Angelucci E, Cavattoni I, Lambertenghi Deliliers G, Mannelli F, Levis A, Mattei D, Borlenghi E, Terruzzi E, Borghero C, Romani C, Tosi M, Bussini A, Intermesoli T, Bassan R., CICERI , FABIO, Rambaldi, A, Spinelli, O, Oldani, E, Grassi, A, Rossi, G, Pogliani, Em, Di Bona, E, Angelucci, E, Cavattoni, I, Lambertenghi Deliliers, G, Mannelli, F, Levis, A, Ciceri, Fabio, Mattei, D, Borlenghi, E, Terruzzi, E, Borghero, C, Romani, C, Tosi, M, Bussini, A, Intermesoli, T, and Bassan, R.

Published
2010

27. Myeloablative, reduced toxicity versus standard conditioning in AML: a randomized clinical trial from Gruppo Italiano Trapianto di Midollo Osseo (GITMO)

Author

Grassi, A., Mico, C., Oldani, E., Boschini, C., Busca, A., Benedetto, B., Cavattoni, I., Santarone, S., Raimondi, R., Montanari, M., Milone, G., Patrizia Chiusolo, Specchia, G., Guidi, S., Patriarca, F., Bacigalupo, A., Risitano, A. M., Saporiti, G., Pini, M., Pogliani, E. M., Arcese, W., Marotta, G., Carella, A. M., Nagler, A., Corradini, P., Russo, D., Alessandrino, E. P., Torelli, G. F., Mordini, N., Scime, R., Bosi, A., Masciulli, A., Marfisi, R. M., and Rambaldi, A.

Published
2015

28. Evidence for CD19B–CD8T cell interactions in blood and tissues from patients with GvHD

Author

Deola, S, primary, Cugno, C, additional, Comoli, P, additional, Guido, I, additional, Rubert, L, additional, Zecca, M, additional, Zanolini, D, additional, Follenzi, A, additional, Langes, M, additional, Negri, G, additional, Tauber, M, additional, Pusceddu, I, additional, Cavattoni, I, additional, Svaldi, M, additional, Grigoleit, G U, additional, Baumeister, E, additional, Wang, E, additional, Rutella, S, additional, and Marincola, F M, additional

Published
2016
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29. Mutations of TP53 gene in adult acute lymphoblastic leukemia at diagnosis do not affect the achievement of hematologic response but correlate with early relapse and very poor survival

Author

Salmoiraghi, S., primary, Montalvo, M. L. G., additional, Ubiali, G., additional, Tosi, M., additional, Peruta, B., additional, Zanghi, P., additional, Oldani, E., additional, Boschini, C., additional, Kohlmann, A., additional, Bungaro, S., additional, Intermesoli, T., additional, Terruzzi, E., additional, Angelucci, E., additional, Cavattoni, I., additional, Ciceri, F., additional, Bassan, R., additional, Rambaldi, A., additional, and Spinelli, O., additional

Published
2016
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30. Multicenter experience using total lymphoid irradiation and antithymocyte globulin as conditioning for allografting in hematological malignancies

Author

Messina, G, Giaccone, Luisa, Festuccia, M, Irrera, G, Scortechini, I, Sorasio, R, Gigli, F, Passera, R, Cavattoni, I, Filippi, Andrea Riccardo, Schianca, Fc, Pini, M, Risitano, Am, Selleri, C, Levis, A, Mordini, N, Gallamini, A, Pastano, R, Casini, M, Aglietta, Massimo, Montanari, M, Console, G, Boccadoro, Mario, Ricardi, Umberto, Bruno, Benedetto, and Gruppo Italiano Trapianti di Midollo

Subjects
Male, Myeloid, Transplantation Conditioning, Graft vs Host Disease, total lymphoid irradiation, antithymocyte globulin, bone marrow transplantation, Graft-versus-host disease, Gastroenterology, Severity of Illness Index, HLA Antigens, Recurrence, Nonmyeloablative conditioning, biology, Incidence (epidemiology), Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, surgical procedures, operative, medicine.anatomical_structure, Hematologic Neoplasms, Histocompatibility, Cyclosporine, Female, Whole-Body Irradiation, Total lymphoid irradiation/antithymocyte globulin, Adult, medicine.medical_specialty, Globulin, anti-thymocyte globulin, Refractory, Antigen, Internal medicine, medicine, Humans, Transplantation, Homologous, hematological malignancies, Aged, Antilymphocyte Serum, Transplantation, business.industry, Mycophenolic Acid, medicine.disease, Survival Analysis, Anti-thymocyte globulin, Surgery, biology.protein, business
Abstract

A non myeloablative conditioning with total lymphoid irradiation (TLI) and antithymocyte globulin (ATG) was shown to protect against graft-versus-host disease (GVHD). To evaluate the effects of TLI-ATG in a multicenter study, 45 heavily pretreated patients, median age 51, with lymphoid (n = 38) and myeloid (n = 7) malignancies were enrolled at 9 centers. Twenty-eight patients (62%) received at least 3 lines of treatment before allografting, and 13 (29%) had refractory/relapsed disease at the time of transplantation. Peripheral blood hematopoietic cells were from HLA identical sibling (n = 30), HLA-matched (n = 9), or 1 antigen HLA-mismatched (n = 6) unrelated donors. A cumulative TLI dose of 8 Gy was administered from day −11 through −1 with ATG at the dose of 1.5 mg/kg/day (from day −11 through −7). GVHD prophylaxis consisted of cyclosporine and mycophenolate mofetil. Donor engraftment was reached in 95% of patients. Grade II to IV acute GVHD (aGVHD) developed in 6 patients (13.3%), and in 2 of these patients, it developed beyond day 100. Incidence of chronic GVHD (cGVHD) was 35.8%. One-year nonrelapse mortality was 9.1%. After a median follow-up of 28 months (range, 3-57 months) from transplantation, median overall survival was not reached, whereas median event-free survival was 20 months. This multicenter experience confirms that TLI-ATG protects against GVHD and maintains graft-vs-tumor effects.

Published
2012

33. Busulfan plus cyclophosphamide versus busulfan plus fludarabine as a preparative regimen for allogeneic haemopoietic stem-cell transplantation in patients with acute myeloid leukaemia: an open-label, multicentre, randomised, phase 3 trial

Author

Rambaldi, A, Grassi, A, Masciulli, A, Boschini, C, Micò, Mc, Busca, A, Bruno, B, Cavattoni, I, Santarone, S, Raimondi, R, Montanari, M, Milone, G, Chiusolo, Patrizia, Pastore, D, Guidi, S, Patriarca, F, Risitano, Am, Saporiti, G, Pini, M, Terruzzi, E, Arcese, W, Marotta, G, Carella, Am, Nagler, A, Russo, D, Corradini, P, Alessandrino, Ep, Torelli, Gf, Scimè, R, Mordini, N, Oldani, E, Marfisi, Rm, Bacigalupo, A, Bosi, A., Chiusolo, Patrizia (ORCID:0000-0002-1355-1587), Rambaldi, A, Grassi, A, Masciulli, A, Boschini, C, Micò, Mc, Busca, A, Bruno, B, Cavattoni, I, Santarone, S, Raimondi, R, Montanari, M, Milone, G, Chiusolo, Patrizia, Pastore, D, Guidi, S, Patriarca, F, Risitano, Am, Saporiti, G, Pini, M, Terruzzi, E, Arcese, W, Marotta, G, Carella, Am, Nagler, A, Russo, D, Corradini, P, Alessandrino, Ep, Torelli, Gf, Scimè, R, Mordini, N, Oldani, E, Marfisi, Rm, Bacigalupo, A, Bosi, A., and Chiusolo, Patrizia (ORCID:0000-0002-1355-1587)

Abstract

BACKGROUND: The standard busulfan-cyclophosphamide myeloablative conditioning regimen is associated with substantial non-relapse mortality in patients older than 40 years with acute myeloid leukaemia who are undergoing allogeneic stem-cell transplantation. Because the combination of busulfan plus fludarabine has been proposed to reduce non-relapse mortality, we aimed to compare this treatment with busulfan plus cyclophosphamide as a preparative regimen in these patients. METHODS: We did an open-label, multicentre, randomised, phase 3 trial for patients with acute myeloid leukaemia at 25 hospital transplant centres in Italy and one in Israel. Eligible patients were aged 40-65 years, had an Eastern Cooperative Oncology Group performance status less than 3, and were in complete remission. Patients were randomly assigned 1:1 to receive intravenous busulfan plus cyclophosphamide or busulfan plus fludarabine. Treatment allocations were not masked to investigators or patients. Randomisation was done centrally via a dedicated web-based system using remote data entry, with patients stratified by donor type and complete remission status. Patients allocated to busulfan plus cyclophosphamide received intravenous busulfan 0·8 mg/kg four times per day during 2 h infusions for four consecutive days (16 doses from days -9 through -6; total dose 12·8 mg/kg) and cyclophosphamide at 60 mg/kg per day for two consecutive days (on days -4 and -3; total dose 120 mg/kg). Patients allocated to busulfan plus fludarabine received the same dose of intravenous busulfan (from days -6 through -3) and fludarabine at 40 mg/m(2) per day for four consecutive days (from days -6 through -3; total dose 160 mg/m(2)). The primary endpoint was 1-year non-relapse mortality, which was assessed on an intention-to-treat basis; safety outcomes were assessed in the per-protocol population. This trial has been completed and is registered with ClinicalTrials.gov, number NCT01191957. FINDINGS: Between Jan 3, 2008

Published
2015

34. Treatment of Graft versus Host Disease with Mesenchymal Stromal Cells: A Phase I Study on 40 Adult and Pediatric Patients

Author

Introna, M, Lucchini, G, Dander, E, Galimberti, S, Rovelli, A, Balduzzi, A, Longoni, D, Pavan, F, Masciocchi, F, Algarotti, A, Micò, C, Grassi, A, Deola, S, Cavattoni, I, Gaipa, G, Belotti, D, Perseghin, P, Parma, M, Pogliani, E, Golay, J, Pedrini, O, Capelli, C, Cortelazzo, S, D'Amico, G, Biondi, A, Rambaldi, A, Biagi, E, DANDER, ERICA, GALIMBERTI, STEFANIA, PAVAN, FABIO, MASCIOCCHI, FRANCESCA, GRASSI, ALICE, DEOLA, SARA, GAIPA, GIUSEPPE, BELOTTI, DANIELA, POGLIANI, ENRICO MARIA, BIONDI, ANDREA, BIAGI, ETTORE, Introna, M, Lucchini, G, Dander, E, Galimberti, S, Rovelli, A, Balduzzi, A, Longoni, D, Pavan, F, Masciocchi, F, Algarotti, A, Micò, C, Grassi, A, Deola, S, Cavattoni, I, Gaipa, G, Belotti, D, Perseghin, P, Parma, M, Pogliani, E, Golay, J, Pedrini, O, Capelli, C, Cortelazzo, S, D'Amico, G, Biondi, A, Rambaldi, A, Biagi, E, DANDER, ERICA, GALIMBERTI, STEFANIA, PAVAN, FABIO, MASCIOCCHI, FRANCESCA, GRASSI, ALICE, DEOLA, SARA, GAIPA, GIUSEPPE, BELOTTI, DANIELA, POGLIANI, ENRICO MARIA, BIONDI, ANDREA, and BIAGI, ETTORE

Abstract

This phase I multicenter study was aimed at assessing the feasibility and safety of intravenous administration of third party bone marrow-derived mesenchymal stromal cells (MSC) expanded in platelet lysate in 40 patients (15 children and 25 adults), experiencing steroid-resistant grade II to IV graft-versus-host disease (GVHD). Patients received a median of 3 MSC infusions after having failed conventional immunosuppressive therapy. A median cell dose of 1.5 × 10(6)/kg per infusion was administered. No acute toxicity was reported. Overall, 86 adverse events and serious adverse events were reported in the study, most of which (72.1%) were of infectious nature. Overall response rate, measured at 28 days after the last MSC injection, was 67.5%, with 27.5% complete response. The latter was significantly more frequent in patients exhibiting grade II GVHD as compared with higher grades (61.5% versus 11.1%, P = .002) and was borderline significant in children as compared with adults (46.7 versus 16.0%, P = .065). Overall survival at 1 and 2 years from the first MSC administration was 50.0% and 38.6%, with a median survival time of 1.1 years. In conclusion, MSC can be safely administered on top of conventional immunosuppression for steroid resistant GVHD treatment. Eudract Number 2008-007869-23, NCT01764100

Published
2014

35. CD20 expression has no prognostic role in Philadelphia-negative B-precursor acute lymphoblastic leukemia: new insights from the molecular study of minimal residual disease

Author

Mannelli, F, Gianfaldoni, G, Intermesoli, T, Cattaneo, C, Borlenghi, E, Cortelazzo, S, Cavattoni, I, Pogliani, E, Fumagalli, M, Angelucci, E, Romani, C, Ciceri, F, Corti, C, Scattolin, A, Cortelezzi, A, Mattei, D, Audisio, E, Spinelli, O, Oldani, E, Bosi, A, Rambaldi, A, Bassan, R, Bassan, R., INTERMESOLI, TAMARA, POGLIANI, ENRICO MARIA, FUMAGALLI, MONICA, Mannelli, F, Gianfaldoni, G, Intermesoli, T, Cattaneo, C, Borlenghi, E, Cortelazzo, S, Cavattoni, I, Pogliani, E, Fumagalli, M, Angelucci, E, Romani, C, Ciceri, F, Corti, C, Scattolin, A, Cortelezzi, A, Mattei, D, Audisio, E, Spinelli, O, Oldani, E, Bosi, A, Rambaldi, A, Bassan, R, Bassan, R., INTERMESOLI, TAMARA, POGLIANI, ENRICO MARIA, and FUMAGALLI, MONICA

Abstract

The prognostic significance of CD20 expression in acute lymphoblastic leukemia has been investigated in children and adults and is still under debate. The aim of our study was to correlate CD20 expression with clinical-biological characteristics and outcome in 172 Philadelphia-negative patients prospectively treated in a multicenter trial introducing the molecular evaluation of minimal residual disease for therapeutic purposes. We considered 20% as the threshold for CD20 positivity. Complete remission rate, minimal residual disease negativity rate at weeks 10, 16 and 22, and disease-free and overall survival were similar among CD20 positive and negative patients, even considering minimal residual disease results and related therapeutic choices. Our study failed to demonstrate any prognostic significance for CD20 expression in Philadelphia-negative acute lymphoblastic leukemia. This conclusion is supported for the first time by a comparable minimal residual disease response rate among CD20 negative and positive patients. ClinicalTrials.gov ID, NCT00358072., The prognostic significance of CD20 expression in acute lymphoblastic leukemia has been investigated in children and adults but is still a subject of debate. The aim of our study was to correlate CD20 expression with clinical-biological characteristics and outcome in 172 Philadelphia chromosome negative patients prospectively treated in a multicenter trial introducing the molecular evaluation of minimal residual disease for therapeutic purposes. We considered 20% as the threshold for CD20 positivity. Complete remission rate, minimal residual disease negativity rate at weeks 10, 16 and 22, and disease-free and overall survival were similar among CD20-positive and -negative patients, even considering minimal residual disease results and related therapeutic choices. Our study failed to demonstrate any prognostic significance for CD20 expression in Philadelphia chromosome negative acute lymphoblastic leukemia. This conclusion is supported for the first time by a comparable minimal residual disease response rate among CD20-positive and -negative and positive patients.

Published
2012

36. Safe and Effective Treatment of Graft Versus Host Disease with Platelet Lysate-Expanded Human Mesenchymal Stromal Cells: A Phase 1 Study On 47 Adult and Pediatric Patients

Author

Introna, M, Lucchini, G, Dander, E, Rovelli, A, Balduzzi, A, Longoni, D, Pavan, F, Masciochi, F, Algarotti, A, Micò, C, Grassi, A, Cavattoni, I, Deola, S, Gaipa, G, Belotti, D, Perseghin, P, Parma, M, Pogliani, E, Golay, J, Gotti, E, Capelli, C, Cortelazzo, S, D'Amico, G, Biondi, A, Rambaldi, A, Biagi, E, DANDER, ERICA, PAVAN, FABIO, DEOLA, SARA, GAIPA, GIUSEPPE, BELOTTI, DANIELA, POGLIANI, ENRICO MARIA, BIONDI, ANDREA, BIAGI, ETTORE, Introna, M, Lucchini, G, Dander, E, Rovelli, A, Balduzzi, A, Longoni, D, Pavan, F, Masciochi, F, Algarotti, A, Micò, C, Grassi, A, Cavattoni, I, Deola, S, Gaipa, G, Belotti, D, Perseghin, P, Parma, M, Pogliani, E, Golay, J, Gotti, E, Capelli, C, Cortelazzo, S, D'Amico, G, Biondi, A, Rambaldi, A, Biagi, E, DANDER, ERICA, PAVAN, FABIO, DEOLA, SARA, GAIPA, GIUSEPPE, BELOTTI, DANIELA, POGLIANI, ENRICO MARIA, BIONDI, ANDREA, and BIAGI, ETTORE

Published
2012

37. Chemotherapy-phased imatinib pulses improve long-term outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia: Northern Italy Leukemia Group protocol 09/00

Author

Bassan, R, Rossi, G, Pogliani, E, Di Bona, E, Angelucci, E, Cavattoni, I, Lambertenghi Deliliers, G, Mannelli, F, Levis, A, Ciceri, F, Mattei, D, Borlenghi, E, Terruzzi, E, Borghero, C, Romani, C, Spinelli, O, Tosi, M, Oldani, E, Intermesoli, T, Rambaldi, A, POGLIANI, ENRICO MARIA, Rambaldi, A., Bassan, R, Rossi, G, Pogliani, E, Di Bona, E, Angelucci, E, Cavattoni, I, Lambertenghi Deliliers, G, Mannelli, F, Levis, A, Ciceri, F, Mattei, D, Borlenghi, E, Terruzzi, E, Borghero, C, Romani, C, Spinelli, O, Tosi, M, Oldani, E, Intermesoli, T, Rambaldi, A, POGLIANI, ENRICO MARIA, and Rambaldi, A.

Abstract

Purpose: Short imatinib pulses were added to chemotherapy to improve the long-term survival of adult patients with Philadelphia chromosome (Ph) -positive acute lymphoblastic leukemia (ALL), to optimize complete remission (CR) and stem-cell transplantation (SCT) rates. Patients and Methods: Of 94 total patients (age range, 19 to 66 years), 35 represented the control cohort (ie, imatinib-negative [IM-negative] group), and 59 received imatinib 600 mg/d orally for 7 consecutive days (ie, imatinib-positive [IM-positive] group), starting from day 15 of chemotherapy course 1 and from 3 days before chemotherapy during courses 2 to 8. Patients in CR were eligible for allogeneic SCT or, alternatively, for high-dose therapy with autologous SCT followed by long-term maintenance with intermittent imatinib. Results: CR and SCT rates were greater in the IM-positive group (CR: 92% v 80.5%; P = .08; allogeneic SCT: 63% v 39%; P = .041). At a median observation time of 5 years (range, 0.6 to 9.2 years), 22 patients in the IM-positive group versus five patients in the IM-negative group were alive in first CR (P = .037). Patients in the IM-positive group had significantly greater overall and disease-free survival probabilities (overall: 0.38 v 0.23; P = .009; disease free: 0.39 v 0.25; P = .044) and a lower incidence of relapse (P = .005). SCT-related mortality was 28% (ie, 15 of 54 patients), and postgraft survival probability was 0.46 overall. Conclusion: This imatinib-based protocol improved long-term outcome of adult patients with Ph-positive ALL. With SCT, post-transplantation mortality and relapse remain the major hindrance to additional therapeutic improvement. Additional intensification of imatinib therapy should warrant a better molecular response and clinical outcome, both in patients selected for SCT and in those unable to undergo this procedure. © 2010 by American Society of Clinical Oncology.

Published
2010

38. CD20 expression has no prognostic role in Philadelphia-negative B-precursor acute lymphoblastic leukemia: new insights from the molecular study of minimal residual disease

Author

Mannelli, F., primary, Gianfaldoni, G., additional, Intermesoli, T., additional, Cattaneo, C., additional, Borlenghi, E., additional, Cortelazzo, S., additional, Cavattoni, I., additional, Pogliani, E. M., additional, Fumagalli, M., additional, Angelucci, E., additional, Romani, C., additional, Ciceri, F., additional, Corti, C., additional, Scattolin, A., additional, Cortelezzi, A., additional, Mattei, D., additional, Audisio, E., additional, Spinelli, O., additional, Oldani, E., additional, Bosi, A., additional, Rambaldi, A., additional, and Bassan, R., additional

Published
2011
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39. Allogeneic transplantation following a reduced-intensity conditioning regimen in relapsed/refractory peripheral T-cell lymphomas: long-term remissions and response to donor lymphocyte infusions support the role of a graft-versus-lymphoma effect

Author

Dodero, A, primary, Spina, F, additional, Narni, F, additional, Patriarca, F, additional, Cavattoni, I, additional, Benedetti, F, additional, Ciceri, F, additional, Baronciani, D, additional, Scimè, R, additional, Pogliani, E, additional, Rambaldi, A, additional, Bonifazi, F, additional, Dalto, S, additional, Bruno, B, additional, and Corradini, P, additional

Published
2011
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43. B- and T-cell interactions in graft-versus-host disease

Author

Sara Deola, Cavattoni, I., Pusceddu, I., Negri, G., Kasal, A., Svaldi, M., Langes, M., Gambato, R., Morello, E., Casini, M., Bondanza, A., Introna, M., Marincola, F. M., Cortelazzo, S., Deola, S, Cavattoni, I, Pusceddu, I, Negri, G, Kasal, A, Svaldi, M, Langes, M, Gambato, R, Morello, E, Casini, M, Bondanza, Attilio, Introna, M, Marincola, Fm, and Cortelazzo, S.

46. ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS OLDER THAN 60 YEARS: A REGISTRY STUDY OF THE TRANSPLANT ACTIVITY FROM 2000 TO 2017 ON BEHALF OF THE GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO (GITMO)

Author

Malagola, M., Polverelli, N., Martino, M., Rubini, V., Stanghellini, M. T. Lupo, Patriarca, F., Fanin, R., Bruno, B., Giaccone, L., Faraci, D. G., Grillo, G., Bramanti, S., Castagna, L., Bernasconi, P., Colombo, A. A., Gobbi, M., Nicoli, P., Natale, A., Santarone, S., Terruzzi, E., Olivieri, A., Scortechini, I., Chiusolo, P., Metafuni, E., Carella, A. M., Merla, E., Casini, M., Cavattoni, I., Arpinati, M., Nozzoli, C., Cutini, I., Mazza, P., Mazzone, A., Bassi, S., Onida, F., Saporiti, G., Canale, F. A., Vacca, A., Piras, E., Galieni, P., Falcioni, S., Luppi, M., Debbia, G., Iori, P. A., Ursula La Rocca, Pavone, V., Mele, A., Skert, C., Carobolante, F., Carluccio, P., Borghero, C., Elice, F., Proia, A., Fanelli, F., Selleri, C., Sacchi, N., Mammoliti, S., Oldani, E., Ciceri, F., Russo, D., and Bonifazi, F.

48. High Throughput Molecular Characterization of Normal Karyotype Acute Myeloid Leukemia in the Context of the Prospective Trial 02/06 of the Northern Italy Leukemia Group (NILG)

Author

Renato Bassan, Chiara Pavoni, Pamela Zanghì, Elisabetta Todisco, Nicola Stefano Fracchiolla, Anna Michelato, Leonardo Campiotti, Federico Lussana, Roberta Cavagna, Annamaria Scattolin, Giacomo Gianfaldoni, Chiara Caprioli, Erika Borlenghi, Fabio Ciceri, Ernesta Audisio, Alessandro Rambaldi, Lorella De Paoli, Tamara Intermesoli, Elisabetta Terruzzi, Orietta Spinelli, Ksenija Buklijas, Lara Elidi, Silvia Salmoiraghi, Paola Stefanoni, Paolo Corradini, Daniele Mattei, Irene Cavattoni, Monica Tajana, Elena Oldani, Salmoiraghi, S, Cavagna, R, Zanghì, P, Pavoni, C, Michelato, A, Buklijas, K, Elidi, L, Intermesoli, T, Lussana, F, Oldani, E, Caprioli, C, Stefanoni, P, Gianfaldoni, G, Audisio, E, Terruzzi, E, De Paoli, L, Borlenghi, E, Cavattoni, I, Mattei, D, Scattolin, A, Tajana, M, Ciceri, F, Todisco, E, Campiotti, L, Corradini, P, Fracchiolla, N, Bassan, R, Rambaldi, A, Spinelli, O, Salmoiraghi, S., Cavagna, R., Zanghi, P., Pavoni, C., Michelato, A., Buklijas, K., Elidi, L., Intermesoli, T., Lussana, F., Oldani, E., Caprioli, C., Stefanoni, P., Gianfaldoni, G., Audisio, E., Terruzzi, E., Paoli, L. D., Borlenghi, E., Cavattoni, I., Mattei, D., Scattolin, A., Tajana, M., Ciceri, F., Todisco, E., Campiotti, L., Corradini, P., Fracchiolla, N., Bassan, R., Rambaldi, A., and Spinelli, O.

Subjects
Oncology, Acute Myeloid Leukemia, Cancer Research, medicine.medical_specialty, NPM1, Context (language use), Gene mutation, Molecular marker, lcsh:RC254-282, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, hemic and lymphatic diseases, Medicine, Prospective cohort study, molecular marker, business.industry, Induction chemotherapy, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Transplantation, Leukemia, 030220 oncology & carcinogenesis, NGS, embryonic structures, business, 030215 immunology, Cohort study
Abstract

By way of a Next-Generation Sequencing NGS high throughput approach, we defined the mutational profile in a cohort of 221 normal karyotype acute myeloid leukemia (NK-AML) enrolled into a prospective randomized clinical trial, designed to evaluate an intensified chemotherapy program for remission induction. NPM1, DNMT3A, and FLT3-ITD were the most frequently mutated genes while DNMT3A, FLT3, IDH1, PTPN11, and RAD21 mutations were more common in the NPM1 mutated patients (p &lt, 0.05). IDH1 R132H mutation was strictly associated with NPM1 mutation and mutually exclusive with RUNX1 and ASXL1. In the whole cohort of NK-AML, no matter the induction chemotherapy used, by multivariate analysis, the achievement of complete remission was negatively affected by the SRSF2 mutation. Alterations of FLT3 (FLT3-ITD) and U2AF1 were associated with a worse overall and disease-free survival (p &lt, 0.05). FLT3-ITD positive patients who proceeded to alloHSCT had a survival probability similar to FLT3-ITD negative patients and the transplant outcome was no different when comparing high and low-AR-FLT3-ITD subgroups in terms of both OS and DFS. In conclusion, a comprehensive molecular profile for NK-AML allows for the identification of genetic lesions associated to different clinical outcomes and the selection of the most appropriate and effective treatment strategies, including stem cell transplantation and targeted therapies.

Published
2020

49. Clinical significance of chromatin-spliceosome acute myeloid leukemia: a report from the Northern Italy Leukemia Group (NILG) randomized trial 02/06

Author

Anna Michelato, Fabio Ciceri, Dario Ferrero, Lorella De Paoli, Renato Bassan, Chiara Caprioli, Paolo Corradini, Silvia Salmoiraghi, Brunangelo Falini, Chiara Cattaneo, Giacomo Gianfaldoni, Agostino Cortelezzi, Federica Delaini, Alessandro Rambaldi, Francesco Mannelli, Leonardo Campiotti, Anna Maria Scattolin, Pamela Zanghì, Erika Borlenghi, Federico Lussana, Massimo Bernardi, Ksenija Buklijas, Daniele Mattei, Elena Oldani, Monica Tajana, Tamara Intermesoli, Roberta Cavagna, Anna De Grassi, Irene Cavattoni, Ernesta Audisio, Elisabetta Terruzzi, Orietta Spinelli, Lara Elidi, Elisabetta Todisco, Chiara Pavoni, Caprioli, C, Lussana, F, Salmoiraghi, S, Cavagna, R, Buklijas, K, Elidi, L, Zanghi', P, Michelato, A, Delaini, F, Oldani, E, Intermesoli, T, Grassi, A, Gianfaldoni, G, Mannelli, F, Ferrero, D, Audisio, E, Terruzzi, E, De Paoli, L, Cattaneo, C, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, A, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Falini, B, Pavoni, C, Bassan, R, Spinelli, O, Rambaldi, A, Caprioli, Chiara, Lussana, Federico, Salmoiraghi, Silvia, Cavagna, Roberta, Buklijas, Ksenija, Elidi, Lara, Zanghi', Pamela, Michelato, Anna, Delaini, Federica, Oldani, Elena, Intermesoli, Tamara, Grassi, Anna, Gianfaldoni, Giacomo, Mannelli, Francesco, Ferrero, Dario, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Cattaneo, Chiara, Borlenghi, Erika, Cavattoni, Irene, Tajana, Monica, Scattolin, Anna Maria, Mattei, Daniele, Corradini, Paolo, Campiotti, Leonardo, Ciceri, Fabio, Bernardi, Massimo, Todisco, Elisabetta, Cortelezzi, Agostino, Falini, Brunangelo, Pavoni, Chiara, Bassan, Renato, Spinelli, Orietta, and Rambaldi, Alessandro

Subjects
Acute Myeloid Leukemia, Oncology, medicine.medical_specialty, Myeloid, Cytogenetics and Molecular Genetics, Myelodysplastic Syndromes, Article, law.invention, Cytogenetics and Molecular Genetic, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, hemic and lymphatic diseases, Internal medicine, medicine, Humans, Secondary Acute Myeloid Leukemia, Clinical significance, Prospective Studies, Prospective cohort study, neoplasms, Aged, Myeloproliferative Disorders, business.industry, Myelodysplastic syndromes, Myeloid leukemia, Hematology, Prognosis, medicine.disease, Chromatin, Leukemia, Myeloid, Acute, Leukemia, medicine.anatomical_structure, Spliceosomes, business, 030215 immunology
Abstract

Secondary acute myeloid leukemia (sAML) after myelodysplastic or myeloproliferative disorders is a high-risk category currently identified by clinical history or specific morphological and cytogenetic abnormalities. However, in the absence of these features, uncertainties remain to identify the secondary nature of some cases otherwise defined as de novo AML. To test whether a chromatin-spliceosome (CS) mutational signature might better inform the definition of the de novo AML group, we analyzed a prospective cohort of 413 newly diagnosed AML patients enrolled into a randomized clinical trial (NILG AML 02/06) and provided with accurate cytogenetic and molecular characterization. Among clinically defined de novo AML, 17.6% carried CS mutations (CS-AML) and showed clinical characteristics closer to sAML (older age, lower white blood cell counts and higher rate of multilineage dysplasia). Outcomes in this group were adverse, more similar to those of sAML as compared to de novo AML (overall survival, 30% in CS-AML and 17% in sAML vs 61% in de novo AML, P

Published
2020
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50. Treatment of Graft versus Host Disease with Mesenchymal Stromal Cells: A Phase I Study on 40 Adult and Pediatric Patients

Author

Francesca Masciocchi, Attilio Rovelli, Giovanna D'Amico, Sergio Cortelazzo, Adriana Balduzzi, Anna Grassi, Ettore Biagi, Martino Introna, Olga Pedrini, Giovanna Lucchini, Paolo Perseghin, Andrea Biondi, Giuseppe Gaipa, Daniela Longoni, Chiara Capelli, Stefania Galimberti, Erica Dander, Enrico Maria Pogliani, Fabio Pavan, Irene Cavattoni, Matteo Parma, Sara Deola, Josée Golay, Alessandra Algarotti, Daniela Belotti, Caterina Micò, Alessandro Rambaldi, Introna, M, Lucchini, G, Dander, E, Galimberti, S, Rovelli, A, Balduzzi, A, Longoni, D, Pavan, F, Masciocchi, F, Algarotti, A, Micò, C, Grassi, A, Deola, S, Cavattoni, I, Gaipa, G, Belotti, D, Perseghin, P, Parma, M, Pogliani, E, Golay, J, Pedrini, O, Capelli, C, Cortelazzo, S, D'Amico, G, Biondi, A, Rambaldi, A, and Biagi, E

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Mesenchymal stromal cells, Graft vs Host Disease, Antineoplastic Agents, Disease, Mesenchymal Stem Cell Transplantation, Severity of Illness Index, Gastroenterology, Steroid refractory graft-versus-host disease (GVHD), Cell therapy, Internal medicine, medicine, Humans, Transplantation, Homologous, Child, Adverse effect, Aged, Transplantation, Mesenchymal stromal cell, business.industry, Remission Induction, Mesenchymal stem cell, Infant, Immunosuppression, Hematology, Middle Aged, medicine.disease, Survival Analysis, Acute toxicity, Immunosuppressive treatment, Surgery, Graft-versus-host disease, Drug Resistance, Neoplasm, Child, Preschool, Hematologic Neoplasms, Hematopoietic stem cell transplantation (HSCT), Female, Steroids, Platelet lysate, business, Immunosuppressive Agents
Abstract

This phase I multicenter study was aimed at assessing the feasibility and safety of intravenous administration of third party bone marrow–derived mesenchymal stromal cells (MSC) expanded in platelet lysate in 40 patients (15 children and 25 adults), experiencing steroid-resistant grade II to IV graft-versus-host disease (GVHD). Patients received a median of 3 MSC infusions after having failed conventional immunosuppressive therapy. A median cell dose of 1.5 × 106/kg per infusion was administered. No acute toxicity was reported. Overall, 86 adverse events and serious adverse events were reported in the study, most of which (72.1%) were of infectious nature. Overall response rate, measured at 28 days after the last MSC injection, was 67.5%, with 27.5% complete response. The latter was significantly more frequent in patients exhibiting grade II GVHD as compared with higher grades (61.5% versus 11.1%, P = .002) and was borderline significant in children as compared with adults (46.7 versus 16.0%, P = .065). Overall survival at 1 and 2 years from the first MSC administration was 50.0% and 38.6%, with a median survival time of 1.1 years. In conclusion, MSC can be safely administered on top of conventional immunosuppression for steroid resistant GVHD treatment. Eudract Number 2008-007869-23, NCT01764100.

Published
2014
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