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1. Effective Tumor Debulking with Ibrutinib Before Initiation of Venetoclax: Results from the CAPTIVATE Minimal Residual Disease and Fixed-Duration Cohorts

Author

Barr, Paul M, Tedeschi, Alessandra, Wierda, William G, Allan, John N, Ghia, Paolo, Vallisa, Daniele, Jacobs, Ryan, O'Brien, Susan, Grigg, Andrew P, Walker, Patricia, Zhou, Cathy, Ninomoto, Joi, Krigsfeld, Gabriel, and Tam, Constantine S

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Rare Diseases, Clinical Research, Hematology, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adenine, Antineoplastic Combined Chemotherapy Protocols, Bridged Bicyclo Compounds, Heterocyclic, Creatinine, Cytoreduction Surgical Procedures, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasm, Residual, Piperidines, Sulfonamides, Tumor Lysis Syndrome, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeThe phase II CAPTIVATE study investigated first-line treatment with ibrutinib plus venetoclax for chronic lymphocytic leukemia in two cohorts: minimal residual disease (MRD)-guided randomized treatment discontinuation (MRD cohort) and fixed duration (FD cohort). We report tumor debulking and tumor lysis syndrome (TLS) risk category reduction with three cycles of single-agent ibrutinib lead-in before initiation of venetoclax using pooled data from the MRD and FD cohorts.Patients and methodsIn both cohorts, patients initially received three cycles of ibrutinib 420 mg/day then 12 cycles of ibrutinib plus venetoclax (5-week ramp-up to 400 mg/day).ResultsIn the total population (N = 323), the following decreases from baseline to after ibrutinib lead-in were observed: percentage of patients with a lymph node diameter ≥5 cm decreased from 31% to 4%, with absolute lymphocyte count ≥25 × 109/L from 76% to 65%, with high tumor burden category for TLS risk from 23% to 2%, and with an indication for hospitalization (high TLS risk, or medium TLS risk and creatinine clearance

Published
2022

2. A Fondazione Italiana Linfomi cohort study of R-COMP vs R-CHOP in older patients with diffuse large B-cell lymphoma

Author

Arcari, Annalisa, Rigacci, Lugi, Tucci, Alessandra, Puccini, Benedetta, Usai, Sara Veronica, Cavallo, Federica, Fabbri, Alberto, Balzarotti, Monica, Pelliccia, Sabrina, Luminari, Stefano, Pennese, Elsa, Zilioli, Vittorio Ruggero, Mahmoud, Abdurraouf Mokhtar, Musuraca, Gerardo, Marino, Dario, Sartori, Roberto, Botto, Barbara, Gini, Guido, Zanni, Manuela, Hohaus, Stefan, Tarantini, Giuseppe, Flenghi, Leonardo, Tani, Monica, Di Rocco, Alice, Merli, Michele, Vallisa, Daniele, Pagani, Chiara, Nassi, Luca, Dessì, Daniela, Ferrero, Simone, Cencini, Emanuele, Bernuzzi, Patrizia, Mammi, Caterina, Marcheselli, Luigi, Tabanelli, Valentina, Spina, Michele, and Merli, Francesco

Published
2023
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3. A prognostic model for patients with lymphoma and COVID-19: a multicentre cohort study

Author

Visco, Carlo, Marcheselli, Luigi, Mina, Roberto, Sassone, Marianna, Guidetti, Anna, Penna, Domenico, Cattaneo, Chiara, Bonuomo, Valentina, Busca, Alessandro, Ferreri, Andrés José María, Bruna, Riccardo, Petrucci, Luigi, Cairoli, Roberto, Salvini, Marco, Bertù, Lorenza, Ladetto, Marco, Pilerci, Sofia, Pinto, Antonello, Ramadan, Safaa, Marchesi, Francesco, Cavo, Michele, Arcaini, Luca, Coviello, Elisa, Romano, Alessandra, Musto, Pellegrino, Massaia, Massimo, Fracchiolla, Nicola, Marchetti, Monia, Scattolin, Annamaria, Tisi, Maria Chiara, Cuneo, Antonio, Della Porta, Matteo, Trentin, Livio, Turrini, Marco, Gherlinzoni, Filippo, Tafuri, Agostino, Galimberti, Sara, Bocchia, Monica, Cardinali, Valeria, Cilloni, Daniela, Corso, Alessandro, Armiento, Daniele, Rigacci, Luigi, La Barbera, Elettra Ortu, Gambacorti-Passerini, Carlo, Visani, Giuseppe, Vallisa, Daniele, Venditti, Adriano, Selleri, Carmine, Conconi, Annarita, Tosi, Patrizia, Lanza, Francesco, Candoni, Anna, Krampera, Mauro, Corradini, Paolo, Passamonti, Francesco, and Merli, Francesco

Published
2022
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4. Health-related Quality of Life Profile of Newly Diagnosed Patients With Myelodysplastic Syndromes by Age, Sex, and Risk Group: A Real-world Study by the GIMEMA

Author

Efficace, Fabio, primary, Al Essa, Wael, additional, Platzbecker, Uwe, additional, Niscola, Pasquale, additional, Palumbo, Giuseppe A., additional, Caocci, Giovanni, additional, Cottone, Francesco, additional, Breccia, Massimo, additional, Luppi, Mario, additional, Stauder, Reinhard, additional, Ricco, Alessandra, additional, Petranovic, Duska, additional, Baron, Frederic, additional, Voso, Maria Teresa, additional, Fianchi, Luana, additional, Frairia, Chiara, additional, Capodanno, Isabella, additional, Sarlo, Chiara, additional, Fedele, Marilena, additional, Lemoli, Roberto Massimo, additional, Invernizzi, Rosangela, additional, Vallisa, Daniele, additional, Di Renzo, Nicola, additional, Fozza, Claudio, additional, Doro, Maribel, additional, Giesinger, Johannes M., additional, and Vignetti, Marco, additional

Published
2023
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5. P547: UPFRONT INTENSIVE TREATMENT ANALYSIS OF THE ITALIAN COHORT STUDY ON FLT3-MUTATED AML PATIENTS (FLAM): THE IMPACT OF A FLT3 INHIBITOR ADDITION TO STANDARD CHEMOTHERAPY IN THE REAL-LIFE SETTING

Author

Nanni, Jacopo, primary, Mulè, Antonino, additional, Audisio, Ernesta, additional, Paola Martelli, Maria, additional, Scappini, Barbara, additional, Petracci, Elisabetta, additional, Valli, Irene, additional, Azzali, Irene, additional, Zingaretti, Chiara, additional, Benedetta Giannini, Maria, additional, Sica, Simona, additional, Cambò, Benedetta, additional, Candoni, Anna, additional, Lunghi, Monia, additional, Albano, Francesco, additional, Olivieri, Attilio, additional, Fracchiolla, Nicola, additional, Matteo Rigolin, Gian, additional, Bernardi, Massimo, additional, Romani, Claudio, additional, Todisco, Elisabetta, additional, Gigli, Federica, additional, Bocchia, Monica, additional, Cilloni, Daniela, additional, DI Renzo, Nicola, additional, Vallisa, Daniele, additional, Maria Mianulli, Anna, additional, Cignetti, Alessandro, additional, Lanza, Francesco, additional, Robustelli, Valentina, additional, Simonetti, Giorgia, additional, Teresa Bochicchio, Maria, additional, Marconi, Giovanni, additional, Flam Collaborative Group, The, additional, Papayannidis, Cristina, additional, and Martinelli, Giovanni, additional

Published
2023
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6. P1539: INFECTION-RELATED MORTALITY CLINICAL-BIOLOGICAL SCORING SYSTEM (IRM-SCORE) AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: A VALIDATION STUDY IN GITMO CENTRES

Author

Clerici, Daniela, primary, Liberatore, Carmine, additional, Rancoita, Paola Maria, additional, Dellacasa, Chiara Maria, additional, Patriarca, Francesca, additional, Corradini, Paolo, additional, Saccardi, Riccardo, additional, Carella, Angelo Michele, additional, Santarone, Stella, additional, Musso, Maurizio, additional, Iori, Anna Paola, additional, Chiusolo, Patrizia, additional, Onida, Francesco, additional, Mordini, Nicola, additional, Gobbi, Marco De, additional, Galieni, Piero, additional, Luppi, Mario, additional, Aglietta, Massimo, additional, Vallisa, Daniele, additional, Storti, Gabriella, additional, Facchini, Luca, additional, Peccatori, Jacopo, additional, Ruggeri, Annalisa, additional, Greco, Raffaella, additional, Corti, Consuelo, additional, Bonifazi, Francesca, additional, and Ciceri, Fabio, additional

Published
2023
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7. Haploidentical related donor compared to HLA-identical donor transplantation for chemosensitive Hodgkin lymphoma patients

Author

Castagna, Luca, Busca, Alessandro, Bramanti, Stefania, Raiola Anna, Maria, Malagola, Michele, Ciceri, Fabio, Arcese, William, Vallisa, Daniele, Patriarca, Francesca, Specchia, Giorgina, Raimondi, Roberto, Devillier, Raynier, Furst, Sabine, Giordano, Laura, Sarina, Barbara, Mariotti, Jacopo, Olivieri, Attilio, Bouabdallah, Reda, Carlo-Stella, Carmelo, Rambaldi, Alessandro, Santoro, Armando, Corradini, Paolo, Bacigalupo, Andrea, Bonifazi, Francesca, and Blaise, Didier

Published
2020
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9. Six-Month Doxycycline Is Safe and Effective As Upfront Monotherapy for Stage-I Malt Lymphoma of the Ocular Adnexae: Primary Endpoint Results of the IELSG39 Trial

Author

Ferreri, Andrés J.M., primary, Sassone, Marianna C., additional, Cangi, Maria Giulia, additional, Magliacane, Gilda, additional, Zanussi, Stefania, additional, Flospergher, Elena, additional, Marino, Fabrizio, additional, Bongiovanni, Lucia, additional, Ladetto, Marco, additional, Cavallo, Federica, additional, Aversa, Franco, additional, Anastasia, Antonella, additional, Mannina, Donato, additional, Pascarella, Anna, additional, Vallisa, Daniele, additional, Pulsoni, Alessandro, additional, Bonomini, Luisella, additional, Bertoni, Francesco, additional, Dolcetti, Riccardo, additional, Zucca, Emanuele, additional, and Ponzoni, Maurilio, additional

Published
2022
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10. Dosing Pattern of Ruxolitinib (RUX) in Patients with Myelofibrosis (MF) in Italy: Results from a Prospective Observational Study (ROMEI)

Author

Breccia, Massimo, primary, Guglielmelli, Paola, additional, Mendicino, Francesco, additional, Malato, Alessandra, additional, Palumbo, Giuseppe A., additional, Selleri, Carmine, additional, Cilloni, Daniela, additional, Mazza, Patrizio, additional, Siragusa, Sergio, additional, Abruzzese, Elisabetta, additional, Martelli, Maurizio, additional, Benevolo, Giulia, additional, Rinaldi, Erminia, additional, Crugnola, Monica, additional, Rupoli, Serena, additional, Pavone, Vincenzo, additional, Bonifacio, Massimiliano, additional, Pane, Fabrizio, additional, Carli, Giuseppe, additional, Langella, Maria, additional, Bruno Ventre, Marta, additional, Elli, Elena Maria, additional, Impera, Stefana, additional, Liberati, Anna Marina, additional, Di Renzo, Nicola, additional, Martino, Bruno, additional, Sportoletti, Paolo, additional, Tiribelli, Mario, additional, Binotto, Gianni, additional, Annunziata, Mario, additional, Di Ianni, Mauro, additional, La Nasa, Giorgio, additional, Falcone, Antonietta Pia, additional, Leanza, Rossana, additional, Volpe, Antonio, additional, Gherlinzoni, Filippo, additional, De Stefano, Valerio, additional, Vallisa, Daniele, additional, Leonetti Crescenzi, Sabrina, additional, Cavazzini, Francesco, additional, Ricco, Alessandra, additional, Barberio, Carmela, additional, Misto, Alessandra, additional, Passamonti, Francesco, additional, and Palandri, Francesca, additional

Published
2022
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11. Ibrutinib as a bridge to transplant in high-risk chronic lymphocytic leukemia: A case report and review of the literature

Author

Arcari Annalisa, Bassi Simona, Pochintesta Lara, Trabacchi Elena, Moroni Carlo Filippo, Rossi Angela, Zanlari Luca, and Vallisa Daniele

Subjects
Chronic lymphocytic leukemia, B-cell receptor inhibitors, Allogeneic hematopoietic stem cell transplantation, TP53 mutation, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

The treatment landscape of chronic lymphocytic leukemia (CLL) has been challenged by the advent of novel classes of drugs, such as B-cell receptor (BCR)-inhibitors and BCL-2 antagonists. In selected high-risk patients, the choice to start allogeneic hematopoietic stem cell transplantation (alloHCT) or continue these agents is a matter of debate. Furthermore, published data about the impact on the feasibility of alloHCT and the optimal timing of administration are limited. Here we present a case of relapsed TP53 mutated CLL treated with ibrutinib as a bridge to alloHCT, discussing risks and benefits of different treatment options in a “real life” situation.

Published
2017
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12. Incidence and Outcome of Invasive Fungal Diseases after Allogeneic Stem Cell Transplantation: A Prospective Study of the Gruppo Italiano Trapianto Midollo Osseo (GITMO)

Author

Girmenia, Corrado, Raiola, Anna Maria, Piciocchi, Alfonso, Algarotti, Alessandra, Stanzani, Marta, Cudillo, Laura, Pecoraro, Clara, Guidi, Stefano, Iori, Anna Paola, Montante, Barbara, Chiusolo, Patrizia, Lanino, Edoardo, Carella, Angelo Michele, Zucchetti, Elisa, Bruno, Benedetto, Irrera, Giuseppe, Patriarca, Francesca, Baronciani, Donatella, Musso, Maurizio, Prete, Arcangelo, Risitano, Antonio Maria, Russo, Domenico, Mordini, Nicola, Pastore, Domenico, Vacca, Adriana, Onida, Francesco, Falcioni, Sadia, Pisapia, Giovanni, Milone, Giuseppe, Vallisa, Daniele, Olivieri, Attilio, Bonini, Alessandro, Castagnola, Elio, Sica, Simona, Majolino, Ignazio, Bosi, Alberto, Busca, Alessandro, Arcese, William, Bandini, Giuseppe, Bacigalupo, Andrea, Rambaldi, Alessandro, and Locasciulli, Anna

Published
2014
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13. EBV-positive mucocutaneous ulcer arising in a post-hematopoietic cell transplant patient: A difficult diagnosis

Author

Falcioni Federica, Giaimo Mariateresa, Rinalidi Amelia, Palma Benedetta Dalla, Rienzo Gianluca Di, Vallisa Daniele, Prezioso Lucia, Cambo Benedetta, Copelli Valerio, Crafa Pellegrino, and Tafuni Alessandro

Subjects
Community and Home Care, Hematopoietic cell, business.industry, Mucocutaneous zone, Disease, respiratory system, medicine.disease, medicine.disease_cause, respiratory tract diseases, Pneumonia, Immunology, EBV Positive, Medicine, Transplant patient, Respiratory system, business, Coronavirus
Abstract

The coronavirus disease-2019 (COVID-19) is primarily a disease of the respiratory system and is manifested by an infectious pneumonia, with fever, cough and breathlessness as the most common presenting symptoms.

Published
2021

15. A Clinical Prognostic Model Based on Machine Learning from the Fondazione Italiana Linfomi (FIL) MCL0208 Phase III Trial

Author

Zaccaria, Gian Maria, primary, Ferrero, Simone, additional, Hoster, Eva, additional, Passera, Roberto, additional, Evangelista, Andrea, additional, Genuardi, Elisa, additional, Drandi, Daniela, additional, Ghislieri, Marco, additional, Barbero, Daniela, additional, Del Giudice, Ilaria, additional, Tani, Monica, additional, Moia, Riccardo, additional, Volpetti, Stefano, additional, Cabras, Maria Giuseppina, additional, Di Renzo, Nicola, additional, Merli, Francesco, additional, Vallisa, Daniele, additional, Spina, Michele, additional, Pascarella, Anna, additional, Latte, Giancarlo, additional, Patti, Caterina, additional, Fabbri, Alberto, additional, Guarini, Attilio, additional, Vitolo, Umberto, additional, Hermine, Olivier, additional, Kluin-Nelemans, Hanneke C, additional, Cortelazzo, Sergio, additional, Dreyling, Martin, additional, and Ladetto, Marco, additional

Published
2021
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16. INO-CD22: A Multi-Center, Real-Life Study on Inotuzumab-Ozogamicin Safety and Effectiveness in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia

Author

Papayannidis, Cristina, primary, Zappasodi, Patrizia, additional, Fracchiolla, Nicola S, additional, Di Raimondo, Francesco, additional, Mattei, Daniele Giovanni, additional, Lanza, Francesco, additional, Mauro, Endri, additional, Del Principe, Maria Ilaria, additional, Borlenghi, Erika, additional, Fumagalli, Monica, additional, Todisco, Elisabetta, additional, Sica, Simona, additional, Di Renzo, Nicola, additional, De Fabritiis, Paolo, additional, Corradini, Paolo, additional, Vallisa, Daniele, additional, Petruzziello, Fara, additional, Luppi, Mario, additional, Pane, Fabrizio, additional, Ferrara, Felicetto, additional, Passamonti, Francesco, additional, Mulè, Antonino, additional, Zingaretti, Chiara, additional, Marconi, Giovanni, additional, Valli, Irene, additional, Petracci, Elisabetta, additional, Clemente, Alberto, additional, Saglio, Giuseppe Nicola, additional, Ciceri, Fabio, additional, and Martinelli, Giovanni, additional

Published
2021
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17. A Simplified Geriatric Assessment (sGA) Can Identify Older Patients with Relapse/Refractory (R/R) Aggressive Lymphoma Suitable for Autologous Stem Cell Transplantation (ASCT): Final Results of Recanz Multicentre Prospective Phase 2 Study By the Fondazione Italiana Linfomi (FIL)

Author

Tucci, Alessandra, primary, Musuraca, Gerardo, additional, Cavallo, Federica, additional, Zilioli, Vittorio Ruggero, additional, Zanni, Manuela, additional, Pelliccia, Sabrina, additional, Mannina, Donato, additional, Michieli, Mariagrazia, additional, Vallisa, Daniele, additional, Tani, Monica, additional, Merli, Francesco, additional, Re, Francesca, additional, Marcheselli, Luigi, additional, Campostrini, Giulia, additional, Pagani, Chiara, additional, Grimaldi, Daniele, additional, Liardo, Eliana Valentina, additional, Re, Alessandro, additional, Cox, M. Christina, additional, and Rossi, Giuseppe, additional

Published
2021
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18. COVID-19 Pandemic Impact on Chronic Lymphocytic Leukemia (CLL) Patients' Preferences Towards Therapies: The Italian Experience (CHOICE Study)

Author

Molica, Stefano, primary, Laurenti, Luca, additional, Ghia, Paolo, additional, Coscia, Marta, additional, Cuneo, Antonio, additional, Gaidano, Gianluca, additional, Mauro, Francesca, additional, Frustaci, Anna Maria, additional, Vallisa, Daniele, additional, Pane, Fabrizio, additional, Gualberti, Giuliana, additional, Iannella, Emilia, additional, Finsinger, Paola, additional, Caira, Morena, additional, and Sportoletti, Paolo, additional

Published
2021
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19. Case Report: B Lymphocyte Disorders Under COVID-19 Inflammatory Pressure

Author

Taliani, Gloria, Follini, Elena, Guglielmetti, Lorenzo, Bernuzzi, Patrizia, Faggi, Alberto, Ferrante, Patrizia, Fronti, Elisa, Gerna, Laura, Leoni, Maria Cristina, Paolillo, Franco, Ratti, Giovanna, Ruggieri, Alessandro, Valdatta, Caterina, Donisi, Alessandra, Zangrandi, Adriano, Pochintesta, Lara, Moroni, Carlo, Sacchini, Daria, Vallisa, Daniele, Codeluppi, Mauro, COVID-Piacenza Group, Taliani, Gloria, Follini, Elena, Guglielmetti, Lorenzo, Bernuzzi, Patrizia, Faggi, Alberto, Ferrante, Patrizia, Fronti, Elisa, Gerna, Laura, Leoni, Maria Cristina, Paolillo, Franco, Ratti, Giovanna, Ruggieri, Alessandro, Valdatta, Caterina, Donisi, Alessandra, Zangrandi, Adriano, Pochintesta, Lara, Moroni, Carlo, Sacchini, Daria, Vallisa, Daniele, Codeluppi, Mauro, and COVID-Piacenza Group

Abstract

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infects humans through the angiotensin converting enzyme-2 (ACE-2) receptor expressed on many cells, including lymphocytes. In Covid-19 patients IL-6 is overexpressed, and hyperactivated plasmacytoid lymphocytes are detected in peripheral blood film. We hypothesize that, due to the unpredictable interaction between the new virus and the B cell lineage of infected patients, a cascade of out of control events can ensue, capable of determining unexpected pathologic disorders involving such lineage. Here we report two cases of autoimmune hemolytic anemia (AIHA) and two cases of B-cell hematological malignancies developed or reactivated during acute SARS-CoV-2 infection. The temporal relationship of the events may suggest a potential causal relationship between SARS-CoV-2 infection and the hematopoietic disorders. We suggest that special attention should be paid to COVID-19 patients with underlining B cell lineage disorders.

Published
2021

20. COVID-19 and stem cell transplantation; results from an EBMT and GETH multicenter prospective survey

Author

National Institute for Health Research (UK), Ljungman, Per, Cámara, Rafael de la, Mikulska, Malgorzata, Tridello, Gloria, Aguado, Beatriz, Al Zahrani, Mohsen, Apperley, Jane, Berceanu, Ana, Martino, Rodrigo, Calbacho, M., Ciceri, Fabio, López-Corral, L., Crippa, Claudia, Fox, María‐Laura, Grassi, Anna, Jiménez, María J., Koçulu Demir, Safiye, Kwon, Mi, Vallejo Llamas, Carlos, López Lorenzo, José Luis, Mielke, Stephan, Orchard, Kim, Parody Porras, Rocío, Vallisa, Daniele, Xhaard, Alienor, Simone Knelange, Nina, Cedillo, Ángel, Kroger, Nicolaus, Piñana, José Luis, Styczynski, Jan, National Institute for Health Research (UK), Ljungman, Per, Cámara, Rafael de la, Mikulska, Malgorzata, Tridello, Gloria, Aguado, Beatriz, Al Zahrani, Mohsen, Apperley, Jane, Berceanu, Ana, Martino, Rodrigo, Calbacho, M., Ciceri, Fabio, López-Corral, L., Crippa, Claudia, Fox, María‐Laura, Grassi, Anna, Jiménez, María J., Koçulu Demir, Safiye, Kwon, Mi, Vallejo Llamas, Carlos, López Lorenzo, José Luis, Mielke, Stephan, Orchard, Kim, Parody Porras, Rocío, Vallisa, Daniele, Xhaard, Alienor, Simone Knelange, Nina, Cedillo, Ángel, Kroger, Nicolaus, Piñana, José Luis, and Styczynski, Jan

Abstract

This study reports on 382 COVID-19 patients having undergone allogeneic (n = 236) or autologous (n = 146) hematopoietic cell transplantation (HCT) reported to the European Society for Blood and Marrow Transplantation (EBMT) or to the Spanish Group of Hematopoietic Stem Cell Transplantation (GETH). The median age was 54.1 years (1.0–80.3) for allogeneic, and 60.6 years (7.7–81.6) for autologous HCT patients. The median time from HCT to COVID-19 was 15.8 months (0.2–292.7) in allogeneic and 24.6 months (−0.9 to 350.3) in autologous recipients. 83.5% developed lower respiratory tract disease and 22.5% were admitted to an ICU. Overall survival at 6 weeks from diagnosis was 77.9% and 72.1% in allogeneic and autologous recipients, respectively. Children had a survival of 93.4%. In multivariate analysis, older age (p = 0.02), need for ICU (p < 0.0001) and moderate/high immunodeficiency index (p = 0.04) increased the risk while better performance status (p = 0.001) decreased the risk for mortality. Other factors such as underlying diagnosis, time from HCT, GVHD, or ongoing immunosuppression did not significantly impact overall survival. We conclude that HCT patients are at high risk of developing LRTD, require admission to ICU, and have increased mortality in COVID-19.

Published
2021

21. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study

Author

Passamonti, Francesco, Cattaneo, Chiara, Arcaini, Luca, Bruna, Riccardo, Cavo, Michele, Merli, Francesco, Angelucci, Emanuele, Krampera, Mauro, Cairoli, Roberto, Della Porta, Matteo Giovanni, Fracchiolla, Nicola, Ladetto, Marco, Gambacorti Passerini, Carlo, Salvini, Marco, Marchetti, Monia, Lemoli, Roberto, Molteni, Alfredo, Busca, Alessandro, Cuneo, Antonio, Romano, Alessandra, Giuliani, Nicola, Galimberti, Sara, Corso, Alessandro, Morotti, Alessandro, Falini, Brunangelo, Billio, Atto, Gherlinzoni, Filippo, Visani, Giuseppe, Tisi, Maria Chiara, Tafuri, Agostino, Tosi, Patrizia, Lanza, Francesco, Massaia, Massimo, Turrini, Mauro, Ferrara, Felicetto, Gurrieri, Carmela, Vallisa, Daniele, Martelli, Maurizio, Derenzini, Enrico, Guarini, Attilio, Conconi, Annarita, Cuccaro, Annarosa, Cudillo, Laura, Russo, Domenico, Ciambelli, Fabrizio, Scattolin, Anna Maria, Luppi, Mario, Selleri, Carmine, Ortu La Barbera, Elettra, Ferrandina, Celestino, Di Renzo, Nicola, Olivieri, Attilio, Bocchia, Monica, Gentile, Massimo, Marchesi, Francesco, Musto, Pellegrino, Federici, Augusto Bramante, Candoni, Anna, Venditti, Adriano, Fava, Carmen, Pinto, Antonio, Galieni, Piero, Rigacci, Luigi, Armiento, Daniele, Pane, Fabrizio, Oberti, Margherita, Zappasodi, Patrizia, Visco, Carlo, Franchi, Matteo, Grossi, Paolo Antonio, Bertù, Lorenza, Corrao, Giovanni, Pagano, Livio, Corradini, Paolo, Pagano, Livio (ORCID:0000-0001-8287-928X), Passamonti, Francesco, Cattaneo, Chiara, Arcaini, Luca, Bruna, Riccardo, Cavo, Michele, Merli, Francesco, Angelucci, Emanuele, Krampera, Mauro, Cairoli, Roberto, Della Porta, Matteo Giovanni, Fracchiolla, Nicola, Ladetto, Marco, Gambacorti Passerini, Carlo, Salvini, Marco, Marchetti, Monia, Lemoli, Roberto, Molteni, Alfredo, Busca, Alessandro, Cuneo, Antonio, Romano, Alessandra, Giuliani, Nicola, Galimberti, Sara, Corso, Alessandro, Morotti, Alessandro, Falini, Brunangelo, Billio, Atto, Gherlinzoni, Filippo, Visani, Giuseppe, Tisi, Maria Chiara, Tafuri, Agostino, Tosi, Patrizia, Lanza, Francesco, Massaia, Massimo, Turrini, Mauro, Ferrara, Felicetto, Gurrieri, Carmela, Vallisa, Daniele, Martelli, Maurizio, Derenzini, Enrico, Guarini, Attilio, Conconi, Annarita, Cuccaro, Annarosa, Cudillo, Laura, Russo, Domenico, Ciambelli, Fabrizio, Scattolin, Anna Maria, Luppi, Mario, Selleri, Carmine, Ortu La Barbera, Elettra, Ferrandina, Celestino, Di Renzo, Nicola, Olivieri, Attilio, Bocchia, Monica, Gentile, Massimo, Marchesi, Francesco, Musto, Pellegrino, Federici, Augusto Bramante, Candoni, Anna, Venditti, Adriano, Fava, Carmen, Pinto, Antonio, Galieni, Piero, Rigacci, Luigi, Armiento, Daniele, Pane, Fabrizio, Oberti, Margherita, Zappasodi, Patrizia, Visco, Carlo, Franchi, Matteo, Grossi, Paolo Antonio, Bertù, Lorenza, Corrao, Giovanni, Pagano, Livio, Corradini, Paolo, and Pagano, Livio (ORCID:0000-0001-8287-928X)

Abstract

Background: Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19. Methods: This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with ClinicalTrials.gov, NCT04352556, and the prospective part of the study is ongoing. Findings: We enrolled 536 patients with a median follow-up of 20 days (IQR 10-34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77-2·34) in our whole study cohort and 3·72 (2·86-4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1-44·9). Older age (hazard ratio 1·03, 95% CI 1·01-1·05); progressive disease status (2·10, 1·41-3·12); diagnosis of

Published
2020

22. Efficacy of Idelalisib and Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Treated Outside of Clinical Trial. a Report of the Gimema Group

Author

Rigolin, Gian Matteo, primary, Frustaci, Annamaria, additional, Piciocchi, Alfonso, additional, Visentin, Andrea, additional, Vitagliano, Orsola, additional, Coscia, Marta, additional, Farina, Lucia, additional, Gaidano, Gianluca, additional, Murru, Roberta, additional, Varettoni, Marzia, additional, Arcaini, Luca, additional, Cibien, Francesca, additional, Paolini, Rossella, additional, Sportoletti, Paolo, additional, Pietrasanta, Daniela, additional, Molinari, Anna Lia, additional, Quaglia, Francesca M., additional, Laurenti, Luca, additional, Marasca, Roberto, additional, Marchetti, Monia, additional, Chiarenza, Annalisa, additional, Mauro, Francesca Romana, additional, Perbellini, Omar, additional, Mannina, Donato, additional, Sancetta, Rosaria, additional, Olivieri, Attilio, additional, Molica, Stefano, additional, Pane, Fabrizio, additional, Patti, Caterina, additional, Iliariucci, Fiorella, additional, Gozzetti, Alessandro, additional, Califano, Catello, additional, Galieni, Piero, additional, Augello, Accursio Fabio, additional, Vallisa, Daniele, additional, Cura, Francesca, additional, Crea, Enrico, additional, Fazi, Paola, additional, Zamprogna, Giulia, additional, Krampera, Mauro, additional, Trentin, Livio, additional, Ferrara, Felicetto, additional, Gentile, Massimo, additional, Montillo, Marco, additional, Foà, Robin, additional, and Cuneo, Antonio, additional

Published
2020
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23. COVID-19 and Stem Cell Transplantation; Results from the Prospective Survey By the Infectious Diseases Working Party of the European Society for Blood and Marrow Transplantation (EBMT) and the Spanish Hematopoietic Stem Cell Transplantation and Cell Therapy Group (GETH)

Author

Ljungman, Per, primary, De La Camara, Rafael, additional, Mikulska, Malgorzata, additional, Tridello, Gloria, additional, Aguado, Beatriz, additional, Beguin, Yves, additional, Martino Bufarull, Rodrigo, additional, Ciceri, Fabio, additional, Corral, Lucía López, additional, Crippa, Claudia, additional, Deeren, Dries, additional, Duarte, Rafael F., additional, Fox, María Laura, additional, Grassi, Anna, additional, Jimenez, María-José, additional, Koculu, Safiye, additional, Kwon, Mi, additional, Vallejo Llamas, Juan Carlos, additional, Lopez Lorenzo, Jose Luiz, additional, Mielke, Stephan, additional, López Jiménez, Javier, additional, Mesa Morales, Zoraida, additional, Orchard, Kim H., additional, Parody Porras, Rocio, additional, Potter, Victoria, additional, Suárez-Lledó, María, additional, Schaap, Nicolaas, additional, Simand, Celestine, additional, Sisinni, Luisa, additional, Snowden, John A, additional, Vallisa, Daniele, additional, Yonalhindilerden, Ipek, additional, Xhaard, Alienor, additional, Knelange, Nina Simone, additional, Cedillo, Angel, additional, Kröger, Nicolaus, additional, Piñana Sanchez, Jose Luis, additional, and Styczynski, Jan, additional

Published
2020
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24. Total body computed tomography scan in the initial work-up of Binet stage A chronic lymphocytic leukemia patients: Results of the prospective, multicenter O-CLL1-GISL study

Author

Gentile, Massimo, Cutrona, Giovanna, Fabris, Sonia, Pesce, Emanuela Anna, Baldini, Luca, Di Raimondo, Francesco, Musolino, Caterina, Di Tonno, Paolo, Di Renzo, Nicola, Molica, Stefano, Brugiatelli, Maura, Ilariucci, Fiorella, Zupo, Simona, Matis, Serena, Maura, Francesco, Vigna, Ernesto, Angrilli, Francesco, Recchia, Anna Grazia, Quarta, Giovanni, Iannitto, Emilio, Fragasso, Alberto, Musto, Pellegrino, Spriano, Mauro, Vincelli, Iolanda, Vallisa, Daniele, Cortelezzi, Agostino, Mauro, Francesca Romana, Foà, Robin, Federico, Massimo, Neri, Antonino, Ferrarini, Manlio, and Morabito, Fortunato

Published
2013
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25. Splenic marginal zone lymphoma: a prognostic model for clinical use

Author

Arcaini, Luca, Lazzarino, Mario, Colombo, Nora, Burcheri, Sara, Boveri, Emanuela, Paulli, Marco, Morra, Enrica, Gambacorta, Marcello, Cortelazzo, Sergio, Tucci, Alessandra, Ungari, Marco, Ambrosetti, Achille, Menestrina, Fabio, Orsucci, Lorella, Novero, Domenico, Pulsoni, Alessandro, Frezzato, Maurizio, Gaidano, Gianluca, Vallisa, Daniele, Minardi, Viviana, Tripodo, Claudio, Callea, Vincenzo, Baldini, Luca, Merli, Francesco, Federico, Massimo, Franco, Vito, and Iannitto, Emilio

Published
2006
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29. Incidence, Risk Factors and Outcome of Pre-engraftment Gram-Negative Bacteremia After Allogeneic and Autologous Hematopoietic Stem Cell Transplantation: An Italian Prospective Multicenter Survey

Author

Girmenia, Corrado, Bertaina, Alice, Piciocchi, Alfonso, Perruccio, Katia, Algarotti, Alessandra, Busca, Alessandro, Cattaneo, Chiara, Raiola, Anna Maria, Guidi, Stefano, Iori, Anna Paola, Candoni, Anna, Irrera, Giuseppe, Milone, Giuseppe, Marcacci, Giampaolo, Scimè, Rosanna, Musso, Maurizio, Cudillo, Laura, Sica, Simona, Castagna, Luca, Corradini, Paolo, Marchesi, Francesco, Pastore, Domenico, Alessandrino, Emilio Paolo, Annaloro, Claudio, Ciceri, Fabio, Santarone, Stella, Nassi, Luca, Farina, Claudio, Viscoli, Claudio, Rossolini, Gian Maria, Bonifazi, Francesca, Rambaldi, Alessandro, Capria, Saveria, Bertaina, A., Mastronuzzi, Angela, Pagliara, Daria, Bernaschi, Paola, Amico, Lucia, Carotti, Alessandra, Mencacci, Antonella, Busca, A., Bruno, Benedetto, Costa, Cristina, Passi, Angela, Ravizzola, Giuseppe, Angelucci, Emanuele, Marchese, Anna, Pecile, Patrizia, Candoni, A., Ventura, Giovanna, Fanin, Renato, Scarparo, Claudio, Barbaro, Angelo, Milone, G., Leotta, Salvatore, Marchese, Anna Elisa, Marcacci, G., Becchimanzi, Cristina, Donnarumma, Daniela, Tringali, Stefania, Baldi, Maria Teresa, Scalone, Renato, Cudillo, L., Picardi, Alessandra, Arcese, William, Fontana, Carla, Sica, S., Giammarco, Sabrina, Spanu, Teresa, Castagna, L., Crocchiolo, Roberto, Casari, Erminia, Mussetti, Alberto, Conte, Eutilia, Ensoli, Fabrizio, Miragliotta, Giuseppe, Marone, Piero, Arghittu, Milena, Greco, Raffaella, Forcina, Alessandra, Chichero, Paola, Santarone, S., Di Bartolomeo, Paolo, Fazii, Paolo, Kroumova, Vesselina, Decembrino, Nunzia, Zecca, Marco, Pisapia, Giovanni, Palazzo, Giulia, Lanino, Edoardo, Faraci, Maura, Castagnola, Elio, Bandettini, Roberto, Pastano, Rocco, Sammassimo, Simona, Passerini, Rita, Stefani, Piero Maria, Gherlinzoni, Filippo, Rigoli, Roberto, Prezioso, Lucia, Cambò, Benedetta, Calderaro, Adriana, Carella, Angelo Michele, Cascavilla, Nicola, Labonia, Maria Teresa, Celeghini, Ivana, Mordini, Nicola, Piana, Federica, Vacca, Adriana, Sanna, Marco, Podda, Giovanni, Corsetti, Maria Teresa, Rocchetti, Andrea, Cilloni, Daniela, De Gobbi, Marco, Bianco, Ornella, Fagioli, Franca, Carraro, Francesca, De Intinis, Gianfranco, Severino, Alessandro, Proia, Anna, Parisi, Gabriella, Vallisa, Daniele, Confalonieri, Massimo, Russo, Domenico, Malagola, Michele, Galieni, Piero, Falcioni, Sadia, Travaglini, Valeria, Raimondi, Roberto, Borghero, Carlo, Pavan, Giacomina, Prete, Arcangelo, Belotti, Tamara, Ambretti, Simone, Imola, Manuela, Mianulli, Anna Maria, Pedna, Maria Federica, Cesaro, Simone, Lo Cascio, Giuliana, Ferrari, Antonella, Piedimonte, Monica, Santino, Iolanda, Calandrelli, Monica, Olivieri, Attilio, Orecchioni, Francesca, Mirabile, Milena, Centurioni, Riccardo, Gironacci, Luciana, Caravelli, Daniela, Gallo, Susanna, De Filippi, Marco, Cupelli, Luca, Dentamaro, Teresa, Falco, Silvana, Eugenio, Ospedale S, Marotta, Serena, Risitano, Antonio, Lula, Dora, Musto, Pellegrino, Pietrantuono, Giuseppe, Traficante, Antonio, Cerchiara, Elisabetta, Tirindelli, Maria Cristina, Dicuonzo, Giordano, Chierichini, Anna, Anaclerico, Barbara, Placanica, Paola, Girmenia, C, Bertaina, A, Piciocchi, A, Perruccio, K, Algarotti, A, Busca, A, Cattaneo, C, Raiola, Am, Guidi, S, Iori, Ap, Candoni, A, Irrera, G, Milone, G, Marcacci, G, Scimè, R, Musso, M, Cudillo, L, Sica, S, Castagna, L, Corradini, P, Marchesi, F, Pastore, D, Alessandrino, Ep, Annaloro, C, Ciceri, F, Santarone, S, Nassi, L, Farina, C, Viscoli, C, Rossolini, Gm, Bonifazi, F, Rambaldi, A, for the Gruppo Italiano Trapianto di Midollo Osseo, (GITMO), Associazione Microbiologi Clinici Italiani, (AMCLI), Girmenia, Corrado, Bertaina, Alice, Piciocchi, Alfonso, Perruccio, Katia, Algarotti, Alessandra, Busca, Alessandro, Cattaneo, Chiara, Raiola, Anna Maria, Guidi, Stefano, Iori, Anna Paola, Candoni, Anna, Irrera, Giuseppe, Milone, G., Marcacci, Giampaolo, Scimè, Rosanna, Musso, Maurizio, Cudillo, Laura, Sica, Simona, Castagna, Luca, Corradini, Paolo, Marchesi, Francesco, Pastore, Domenico, Alessandrino, Emilio Paolo, Annaloro, Claudio, Ciceri, Fabio, Santarone, Stella, Nassi, Luca, Farina, Claudio, Viscoli, Claudio, Rossolini, Gian Maria, Bonifazi, Francesca, Rambaldi, Alessandro, Capria, Saveria, Bertaina, A., Mastronuzzi, Angela, Pagliara, Daria, Bernaschi, Paola, Amico, Lucia, Carotti, Alessandra, Mencacci, Antonella, Busca, A., Bruno, Benedetto, Costa, Cristina, Passi, Angela, Ravizzola, Giuseppe, Angelucci, Emanuele, Marchese, Anna, Pecile, Patrizia, Candoni, A., Ventura, Giovanna, Fanin, Renato, Scarparo, Claudio, Barbaro, Angelo, Leotta, Salvatore, Marchese, Anna Elisa, Marcacci, G., Becchimanzi, Cristina, Donnarumma, Daniela, Tringali, Stefania, Baldi, Maria Teresa, Scalone, Renato, Cudillo, L., Picardi, Alessandra, Arcese, William, Fontana, Carla, Sica, S., Giammarco, Sabrina, Spanu, Teresa, Castagna, L., Crocchiolo, Roberto, Casari, Erminia, Mussetti, Alberto, Conte, Eutilia, Ensoli, Fabrizio, Miragliotta, Giuseppe, Marone, Piero, Arghittu, Milena, Greco, Raffaella, Forcina, Alessandra, Chichero, Paola, Santarone, S., Di Bartolomeo, Paolo, Fazii, Paolo, Kroumova, Vesselina, Decembrino, Nunzia, Zecca, Marco, Pisapia, Giovanni, Palazzo, Giulia, Lanino, Edoardo, Faraci, Maura, Castagnola, Elio, Bandettini, Roberto, Pastano, Rocco, Sammassimo, Simona, Passerini, Rita, Stefani, Piero Maria, Gherlinzoni, Filippo, Rigoli, Roberto, Prezioso, Lucia, Cambò, Benedetta, Calderaro, Adriana, Carella, Angelo Michele, Cascavilla, Nicola, Labonia, Maria Teresa, Celeghini, Ivana, Mordini, Nicola, Piana, Federica, Vacca, Adriana, Sanna, Marco, Podda, Giovanni, Corsetti, Maria Teresa, Rocchetti, Andrea, Cilloni, Daniela, De Gobbi, Marco, Bianco, Ornella, Fagioli, Franca, Carraro, Francesca, De Intinis, Gianfranco, Severino, Alessandro, Proia, Anna, Parisi, Gabriella, Vallisa, Daniele, Confalonieri, Massimo, Russo, Domenico, Malagola, Michele, Galieni, Piero, Falcioni, Sadia, Travaglini, Valeria, Raimondi, Roberto, Borghero, Carlo, Pavan, Giacomina, Prete, Arcangelo, Belotti, Tamara, Ambretti, Simone, Imola, Manuela, Mianulli, Anna Maria, Pedna, Maria Federica, Cesaro, Simone, Lo Cascio, Giuliana, Ferrari, Antonella, Piedimonte, Monica, Santino, Iolanda, Calandrelli, Monica, Olivieri, Attilio, Orecchioni, Francesca, Mirabile, Milena, Centurioni, Riccardo, Gironacci, Luciana, Caravelli, Daniela, Gallo, Susanna, De Filippi, Marco, Cupelli, Luca, Dentamaro, Teresa, Falco, Silvana, Eugenio, Ospedale S, Marotta, Serena, Risitano, Antonio, Lula, Dora, Musto, Pellegrino, Pietrantuono, Giuseppe, Traficante, Antonio, Cerchiara, Elisabetta, Tirindelli, Maria Cristina, Dicuonzo, Giordano, Chierichini, Anna, Anaclerico, Barbara, and Placanica, Paola

Subjects
0301 basic medicine, Male, Transplantation Conditioning, Drug Resistance, Bacteremia, 0302 clinical medicine, epidemiology, Gram negative bacteremia, multidrug resistance, stem cell transplant, survival, Risk Factors, Drug Resistance, Multiple, Bacterial, Epidemiology, Medicine, Age Factor, Prospective Studies, Prospective cohort study, Child, Transplantation, Homologou, education.field_of_study, Incidence (epidemiology), Incidence, Bacterial, Age Factors, Hematopoietic Stem Cell Transplantation, Middle Aged, Transplantation, Autologou, surgical procedures, operative, Infectious Diseases, Italy, Child, Preschool, Female, medicine.symptom, Multiple, Autologous, Human, Homologous, Microbiology (medical), Adult, medicine.medical_specialty, Adolescent, 030106 microbiology, Population, Transplantation, Autologous, 03 medical and health sciences, Young Adult, Internal medicine, Gram-Negative Bacteria, Gram-Negative Bacterial Infection, Escherichia coli, Humans, Transplantation, Homologous, Preschool, education, Aged, Gram-Negative Bacterial Infections, Infant, Transplantation, business.industry, Risk Factor, medicine.disease, Prospective Studie, Carriage, Otitis, business, Settore MED/15 - Malattie del Sangue, 030215 immunology
Abstract

Background Gram-negative bacteremia (GNB) is a major cause of illness and death after hematopoietic stem cell transplantation (HSCT), and updated epidemiological investigation is advisable. Methods We prospectively evaluated the epidemiology of pre-engraftment GNB in 1118 allogeneic HSCTs (allo-HSCTs) and 1625 autologous HSCTs (auto-HSCTs) among 54 transplant centers during 2014 (SIGNB-GITMO-AMCLI study). Using logistic regression methods. we identified risk factors for GNB and evaluated the impact of GNB on the 4-month overall-survival after transplant. Results The cumulative incidence of pre-engraftment GNB was 17.3% in allo-HSCT and 9% in auto-HSCT. Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa were the most common isolates. By multivariate analysis, variables associated with GNB were a diagnosis of acute leukemia, a transplant from a HLA-mismatched donor and from cord blood, older age, and duration of severe neutropenia in allo-HSCT, and a diagnosis of lymphoma, older age, and no antibacterial prophylaxis in auto-HSCT. A pretransplant infection by a resistant pathogen was significantly associated with an increased risk of posttransplant infection by the same microorganism in allo-HSCT. Colonization by resistant gram-negative bacteria was significantly associated with an increased rate of infection by the same pathogen in both transplant procedures. GNB was independently associated with increased mortality at 4 months both in allo-HSCT (hazard ratio, 2.13; 95% confidence interval, 1.45–3.13; P Conclusions Pre-engraftment GNB is an independent factor associated with increased mortality rate at 4 months after auto-HSCT and allo-HSCT. Previous infectious history and colonization monitoring represent major indicators of GNB. Clinical Trials registration NCT02088840.

Published
2017

34. Ibrutinib as a bridge to transplant in high-risk chronic lymphocytic leukemia: A case report and review of the literature

Author

Zanlari Luca, Arcari Annalisa, Pochintesta Lara, Moroni Carlo Filippo, Trabacchi Elena, Bassi Simona, Rossi Angela, and Vallisa Daniele

Subjects
Oncology, medicine.medical_specialty, Chronic lymphocytic leukemia, medicine.medical_treatment, Hematopoietic stem cell transplantation, Tp53 mutation, lcsh:RC254-282, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, hemic and lymphatic diseases, medicine, Risks and benefits, Bridge to transplant, business.industry, breakpoint cluster region, TP53 mutation, Treatment options, Hematology, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, chemistry, 030220 oncology & carcinogenesis, Ibrutinib, Immunology, Allogeneic hematopoietic stem cell transplantation, B-cell receptor inhibitors, business, 030215 immunology
Abstract

The treatment landscape of chronic lymphocytic leukemia (CLL) has been challenged by the advent of novel classes of drugs, such as B-cell receptor (BCR)-inhibitors and BCL-2 antagonists. In selected high-risk patients, the choice to start allogeneic hematopoietic stem cell transplantation (alloHCT) or continue these agents is a matter of debate. Furthermore, published data about the impact on the feasibility of alloHCT and the optimal timing of administration are limited. Here we present a case of relapsed TP53 mutated CLL treated with ibrutinib as a bridge to alloHCT, discussing risks and benefits of different treatment options in a “real life” situation.

Published
2017

35. Iron overload and Hepcidin overexpression could play a key role in COVID infection, and may explain vulnerability in elderly, diabetics, and obese patients

Author

Banchini, Filippo, Vallisa, Daniele, Maniscalco, Pietro, and Capelli, Patrizio

Subjects
chloroquine, Correspondence / Case Reports, sars-cov, iron, diabetes, ferritin, hepcidin, erythropoietin, heparin, elderly, COVID
Abstract

Background: The COVID epidemic hit like a tsunami worldwide. At the time of its arrival in Italy, available literary data were meager, and most of them concerned its epidemiology. World Health Organization proposed guidelines in march 2020, a strategy of treatment has been developed, and a significant number of subsequent articles have been published to understand, prevent, and cure COVID patients. Methods: From the observation of two patients, we performed a careful analysis of scientific literature to unearth the relation between COVID infection, clinical manifestations as pneumonia and thrombosis, and to find out why it frequently affects obese, diabetics, and elderly patients. Results: The analysis shows that hepcidin could represent one of such correlating factors. Hepcidin is most elevated in older age, in non-insulin diabetics patients and in obese people. It is the final target therapy of many medicaments frequently used. Viral disease, and in particular SARS-CoV19, could induce activation of the hepcidin pathway, which in turn is responsible for an increase in the iron load. Excess of iron can lead to cell death by ferroptosis and release into the bloodstream, such as free iron, which in turn has toxic and pro-coagulative effects. Conclusions: Overexpression of hepcidin and iron overload might play a crucial role in COVID infection, becoming potential targets for treatment. Hepcidin could also be considered as a biomarker to measure the effectiveness of our treatments and the restoration of iron homeostasis the final intent. (www.actabiomedica.it)

Published
2020

37. Autologous bone marrow stem cell intralesional transplantation repairing bisphosphonate related osteonecrosis of the jaw

Author

Cella Luigi, Oppici Aldo, Arbasi Mariacristina, Moretto Mauro, Piepoli Massimo, Vallisa Daniele, Zangrandi Adriano, Di Nunzio Camilla, and Cavanna Luigi

Subjects
Osteonecrosis of the Jaw, bisphoshonate, stem cell transplantation, organ repair, Specialties of internal medicine, RC581-951
Abstract

Abstract Purpose Bisphosphonate - related osteonecrosis of the JAW (BRONJ) is a well known side effect of bisphosphonate therapies in oncologic and non oncologic patients. Since to date no definitive consensus has been reached on the treatment of BRONJ, novel strategies for the prevention, risk reduction and treatment need to be developed. We report a 75 year old woman with stage 3 BRONJ secondary to alendronate and pamidronate treatment of osteoporosis. The patient was unresponsive to recommended treatment of the disease, and her BRONJ was worsening. Since bone marrow stem cells are know as being multipotent and exhibit the potential for differentiation into different cells/tissue lineages, including cartilage, bone and other tissue, we performed autologous bone marrow stem cell transplantation into the BRONJ lesion of the patient. Methods Under local anesthesia a volume of 75 ml of bone marrow were harvested from the posterior superior iliac crest by aspiration into heparinized siringes. The cell suspension was concentrated, using Ficoll - Hypaque® centrifugation procedures, in a final volume of 6 ml. Before the injection of stem cells into the osteonecrosis, the patient underwent surgical toilet, local anesthesia was done and spongostan was applied as a carrier of stem cells suspension in the bone cavity, then 4 ml of stem cells suspension and 1 ml of patient's activated platelet-rich plasma were injected in the lesion of BRONJ. Results A week later the residual spongostan was removed and two weeks later resolution of symptoms was obtained. Then the lesion improved with progressive superficialization of the mucosal layer and CT scan, performed 15 months later, shows improvement also of bone via concentric ossification: so complete healing of BRONJ (stage 0) was obtained in our patient, and 30 months later the patient is well and without signs of BRONJ. Conclusion To our knowledge this is the first case of BRONJ successfully treated with autologous stem cells transplantation with a complete response.

Published
2011
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38. The Engineered MIPI (e-MIPI), a Candidate Data-Mining Based Mantle Cell Lymphoma Prognostic Index Developed from the Dataset of the Fondazione Italiana Linfomi (FIL) MCL0208 Phase III Trial

Author

Zaccaria, Gian Maria, primary, Ferrero, Simone, additional, Passera, Roberto, additional, Evangelista, Andrea, additional, Loschirico, Mariella, additional, Dogliotti, Irene, additional, Ghislieri, Marco, additional, Genuardi, Elisa, additional, Bomben, Riccardo, additional, Gattei, Valter, additional, Ciccone, Giovannino, additional, Tani, Monica, additional, Gaidano, Gianluca, additional, Volpetti, Stefano, additional, Cabras, Maria Giuseppina, additional, Di Renzo, Nicola, additional, Merli, Francesco, additional, Vallisa, Daniele, additional, Spina, Michele, additional, Pascarella, Anna, additional, Latte, Giancarlo, additional, Patti, Caterina, additional, Pozzato, Gabriele, additional, Fabbri, Alberto, additional, Cortelazzo, Sergio, additional, and Ladetto, Marco, additional

Published
2018
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39. Pretreatment Health-Related Quality of Life Profile According to the EORTC QLQ-C30 in Patients with Myelodysplastic Syndromes (MDS): Analysis on 443 Lower-Risk MDS Patients

Author

Efficace, Fabio, primary, Niscola, Pasquale, additional, Patriarca, Andrea, additional, Cottone, Francesco, additional, Palumbo, Giuseppe A., additional, Caocci, Giovanni, additional, Fedele, Marilena, additional, Platzbecker, Uwe, additional, Stauder, Reinhard, additional, Petranovic, Duska, additional, Ricco, Alessandra, additional, Breccia, Massimo, additional, Frairia, Chiara, additional, Luppi, Mario, additional, Invernizzi, Rosangela, additional, Sanpaolo, Grazia, additional, Crugnola, Monica, additional, Fianchi, Luana, additional, Vallisa, Daniele, additional, Voso, Maria Teresa, additional, Fozza, Claudio, additional, Santini, Valeria, additional, Caers, Jo, additional, Capodanno, Isabella, additional, Sarlo, Chiara, additional, Pelaez Doro, Maribel, additional, Bergamaschi, Micaela, additional, Zhang, Huiyong, additional, Lubbert, Michael, additional, Canicattì, Manuela, additional, Kyriakou, Charalampia, additional, Di Renzo, Nicola, additional, Cuneo, Antonio, additional, Karakantza, Marina, additional, and Vignetti, Marco, additional

Published
2018
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40. Ultrasound-guided central venous catheterization in cancer patients improves the success rate of cannulation and reduces mechanical complications: A prospective observational study of 1,978 consecutive catheterizations

Author

Gorgni Silvia, Mordenti Patrizia, Muroni Monica, Biasini Claudia, Cremona Gabriele, Lazzaro Antonio, Cordani Maria, Bertè Raffaella, Cappucciati Lorella, Di Nunzio Camilla, Vallisa Daniele, Civardi Giuseppe, Cavanna Luigi, Zaffignani Elena, Ambroggi Massimo, Bidin Livia, Palladino Maria, Rodinò Carmelina, and Tibaldi Laura

Subjects
Surgery, RD1-811, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background A central venous catheter (CVC) currently represents the most frequently adopted intravenous line for patients undergoing infusional chemotherapy and/or high-dose chemotherapy with hematopoietic stem-cell transplantation and parenteral nutrition. CVC insertion represents a risk for pneumothorax, nerve or arterial punctures. The aim of this prospective observational study was to explore the safety and efficacy of CVC insertion under ultrasound (US) guidance and to confirm its utility in clinical practice in cancer patients. Methods Consecutive adult patients attending the oncology-hematology department were eligible if they had solid or hematologic malignancies and required CVC insertion. Four types of possible complication were defined a priore: mechanical, thrombotic, infection and malfunctioning. The patient was placed in Trendelenburg's position, a 7.5 MHZ puncturing US probe was placed in the supraclavicular site and a 16-gauge needle was advanced under real-time US guidance into the last portion of internal jugular vein. The Seldinger technique was used to place the catheter, which was advanced into the superior vena cava until insertion into right atrium. Within two hours after each procedure, an upright chest X-ray and ultrasound scanning were carried out to confirm the CVC position and to rule out a pneumotorax. CVC-related infections, symptomatic vein thrombosis and malfunctioning were recorded. Results From December 2000 to January 2009, 1,978 CVC insertional procedures were applied to 1,660 consecutive patients. The procedure was performed 580 times in patients with hematologic malignancies and 1,398 times those with solid tumors. A single-needle puncture of the vein was performed on 1,948 of 1,978 procedures (98.48%); only eighteen attempts among 1,978 failed (0.9%). No pneumotorax, no major bleeding, and no nerve puncture were reported; four cases (0.2%) showed self-limiting hematomas. The mean lifespan of CVC was 189.7 +/- 18.6 days (range 7-701). Symptomatic deep-vein thrombosis of the upper limbs developed in 48 patients (2.42%). Catheter-related infections occurred in 197 (9.96%) of the catheters inserted. They were successfully treated with antibiotics and only in 48 (2.9%) patients definitive CVC removal was required for infection and/or thrombosis or malfunctioning. Conclusions This study represents the largest published series of consecutive patients with cancer undergoing CVC insertion under US guidance; this procedure allowed the completion of the therapeutic program for 1,930/1,978 (97.6%) of the catheters inserted. The absence of pneumotorax and other major complications indicates that US guidance should be mandatory for CVC insertion in patients with cancer.

Published
2010
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41. P1686: LONG‐TERM COMORBIDITY AND HEALTH PROBLEMS IN ACUTE MYELOID LEUKEMIA (AML) SURVIVORS: AN INTERNATIONAL AML SURVIVORSHIP STUDY.

Author

Efficace, Fabio, Cannella, Laura, Thomas, Xavier, Yüksel, Meltem Kurt, Trisolini, Silvia Maria, Brini, Alberto, Audisio, Ernesta, Maurillo, Luca, Lemoli, Roberto M., Imovilli, Annalisa, Panovska‐Stavridis, Irina, Pagano, Livio, Ciccone, Maria, Filardi, Nunzio, Fracchiolla, Nicola Stefano, Vallisa, Daniele, Crugnola, Monica, Cascavilla, Nicola, Skerget, Matevz, and Vignetti, Marco

Published
2023
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42. Role of image-guided fine-needle aspiration biopsy in the management of patients with splenic metastasis

Author

Civardi Giuseppe, Vallisa Daniele, Lazzaro Antonio, Cavanna Luigi, and Artioli Fabrizio

Subjects
Surgery, RD1-811, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Splenic metastases are very rare and are mostly diagnosed at the terminal phase of the disease or at the time of autopsy. The cytohistological diagnosis, when done, is made prevalently by splenectomy. Reports on splenic percutaneous biopsies in the diagnosis of splenic metastasis are fragmentary and very poor. The aims of this study are to analyse retrospectively the accuracy, safety and the clinical impact of ultrasound (US)-guided fine-needle aspiration biopsy (UG-FNAB) in patients with suspected splenic metastasis. Methods A retrospective analysis of 1800 percutaneous abdominal biopsies performed at our institute during the period from 1993 to 2003 was done and 160 patients that underwent splenic biopsy were found. Among these 160 patients, 12 cases with the final diagnosis of solitary splenic metastases were encountered and they form the basis of this report. The biopsies were performed under US guidance using a 22-gauge Chiba needle. All the patients underwent laboratory tests, CT examination of the abdomen and chest, US examination of abdomen and pelvis. Results There were 5 women and 7 men, median age 65 years (range 48–80). Eight patients had a known primary cancer at the time of the diagnosis of splenic metastasis: 3 had breast adenocarcinoma, 2 colon adenocarcinoma, 2 melanoma and 1 lung adenocarcinoma. Four patients were undiagnosed at the time of the appearance of splenic metastasis and subsequent investigations showed adenocarcinoma of the lung in 2 patients and colon adenocarcinoma in the remaining 2. There was a complete correspondence between the US and Computed Tomography (CT) in detecting focal lesions of the spleen. The splenic biopsies allowed a cytological diagnosis of splenic metastasis in all the 12 patients and changed clinical management in all cases. Reviewing the 160 patients that underwent UG-FNAB of the spleen we found no complications related to the biopsies. Conclusion These results indicate that UG-FNAB is a successful technique for diagnosis of splenic metastasis allowing an adequate treatment of the affected patients.

Published
2007
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43. Increased SHISA3 expression characterizes chronic lymphocytic leukemia patients sensitive to lenalidomide

Author

Maffei, Rossana, Fiorcari, Stefania, Martinelli, Silvia, Benatti, Stefania, Bulgarelli, Jenny, Rizzotto, Lara, Debbia, Giulia, Santachiara, Rita, Rigolin, Gian Matteo, Forconi, Francesco, Rossi, Davide, Laurenti, Luca, Palumbo, Giuseppe A., Vallisa, Daniele, Cuneo, Antonio, Gaidano, Gianluca, Luppi, Mario, Marasca, Roberto, Laurenti, Luca (ORCID:0000-0002-8327-1396), Maffei, Rossana, Fiorcari, Stefania, Martinelli, Silvia, Benatti, Stefania, Bulgarelli, Jenny, Rizzotto, Lara, Debbia, Giulia, Santachiara, Rita, Rigolin, Gian Matteo, Forconi, Francesco, Rossi, Davide, Laurenti, Luca, Palumbo, Giuseppe A., Vallisa, Daniele, Cuneo, Antonio, Gaidano, Gianluca, Luppi, Mario, Marasca, Roberto, and Laurenti, Luca (ORCID:0000-0002-8327-1396)

Abstract

Lenalidomide is a therapeutically effective drug in chronic lymphocytic leukemia (CLL). Twenty-seven CLL patients were treated with lenalidomide in a phase II clinical trial. Ten patients were grouped as responders (R) and 6 as nonresponders (NR). We evaluated T lymphocytes, NK, monocytes and dendritic cells at baseline and after treatment. A gene expression analysis was performed on 16 CLL samples collected before treatment. The levels of immune cells or immune-related cytokines are not different between R and NR patients. However, CLL patients sensitive to lenalidomide clearly show a peculiar gene expression profile in leukemic cells. The most up-regulated gene (fold change = +23 in R vs. NR) is Wnt inhibitor SHISA homolog 3 (SHISA3). SHISA3highCLL are characterized by a restrained activation of Wnt signaling and sensibility to lenalidomide-induced apoptosis. In conclusion, SHISA3 is a candidate gene for the identification of CLL patients who will benefit of lenalidomide treatment as single agent.

Published
2018

44. The Combination of Rituximab and Bendamustine as First-Line Treatment Is Highly Effective in the Eradicating Minimal Residual Disease in Follicular Lymphoma: An Italian Retrospective Study

Author

Galimberti, Sara, primary, Ciabatti, Elena, additional, Ercolano, Giacomo, additional, Grassi, Susanna, additional, Guerrini, Francesca, additional, Cecconi, Nadia, additional, Rousseau, Martina, additional, Cervetti, Giulia, additional, Mazziotta, Francesco, additional, Iovino, Lorenzo, additional, Falzetti, Franca, additional, Falcinelli, Flavio, additional, Bosi, Alberto, additional, Rigacci, Luigi, additional, Kovalchuk, Sofia, additional, Vallisa, Daniele, additional, Macchia, Lucia, additional, Ciancia, Eugenio, additional, and Petrini, Mario, additional

Published
2017
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45. Italian real life experience with brentuximab vedotin: results of a large observational study on 234 relapsed/refractory Hodgkin’s lymphoma

Author

Pellegrini, Cinzia, primary, Broccoli, Alessandro, additional, Pulsoni, Alessandro, additional, Rigacci, Luigi, additional, Patti, Caterina, additional, Gini, Guido, additional, Mannina, Donato, additional, Tani, Monica, additional, Rusconi, Chiara, additional, Romano, Alessandra, additional, Vanazzi, Anna, additional, Botto, Barbara, additional, Santoro, Armando, additional, Hoaus, Stefan, additional, Rigolin, Gian Matteo, additional, Musto, Pellegrino, additional, Mazza, Patrizio, additional, Molica, Stefano, additional, Corradini, Paolo, additional, Fama, Angelo, additional, Gaudio, Francesco, additional, Merli, Michele, additional, Ronconi, Fioravante, additional, Gritti, Giuseppe, additional, Vallisa, Daniele, additional, Tosi, Patrizia, additional, Liberati, Anna Marina, additional, Pinto, Antonello, additional, Pavone, Vincenzo, additional, Gherlinzoni, Filippo, additional, Bianchi, Maria Paola, additional, Volpetti, Stefano, additional, Trentin, Livio, additional, Goldaniga, Maria Cecilia, additional, Bonfichi, Maurizio, additional, De Renzo, Amalia, additional, Schiavotto, Corrado, additional, Spina, Michele, additional, Carella, Angelo Michele, additional, Stefoni, Vittorio, additional, Argnani, Lisa, additional, and Zinzani, Pier Luigi, additional

Published
2017
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46. Assessment of the interlaboratory variability and robustness of JAK2V617F mutation assays: A study involving a consortium of 19 Italian laboratories

Author

Perricone, Margherita, primary, Palandri, Francesca, additional, Ottaviani, Emanuela, additional, Angelini, Mario, additional, Bagli, Laura, additional, Bellesia, Enrica, additional, Donati, Meris, additional, Gemmati, Donato, additional, Zucchini, Patrizia, additional, Mancini, Stefania, additional, Marchica, Valentina, additional, Trubini, Serena, additional, Matteis, Giovanna De, additional, Zacomo, Silvia Di, additional, Favarato, Mosè, additional, Fioroni, Annamaria, additional, Bolzonella, Caterina, additional, Maccari, Giorgia, additional, Navaglia, Filippo, additional, Gatti, Daniela, additional, Toffolatti, Luisa, additional, Orlandi, Linda, additional, Laloux, Vèronique, additional, Manfrini, Marco, additional, Galieni, Piero, additional, Giannini, Barbara, additional, Tieghi, Alessia, additional, Barulli, Sara, additional, Serino, Maria Luisa, additional, Maccaferri, Monica, additional, Scortechini, Anna Rita, additional, Giuliani, Nicola, additional, Vallisa, Daniele, additional, Bonifacio, Massimiliano, additional, Accorsi, Patrizia, additional, Salbe, Cristina, additional, Fazio, Vinicio, additional, Gusella, Milena, additional, Toffoletti, Eleonora, additional, Salvucci, Marzia, additional, Svaldi, Mirija, additional, Gherlinzoni, Filippo, additional, Cassavia, Francesca, additional, Orsini, Francesco, additional, and Martinelli, Giovanni, additional

Published
2017
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47. Italian Real Life Experience with Brentuximab Vedotin: Results of a National Observational Study on Relapsed/Refractory Hodgkin's Lymphoma

Author

Broccoli, Alessandro, primary, Pulsoni, Alessandro, additional, Rigacci, Luigi, additional, Patti, Caterina, additional, Gini, Guido, additional, Mannina, Donato, additional, Tani, Monica, additional, Rusconi, Chiara, additional, Romano, Alessandra, additional, Vanazzi, Anna, additional, Botto, Barbara, additional, Santoro, Armando, additional, Hohaus, Stefan, additional, Rigolin, Gian Matteo, additional, Musto, Pellegrino, additional, Mazza, Patrizio, additional, Molica, Stefano, additional, Corradini, Paolo, additional, Fama, Angelo, additional, Gaudio, Francesco, additional, Merli, Michele, additional, Ronconi, Fioravante, additional, Gritti, Giuseppe, additional, Vallisa, Daniele, additional, Tosi, Patrizia, additional, Liberati, Anna Marina, additional, Pinto, Antonello, additional, Pavone, Vincenzo, additional, Gherlinzoni, Filippo, additional, Cavalieri, Elena, additional, Volpetti, Stefano, additional, Visentin, Andrea, additional, Goldaniga, Maria Cecilia, additional, Bonfichi, Maurizio, additional, De Renzo, Amalia, additional, Schiavotto, Corrado, additional, Spina, Michele, additional, Carella, Angelo Michele, additional, Argnani, Lisa, additional, and Zinzani, Pier Luigi, additional

Published
2016
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48. Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens

Author

Bassi, Simona, Stroppa, Elisa M., Moroni, Carlo F., Arbasi, Maria C., Trabacchi, Elena, Di Franco, Anna, Lazzaro, Antonio, Bernuzzi, Patrizia, Moretto, Mauro, Arcari, Annalisa, Bosi, Costanza, Riva, Alessandra, Cavanna, Luigi, and Vallisa, Daniele

Subjects
Adult, Male, Transplantation Conditioning, Filgrastim, Lymphoma, Hematopoietic Stem Cell Transplantation, Middle Aged, Costs and Cost Analysis, Humans, Original Article, Female, Autografts, Multiple Myeloma, Biosimilar Pharmaceuticals, Aged, Retrospective Studies
Abstract

Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients.With the aim of assessing the efficacy and the safety of filgrastim biosimilars in post-ASCT bone marrow recovery, we conducted a single institution, retrospective study in 56 lymphoma and myeloma patients who received filgrastim biosimilars (Tevagrastim(®) and Zarzio(®)) at standard doses from day 5. We compared our results with recently published data on the originator. A cost analysis of each biosimilar was performed.Neutrophil counts recovered in 55 patients. The median number of filgrastim biosimilar vials injected was seven per patient. The median time to neutrophil and platelet recovery was 10 and 12 days, respectively. Twenty-six patients had febrile neutropenia, in half of whom the agent involved was identified. In the cost analysis, the use of Tevagrastim(®) and Zarzio(®) was associated with cost reductions of 56% and of 86%, respectively.Despite differences in CD34+ cell counts and time of starting filgrastim, our results in terms of time to engraftment and median number of vials injected are similar to published data. Comparing our results by single conditioning regimen to recent literature data, the time to engraftment and duration of hospitalisation were equivalent. Significant differences were observed in the incidence of febrile neutropenia, perhaps due to different preventive and prophylactic protocols for infections. Although prospective studies should be performed to confirm our results, filgrastim biosimilars were found to be effective and safe in engraftment after ASCT.

Published
2015

49. A Snapshot of the Management of Chronic Lymphocytic Leukemia in Italy. Preliminary Analysis on over 3000 Patients Enrolled in the Gimema CLL2121 Trial

Author

Scarfo, Lydia, Coscia, Marta, Molteni, Alfredo, Rambaldi, Alessandro, Marasca, Roberto, Steffanoni, Sara, Murru, Roberta, Maschio, Nilla, Scortechini, Ilaria, Gambacorti-Passerini, Carlo, Pennese, Elsa, Trentin, Livio, Moia, Riccardo, Farina, Lucia, Innao, Vanessa, Musto, Pellegrino, Sanna, Alessandro, Facchinelli, Davide, Falcucci, Paolo, Pini, Massimo, Laurenti, Luca, Varettoni, Marzia, Angeletti, Ilaria, Orsucci, Lorella, Rago, Angela, D'Arena, Giovanni, Melillo, Lorella Maria Antonia, Maggi, Alessandro, Ilariucci, Fiorella, Massaia, Massimo, Pastore, Domenico, Vallisa, Daniele, Fazi, Paola, Piciocchi, Alfonso, Messina, Monica, Paoloni, Francesca Paola, Foà, Robin, Del Giudice, Ilaria, Rigolin, Gian Matteo, Cuneo, Antonio, and Ghia, Paolo

Abstract

In recent years the management of patients (pts) with chronic lymphocytic leukemia (CLL) has benefited from a deeper knowledge of the mechanisms underlying the disease and from the development of novel therapeutic approaches. That notwithstanding, local and national accessibility to drugs and tests may lead to distinct “real-world” practices in terms of management of pts that are worth of being recorded and compared to understand the degree of reproducibility and applicability of international guidelines. This could also be relevant for the design of future clinical trials, more tailored to the true patient's needs. To this end, within the GIMEMA cooperative study group the observational retrospective and prospective CLL2121 study (NCT04867915) has been designed with the objective of evaluating the diagnosis and management of CLL in all hematological centers in Italy through the assessment of: 1) the methods and the actual diagnostic/prognostic work-up capacity; 2) the algorithms applied to define disease progression and treatment requirements with respect to national and international guidelines; 3) the clinical and biological variables not strictly associated with CLL, but capable of influencing the clinical course and overall survival; 4) the true incidence of some rarer complications associated with CLL. The study consists of a collection of clinico-biological data from all pts with newly diagnosed CLL, small lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL), according to the iwCLL 2018 criteria in Italy. The retrospective part aims at including all cases followed at the participating centers with a diagnosis between January 2010 and September 2021, while the prospective part will include all pts with a documented diagnosis of CLL, SLL or MBL between September 2021 and September 2025. In this pilot analysis of the study, we examined pts' demographics, diagnosis, treatment line and type. Data were collected using the REDCap electronic data capture platform, analyzed using the SAS software v.9.4 and reported as numbers and frequencies. Between 2 November 2021 and 28 June 2023, 3294 eligible pts were enrolled in 75 hematology centers (out of the total of 110 centers who will be activated during the study) across the entire Italian territory. At the time of the present report, 3033 pts had clinical data available for our preliminary analysis. The vast majority of pts registered (N=2599, 85.7%) belonged to the retrospective cohort while only a minority (N=434, 14.3%) to the prospective cohort. Pts had a median age of 68 years ranging from 29 to 97; 60% of pts were males. 2630 pts (86.8%) had a diagnosis of CLL, 187 (6.2%) of SLL and 214 (7.0%) of MBL (2 missing information). Among those with available results 112 pts (12.6%) were TP53mutated, 526 (45.6%) del(13q) positive, 174 (14.9%) del(11q) positive, 142 (11.9%) del(17p) positive and 226 (20.4%) presented a trisomy 12. The majority of pts (57.6%) were untreated, while 42.4% have been treated. Within the latter subset, 67.3% of pts have received one line of therapy, 21.4% 2 lines of therapy, 11.3% ≥3 lines of therapy. The most common therapeutic regimens were the combination of chemotherapy with an anti-CD20 antibody (39.3%), mainly rituximab, and those based on BTK inhibitors (33.3%), mainly ibrutinib. Chemotherapy alone was used in 12% of pts. Only 5% of pts was treated with the BCL2 inhibitor venetoclax. In the remaining 10% of pts, other approaches were used. This is the initial report of a nation-based real-world data collection aimed at describing the biological and clinical features of pts diagnosed with CLL in virtually all Italian hematology centers starting from 2010. The pattern of treatments highlighted in our preliminary analysis, with a wide use of the watch & wait policy and of chemoimmunotherapy, will help understand how the introduction of novel therapies impacted treatment habits also in light of the timing of the local reimbursement policy. The different time of drug access in Italy, typically delayed after the EU approval, may also have affected the limited use of venetoclax-based treatment. The continuous accrual of pts in this study will allow to obtain a close-to-registry vision of CLL management in Italy over time, in terms of coverage of the entire country but enriched with the granularity of the data and flexibility of the collection typical of a real-world study.

Published
2023
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50. International, Prospective Study Comparing Nilotinib Versus Imatinib with Early Switch to Nilotinib to Obtain Sustained Treatment-Free Remission in Patients with Chronic Myeloid Leukemia (SUSTRENIM trial): Analysis of the Eligibility to Treatment Discontinuation

Author

Pane, Fabrizio, Castagnetti, Fausto, Piciocchi, Alfonso, Abruzzese, Elisabetta, Bassan, Renato, Binotto, Gianni, Bonifacio, Massimiliano, Caocci, Giovanni, Cavazzini, Francesco, Cimino, Giuseppe, Gozzini, Antonella, Lunghi, Monia, Marasca, Roberto, Martino, Bruno, Muriano, Francesco, Rosti, Gianantonio, Russo Rossi, Antonella, Sica, Simona, Tafuri, Agostino, Vallisa, Daniele, Messina, Monica, Paoloni, Francesca Paola, Fazi, Paola, Westerweel, Peter E, Janssen, Jeroen J.W.M., Saglio, Giuseppe, and Breccia, Massimo

Abstract

Background. Treatment free remission (TFR) is one of the most important aims of CML treatment but, so far, the best treatment strategy to obtain a durable deep molecular response (DMR) and the overall rate of patients able to achieve a successful TKI discontinuation based on intention-to-treat principle from CML diagnosis are still debated. In November 2016 we launched an international, prospective, randomized, two arms study to evaluate both the depth of the molecular response and the rate of TFR in newly diagnosed CP-CML patients treated with a second generation TKI (Nilotinib, NIL) or with imatinib (IM) followed by switching to NIL in absence of optimal response (Clinical Trial number 02602314). Patients were randomized 1:1 between NIL and IM, stratifying on the Sokal score. All the patients achieving a MR4.0 or better by three years and maintaining this level of response up to the end of the fourth year of therapy were qualified for the discontinuation phase. We recently reported that patients enrolled in the NIL arm had a rate of MR4.5 at two years (primary co-endpoint of the study), significantly higher than those in the IM arm (32 vs 22%, p = 0.023 Pane F. et al, EHA 2022).

Published
2023
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