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3. Safety of Extended Pirtobrutinib Exposure in Relapsed and/or Refractory B-Cell Malignancies.

Author

Roeker, Lindsey E, Coombs, Catherine C, Shah, Nirav N, Jurczak, Wojciech, Woyach, Jennifer A, Cheah, Chan Y, Patel, Krish, Maddocks, Kami, Wang, Yucai, Zinzani, Pier Luigi, Munir, Talha, Koh, Youngil, Thompson, Meghan C, Muehlenbein, Catherine E, Wang, Chunxiao, Sizelove, Richard, Abhyankar, Sarang, Hasanabba, Safarulla, Tsai, Donald E, Eyre, Toby A, and Wang, Michael

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Patient Safety, Infectious Diseases, Cancer, Clinical Trials and Supportive Activities, Rare Diseases, Hematology, Clinical Research, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, B-cell malignancies, Bruton tyrosine kinase inhibitor, Long-term safety, Toxicity, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

IntroductionPirtobrutinib, a highly selective, noncovalent (reversible) Bruton tyrosine kinase inhibitor, has demonstrated promising efficacy in B-cell malignancies and is associated with low rates of discontinuation and dose reduction. Pirtobrutinib is administered until disease progression or toxicity, necessitating an understanding of the safety profile in patients with extended treatment.MethodsHere we report the safety of pirtobrutinib in patients with relapsed/refractory B-cell malignancies with extended (≥12 months) drug exposure from the BRUIN trial. Assessments included median time-to-first-occurrence of adverse events (AEs), dose reductions, and discontinuations due to treatment-emergent AEs (TEAEs) and select AEs of interest (AESIs).ResultsOf 773 patients enrolled, 326 (42%) received treatment for ≥12 months. In the extended exposure cohort, the median time-on-treatment was 19 months. The most common all-cause TEAEs were fatigue (32%) and diarrhea (31%). TEAEs leading to dose reduction occurred in 23 (7%) and discontinuations in 11 (3%) extended exposure patients. One patient had a fatal treatment-related AE (COVID-19 pneumonia). Infections (73.0%) were the most common AESI with a median time-to-first-occurrence of 7.4 months. Majority of TEAEs and AESIs occurred during the first year of therapy.ConclusionsPirtobrutinib therapy continues to demonstrate an excellent safety profile amenable to long-term administration without evidence of new or worsening toxicity signals.

Published
2024

4. Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients.

Author

Brahmer, Julie, Long, Georgina, Hamid, Omid, Garon, Edward, Herbst, Roy, Andre, Thierry, Armand, Philippe, Bajorin, Dean, Bellmunt, Joaquim, Burtness, Barbara, Choueiri, Toni, Cohen, Ezra, Diaz, Luis, Shitara, Kohei, Kulkarni, Girish, McDermott, David, Shah, Manish, Tabernero, Josep, Vogel, Arndt, Zinzani, Pier, Jafari, Niusha, Bird, Steven, Snyder, Ellen, Gause, Christine, Bracco, Oswaldo, Pietanza, M, Gruber, Todd, and Ribas, Antoni

Subjects
Neoplasms, Pembrolizumab, Programmed cell death 1 receptor, Safety, Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Antibodies, Monoclonal, Humanized, Melanoma
Abstract

BACKGROUND: Pembrolizumab has a manageable safety profile as described in its label, which was primarily based on 2799 patients who participated in clinical trials for melanoma or non-small cell lung cancer. Here, we evaluated the safety of pembrolizumab in a broader population of patients from 31 advanced cancer clinical trials across 19 cancer types. METHODS: Safety was analyzed in patients who received at least one dose of pembrolizumab (200 mg every 3 weeks [Q3W], 10 mg/kg Q2W or Q3W, or 2 mg/kg Q3W). Adverse events (AEs) and immune-mediated AEs and infusion reactions were evaluated. RESULTS: Safety data from 8937 patients in 31 trials of pembrolizumab monotherapy were pooled (median, seven administrations; range, 1-59). Median duration on treatment was 4.1 months (range, 0.03-40.1). AEs occurred in 96.6% of patients. Grade 3-5 AEs occurred in 50.6% of patients. AEs led to pembrolizumab discontinuation in 12.7% of patients and death in 5.9%. Immune-mediated AEs and infusion reactions occurred in 23.7% of patients (4.6% experienced multiple immune-mediated AEs/infusion reactions) and led to pembrolizumab discontinuation in 3.6% and death in 0.2%. Grade 3-5 immune-mediated AEs occurred in 6.3% of patients. Serious immune-mediated AEs and infusion reactions occurred in 6.0% of patients. Median time to immune-mediated AE onset was 85 days (range, 13-163). Of 2657 immune-mediated AEs, 22.3% were initially treated with prednisone ≥ 40 mg/day or equivalent, and 8.3% were initially treated with lower steroid doses. CONCLUSIONS: This pooled analysis of 31 clinical trials showed that pembrolizumab has a consistent safety profile across indications.

Published
2024

5. Is CAR T a drug or a therapeutic pathway? Intention to treat versus per protocol analysis of real world studies of CAR-T cell therapy in relapsed refractory diffuse large B cell lymphoma

Author

Di Staso, Rossana, Casadei, Beatrice, Locke, Frederick L., Jain, Michael, Voorhees, Timothy J., Kittai, Adam S., Bastos-Oreiro, Mariana, Gutiérrez, Antonio, Martin Garcia-Sancho, Alejandro, Terol, Maria Jose, Mead, Monica, Maranzano, Michael J., Iacoboni, Gloria, Barba, Pere, Kwon, Mi, Bailen, Rebeca, Reguera-Ortega, Juan Luis, Mian, Agrima, Hill, Brian, Bachy, Emmanuel, Morschhauser, Franck, Houot, Roch, Thieblemont, Catherine, Le Gouill, Steven, Masetti, Riccardo, Gori, Davide, Broccoli, Alessandro, Zinzani, Pier Luigi, and Argnani, Lisa

Published
2024
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9. Effects of a surrounding environment during the coalescence of AuPd nanoparticles

Author

Zinzani, Sofia and Baletto, Francesca

Subjects
Condensed Matter - Mesoscale and Nanoscale Physics, Condensed Matter - Materials Science
Abstract

It is far well accepted that the morphology of nanoparticles and nanoalloys is of paramount importance to understand their properties. Furthemore, the morphology depends on the growth mechanism with coalescence generally accepted as one the most common mechanisms both in liquid and in the gas phase. Coalescence refers when two existing seeds collide and aggregate into a larger object. It is expected that the resulting aggregate shows a compact, often spherical structure, although strongly out of the equilibrium, referring to its global minimum. While the coalescence of liquid droplet is widely studied, the first stages of the coalescence between nanoseeds has attracted less interest, although important as multiple aggregation can take place. Here we simulate the coalescence of Au and Pd seeds by the Molecular Dynamics method, comparing the initial stage of the coalescence in vacuum and when there is an interacting surrounding around them. We show that the surface chemical composition of the resulting aggregate depend on the environment as well as the overall morphology., Comment: 16 pages, 21 figures

Published
2023

11. Hairy cell leukemia variant and WHO classification correspondence Re: 5th edition WHO classification haematolymphoid tumors: lymphoid neoplasms

Author

Grever, Michael, Andritsos, Leslie, Anghelina, Mirela, Arons, Evgeny, Banerji, Versha, Barrientos, Jacqueline, Bhat, Seema A., Blachly, James, Broccoli, Alessandro, Call, Timothy, Dearden, Claire, Dietrich, Sascha, Else, Monica, Epperla, Narendranath, Fagarasanu, Andrei, Falini, Brunangelo, Forconi, Francesco, Gozzetti, Alessandro, Hampel, Paul, Hermel, David J., Iyengar, Sunil, Johnston, James B., Juliusson, Gunnar, Kreitman, Robert J., Lauria, Francesco, Lozanski, Gerard, Oakes, Christopher C., Parikh, Sameer A., Park, Jae, Quest, Graeme, Rai, Kanti, Ravandi, Farhad, Robak, Tadeusz, Rogers, Kerry A., Saven, Alan, Seymour, John F., Tadmor, Tamar, Tallman, Martin S., Tam, Constantine S., Tiacci, Enrico, Troussard, Xavier, Wörmann, Bernhard, Zent, Clive S., Zenz, Thorsten, and Zinzani, Pier Luigi

Published
2024
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12. Axicabtagene ciloleucel treatment is more effective in primary mediastinal large B-cell lymphomas than in diffuse large B-cell lymphomas: the Italian CART-SIE study

Author

Chiappella, Annalisa, Casadei, Beatrice, Chiusolo, Patrizia, Di Rocco, Alice, Ljevar, Silva, Magni, Martina, Angelillo, Piera, Barbui, Anna Maria, Cutini, Ilaria, Dodero, Anna, Bonifazi, Francesca, Tisi, Maria Chiara, Bramanti, Stefania, Musso, Maurizio, Farina, Mirko, Martino, Massimo, Novo, Mattia, Grillo, Giovanni, Patriarca, Francesca, Zacchi, Giulia, Krampera, Mauro, Pennisi, Martina, Galli, Eugenio, Martelli, Maurizio, Ferreri, Andrés J. M., Ferrari, Silvia, Saccardi, Riccardo, Bermema, Anisa, Guidetti, Anna, Miceli, Rosalba, Zinzani, Pier Luigi, and Corradini, Paolo

Published
2024
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13. Multicenter development of a PET-based risk assessment tool for product-specific outcome prediction in large B-cell lymphoma patients undergoing CAR T-cell therapy

Author

Voltin, Conrad-Amadeus, Paccagnella, Andrea, Winkelmann, Michael, Heger, Jan-Michel, Casadei, Beatrice, Beckmann, Laura, Herrmann, Ken, Dekorsy, Franziska J., Kutsch, Nadine, Borchmann, Peter, Fanti, Stefano, Kunz, Wolfgang G., Subklewe, Marion, Kobe, Carsten, Zinzani, Pier Luigi, Stelljes, Matthias, Roth, Katrin S., Drzezga, Alexander, Noppeney, Richard, Rahbar, Kambiz, Reinhardt, H. Christian, von Tresckow, Bastian, Seifert, Robert, Albring, Jörn C., Blumenberg, Viktoria, Farolfi, Andrea, Flossdorf, Sarah, Gödel, Philipp, and Hanoun, Christine

Published
2024
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16. Impact of tumor microenvironment on efficacy of anti-CD19 CAR T cell therapy or chemotherapy and transplant in large B cell lymphoma

Author

Locke, Frederick L., Filosto, Simone, Chou, Justin, Vardhanabhuti, Saran, Perbost, Regis, Dreger, Peter, Hill, Brian T., Lee, Catherine, Zinzani, Pier L., Kröger, Nicolaus, López-Guillermo, Armando, Greinix, Hildegard, Zhang, Wangshu, Tiwari, Gayatri, Budka, Justin, Marincola, Francesco M., To, Christina, Mattie, Mike, Schupp, Marco, Cheng, Paul, Bot, Adrian, Shen, Rhine, Bedognetti, Davide, Miao, Harry, and Galon, Jérôme

Published
2024
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19. RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma

Author

Nowakowski, Grzegorz S., Yoon, Dok Hyun, Mondello, Patrizia, Joffe, Erel, Peters, Anthea, Fleury, Isabelle, Greil, Richard, Ku, Matthew, Marks, Reinhard, Kim, Kibum, Zinzani, Pier Luigi, Trotman, Judith, Sabatelli, Lorenzo, Waltl, Eva E., Winderlich, Mark, Sporchia, Andrea, Kurukulasuriya, Nuwan C., Cordoba, Raul, Hess, Georg, and Salles, Gilles

Published
2023
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20. Response to brentuximab vedotin versus physician’s choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis

Author

Kim, Youn H, Prince, H Miles, Whittaker, Sean, Horwitz, Steven M, Duvic, Madeleine, Bechter, Oliver, Sanches, Jose A, Stadler, Rudolf, Scarisbrick, Julia, Quaglino, Pietro, Zinzani, Pier Luigi, Wolter, Pascal, Eradat, Herbert, Pinter-Brown, Lauren C, Ortiz-Romero, Pablo L, Akilov, Oleg E, Trotman, Judith, Taylor, Kerry, Weichenthal, Michael, Walewski, Jan, Fisher, David, McNeeley, Marise, Gru, Alejandro A, Brown, Lisa, Palanca-Wessels, M Corinna, Lisano, Julie, Onsum, Matthew, Bunn, Veronica, Little, Meredith, Trepicchio, William L, and Dummer, Reinhard

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Lymphoma, Clinical Research, Hematology, Orphan Drug, Cancer, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological, Brentuximab Vedotin, Choice Behavior, Decision Support Techniques, Female, Follow-Up Studies, Humans, International Agencies, Ki-1 Antigen, Male, Middle Aged, Mycosis Fungoides, Physicians, Prognosis, Retrospective Studies, Survival Rate, Young Adult, Antibody-drug conjugate, Brentuximab vedotin, CD30, Cutaneous T-cell lymphoma, Efficacy, Large-cell transformation, Mycosis fungoides, Objective response, Progression-free survival, Safety, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

IntroductionMycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections. This study assessed response to brentuximab vedotin in patients with MF in the phase III ALCANZA study.MethodsBaseline CD30 levels and large-cell transformation (LCT) status were centrally reviewed in patients with previously-treated CD30-positive MF using ≥2 skin biopsies obtained at screening; eligible patients required ≥1 biopsy with ≥10% CD30 expression. Patients were categorised as CD30min

Published
2021

21. CAR t-cell therapy in BOlogNa–NEUrotoxicity TReatment and Assessment in Lymphoma (CARBON–NEUTRAL): proposed protocol and results from an Italian study

Author

Pensato, Umberto, Amore, Giulia, Muccioli, Lorenzo, Sammali, Susanna, Rondelli, Francesca, Rinaldi, Rita, D’Angelo, Roberto, Nicodemo, Marianna, Mondini, Susanna, Sambati, Luisa, Asioli, Gian Maria, Rossi, Simone, Santoro, Rossella, Cretella, Lucia, Ferrari, Susy, Spinardi, Luca, Faccioli, Luca, Fanti, Stefano, Paccagnella, Andrea, Pierucci, Elisabetta, Casadei, Beatrice, Pellegrini, Cinzia, Zinzani, Pier Luigi, Bonafè, Massimiliano, Cortelli, Pietro, Bonifazi, Francesca, and Guarino, Maria

Published
2023
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22. Expert Consensus on the Characteristics of Patients with Epstein–Barr Virus-Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) for Whom Standard-Dose Chemotherapy May be Inappropriate: A Modified Delphi Study

Author

Chaganti, Sridhar, Barlev, Arie, Caillard, Sophie, Choquet, Sylvain, Cwynarski, Kate, Friedetzky, Anke, González-Barca, Eva, Sadetsky, Natalia, Schneeberger, Stefan, Thirumalai, Dhanalakshmi, Zinzani, Pier L., and Trappe, Ralf U.

Published
2023
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24. Correction to: RE‑MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola‑BR), CAR‑T therapies, and lenalidomide/rituximab (R2) based on real‑world data in patients with relapsed/refractory diffuse large B‑cell lymphoma

Author

Nowakowski, Grzegorz S., Yoon, Dok Hyun, Mondello, Patrizia, Joffe, Erel, Peters, Anthea, Fleury, Isabelle, Greil, Richard, Ku, Matthew, Marks, Reinhard, Kim, Kibum, Zinzani, Pier Luigi, Trotman, Judith, Sabatelli, Lorenzo, Waltl, Eva E., Winderlich, Mark, Sporchia, Andrea, Kurukulasuriya, Nuwan C., Cordoba, Raul, Hess, Georg, and Salles, Gilles

Published
2023
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25. Optimal Management of Adverse Events From Copanlisib in the Treatment of Patients With Non-Hodgkin Lymphomas

Author

Cheson, Bruce D, O’Brien, Susan, Ewer, Michael S, Goncalves, Marcus D, Farooki, Azeez, Lenz, Georg, Yu, Anthony, Fisher, Richard I, Zinzani, Pierre L, and Dreyling, Martin

Subjects
Rare Diseases, Cancer, Lymphoma, Cardiovascular, Hematology, Digestive Diseases, Patient Safety, Antineoplastic Agents, Drug-Related Side Effects and Adverse Reactions, Humans, Lymphoma, Non-Hodgkin, Pyrimidines, Quinazolines, Copanlisib, Follicular lymphoma, Hyperglycemia, Hypertension, PI3K, Clinical Sciences, Oncology and Carcinogenesis
Abstract

IntroductionCopanlisib is a phosphoinositol 3-kinase (PI3K) inhibitor approved for the third-line treatment of follicular non-Hodgkin lymphoma. Although the drug is generally well-tolerated, it can be associated with several unique and potentially serious adverse effects (AEs). Two of the most common toxicities not seen with other PI3K inhibitors include hyperglycemia and hypertension, which primarily occur during infusion and resolve shortly thereafter, and likely relate to targeting the PI3K alpha isoform. Other toxicities less commonly observed with copanlisib than with other approved drugs in this class include non-infectious pneumonitis, infections, diarrhea and colitis, and hepatobiliary toxicity.Materials and methodsA panel composed of experts in lymphoma, diabetes, and hypertension convened to develop guidance pertaining to the administration of copanlisib and the management of the AEs associated with copanlisib treatment.ResultsRecommendations were formulated pertaining to the management of AEs associated with copanlisib treatment, particularly infusion-related hyperglycemia and hypertension, noninfectious pneumonitis, infections, diarrhea, and colitis. The recommendations herein reflect the consensus of the members of this panel, all of whom contributed to these suggested approaches to patient supportive care.ConclusionThere are a number of challenges associated with the use of copanlisib. Infusion-related hypertension and hyperglycemia occur frequently, although they are transient, reversible, and rarely of clinical significance; this report provides guidance as to their management.

Published
2019

28. Exposure to obinutuzumab does not affect outcomes of SARS‐CoV‐2 infection in vaccinated patients with newly diagnosed advanced‐stage follicular lymphoma.

Author

Pinto, A., Caltagirone, M., Battista, M., Gazzoli, G. C., Patti, C., Pennese, E., De Lorenzo, S., Pavone, V., Merli, M., Chiarenza, A., Gorgone, A. G., Piazza, F., Puccini, B., Noto, A., Arcaini, L., De Filippi, R., Zinzani, P. L., Ferreri, A. J. M., Ladetto, M., and Ferrari, S.

Subjects
SARS-CoV-2 Omicron variant, SARS-CoV-2 Delta variant, FOLLICULAR lymphoma, EMERGENCY management, DEATH rate
Abstract

Summary: URBAN is a multicentric, ambispective study evaluating the effectiveness and safety of obinutuzumab‐based immuno‐chemotherapy and maintenance in patients with untreated advanced follicular lymphoma (FL). The study began before the COVID‐19 emergency declaration in Italy. It is currently ongoing for follow‐up, and the enrolment timeline encompassed different stages of the pandemic, various vaccination roll‐out phases and prevalence of SARS‐CoV‐2 variants. Outcomes of interest of the present sub‐analysis included SARS‐CoV‐2 infection rates and COVID‐19‐related hospitalizations/deaths. At data cut‐off, 86 (28.8%) and 213 patients (71.2%) were treated before and during/after the COVID‐19 outbreak respectively; 294 (98.3%) completed the induction, 31 (10.4%) completed maintenance and 170 (56.9%) were still on maintenance. Overall, 245 patients (81.9%) received at least one SARS‐CoV‐2 vaccine dose: 13.5%, 31.4% and 55.1% received one, two and three doses respectively. We observed a substantial decrease in COVID‐19‐related mortality rates in pre‐ versus post‐vaccination phases, along with a reduction in COVID‐19‐related outcomes due to the shift from alpha/delta to omicron variant predominance. No differences emerged between patients given maintenance or not, although the schedule was modified in 65% of cases. To our knowledge, URBAN represents the largest dataset of COVID‐19‐related outcomes in FL patients extensively exposed to obinutuzumab. ClinicalTrials.gov identifier: NCT04034056. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia.

Author

Kreitman, Robert, Dearden, Claire, Zinzani, Pier, Delgado, Julio, Karlin, Lionel, Robak, Tadeusz, Gladstone, Douglas, le Coutre, Philipp, Dietrich, Sascha, Gotic, Mirjana, Larratt, Loree, Offner, Fritz, Schiller, Gary, Swords, Ronan, Bacon, Larry, Bocchia, Monica, Bouabdallah, Krimo, Breems, Dimitri, Cortelezzi, Agostino, Dinner, Shira, Doubek, Michael, Gjertsen, Bjorn, Gobbi, Marco, Hellmann, Andrzej, Lepretre, Stephane, Maloisel, Frederic, Ravandi, Farhad, Rousselot, Philippe, Rummel, Mathias, Siddiqi, Tanya, Tadmor, Tamar, Troussard, Xavier, Yi, Cecilia, Saglio, Giuseppe, Roboz, Gail, Balic, Kemal, Standifer, Nathan, He, Peng, Marshall, Shannon, Wilson, Wyndham, Pastan, Ira, Yao, Nai-Shun, and Giles, Francis

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Bacterial Toxins, Drug Resistance, Neoplasm, Exotoxins, Female, Follow-Up Studies, Humans, Leukemia, Hairy Cell, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Remission Induction, Salvage Therapy, Survival Rate
Abstract

This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.

Published
2018

31. Consensus opinion from an international group of experts on measurable residual disease in hairy cell leukemia

Author

Ravandi, Farhad, Kreitman, Robert J., Tiacci, Enrico, Andritsos, Leslie, Banerji, Versha, Barrientos, Jacqueline C., Bhat, Seema A., Blachly, James S., Broccoli, Alessandro, Call, Timothy, Chihara, Dai, Dearden, Claire, Demeter, Judit, Dietrich, Sasha, Else, Monica, Epperla, Narendranath, Falini, Brunangelo, Forconi, Francesco, Gladstone, Douglas E., Gozzetti, Alessandro, Iyengar, Sunil, Johnston, James B., Jorgensen, Jeffrey, Juliusson, Gunnar, Lauria, Francesco, Lozanski, Gerard, Parikh, Sameer A., Park, Jae H., Polliack, Aaron, Quest, Graeme, Robak, Tadeusz, Rogers, Kerry A., Saven, Alan, Seymour, John F., Tadmor, Tamar, Tallman, Martin S., Tam, Constantine S., Thompson, Philip A., Troussard, Xavier, Zent, Clive S., Zenz, Thorsten, Zinzani, Pier Luigi, Wörmann, Bernhard, Rai, Kanti, and Grever, Michael

Published
2022
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32. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

Author

Fowler, Nathan Hale, Dickinson, Michael, Dreyling, Martin, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, José Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrés José María, Teshima, Takanori, Patten, Piers E. M., McGuirk, Joseph P., Petzer, Andreas L., Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Zia, Aiesha, Awasthi, Rakesh, Masood, Aisha, Anak, Oezlem, Schuster, Stephen J., and Thieblemont, Catherine

Published
2022
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33. Frontal predominant encephalopathy with early paligraphia as a distinctive signature of CAR T-cell therapy-related neurotoxicity

Author

Pensato, Umberto, Amore, Giulia, D’Angelo, Roberto, Rinaldi, Rita, Nicodemo, Marianna, Rondelli, Francesca, Mondini, Susanna, Santoro, Rossella, Sammali, Susanna, Farolfi, Andrea, Spinardi, Luca, Faccioli, Luca, Casadei, Beatrice, Dicataldo, Michele, Bonifazi, Francesca, Zinzani, Pierluigi, Cortelli, Pietro, Stracciari, Andrea, and Guarino, Maria

Published
2022
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34. Dual targeting of the DNA damage response pathway and BCL-2 in diffuse large B-cell lymphoma

Author

Rossi, Alessandra, Orecchioni, Stefania, Falvo, Paolo, Tabanelli, Valentina, Baiardi, Elena, Agostinelli, Claudio, Melle, Federica, Motta, Giovanna, Calleri, Angelica, Fiori, Stefano, Corsini, Chiara, Casadei, Beatrice, Mazzara, Saveria, Vitolo, Umberto, Bertolini, Francesco, Zinzani, Pier Luigi, Alcalay, Myriam, Pelicci, Pier Giuseppe, Pileri, Stefano, Tarella, Corrado, and Derenzini, Enrico

Published
2022
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37. Allogeneic transplantation after PD-1 blockade for classic Hodgkin lymphoma

Author

Merryman, Reid W., Castagna, Luca, Giordano, Laura, Ho, Vincent T., Corradini, Paolo, Guidetti, Anna, Casadei, Beatrice, Bond, David A., Jaglowski, Samantha, Spinner, Michael A., Arai, Sally, Lowsky, Robert, Shah, Gunjan L., Perales, Miguel-Angel, De Colella, Jean Marc Schiano, Blaise, Didier, Herrera, Alex F., Shouse, Geoffrey, Spilleboudt, Chloe, Ansell, Stephen M., Nieto, Yago, Badar, Talha, Hamadani, Mehdi, Feldman, Tatyana A., Dahncke, Lori, Singh, Anurag K., McGuirk, Joseph P., Nishihori, Taiga, Chavez, Julio, Serritella, Anthony V., Kline, Justin, Mohty, Mohamad, Dulery, Remy, Stamatoulas, Aspasia, Houot, Roch, Manson, Guillaume, Moles-Moreau, Marie-Pierre, Orvain, Corentin, Bouabdallah, Kamal, Modi, Dipenkumar, Ramchandren, Radhakrishnan, Lekakis, Lazaros, Beitinjaneh, Amer, Frigault, Matthew J., Chen, Yi-Bin, Lynch, Ryan C., Smith, Stephen D., Rao, Uttam, Byrne, Michael, Romancik, Jason T., Cohen, Jonathon B., Nathan, Sunita, Phillips, Tycel, Joyce, Robin M., Rahimian, Maryam, Bashey, Asad, Ballard, Hatcher J., Svoboda, Jakub, Torri, Valter, Sollini, Martina, De Philippis, Chiara, Magagnoli, Massimo, Santoro, Armando, Armand, Philippe, Zinzani, Pier Luigi, and Carlo-Stella, Carmelo

Published
2021
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39. Hairy cell leukemia and COVID-19 adaptation of treatment guidelines

Author

Grever, Michael, Andritsos, Leslie, Banerji, Versha, Barrientos, Jacqueline C., Bhat, Seema, Blachly, James S., Call, Timothy, Cross, Matthew, Dearden, Claire, Demeter, Judit, Dietrich, Sasha, Falini, Brunangelo, Forconi, Francesco, Gladstone, Douglas E., Gozzetti, Alessandro, Iyengar, Sunil, Johnston, James B., Juliusson, Gunnar, Kraut, Eric, Kreitman, Robert J., Lauria, Francesco, Lozanski, Gerard, Parikh, Sameer A., Park, Jae, Polliack, Aaron, Ravandi, Farhad, Robak, Tadeusz, Rogers, Kerry A., Saven, Alan, Seymour, John F., Tadmor, Tamar, Tallman, Martin S., Tam, Constantine S., Tiacci, Enrico, Troussard, Xavier, Zent, Clive, Zenz, Thorsten, Zinzani, Pier Luigi, and Wörmann, Bernhard

Published
2021
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40. Long-term follow-up of cladribine treatment in hairy cell leukemia: 30-year experience in a multicentric Italian study

Author

Pagano, Livio, Criscuolo, Marianna, Broccoli, Alessandro, Piciocchi, Alfonso, Varettoni, Marzia, Galli, Eugenio, Anastasia, Antonella, Cantonetti, Maria, Trentin, Livio, Kovalchuk, Sofia, Orsucci, Lorella, Frustaci, Annamaria, Spolzino, Angelica, Volpetti, Stefano, Annibali, Ombretta, Storti, Sergio, Stelitano, Caterina, Marchesi, Francesco, Offidani, Massimo, Casadei, Beatrice, Nizzoli, Maria Elena, De Luca, Maria Lucia, Fianchi, Luana, Motta, Marina, Guarnera, Luca, Simonetti, Edoardo, Visentin, Andrea, Vassallo, Francesco, Deodato, Marina, Sarlo, Chiara, Olivieri, Attilio, Falini, Brunangelo, Pulsoni, Alessandro, Tiacci, Enrico, and Zinzani, Pier Luigi

Published
2022
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42. Atezolizumab, venetoclax, and obinutuzumab combination in Richter transformation diffuse large B-cell lymphoma (MOLTO): a multicentre, single-arm, phase 2 trial

Author

Tedeschi, A, Frustaci, A, Condoluci, A, Coscia, M, Chiarle, R, Zinzani, P, Motta, M, Gaidano, G, Quaresmini, G, Scarfò, L, Catania, G, Deodato, M, Jones, R, Tabanelli, V, Griggio, V, Stüssi, G, Calleri, A, Pini, K, Cairoli, R, Zenz, T, Signori, A, Zucca, E, Rossi, D, Montillo, M, Tedeschi, Alessandra, Frustaci, Anna Maria, Condoluci, Adalgisa, Coscia, Marta, Chiarle, Roberto, Zinzani, Pier Luigi, Motta, Marina, Gaidano, Gianluca, Quaresmini, Giulia, Scarfò, Lydia, Catania, Gioacchino, Deodato, Marina, Jones, Rebecca, Tabanelli, Valentina, Griggio, Valentina, Stüssi, Georg, Calleri, Angelica, Pini, Katia, Cairoli, Roberto, Zenz, Thorsten, Signori, Alessio, Zucca, Emanuele, Rossi, Davide, Montillo, Marco, Tedeschi, A, Frustaci, A, Condoluci, A, Coscia, M, Chiarle, R, Zinzani, P, Motta, M, Gaidano, G, Quaresmini, G, Scarfò, L, Catania, G, Deodato, M, Jones, R, Tabanelli, V, Griggio, V, Stüssi, G, Calleri, A, Pini, K, Cairoli, R, Zenz, T, Signori, A, Zucca, E, Rossi, D, Montillo, M, Tedeschi, Alessandra, Frustaci, Anna Maria, Condoluci, Adalgisa, Coscia, Marta, Chiarle, Roberto, Zinzani, Pier Luigi, Motta, Marina, Gaidano, Gianluca, Quaresmini, Giulia, Scarfò, Lydia, Catania, Gioacchino, Deodato, Marina, Jones, Rebecca, Tabanelli, Valentina, Griggio, Valentina, Stüssi, Georg, Calleri, Angelica, Pini, Katia, Cairoli, Roberto, Zenz, Thorsten, Signori, Alessio, Zucca, Emanuele, Rossi, Davide, and Montillo, Marco

Published
2024

43. Axicabtagene ciloleucel treatment is more effective in primary mediastinal large B-cell lymphomas than in diffuse large B-cell lymphomas: the Italian CART-SIE study

Author

Chiappella, A., Casadei, B., Chiusolo, Patrizia, Di Rocco, A., Ljevar, S., Magni, M., Angelillo, P., Barbui, A. M., Cutini, I., Dodero, A., Bonifazi, F., Tisi, M. C., Bramanti, S., Musso, M., Farina, M., Martino, M., Novo, M., Grillo, G., Patriarca, F., Zacchi, G., Krampera, M., Pennisi, M., Galli, Eugenio, Martelli, M., Ferreri, A. J. M., Ferrari, S., Saccardi, R., Bermema, A., Guidetti, A., Miceli, R., Zinzani, P. L., Corradini, P., Chiusolo P. (ORCID:0000-0002-1355-1587), Galli E. (ORCID:0000-0002-2839-916X), Chiappella, A., Casadei, B., Chiusolo, Patrizia, Di Rocco, A., Ljevar, S., Magni, M., Angelillo, P., Barbui, A. M., Cutini, I., Dodero, A., Bonifazi, F., Tisi, M. C., Bramanti, S., Musso, M., Farina, M., Martino, M., Novo, M., Grillo, G., Patriarca, F., Zacchi, G., Krampera, M., Pennisi, M., Galli, Eugenio, Martelli, M., Ferreri, A. J. M., Ferrari, S., Saccardi, R., Bermema, A., Guidetti, A., Miceli, R., Zinzani, P. L., Corradini, P., Chiusolo P. (ORCID:0000-0002-1355-1587), and Galli E. (ORCID:0000-0002-2839-916X)

Abstract

Axicabtagene ciloleucel showed efficacy for relapsed/refractory large B-cell lymphomas (LBCL), including primary mediastinal B-cell lymphomas (PMBCL); however, only few PMBCLs were reported. Aim was to evaluate efficacy and safety of axicabtagene ciloleucel in patients with PMBCL compared to those with other LBCL, enrolled in the Italian prospective observational CART-SIE study. PMBCLs (n = 70) were younger, with higher percentage of bulky and refractory disease, compared to other LBCLs (n = 190). Median follow-up time for infused patients was 12.17 months (IQR 5.53,22.73). The overall (complete + partial) response rate (ORR,CR + PR) after bridging was 41% for PMBCL and 28% for other LBCL, p = 0.0102. Thirty days ORR was 78% (53/68) with 50% (34) CR in PMBCL, and 75% (141/187) with 53% (100) CR in other LBCL, p = 0.5457. Ninety days ORR was 69% (45/65) with 65% (42) CR in PMBCL, and 54% (87/162) with 47% (76) CR in other LBCL; progressive disease was 21% in PMBCL and 45% in other LBCL, p = 0.0336. Twelve months progression-free survival was 62% (95% CI: 51–75) in PMBCL versus 48% (95% CI: 41–57) in other LBCL, p = 0.0386. Twelve months overall survival was 86% (95% CI: 78–95) in PMBCL versus 71% (95% CI: 64–79) in other LBCL, p = 0.0034. All grade cytokine release syndrome was 88% (228/260); all grade neurotoxicity was 34% (88/260), with 6% of fatal events in PMBCL. Non-relapse mortality was 3%. In conclusion, PMBCLs achieved significantly better response and survival rates than other LBCLs.

Published
2024

48. CHRONOS-4: phase 3 study of copanlisib plus rituximab-based immunochemotherapy in relapsed indolent B-cell lymphoma

Author

Zinzani, Pier Luigi, Wang, Huaqing, Feng, Jifeng, Kim, Tae Min, Tao, Rong, Zhang, Huilai, Fogliatto, Laura, Maluquer Artigal, Clara, Özcan, Muhit, Yanez, Eduardo, Kim, Won Seog, Kirtbaya, Dmitry, Kriachok, Iryna, Maciel, Felipe, Xue, Hongwei, Bouabdallah, Krimo, Phelps, Charles, Chaturvedi, Shalini, Weispfenning, Anke, Morcos, Peter N., Odongo, Fatuma, Buvaylo, Viktoriya, Childs, Barrett H., Dreyling, Martin, Matasar, Matthew, and Ghione, Paola

Abstract

•Copanlisib plus R-B did not demonstrate improved PFS or overall survival in patients with relapsed iNHL.•Copanlisib plus R-B was associated with more serious TEAEs, TEAE-related deaths, and discontinuations than placebo plus R-B.

Published
2024
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49. EFFICACY AND SAFETY OF MOLTO, A MULTICENTER, OPEN LABEL, PHASE II CLINICAL TRIAL EVALUATING VENETOCLAX, ATEZOLIZUMAB AND OBINUTUZUMAB COMBINATION IN RICHTER SYNDROME

Author

Frustaci, A, Montillo, M, Rossi, D, Zinzani, P, Motta, M, Gaidano, G, Quaresmini, G, Scarfò, L, Pietrasanta, D, Coscia, M, Deodato, M, Zamprogna, G, Cairoli, R, Stüssi, G, Zucca, E, Pileri, S, Zenz, T, Tedeschi, A, Frustaci A. M., Montillo M., Rossi D., Zinzani P. L., Motta M., Gaidano G., Quaresmini G., Scarfò L., Pietrasanta D., Coscia M., Deodato M., Zamprogna G., Cairoli R., Stüssi G., Zucca E., Pileri S., Zenz T., Tedeschi A., Frustaci, A, Montillo, M, Rossi, D, Zinzani, P, Motta, M, Gaidano, G, Quaresmini, G, Scarfò, L, Pietrasanta, D, Coscia, M, Deodato, M, Zamprogna, G, Cairoli, R, Stüssi, G, Zucca, E, Pileri, S, Zenz, T, Tedeschi, A, Frustaci A. M., Montillo M., Rossi D., Zinzani P. L., Motta M., Gaidano G., Quaresmini G., Scarfò L., Pietrasanta D., Coscia M., Deodato M., Zamprogna G., Cairoli R., Stüssi G., Zucca E., Pileri S., Zenz T., and Tedeschi A.

Published
2023

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