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1. 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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2. 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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3. 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

4. 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.

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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5. 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., 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.

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

6. International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017)

Author

Younes, A., Hilden, P., Coiffier, B., Hagenbeek, A., Salles, G., Wilson, W., Seymour, J.F., Kelly, K., Gribben, J., Pfreunschuh, M., Morschhauser, F., Schoder, H., Zelenetz, A.D., Rademaker, J., Advani, R., Valente, N., Fortpied, C., Witzig, T.E., Sehn, L.H., Engert, A., Fisher, R.I., Zinzani, P.-L., Federico, M., Hutchings, M., Bollard, C., Trneny, M., Elsayed, Y.A., Tobinai, K., Abramson, J.S., Fowler, N., Goy, A., Smith, M., Ansell, S., Kuruvilla, J., Dreyling, M., Thieblemont, C., Little, R.F., Aurer, I., Van Oers, M.H.J., Takeshita, K., Gopal, A., Rule, S., de Vos, S., Kloos, I., Kaminski, M.S., Meignan, M., Schwartz, L.H., Leonard, J.P., Schuster, S.J., and Seshan, V.E.

Published
2017
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7. The Italian CART‐SIE real life multicenter observational study on Chimeric Antigen Receptor T‐cell (CAR‐T) therapy for large B‐cell (LBCL) and mantle cell (MCL) lymphomas

Author

Chiappella, A., primary, Dodero, A., additional, Ljevar, S., additional, Pennisi, M., additional, Bonifazi, F., additional, De Philippis, C., additional, Galli, E., additional, Di Rocco, A., additional, Tisi, M. C., additional, Cutini, I., additional, Carrabba, M. G., additional, Musso, M., additional, Martino, M., additional, Barbui, A. M., additional, Botto, B., additional, Farina, M., additional, Grillo, G., additional, Patriarca, F., additional, Ladetto, M., additional, Arcaini, L., additional, Bermema, A., additional, Miceli, R., additional, Magni, M., additional, Zinzani, P. L., additional, Bramanti, S., additional, Chiusolo, P., additional, Martelli, M., additional, Carniti, C., additional, and Corradini, P., additional

Published
2023
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8. Final safety and efficacy results of copanlisib monotherapy in patients with relapsed or refractory iNHL: 6‐year follow‐up of CHRONOS‐1

Author

Dreyling, M., primary, Santoro, A., additional, Mollica, L., additional, Leppä, S., additional, Follows, G. A., additional, Lenz, G., additional, Kim, W. S., additional, Nagler, A., additional, Panayiotidis, P., additional, Demeter, J., additional, Özcan, M., additional, Kosinova, M., additional, Provencio, M., additional, Magagnoli, M., additional, Bouabdallah, K., additional, Heo, D. S., additional, Diong, C. P., additional, Munoz, J., additional, Cao, A., additional, Hiemeyer, F., additional, Odongo, F., additional, Garcia‐Vargas, J., additional, Childs, B. H., additional, and Zinzani, P. L., additional

Published
2023
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10. ZANUBRUTINIB PLUS OBINUTUZUMAB VERSUS OBINUTUZUMAB IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA: UPDATED ANALYSIS OF THE ROSEWOOD STUDY

Author

Zinzani, P. L., primary, Mayer, J., additional, Trotman, J., additional, Bijou, F., additional, de Oliveira, A. C., additional, Song, Y., additional, Zhang, Q., additional, Merli, M., additional, Bouabdallah, K., additional, Ganly, P. S., additional, Zhang, H., additional, Johnson, R., additional, Garcia‐Sancho, A. M., additional, Pulla, M. Provencio, additional, Trněný, M., additional, Yuen, S., additional, Assouline, S. E., additional, Auer, R., additional, Ivanoa, E., additional, Kim, P., additional, Greenbaum, A., additional, Huang, S., additional, Delarue, R., additional, and Flowers, C. R., additional

Published
2023
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11. GLOFITAMAB PLUS POLATUZUMAB VEDOTIN DEMONSTRATES DURABLE RESPONSES AND A MANAGEABLE SAFETY PROFILE IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B‐CELL LYMPHOMA

Author

Hutchings, M., primary, Avigdor, A., additional, Sureda, A., additional, Terol, M. J., additional, Bosch, F., additional, Corradini, P., additional, Larsen, T. Stauffer, additional, Domínguez, A. Rueda, additional, Skarbnik, A., additional, Jørgensen, J., additional, Goldschmidt, N., additional, Gurion, R., additional, Zinzani, P. L., additional, Pinto, A., additional, Cordoba, R., additional, Bottos, A., additional, Huang, Z., additional, Simko, S., additional, Relf, J., additional, Filézac de L’Etang, A., additional, Sellam, G., additional, and Gritti, G., additional

Published
2023
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13. 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

14. Humoral and T-Cell Immune Response After 3 Doses of Messenger RNA Severe Acute Respiratory Syndrome Coronavirus 2 Vaccines in Fragile Patients: The Italian VAX4FRAIL Study

Author

Corradini, P., Agrati, C., Apolone, G., Mantovani, A., Giannarelli, D., Marasco, V., Bordoni, V., Sacchi, A., Matusali, G., Salvarani, C., Zinzani, P. L., Mantegazza, R., Tagliavini, F., Lupo-Stanghellini, M. T., Ciceri, F., Damian, S., Uccelli, A., Fenoglio, D., Silvestris, N., Baldanti, F., Piaggio, G., Ciliberto, G., Morrone, A., Locatelli, Franco, Sinno, V., Rescigno, M., Costantini, M., Locatelli F. (ORCID:0000-0002-7976-3654), Corradini, P., Agrati, C., Apolone, G., Mantovani, A., Giannarelli, D., Marasco, V., Bordoni, V., Sacchi, A., Matusali, G., Salvarani, C., Zinzani, P. L., Mantegazza, R., Tagliavini, F., Lupo-Stanghellini, M. T., Ciceri, F., Damian, S., Uccelli, A., Fenoglio, D., Silvestris, N., Baldanti, F., Piaggio, G., Ciliberto, G., Morrone, A., Locatelli, Franco, Sinno, V., Rescigno, M., Costantini, M., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

BACKGROUND: Patients with solid or hematological tumors or neurological and immune-inflammatory disorders are potentially fragile subjects at increased risk of experiencing severe coronavirus disease 2019 and an inadequate response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. METHODS: We designed a prospective Italian multicenter study to assess humoral and T-cell responses to SARS-CoV-2 vaccination in patients (n = 378) with solid tumors (ST), hematological malignancies (HM), neurological disorders (ND), and immunorheumatological diseases (ID). A group of healthy controls was also included. We analyzed the immunogenicity of the primary vaccination schedule and booster dose. RESULTS: The overall seroconversion rate in patients after 2 doses was 62.1%. Significantly lower rates were observed in HM (52.4%) and ID (51.9%) than in ST (95.6%) and ND (70.7%); a lower median antibody level was detected in HM and ID versus ST and ND (P < .0001). Similar rates of patients with a positive SARS-CoV-2 T-cell response were found in all disease groups, with a higher level observed in ND. The booster dose improved the humoral response in all disease groups, although to a lesser extent in HM patients, whereas the T-cell response increased similarly in all groups. In the multivariable logistic model, independent predictors of seroconversion were disease subgroup, treatment type, and age. Ongoing treatment known to affect the immune system was associated with the worst humoral response to vaccination (P < .0001) but had no effect on T-cell responses. CONCLUSIONS: Immunosuppressive treatment more than disease type per se is a risk factor for a low humoral response after vaccination. The booster dose can improve both humoral and T-cell responses.

Published
2023

15. Neutralizing antibodies to Omicron after the fourth SARS-CoV-2 mRNA vaccine dose in immunocompromised patients highlight the need of additional boosters

Author

Rescigno, M., Agrati, C., Salvarani, C., Giannarelli, D., Costantini, M., Mantovani, A., Massafra, R., Zinzani, P. L., Morrone, A., Notari, S., Matusali, G., Pinter, G. L., Uccelli, A., Ciliberto, G., Baldanti, F., Locatelli, Franco, Silvestris, N., Sinno, V., Turola, E., Lupo-Stanghellini, M. T., and Apolone, G.

Subjects
cross immunity, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, immunocompromised patients, Immunology, SARS-CoV-2 mRNA vaccine, Immunology and Allergy, Omicron neutralization, T cell response, humoral response
Abstract

IntroductionImmunocompromised patients have been shown to have an impaired immune response to COVID-19 vaccines.MethodsHere we compared the B-cell, T-cell and neutralizing antibody response to WT and Omicron BA.2 SARS-CoV-2 virus after the fourth dose of mRNA COVID-19 vaccines in patients with hematological malignancies (HM, n=71), solid tumors (ST, n=39) and immune-rheumatological (IR, n=25) diseases. The humoral and T-cell responses to SARS-CoV-2 vaccination were analyzed by quantifying the anti-RBD antibodies, their neutralization activity and the IFN-γ released after spike specific stimulation.ResultsWe show that the T-cell response is similarly boosted by the fourth dose across the different subgroups, while the antibody response is improved only in patients not receiving B-cell targeted therapies, independent on the pathology. However, 9% of patients with anti-RBD antibodies did not have neutralizing antibodies to either virus variants, while an additional 5.7% did not have neutralizing antibodies to Omicron BA.2, making these patients particularly vulnerable to SARS-CoV-2 infection. The increment of neutralizing antibodies was very similar towards Omicron BA.2 and WT virus after the third or fourth dose of vaccine, suggesting that there is no preferential skewing towards either virus variant with the booster dose. The only limited step is the amount of antibodies that are elicited after vaccination, thus increasing the probability of developing neutralizing antibodies to both variants of virus.DiscussionThese data support the recommendation of additional booster doses in frail patients to enhance the development of a B-cell response directed against Omicron and/or to enhance the T-cell response in patients treated with anti-CD20.

Published
2023
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16. ALK-negative anaplastic large cell lymphoma: features and outcomes of 235 patients from the International T-Cell Project

Author

Shustov, A., Cabrera, M. E., Civallero, M., Bellei, M., Y. H., Ko, Manni, M., Skrypets, T., Horwitz, S. M., de Souza, C. A., Radford, J. A., Bobillo, S., Prates, M. V., Ferreri, A. J. M., Chiattone, C., Spina, M., Vose, J. M., Chiappella, A., Laszlo, D., Marino, D., Stelitano, C., Federico, M., Savage, K., Connors, J., Gascoyne, R., Chhanabhai, M., Wilson, W., Jaffe, E. S., Armitage, J. O., Weisenburger, D. D., Anderson, J., Ullrich, F., Bast, M., Hochberg, E., Harris, N., Smogorzews ka, A., Levine, A., Nathwani, B. N., Miller, T., Rimsza, L., Montserrat, E., Lopez-Guillermo, A., Campo, E., Cuadros, M., Ferreira, J. A., Delgado, B. M., Holte, H., Delabie, J., Rudiger, T., Muller-Hermelink, K., Reimer, P., Adam, P., Wilhelm, M., Schmitz, N., Nerl, C., Lister, A., Norton, A., Maclennan, K. A., Zinzani, P. L., Pileri, S. A., Bellai, M., Luminari, S., Coiffier, B., Berger, F., Tanin, I., Wannakrairot, P., W. Y., Au, Liang, R., Loong, F., Rajan, S., Sng, I., Tobinai, K., Matsuno, Y., Morishima, Y., Nakamura, S., Seto, M., Tanimoto, M., Yoshino, T., Suzumiya, J., Ohshima, K., and Kim, W. -S.

Subjects
Male, Oncology, medicine.medical_specialty, Anaplastic Lymphoma, Clinical Trials and Observations, T-Lymphocytes, medicine.medical_treatment, International Prognostic Index, hemic and lymphatic diseases, Internal medicine, medicine, Humans, Anaplastic Lymphoma Kinase, Prospective Studies, Prospective cohort study, Anaplastic large-cell lymphoma, Etoposide, Retrospective Studies, Chemotherapy, Manchester Cancer Research Centre, business.industry, ResearchInstitutes_Networks_Beacons/mcrc, Receptor Protein-Tyrosine Kinases, Hematology, medicine.disease, Lymphoma, Transplantation, Lymphoma, Large-Cell, Anaplastic, Female, business, medicine.drug
Abstract

Anaplastic lymphoma kinase–negative anaplastic large cell lymphoma (ALK– ALCL) is an aggressive neoplasm of T-cell/null-cell lineage. The T-Cell Project is a global prospective cohort study that consecutively enrolled patients newly diagnosed with peripheral T-cell lymphoma, registered through a centralized computer database between September 2006 and February 2018. Of 1553 validated cases from 74 sites in 13 countries worldwide, 235 were reported as ALK– ALCL. The median age at diagnosis was 54 years (range, 18-89 years), with a male predominance (62%). Stage III to IV disease was identified in 71% of patients, bulky disease and bone marrow involvement were uncommon, and 66% of patients presented with a low (0-1) International Prognostic Index score. Of all treated patients, 85% received multiagent initial chemotherapy, and 8% were consolidated with autologous hematopoietic cell transplantation. The initial overall and complete response rates were 77% and 63%, respectively. After a median follow-up of 52 months (95% confidence interval [CI], 41-63), the median progression-free survival (PFS) and overall survival (OS) were 41 months (95% CI, 17-62) and 55 months (95% CI, 36-75), respectively. The 3- and 5-year PFS rates were 52% and 43%, and the 3- and 5-year OS rates were 60% and 49%. Treatments containing both anthracycline and etoposide were associated with superior OS (P = .05) but not PFS (P = .18). In this large prospective cohort study, outcomes comparable to those previously reported in the retrospective International Peripheral T-Cell Lymphoma Project were observed. The study underscores the need for introducing novel platforms for ALK– ALCL and establishes a benchmark for future clinical trials. This trial was registered at www.clinicaltrials.gov as #NCT01142674.

Published
2021
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17. The International Consensus Classification of Mature Lymphoid Neoplasms: a report from the Clinical Advisory Committee

Author

Campo, E, Jaffe, ES, Cook, JR, Quintanilla-Martinez, L, Swerdlow, SH, Anderson, KC, Brousset, P, Cerroni, L, de Leval, L, Dirnhofer, S, Dogan, A, Feldman, AL, Fend, F, Friedberg, JW, Gaulard, P, Ghia, P, Horwitz, SM, King, RL, Salles, G, San-Miguel, J, Seymour, JF, Treon, SP, Vose, JM, Zucca, E, Advani, R, Ansell, S, Au, W-Y, Barrionuevo, C, Bergsagel, L, Chan, WC, Cohen, JI, d'Amore, F, Davies, A, Falini, B, Ghobrial, IM, Goodlad, JR, Gribben, JG, Hsi, ED, Kahl, BS, Kim, W-S, Kumar, S, LaCasce, AS, Laurent, C, Lenz, G, Leonard, JP, Link, MP, Lopez-Guillermo, A, Mateos, MV, Macintyre, E, Melnick, AM, Morschhauser, F, Nakamura, S, Narbaitz, M, Pavlovsky, A, Pileri, SA, Piris, M, Pro, B, Rajkumar, V, Rosen, ST, Sander, B, Sehn, L, Shipp, MA, Smith, SM, Staudt, LM, Thieblemont, C, Tousseyn, T, Wilson, WH, Yoshino, T, Zinzani, P-L, Dreyling, M, Scott, DW, Winter, JN, Zelenetz, A, Campo, E, Jaffe, ES, Cook, JR, Quintanilla-Martinez, L, Swerdlow, SH, Anderson, KC, Brousset, P, Cerroni, L, de Leval, L, Dirnhofer, S, Dogan, A, Feldman, AL, Fend, F, Friedberg, JW, Gaulard, P, Ghia, P, Horwitz, SM, King, RL, Salles, G, San-Miguel, J, Seymour, JF, Treon, SP, Vose, JM, Zucca, E, Advani, R, Ansell, S, Au, W-Y, Barrionuevo, C, Bergsagel, L, Chan, WC, Cohen, JI, d'Amore, F, Davies, A, Falini, B, Ghobrial, IM, Goodlad, JR, Gribben, JG, Hsi, ED, Kahl, BS, Kim, W-S, Kumar, S, LaCasce, AS, Laurent, C, Lenz, G, Leonard, JP, Link, MP, Lopez-Guillermo, A, Mateos, MV, Macintyre, E, Melnick, AM, Morschhauser, F, Nakamura, S, Narbaitz, M, Pavlovsky, A, Pileri, SA, Piris, M, Pro, B, Rajkumar, V, Rosen, ST, Sander, B, Sehn, L, Shipp, MA, Smith, SM, Staudt, LM, Thieblemont, C, Tousseyn, T, Wilson, WH, Yoshino, T, Zinzani, P-L, Dreyling, M, Scott, DW, Winter, JN, and Zelenetz, A

Abstract

Since the publication of the Revised European-American Classification of Lymphoid Neoplasms in 1994, subsequent updates of the classification of lymphoid neoplasms have been generated through iterative international efforts to achieve broad consensus among hematopathologists, geneticists, molecular scientists, and clinicians. Significant progress has recently been made in the characterization of malignancies of the immune system, with many new insights provided by genomic studies. They have led to this proposal. We have followed the same process that was successfully used for the third and fourth editions of the World Health Organization Classification of Hematologic Neoplasms. The definition, recommended studies, and criteria for the diagnosis of many entities have been extensively refined. Some categories considered provisional have now been upgraded to definite entities. Terminology for some diseases has been revised to adapt nomenclature to the current knowledge of their biology, but these modifications have been restricted to well-justified situations. Major findings from recent genomic studies have impacted the conceptual framework and diagnostic criteria for many disease entities. These changes will have an impact on optimal clinical management. The conclusions of this work are summarized in this report as the proposed International Consensus Classification of mature lymphoid, histiocytic, and dendritic cell tumors.

Published
2022

18. Safety of third dose of COVID-19 vaccination in frail patients: Results from the prospective Italian VAX4FRAIL study

Author

Di Cosimo, S., Lupo-Stanghellini, M. T., Costantini, M., Mantegazza, R., Ciceri, F., Salvarani, C., Zinzani, P. L., Mantovani, A., Ciliberto, G., Uccelli, A., Baldanti, F., Apolone, G., Delcuratolo, S., Morrone, A., Locatelli, Franco, Agrati, C., Silvestris, N., Locatelli F. (ORCID:0000-0002-7976-3654), Di Cosimo, S., Lupo-Stanghellini, M. T., Costantini, M., Mantegazza, R., Ciceri, F., Salvarani, C., Zinzani, P. L., Mantovani, A., Ciliberto, G., Uccelli, A., Baldanti, F., Apolone, G., Delcuratolo, S., Morrone, A., Locatelli, Franco, Agrati, C., Silvestris, N., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Importance: Despite people with impaired immune competence due to an underlying disease or ongoing therapy, hereinafter frail patients, are (likely to be) the first to be vaccinated, they were usually excluded from clinical trials. Objective: To report adverse reactions of frail patients after receipt of the third dose (booster) administered after completion of a two-dose mRNA vaccination and to compare with those reported after the receipt of the first two doses. Design: A multicenter, observational, prospective study aimed at evaluating both the safety profile and the immune response of Pfizer-BioNTech or Moderna vaccines in frail patients. Setting: National Project on Vaccines, COVID-19 and Frail Patients (VAX4FRAIL) Participants: People consenting and included in the VAX4FRAIL trial. Exposure: A series of three doses of COVID-19 mRNA vaccination from the same manufacturer. Main outcome(s) and measure(s): Evaluation of a self-assessment questionnaire addressing a predefined list of eight symptoms on a five-item Likert scale. Symptoms were classified as severe if the patient rated them as severe or overwhelming. Results: Among 320 VAX4FRAIL participants diagnosed/treated for hematological malignancies (N=105; 32.8%), solid tumors (N=48; 15.0%), immune-rheumatological diseases (N=60; 18.8%), neurological diseases (N=107; 33.4%), and receiving the booster dose, 70.3% reported at least one loco-regional or systemic reactions. Adverse events were mostly mild or moderate, none being life-threatening. Only six of the 320 (1.9%) patients had their treatment postponed due to the vaccine. The safety profile of the booster compared to previously administered two doses showed a stable prevalence of patients with one or more adverse events (73.5%, 79.7% and 73.9% respectively), and a slightly increment of patients with one or more severe adverse events (13.4%, 13.9% and 19.2% respectively). Conclusions and relevance: The booster of the mRNA COVID-19 vaccine was safely adminis

Published
2022

19. mRNA-COVID19 Vaccination Can Be Considered Safe and Tolerable for Frail Patients

Author

Lupo-Stanghellini, M. T., Di Cosimo, S., Costantini, M., Monti, S., Mantegazza, R., Mantovani, A., Salvarani, C., Zinzani, P. L., Inglese, M., Ciceri, F., Apolone, G., Ciliberto, G., Baldanti, F., Morrone, A., Sinno, V., Locatelli, Franco, Notari, S., Turola, E., Giannarelli, D., Silvestris, N., Locatelli F. (ORCID:0000-0002-7976-3654), Lupo-Stanghellini, M. T., Di Cosimo, S., Costantini, M., Monti, S., Mantegazza, R., Mantovani, A., Salvarani, C., Zinzani, P. L., Inglese, M., Ciceri, F., Apolone, G., Ciliberto, G., Baldanti, F., Morrone, A., Sinno, V., Locatelli, Franco, Notari, S., Turola, E., Giannarelli, D., Silvestris, N., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Background: Frail patients are considered at relevant risk of complications due to coronavirus disease 2019 (COVID-19) infection and, for this reason, are prioritized candidates for vaccination. As these patients were originally not included in the registration trials, fear related to vaccine adverse events and disease worsening was one of the reasons for vaccine hesitancy. Herein, we report the safety profile of the prospective, multicenter, national VAX4FRAIL study (NCT04848493) to evaluate vaccines in a large trans-disease cohort of patients with solid or hematological malignancies and neurological and rheumatological diseases. Methods: Between March 3 and September 2, 2021, 566 patients were evaluable for safety endpoint: 105 received the mRNA-1273 vaccine and 461 the BNT162b2 vaccine. Frail patients were defined per protocol as patients under treatment with hematological malignancies (n = 131), solid tumors (n = 191), immune-rheumatological diseases (n = 86), and neurological diseases (n = 158), including multiple sclerosis and generalized myasthenia. The impact of the vaccination on the health status of patients was assessed through a questionnaire focused on the first week after each vaccine dose. Results: The most frequently reported moderate–severe adverse events were pain at the injection site (60.3% after the first dose, 55.4% after the second), fatigue (30.1%–41.7%), bone pain (27.4%–27.2%), and headache (11.8%–18.9%). Risk factors associated with the occurrence of severe symptoms after vaccine administration were identified through a multivariate logistic regression analysis: age was associated with severe fever presentation (younger patients vs. middle-aged vs. older ones), female individuals presented a higher probability of severe pain at the injection site, fatigue, headache, and bone pain; and the mRNA-1237 vaccine was associated with a higher probability of severe pain at the injection site and fever. After the first dose, patients presenting a se

Published
2022

20. 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, A., Piciocchi, A., Varettoni, M., Galli, Eugenio, Anastasia, A., Cantonetti, M., Trentin, L., Kovalchuk, S., Orsucci, L., Frustaci, A., Spolzino, A., Volpetti, S., Annibali, O., Storti, Sergio, Stelitano, C., Marchesi, F., Offidani, M., Casadei, B., Nizzoli, M. E., De Luca, M. L., Fianchi, Luana, Motta, M., Guarnera, L., Simonetti, E., Visentin, A., Vassallo, F., Deodato, M., Sarlo, C., Olivieri, A., Falini, B., Pulsoni, A., Tiacci, E., Zinzani, P. L., Pagano L. (ORCID:0000-0001-8287-928X), Criscuolo M., Galli E., Storti S. (ORCID:0000-0002-4374-3985), Fianchi L., Pagano, Livio, Criscuolo, Marianna, Broccoli, A., Piciocchi, A., Varettoni, M., Galli, Eugenio, Anastasia, A., Cantonetti, M., Trentin, L., Kovalchuk, S., Orsucci, L., Frustaci, A., Spolzino, A., Volpetti, S., Annibali, O., Storti, Sergio, Stelitano, C., Marchesi, F., Offidani, M., Casadei, B., Nizzoli, M. E., De Luca, M. L., Fianchi, Luana, Motta, M., Guarnera, L., Simonetti, E., Visentin, A., Vassallo, F., Deodato, M., Sarlo, C., Olivieri, A., Falini, B., Pulsoni, A., Tiacci, E., Zinzani, P. L., Pagano L. (ORCID:0000-0001-8287-928X), Criscuolo M., Galli E., Storti S. (ORCID:0000-0002-4374-3985), and Fianchi L.

Abstract

Hairy cell leukemia (HCL) is a rare lymphoproliferative disease with an excellent prognosis after treatment with cladribine (2CDA), although relapse may occur during follow-up. The aim of the study is to review the efficacy, safety, long-term remission rate, and overall survival (OS) in those patients who received 2CDA as first-line treatment. We retrospectively reviewed data of HCL patients treated with 2CDA between March 1991 and May 2019 at 18 Italian Hematological centers: 513 patients were evaluable for study purpose. The median age was 54 years (range 24–88) and ECOG was 0 in 84.9% of cases. A total of 330 (64.3%) patients received 2CDA intravenously and 183 (35.7%) subcutaneously. ORR was 91.8%: CR was obtained in 335 patients (65.3%), PR in 96 (18.7%), and hematological response in 40 (7.8%) patients; in 42 (8.2%) no response was observed. Hemoglobin value (p = 0.044), frequency of circulating hairy cells (p = 0.039), recovery of absolute neutrophil count (p = 0.006), and normalization of spleen (p ≤ 0.001) were associated with CR compared to PR in univariable analysis. At a median follow-up of 6.83 years (range 0.04–28.52), the median time to relapse was 12.2 years. A significant difference in duration of response was identified between patients that obtained a CR and PR (19.4 years versus 4.8 years, p < 0.0001). Non-hematological grade 3 or higher early toxicity was reported in 103 (20.1%) patients. Median OS was not reached: 95.3%, 92.4%, and 81.8% of patients were estimated to be alive at 5, 10, and 15 years, respectively. Forty-nine patients died (9.5%), following an infection in 14 cases (2.7%), natural causes in 14 (2.7%), cardiovascular events in 13 (2.5%), a second neoplasm in 6 (1.2%), and progression of HCL in 2 cases (0.4%). Following treatment of HCL with 2CDA, 80% of patients are estimated to be alive 15 years after diagnosis.

Published
2022

21. Global patterns of care in advanced stage mycosis fungoides/Sezary syndrome: a multicenter retrospective follow-up study from the Cutaneous Lymphoma International Consortium

Author

Quaglino, P., Maule, M., Prince, H. M., Porcu, P., Horwitz, S., Duvic, M., Talpur, R., Vermeer, M., Bagot, M., Guitart, J., Papadavid, E., Sanches, J. A., Hodak, E., Sugaya, M., Berti, E., Ortiz-Romero, P., Pimpinelli, N., Servitje, O., Pileri, A., Zinzani, P. L., Estrach, T., Knobler, R., Stadler, R., Fierro, M. T., Alberti Violetti, S., Amitay-Laish, I., Antoniou, C., Astrua, C., Chaganti, S., Child, F., Combalia, A., Fabbro, S., Fava, P., Grandi, V., Jonak, C., Martinez-Escala, E., Kheterpal, M., Kim, E. J., McCormack, C., Miyagaki, T., Miyashiro, D., Morris, S., Muniesa, C., Nikolaou, V., Ognibene, G., Onida, F., Osella-Abate, S., Porkert, S., Postigo-Llorente, C., Ram-Wolff, C., Ribero, S., Rogers, K., Sanlorenzo, M., Stranzenbach, R., Spaccarelli, N., Stevens, A., Zugna, D., Rook, A. H., Geskin, L. J., Willemze, R., Whittaker, S., Hoppe, R., Scarisbrick, J., and Kim, Y.

Published
2017
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23. LONG‐TERM RESPONSES WITH LONCASTUXIMAB TESIRINE: UPDATED RESULTS FROM LOTIS‐2, THE PIVOTAL PHASE 2 STUDY IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B‐CELL LYMPHOMA.

Author

Caimi, P. F, Ai, W. Z, Alderuccio, J. P., Ardeshna, K. M, Hamadani, M., Hess, B., Kahl, B. S, Radford, J., Solh, M., Stathis, A., Zinzani, P. L., Wang, Y., Qin, Y., Wang, L., Xu, C., and Carlo‐Stella, C.

Subjects
DIFFUSE large B-cell lymphomas, STEM cell transplantation, CHIMERIC antigen receptors
Abstract

B Introduction: b Patients (pts) with diffuse large B-cell lymphoma (DLBCL) who relapse after stem cell transplant or chimeric antigen receptor therapy or are refractory to second-line therapy have poor prognosis and few treatment options (Chow et al., 2019). LONG-TERM RESPONSES WITH LONCASTUXIMAB TESIRINE: UPDATED RESULTS FROM LOTIS-2, THE PIVOTAL PHASE 2 STUDY IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA Stock ownership: ADC Therapeutics Research funding: ADC Therapeutics B L. Wang b Employment or leadership position: ADC Therapeutics. [Extracted from the article]

Published
2023
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24. S208: EFFICACY AND SAFETY OF ZANDELISIB ADMINISTERED BY INTERMITTENT DOSING (ID) IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA: PRIMARY ANALYSIS OF THE GLOBAL PHASE 2 STUDY TIDAL

Author

Zelenetz, A., primary, Jurczak, W., additional, Ribrag, V., additional, Linton, K., additional, Collins, G., additional, Lopéz-Jiménez, J., additional, Reddy, N., additional, Mengarelli, A., additional, Phillips, T., additional, Musuraca, G., additional, Sheehy, O., additional, Li, J., additional, Xu, W., additional, Azoulay, M., additional, Ghalie, R., additional, and Zinzani, P. L., additional

Published
2022
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25. S205: ZANUBRUTINIB + OBINUTUZUMAB (ZO) VS OBINUTUZUMAB (O) MONOTHERAPY IN PATIENTS (PTS) WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL): PRIMARY ANALYSIS OF THE PHASE 2 RANDOMIZED ROSEWOOD TRIAL

Author

Zinzani, P. L., primary, Mayer, J., additional, Auer, R., additional, Bijou, F., additional, de Oliveira, A. C., additional, Flowers, C. R., additional, Merli, M., additional, Bouabdallah, K., additional, Ganly, P. S., additional, Song, Y., additional, Zhang, H., additional, Johnson, R., additional, García-Sancho, A. M, additional, Provencio, M., additional, Trněný, M., additional, Yuen, S., additional, Tilly, H., additional, Kingsley, E., additional, Tuyman, G., additional, Assouline, S. E., additional, Ivanova, E., additional, Kim, P., additional, Huang, J., additional, Delarue, R., additional, and Trotman, J., additional

Published
2022
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26. P1123: TEMPO: A PHASE 2, RANDOMIZED, OPEN-LABEL, 2-ARM STUDY COMPARING TWO INTERMITTENT DOSING SCHEDULES OF DUVELISIB IN SUBJECTS WITH INDOLENT NON-HODGKIN LYMPHOMA (INHL)

Author

Vorobyev, V., primary, Yoon, D. H., additional, Kaźmierczak, M., additional, Grosicki, S., additional, Tarella, C., additional, Genua, A., additional, Kim, J. S., additional, Cohan, D., additional, Daugherty, M., additional, Flinn, I. W., additional, Zinzani, P. L., additional, and Gordon, L. I., additional

Published
2022
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27. PB1862: BRUIN CLL-313: A PHASE 3 OPEN-LABEL, RANDOMIZED STUDY OF PIRTOBRUTINIB VS BENDAMUSTINE+RITUXIMAB IN UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA (TRIAL IN PROGRESS)

Author

Jurczak, W., primary, Dartigeas, C., additional, Coscia, M., additional, Ganly, P., additional, Al-Jazayrly, G., additional, Wang, C., additional, Bao, K., additional, Leow, C. C., additional, Shahda, S., additional, and Zinzani, P. L., additional

Published
2022
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28. P1115: A MULTICENTER PHASE 1/2 TRIAL OF EO2463, A MICROBIAL-DERIVED PEPTIDE THERAPEUTIC VACCINE, AS MONOTHERAPY AND IN COMBINATION WITH LENALIDOMIDE AND RITUXIMAB, FOR TREATMENT OF PATIENTS WITH INDOLENT NHL

Author

Zinzani, P. L., primary, Ansell, S. M., additional, Bosch, F., additional, Friedberg, J. W., additional, Marolleau, J. P., additional, Arcaini, L., additional, Garcia-Sanz, R., additional, Gopal, A. K., additional, Grande, C., additional, Merryman, R., additional, Pinto, A., additional, Smith, S. D., additional, Villasboas, J. C., additional, Wallace, D., additional, Fagerberg, J., additional, Magalhaes, J. G., additional, and Armand, P., additional

Published
2022
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29. P1239: TISLELIZUMAB, A PD-1 INHIBITOR FOR RELAPSED/REFRACTORY MATURE T- AND NK-CELL NEOPLASMS: RESULTS FROM A PHASE 2 STUDY

Author

Bachy, E., primary, Savage, K. J., additional, Huang, H., additional, Kwong, Y. L., additional, Gritti, G., additional, Zhang, Q., additional, Liberati, A. M., additional, Cao, J., additional, Yang, H., additional, Hao, S., additional, Hu, J., additional, Zhou, K., additional, Russo, F., additional, Zhang, H., additional, Sang, W., additional, Ji, J., additional, Ferreri, A. J. M., additional, Damaj, G. L., additional, Liu, H., additional, Zhang, W., additional, Ke, X., additional, Ghiggi, C., additional, Huang, S., additional, Li, X., additional, Yao, H., additional, Paik, J., additional, Novotny, W., additional, Zhou, W., additional, Zhu, H., additional, Huang, J., additional, and Zinzani, P. L., additional

Published
2022
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30. P1138: COPANLISIB + RITUXIMAB VS RITUXIMAB + PLACEBO IN PATIENTS WITH RELAPSED INDOLENT NON-HODGKIN LYMPHOMA (NHL): UPDATED SAFETY AND EFFICACY FROM THE PHASE III CHRONOS-3 TRIAL

Author

Zinzani, P. L., primary, Özcan, M., additional, Sapunarova, K., additional, Jurczak, W., additional, Hamed, A., additional, Bouabdallah, K., additional, Saydam, G., additional, Geissler, K., additional, Szomor, Á., additional, Lazaroiu, M., additional, Salar, A., additional, Tempescul, A., additional, Nalcaci, M., additional, Gercheva, L., additional, Egyed, M., additional, Panayiotidis, P., additional, Mongay Soler, L., additional, Cao, A., additional, Phelps, C., additional, H Childs, B., additional, and J Matasar, M., additional

Published
2022
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31. P683: A FIRST-IN-HUMAN PHASE 1 STUDY OF ORAL LOXO-338, A SELECTIVE BCL2 INHIBITOR, IN PATIENTS WITH ADVANCED HEMATOLOGIC MALIGNANCIES (TRIAL IN PROGRESS)

Author

Jurczak, W., primary, Alencar, A. J., additional, Guru Murthy, G. S., additional, Hoffmann, M., additional, Pagel, J. M., additional, Patel, V., additional, Pauff, J. M., additional, Zinzani, P. L., additional, Le Gouill, S., additional, Mato, A. R., additional, and Roeker, L. E., additional

Published
2022
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32. S101: GENETIC AND EPIGENETIC FACTORS DRIVING PRIMARY MEDIASTINAL B-CELL LYMPHOMA PATHOGENESIS AND OUTCOME

Author

Noerenberg, D., primary, Briest, F., additional, Hennch, C., additional, Yoshida, K., additional, Nimo, J., additional, Hablesreiter, R., additional, Takeuchi, Y., additional, Sasca, D., additional, Ueno, H., additional, Mansouri, L., additional, Inoue, Y., additional, Wiegand, L., additional, Staiger, A. M., additional, Casadei, B., additional, Ziepert, M., additional, Asmar, F., additional, Korkolopoulou, P., additional, Kirchner, M., additional, Mertins, P., additional, Weiner, J., additional, Toth, E., additional, Weber, T., additional, Warth, A., additional, Schneider, T., additional, Amini, R.-M., additional, Klapper, W., additional, Hummel, M., additional, Poeschel, V., additional, Kanellis, G., additional, Rosenwald, A., additional, Held, G., additional, Campo, E., additional, Stamatopoulos, K., additional, Anagnostopoulos, I., additional, Bullinger, L., additional, Goldschmidt, N., additional, Zinzani, P. L., additional, Bödor, C., additional, Rosenquist, R., additional, Vassilakopoulos, T. P., additional, Ott, G., additional, Ogawa, S., additional, and Damm, F., additional

Published
2022
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33. P1162: ZANUBRUTINIB IN OLDER PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) MARGINAL ZONE LYMPHOMA (MZL): SUBGROUP ANALYSIS OF THE MAGNOLIA STUDY

Author

Opat, S., primary, Hu, B., additional, Tedeschi, A., additional, Linton, K. M., additional, McKay, P., additional, Chan, H., additional, Jin, J., additional, Sun, M., additional, Sobieraj-Teague, M., additional, Zinzani, P. L., additional, Coleman, M., additional, Browett, P., additional, Ke, X., additional, Portell, C. A., additional, Thieblemont, C., additional, Ardeshna, K., additional, Bijou, F., additional, Walker, P., additional, Hawkes, E. A., additional, Ho, S.-J., additional, Zhou, K.-S., additional, Co, M., additional, Xu, J., additional, Liang, Z., additional, Anderson, J., additional, Tankersley, C., additional, Huang, J., additional, and Trotman, J., additional

Published
2022
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34. P1198: ASSOCIATION OF PRETREATMENT TUMOR CHARACTERISTICS AND CLINICAL OUTCOMES FOLLOWING SECOND-LINE AXICABTAGENE CILOLEUCEL VS STANDARD OF CARE IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA

Author

Locke, F. L., primary, Chou, J., additional, Vardhanabhuti, S., additional, Perbost, R., additional, Dreger, P., additional, Hill, B. T., additional, Lee, C., additional, Zinzani, P. L., additional, Kröger, N., additional, López-Guillermo, A., additional, Greinix, H., additional, Zhang, W., additional, Tiwari, G., additional, To, C., additional, Cheng, P., additional, Bot, A., additional, Shen, R., additional, Filosto, S., additional, and Galon, J., additional

Published
2022
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35. P1351: CHARACTERIZING ALLOGENEIC STEM CELL TRANSPLANTATION SAFETY IN PATIENTS WITH HEMATOLOGIC MALIGNANCIES AFTER PEMBROLIZUMAB THERAPY

Author

Kuruvilla, J., primary, Armand, P., additional, Herrera, A. F., additional, Ribrag, V., additional, Brice, P., additional, Thieblemont, C., additional, Von Tresckow, B., additional, Kim, E., additional, Marinello, P., additional, Chakraborty, S., additional, Orlowski, R., additional, and Zinzani, P. L., additional

Published
2022
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36. S201: CAMIDANLUMAB TESIRINE: UPDATED EFFICACY AND SAFETY IN AN OPEN-LABEL, MULTICENTER, PHASE 2 STUDY OF PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA (R/R CHL)

Author

Carlo-Stella, C., primary, Ansell, S., additional, Zinzani, P. L, additional, Radford, J., additional, Maddocks, K., additional, Pinto, A., additional, Collins, G. P., additional, Bachanova, V., additional, Bartlett, N., additional, Bence-Bruckler, I., additional, Hamadani, M., additional, Kline, J., additional, Mayer, J., additional, Savage, K. J., additional, Advani, R., additional, Caimi, P., additional, Casasnovas, R.-O., additional, Feldman, T., additional, Hess, B., additional, Bastos-Oreiro, M., additional, Iyengar, S., additional, Eisen, S., additional, Negievich, Y., additional, Wang, L., additional, Wuerthner, J., additional, and Herrera, A. F., additional

Published
2022
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37. P1172: DUVELISIB IN PATIENTS WITH RELAPSED/REFRACTORY PERIPHERAL T-CELL LYMPHOMA FROM THE PHASE 2 PRIMO TRIAL: UPDATED EXPANSION PHASE ANALYSIS

Author

Zinzani, P. L., primary, Zain, J., additional, Mead, M., additional, Casulo, C., additional, Jacobsen, E. D., additional, Gritti, G., additional, Pinter-Brown, L., additional, Isutzu, K., additional, Cohan, D., additional, Daugherty, M., additional, Brammer, J. E., additional, Mehta-Shah, N., additional, Pro, B., additional, and Horwitz, S. M., additional

Published
2022
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38. P1087: FAVEZELIMAB (ANTI–LAG-3) AND PEMBROLIZUMAB CO-BLOCKADE IN PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA WHO PROGRESSED AFTER ANTI–PD-1 THERAPY: AN OPEN-LABEL PHASE 1/2 STUDY

Author

Herrera, A. F., primary, Lavie, D., additional, Johnson, N. A., additional, Avigdor, A., additional, Borchmann, P., additional, Andreadis, C., additional, Bazargan, A., additional, Gregory, G., additional, Keane, C., additional, Inna, T., additional, Vucinic, V., additional, Zinzani, P. L., additional, Zhang, H., additional, Pillai, P., additional, Marinello, P., additional, and Timmerman, J., additional

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2022
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39. S217: PRELIMINARY ANALYSIS OF THE PHASE II STUDY USING TOLINAPANT (ASTX660) MONOTHERAPY IN 98 PERIPHERAL T-CELL LYMPHOMA AND 51 CUTANEOUS T-CELL LYMPHOMA SUBJECTS WITH RELAPSED REFRACTORY DISEASE.

Author

Michot, J.-M., primary, Mehta, A., additional, Samaniego, F., additional, Bachy, E., additional, Zinzani, P. L., additional, Prica, A., additional, Colins, G. P., additional, Ribrag, V, additional, Wagner-Johnston, N., additional, El-Sharkawi, D., additional, O’Connor, O. A., additional, Wilcox, R., additional, Wang, L., additional, Wilson, L., additional, Sims, M., additional, Taylor, J. A., additional, Keer, H. N., additional, and Foss, F., additional

Published
2022
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40. P1104: A PHASE 1 STUDY EVALUATING SAFETY AND EFFICACY OF PARSACLISIB IN COMBINATION WITH BENDAMUSTINE + OBINUTUZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (CITADEL-102)

Author

Hamadani, M., primary, Coleman, M., additional, Boccia, R., additional, Duras, J., additional, Hutchings, M., additional, Zinzani, P. L., additional, Cordoba, R., additional, Oreiro, M. B., additional, Williams, V., additional, Stouffs, M., additional, Langmuir, P., additional, and Sancho, J.-M., additional

Published
2022
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41. P1101: PIRTOBRUTINIB, A HIGHLY SELECTIVE, NON-COVALENT (REVERSIBLE) BTK INHIBITOR IN PREVIOUSLY TREATED MANTLE CELL LYMPHOMA: UPDATED RESULTS FROM THE PHASE 1/2 BRUIN STUDY

Author

Eyre, T. A., primary, Wang, M. L., additional, Shah, N. N., additional, Alencar, A. J., additional, Gerson, J. N., additional, Patel, M. R., additional, Fakhri, B., additional, Vandenberghe, E., additional, Jurczak, W., additional, Tan, X. N., additional, Lewis, K. L., additional, Fenske, T., additional, Wang, Y., additional, Coombs, C. C., additional, Flinn, I., additional, Lewis, D., additional, Le Gouill, S., additional, Gandhi, M., additional, Chay, C., additional, Palomba, M. L., additional, Woyach, J. A., additional, Pagel, J. M., additional, Lamanna, N., additional, Sharman, J. P., additional, Andorsky, D. J., additional, Cohen, J. B., additional, Barve, M. A., additional, Ghia, P., additional, Yin, M., additional, Zinzani, P. L., additional, Ujjani, C., additional, Koh, Y., additional, Izutsu, K., additional, Lech-Maranda, E., additional, Kherani, J., additional, Tam, C., additional, Sundaram, S., additional, Nair, B., additional, Tsai, D. E., additional, Balbas, M., additional, Mato, A. R., additional, and Cheah, C. Y., additional

Published
2022
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42. PB1863: BRUIN CLL-322: A PHASE 3 OPEN-LABEL, RANDOMIZED STUDY OF FIXED DURATION PIRTOBRUTINIB+VENETOCLAX AND RITUXIMAB VS VENETOCLAX AND RITUXIMAB IN PREVIOUSLY TREATED CLL/SLL (TRIAL IN PROGRESS)

Author

Mato, A. R., primary, Wierda, W. G., additional, Pagel, J. M., additional, Davids, M. S., additional, Zinzani, P. L., additional, Lu, Y., additional, Liu, H., additional, Shahda, S., additional, Leow, C. C., additional, Tam, C. S., additional, Woyach, J. A., additional, and Eyre, T. A., additional

Published
2022
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43. P1178: BRENTUXIMAB VEDOTIN IN COMBINATION WITH LENALIDOMIDE AND RITUXIMAB IN PATIENTS WITH RELAPSED/REFRACTORY DLBCL: SAFETY AND EFFICACY RESULTS FROM THE SAFETY RUN-IN PERIOD OF THE PHASE 3 ECHELON-3 STUDY

Author

Bartlett, N. L., primary, Yasenchak, C. A., additional, Ashraf, K. K., additional, Harwin, W. N., additional, Orcutt, J., additional, Kuriakose, P., additional, Zinzani, P. L., additional, Mamidipalli, A., additional, Fenton, K., additional, Glenn, C., additional, and Nowakowski, G., additional

Published
2022
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44. PB2111: SUBGROUP ANALYSIS IN RE-MIND2, AN OBSERVATIONAL, RETROSPECTIVE COHORT STUDY OF TAFASITAMAB + LENALIDOMIDE VERSUS SYSTEMIC THERAPIES IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

Author

Nowakowski, G. S., primary, Yoon, D. H., additional, Joffe, E., additional, Zinzani, P. L., additional, Sabatelli, L., additional, Waltl, E. E., additional, Alvero, C. G., additional, Hess, G., additional, Riedell, P., additional, Kim, K., additional, Brixner, D., additional, and Salles, G., additional

Published
2022
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45. The ECHELON-2 Trial:5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma

Author

Horwitz, S, O'Connor, O A, Pro, B, Trümper, L, Iyer, S, Advani, R, Bartlett, N L, Christensen, J H, Morschhauser, F, Domingo-Domenech, E, Rossi, G, Kim, W S, Feldman, T, Menne, T, Belada, D, Illés, Á, Tobinai, K, Tsukasaki, K, Yeh, S-P, Shustov, A, Hüttmann, A, Savage, K J, Yuen, S, Zinzani, P L, Miao, H, Bunn, V, Fenton, K, Fanale, M, Puhlmann, M, and Illidge, T

Subjects
Brentuximab Vedotin, Manchester Cancer Research Centre, ResearchInstitutes_Networks_Beacons/mcrc, overall survival, Medizin, Ki-1 Antigen, Lymphoma, T-Cell, Peripheral, Hematology, frontline treatment, randomized clinical trial, Oncology, Vincristine, brentuximab vedotin, Antineoplastic Combined Chemotherapy Protocols, Humans, peripheral T-cell lymphoma, CHOP
Abstract

BACKGROUND: For patients with peripheral T-cell lymphoma (PTCL), outcomes using frontline treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like therapy are typically poor. The ECHELON-2 study demonstrated that brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A+CHP) exhibited statistically superior progression-free survival (PFS) per independent central review and improvements in overall survival versus CHOP for the frontline treatment of patients with systemic anaplastic large cell lymphoma or other CD30-positive PTCL.PATIENTS AND METHODS: ECHELON-2 is a double-blind, double-dummy, randomized, placebo-controlled, active-comparator phase III study. We present an exploratory update of the ECHELON-2 study, including an analysis of 5-year PFS per investigator in the intent-to-treat analysis group.RESULTS: A total of 452 patients were randomized (1 : 1) to six or eight cycles of A+CHP (N = 226) or CHOP (N = 226). At median follow-up of 47.6 months, 5-year PFS rates were 51.4% [95% confidence interval (CI): 42.8% to 59.4%] with A+CHP versus 43.0% (95% CI: 35.8% to 50.0%) with CHOP (hazard ratio = 0.70; 95% CI: 0.53-0.91), and 5-year overall survival (OS) rates were 70.1% (95% CI: 63.3% to 75.9%) with A+CHP versus 61.0% (95% CI: 54.0% to 67.3%) with CHOP (hazard ratio = 0.72; 95% CI: 0.53-0.99). Both PFS and OS were generally consistent across key subgroups. Peripheral neuropathy was resolved or improved in 72% (84/117) of patients in the A+CHP arm and 78% (97/124) in the CHOP arm. Among patients who relapsed and subsequently received brentuximab vedotin, the objective response rate was 59% with brentuximab vedotin retreatment after A+CHP and 50% with subsequent brentuximab vedotin after CHOP.CONCLUSIONS: In this 5-year update of ECHELON-2, frontline treatment of patients with PTCL with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, with a manageable safety profile, including continued resolution or improvement of peripheral neuropathy.

Published
2022
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47. ECHELON-2 (NCT01777152), A RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF BRENTUXIMAB VEDOTIN plus CHP VS CHOP IN PREVIOUSLY UNTREATED PATIENTS WITH CD30-POSITIVE PERIPHERAL T-CELL LYMPHOMA: 5-YEAR RESULTS

Author

Zinzani, P. L., Illidge, T., Horwitz, S. M., O'Connor, O. A., Pro, B., Iyer, S. P., Advani, R., Bartlett, N. L., Christensen, J. H., Morschhauser, F., Domingo-Domenech, E., Rossi, G., Kim, W. S., Feldman, T. A., Menne, T., Belada, D., Illes, A., Tobinai, K., Tsukasaki, K., Yeh, S-P., Huttmann, A., Savage, K. J., Yuen, S., Miao, H., Bunn, V., Fenton, K., Fanale, M. A., Puhlmann, M., and Trumper, L.

Published
2021
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