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2. Shift from Widespread to Tailored Antifungal Prophylaxis in Lymphoma Patients Treated with CD19 CAR T Cell Therapy: Results from a Large Retrospective Cohort

Author

Melica, Giovanna, Luna de Abia, Alejandro, Shah, Gunjan L., Devlin, Sean, Corona, Magdalena, Fein, Joshua, Dahi, Parastoo B., Giralt, Sergio A., Lin, Richard J., Palomba, M. Lia, Parascondola, Allison, Park, Jae, Salles, Gilles, Saldia, Amethyst, Scordo, Michael, Shouval, Roni, Perales, Miguel-Angel, and Seo, Susan K.

Published
2025
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5. List of contributors

Author

Ahn, Joseph C., primary, Anand, Shankara, additional, Arnaout, O., additional, Bandyopadhyay, Anuja, additional, Bartholomew, Erin, additional, Bates, David W., additional, Bender, Sarah M.L., additional, Bhullar, Puneet K., additional, Bhutani, Tina, additional, Boaro, A., additional, Boyer, Edward W., additional, Brown, Ethan D.L., additional, Carreiro, Stephanie, additional, Chahla, Jorge, additional, Chandran, Viji Pulikkel, additional, Cheng, Ching-Yu, additional, Cheung, Carol Y., additional, Choudhary, Anirudh, additional, Choudhury, Avishek, additional, Chung, Mimi, additional, Ciurtin, Coziana, additional, Comfere, Nneka I., additional, Corriveau-Lecavalier, Nick, additional, Côté, Mélina, additional, del Alamo, Diego, additional, Dias, Roger D., additional, Dönnes, Pierre, additional, Duong, Dat, additional, Ebnali, Mahdi, additional, El Sherbini, Adham, additional, ElZarrad, M. Khair, additional, Fakhouri, Tala H., additional, Fakhoury, Marc, additional, Fein, Joshua A., additional, Fischer, Uwe M., additional, Glicksberg, Benjamin S., additional, Goldstein, Cathy, additional, Gonem, Sherif, additional, Green, Darren V.S., additional, Gupta, Raghav, additional, Hakimi, Marwa, additional, Halamka, John D., additional, Han, Christina S., additional, Hannah-Shmouni, Fady, additional, Harrer, Stefan, additional, Hazime, Ali Amer, additional, Howard, Michael A., additional, Hui, Herbert Y.H., additional, Ildardashty, Alexander, additional, J.F. Shaikh, Hashim, additional, Jeliazkov, Jeliazko R., additional, Jones, David T., additional, Juhn, Young J., additional, Jury, Elizabeth C., additional, Kandaswamy, Swaminathan, additional, Kang, Yanna, additional, Kann, Benjamin H., additional, Kaplin, Scott, additional, Karpiak, Joel, additional, Kassir, Elias, additional, Kaur, Harsimran, additional, Khan, Sohil, additional, Khatib, Reem, additional, Kherabi, Yousra, additional, Knake, Lindsey A., additional, Krittanawong, Chayakrit, additional, Kuhn, Veronica C., additional, Kunze, Kyle, additional, Lamarche, Benoît, additional, Laplante, Simon, additional, Lehmann, Lisa Soleymani, additional, Li, Dawei, additional, Liao, Wilson, additional, Likitlersuang, Jirapat, additional, Liu, Qi, additional, Madani, Amin, additional, Malik, Momin M., additional, Mann, Matthias, additional, Masood, Sameer, additional, Mathur, Piyush, additional, McManus, Sean, additional, Menard, Jeffrey, additional, Mivalt, Filip, additional, Murphree, Dennis, additional, Myers, Thomas G., additional, Narayan, Sanjiv M., additional, Natarajan, Vivek, additional, Pandav, Krunal, additional, Parwani, Anil V., additional, Pedraza Bermeo, Adriana Marcela, additional, Peiffer-Smadja, Nathan, additional, Peng, Junjie, additional, Peng, Lily, additional, Peters, Margot S., additional, Petrick, Nicholas, additional, Polce, Evan, additional, Poojari, Pooja Gopal, additional, Price, W. Nicholson, additional, Raghavan, Lavanya, additional, Rajan, Asha K., additional, Ran, An Ran, additional, Rangu, Sowmith, additional, Rashid, Muhammed, additional, Reddy, Charitha D., additional, Rider, Nicholas L., additional, Rigatti, Marc, additional, Rivers, Michael, additional, Robinson, George, additional, Rogers, Albert J., additional, Rogerson, Colin M., additional, Ryu, Euijung, additional, Sahiner, Berkman, additional, Sarnaik, Kunaal, additional, Shafi, Saba, additional, Shah, Vijay H., additional, Shapovalov, Maxim V., additional, Sharma, Samin K, additional, Shekhar, Skand, additional, Shin, Harold, additional, Shouval, Roni, additional, Smith, Kenneth, additional, Sokumbi, Olayemi, additional, Solomon, Benjamin D., additional, Somani, Sulaiman S., additional, Sternke, Matt C., additional, Strauss, Maximillian T., additional, Syrowatka, Ania, additional, Tang, W. H. Wilson, additional, Teven, Chad M., additional, Tewari, Ashutosh Kumar, additional, Thunga, Girish, additional, Urena, Estefania, additional, Verma, Ashish, additional, Vietas, Jay, additional, Waikel, Rebekah L., additional, Wi, Chung-Il, additional, Winter, Meredith C., additional, Wong, Melissa S., additional, Wong, Tien Yin, additional, Wu, Chao-Ping, additional, Yeroushalmi, Samuel, additional, Zenati, Marco A., additional, Zeng, Wen-Feng, additional, and Zheng, Yingfeng, additional

Published
2024
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6. Absolute lymphocyte count after BCMA CAR-T therapy is a predictor of response and outcomes in relapsed multiple myeloma

Author

Mejia Saldarriaga, Mateo, Pan, Darren, Unkenholz, Caitlin, Mouhieddine, Tarek H., Velez-Hernandez, Juan Esteban, Engles, Katherine, Fein, Joshua A., Monge, Jorge, Rosenbaum, Cara, Pearse, Roger, Jayabalan, David, Gordillo, Christian, Chan, Hei Ton, Yamshon, Samuel, Thibaud, Santiago, Mapara, Markus, Inghirami, Giorgio, Lentzsch, Suzanne, Reshef, Ran, Rossi, Adriana, Parekh, Samir, Jagannath, Sundar, Richard, Shambavi, Niesvizky, Ruben, and Bustoros, Mark

Published
2024
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7. Systematic evaluation of donor-KIR/recipient-HLA interactions in HLA-matched hematopoietic cell transplantation for AML

Author

Fein, Joshua A., Shouval, Roni, Krieger, Elizabeth, Spellman, Stephen R., Wang, Tao, Baldauf, Henning, Fleischhauer, Katharina, Kröger, Nicolaus, Horowitz, Mary, Maiers, Martin, Miller, Jeffrey S, Mohty, Mohamad, Nagler, Arnon, Weisdorf, Daniel, Malmberg, Karl-Johan, Toor, Amir A., Schetelig, Johannes, Romee, Rizwan, and Koreth, John

Published
2024
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8. Phase 2 trial of cyclosporine-A, mycophenolate mofetil, and tocilizumab GVHD prophylaxis in cord blood transplantation

Author

Politikos, Ioannis, Brown, Samantha, Fein, Joshua A., Eng, Stephen, Casem, Kristian, Chinapen, Stephanie, Quach, Sean, Scaradavou, Andromachi, Cho, Christina, Dahi, Parastoo, Giralt, Sergio A., Gyurkocza, Boglarka, Hanash, Alan M., Jakubowski, Ann, Papadopoulos, Esperanza B., Perales, Miguel-Angel, Ponce, Doris M., Shaffer, Brian C., Tamari, Roni, Young, James W., Devlin, Sean, Peled, Jonathan U., and Barker, Juliet N.

Published
2024
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9. Patterns of salivary microbiota injury and oral mucositis in recipients of allogeneic hematopoietic stem cell transplantation

Author

Shouval, Roni, Eshel, Adi, Dubovski, Bar, Kuperman, Amir A, Danylesko, Ivetta, Fein, Joshua A, Fried, Shalev, Geva, Mika, Kouniavski, Elizaveta, Neuman, Hadar, Armon-Omer, Ayelet, Shahien, Radi, Muller, Efrat, Noecker, Cecilia, Borenstein, Elhanan, Louzoun, Yoram, Nagler, Arnon, and Koren, Omry

Subjects
Stem Cell Research, Regenerative Medicine, Dental/Oral and Craniofacial Disease, Stem Cell Research - Nonembryonic - Human, Genetics, Cancer, Transplantation, Gastrointestinal Microbiome, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Microbiota, Stomatitis
Abstract

Oral mucositis (OM) is a common debilitating dose-limiting toxicity of cancer treatment, including hematopoietic stem cell transplantation (HSCT). We hypothesized that the oral microbiome is disturbed during allogeneic HSCT, partially accounting for the variability in OM severity. Using 16S ribosomal RNA gene sequence analysis, metabolomic profiling, and computational methods, we characterized the behavior of the salivary microbiome and metabolome of 184 patients pre- and post-HSCT. Transplantation was associated with a decrease in oral α diversity in all patients. In contrast to the gut microbiome, an association with overall survival was not detected. Among 135 patients given methotrexate for graft-versus-host disease prophylaxis pre-HSCT, Kingella and Atopobium abundance correlated with future development of severe OM. Posttransplant, Methylobacterium species were significantly enriched in patients with severe OM. Moreover, the oral microbiome and metabolome of severe OM patients underwent distinct changes post-HSCT, compared with patients with no or mild OM. Changes in specific metabolites were well explained by microbial composition, and the common metabolic pathway was the polyamines pathway, which is essential for epithelial homeostasis. Together, our findings suggest that salivary microbial composition and metabolites are associated with the development of OM, offering new insights on pathophysiology and potential avenues of intervention.

Published
2020

10. Outcomes of first therapy after CD19-CAR-T treatment failure in large B-cell lymphoma

Author

Alarcon Tomas, Ana, Fein, Joshua A., Fried, Shalev, Flynn, Jessica R., Devlin, Sean M., Fingrut, Warren B., Anagnostou, Theodora, Alperovich, Anna, Shah, Nishi, Fraint, Ellen, Lin, Richard J., Scordo, Michael, Batlevi, Connie Lee, Besser, Michal J., Dahi, Parastoo B., Danylesko, Ivetta, Giralt, Sergio, Imber, Brandon S., Jacoby, Elad, Kedmi, Meirav, Nagler, Arnon, Palomba, M. Lia, Roshal, Mikhail, Salles, Gilles A., Sauter, Craig, Shem-Tov, Noga, Shimoni, Avichai, Yahalom, Joachim, Yerushalmi, Ronit, Shah, Gunjan L., Avigdor, Abraham, Perales, Miguel-Angel, and Shouval, Roni

Published
2023
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11. Comorbidities in transplant recipients with acute myeloid leukemia receiving low-intensity conditioning regimens: an ALWP EBMT study

Author

Fein, Joshua A., Shouval, Roni, Galimard, Jacques-Emmanuel, Labopin, Myriam, Socié, Gérard, Finke, Jürgen, Cornelissen, Jan J., Malladi, Ram, Itälä-Remes, Maija, Chevallier, Patrice, Orchard, Kim H., Bunjes, Donald, Aljurf, Mahmoud, Rubio, Marie Thérèse, Versluis, Jurjen, Mohty, Mohamad, and Nagler, Arnon

Published
2023
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12. Efficacy results of a phase 2 trial of first-line idelalisib plus ofatumumab in chronic lymphocytic leukemia

Author

Lampson, Benjamin L, Kim, Haesook T, Davids, Matthew S, Abramson, Jeremy S, Freedman, Arnold S, Jacobson, Caron A, Armand, Philippe A, Joyce, Robin M, Arnason, Jon E, Rassenti, Laura Z, Kipps, Thomas J, Fein, Joshua, Fernandes, Stacey M, Hanna, John R, Fisher, David C, and Brown, Jennifer R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Lymphatic Research, Clinical Research, Clinical Trials and Supportive Activities, Lymphoma, Rare Diseases, Hematology, Patient Safety, 6.1 Pharmaceuticals, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Purines, Quinazolinones, Safety-Based Drug Withdrawals, Survival Analysis, Treatment Outcome, Cardiovascular medicine and haematology
Abstract

PI3 kinase (PI3K) activity is critical for survival of neoplastic B cells in patients with chronic lymphocytic leukemia (CLL). Blockade of PI3K signaling with idelalisib is effective for the treatment of relapsed CLL in combination with the anti-CD20 antibody ofatumumab. In this single-arm, open-label, nonrandomized phase 2 study, we investigated the efficacy and safety of idelalisib with ofatumumab in 27 patients with treatment-naïve CLL in need of therapy. Patients were planned to receive idelalisib for 2 monthly cycles, then idelalisib and ofatumumab for 6 cycles, followed by idelalisib indefinitely. The study was closed early and all patients ceased therapy when an increased rate of death as a result of infection was observed on other first-line idelalisib trials. Median time on therapy was 8.1 months, and median duration of follow-up was 39.7 months. We previously reported high rates of hepatotoxicity in a smaller cohort of patients in this trial; toxicities necessitated therapy discontinuation in 15 patients after a median of 7.7 months. The most frequent grade ≥3 adverse events were transaminitis (52% of patients), neutropenia (33%), and colitis/diarrhea (15%). The best overall response rate (ORR) was 88.9%, including 1 complete response. Median progression-free survival (PFS) was 23 months (95% confidence interval [CI], 18-36 months); 11 patients have not yet required second-line therapy. Idelalisib and ofatumumab demonstrated an unacceptable safety profile in the first-line setting, which resulted in a short PFS despite a high ORR. Future development of PI3K inhibitors for use in treatment-naïve CLL will require novel approaches to mitigate toxicities. This trial was registered at www.clinicaltrials.gov as #NCT02135133.

Published
2019

13. A Shared Care Model between community and transplant centers facilitates access to allogeneic and autologous transplantation.

Author

Fein, Joshua A., McAuliffe, Agnes, Fischer, Kimberly, Brady, Owen, Devlin, Sean M., Willumsen, Silvia, Ozcan, Gonca, Montanaro, Pat, Pristyazhnyuk, Yelena, DiGiuseppe, Joseph, Lahoud, Oscar B., Perales, Miguel-Angel, Pfister, David G., Giralt, Sergio, Dailey, Mark, Yu, Peter Paul, and Sauter, Craig Steven

Subjects
*HEMATOPOIETIC stem cell transplantation, *STEM cell transplantation, *MULTIPLE myeloma, *HEMATOLOGIC malignancies, *ACUTE myeloid leukemia
Abstract

AbstractAccess to allogeneic and autologous hematopoietic stem cell transplantation (SCT) remains inadequate despite its curative potential across hematologic malignancies. In 2015, Hartford HealthCare (HHC) and the Memorial Sloan Kettering Cancer Center (MSK) established the Shared Care Model (SCM) with a primary aim of enhancing SCT access for HHC patients. The SCM comprises several components: an SCT-dedicated nurse-navigator, a health-information exchange for record sharing, telemedicine, and ongoing training of HHC clinicians in transplant patient selection and management. We evaluated the SCM’s impact on SCT access across 126 patients with acute leukemia, myelodysplastic syndrome, and multiple myeloma from 2016-2020. The SCM facilitated 34 referrals. Socio-economic status of HHC referrals by Area Deprivation Index was significantly inferior (38 vs. 14, p < 0.001) when compared to 3,108 non-SCM referrals to MSK during the same period. Allogeneic recipients spent 68-247 days away from home, and autologous recipients 15-48, both requiring few subsequent visits to MSK. [ABSTRACT FROM AUTHOR]

Published
2024
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15. The Simplified Comorbidity Index: a new tool for prediction of nonrelapse mortality in allo-HCT

Author

Shouval, Roni, Fein, Joshua A., Cho, Christina, Avecilla, Scott T., Ruiz, Josel, Tomas, Ana Alarcon, Sanchez-Escamilla, Miriam, Flores, Nerea Castillo, Yáñez, Lucrecia, Barker, Juliet N., Dahi, Parastoo, Giralt, Sergio A., Geyer, Alexander I., Gyurkocza, Boglarka, Jakubowski, Ann A., Lin, Richard J., O'Reilly, Richard J., Papadopoulos, Esperanza B., Politikos, Ioannis, Ponce, Doris M., Sauter, Craig S., Scordo, Michael, Shaffer, Brian, Shah, Gunjan L., Sullivan, James P., Tamari, Roni, van den Brink, Marcel R.M., Young, James W., Nagler, Arnon, Devlin, Sean, Shimoni, Avichai, and Perales, Miguel-Angel

Published
2022
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18. Development and validation of a disease risk stratification system for patients with haematological malignancies: a retrospective cohort study of the European Society for Blood and Marrow Transplantation registry

Author

Shouval, Roni, Fein, Joshua A, Labopin, Myriam, Cho, Christina, Bazarbachi, Ali, Baron, Frédéric, Bug, Gesine, Ciceri, Fabio, Corbacioglu, Selim, Galimard, Jacques-Emmanuel, Giebel, Sebastian, Gilleece, Maria H, Giralt, Sergio, Jakubowski, Ann, Montoto, Silvia, O'Reilly, Richard J, Papadopoulos, Esperanza B, Peric, Zinaida, Ruggeri, Annalisa, Sanz, Jaime, Sauter, Craig S, Savani, Bipin N, Schmid, Christoph, Spyridonidis, Alexandros, Tamari, Roni, Versluis, Jurjen, Yakoub-Agha, Ibrahim, Perales, Miguel Angel, Mohty, Mohamad, and Nagler, Arnon

Published
2021
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19. Atrial arrhythmias following CAR‐chimeric antigen receptor T‐cell therapy: Incidence, risk factors and biomarker profile.

Author

Shouval, Roni, Goldman, Adam, Flynn, Jessica R., El‐Moghraby, Ahmed, Rehman, Mahin, Devlin, Sean M., Corona, Magdalena, Landego, Ivan, Lin, Richard J., Scordo, Michael, Raj, Sandeep S., Giralt, Sergio A., Palomba, M. Lia, Dahi, Parastoo B., Walji, Moneeza, Salles, Gilles, Nath, Karthik, Geyer, Mark B., Park, Jae H., and Fein, Joshua A.

Subjects
DISEASE risk factors, CHIMERIC antigen receptors, CYTOKINE release syndrome, ANTIGEN receptors, ATRIAL arrhythmias, CARDIOTOXICITY
Abstract

Summary: Recent reports have raised concerns about the association of chimeric antigen receptor T cell (CAR‐T) with non‐negligible cardiotoxicity, particularly atrial arrhythmias. First, we conducted a pharmacovigilance study to assess the reporting of atrial arrhythmias following CD19‐directed CAR‐T. Subsequently, to determine the incidence, risk factors and outcomes of atrial arrhythmias post‐CAR‐T, we compiled a retrospective single‐centre cohort of non‐Hodgkin lymphoma patients. Only commercial CAR‐T products were considered. Atrial arrhythmias were nearly fourfold more likely to be reported after CAR‐T therapy compared to all other cancer patients in the FAERS (adjusted ROR = 3.76 [95% CI 2.67–5.29]). Of the 236 patients in our institutional cohort, 23 (10%) developed atrial arrhythmias post‐CAR‐T, including 12 de novo arrhythmias, with most (83%) requiring medical intervention. Atrial arrhythmias frequently co‐occurred with cytokine release syndrome and were associated with higher post‐CAR‐T infusion peak levels of IL‐10, TNF‐alpha and LDH, and lower trough levels of fibrinogen. In a multivariable analysis, risk factors for atrial arrhythmia were history of atrial arrhythmia (OR = 6.80 [2.39–19.6]) and using CAR‐T product with a CD28‐costimulatory domain (OR = 5.17 [1.72–18.6]). Atrial arrhythmias following CD19‐CAR‐T therapy are prevalent and associated with elevated inflammatory biomarkers, a history of atrial arrhythmia and the use of a CAR‐T product with a CD28 costimulatory domain. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Donor KIR genotype based outcome prediction after allogeneic stem cell transplantation: no land in sight

Author

Schetelig, Johannes, primary, Baldauf, Henning, additional, Heidenreich, Falk, additional, Hoogenboom, Jorinde D., additional, Spellman, Stephen R., additional, Kulagin, Alexander, additional, Schroeder, Thomas, additional, Sengeloev, Henrik, additional, Dreger, Peter, additional, Forcade, Edouard, additional, Vydra, Jan, additional, Wagner-Drouet, Eva Maria, additional, Choi, Goda, additional, Paneesha, Shankara, additional, Miranda, Nuno A. A., additional, Tanase, Alina, additional, de Wreede, Liesbeth C., additional, Lange, Vinzenz, additional, Schmidt, Alexander H., additional, Sauter, Jürgen, additional, Fein, Joshua A., additional, Bolon, Yung-Tsi, additional, He, Meilun, additional, Marsh, Steven G. E., additional, Gadalla, Shahinaz M., additional, Paczesny, Sophie, additional, Ruggeri, Annalisa, additional, Chabannon, Christian, additional, and Fleischhauer, Katharina, additional

Published
2024
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22. Outcomes of allogeneic haematopoietic stem cell transplantation from HLA-matched and alternative donors: a European Society for Blood and Marrow Transplantation registry retrospective analysis

Author

Shouval, Roni, Fein, Joshua A, Labopin, Myriam, Kröger, Nicolaus, Duarte, Rafael F, Bader, Peter, Chabannon, Christian, Kuball, Jurgen, Basak, Grzegorz Wladyslaw, Dufour, Carlo, Galimard, Jacques-Emmanuel, Polge, Emmanuelle, Lankester, Arjan, Montoto, Silvia, Snowden, John A, Styczynski, Jan, Yakoub-Agha, Ibrahim, Mohty, Mohamad, and Nagler, Arnon

Published
2019
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26. Vitamin D Insufficiency and Clinical Outcomes with Chimeric Antigen Receptor T-Cell Therapy in Large B-cell Lymphoma

Author

Nath, Karthik, Tomas, Ana Alarcon, Flynn, Jessica, Fein, Joshua A., Alperovich, Anna, Anagnostou, Theodora, Batlevi, Connie Lee, Dahi, Parastoo B., Fingrut, Warren B., Giralt, Sergio A., Lin, Richard J., Palomba, M. Lia, Peled, Jonathan U., Salles, Gilles, Sauter, Craig S., Scordo, Michael, Fraint, Ellen, Feuer, Elise, Shah, Nishi, Slingerland, John B., Devlin, Sean, Shah, Gunjan L., Gupta, Gaurav, Perales, Miguel-Angel, and Shouval, Roni

Published
2022
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32. Idelalisib given front-line for treatment of chronic lymphocytic leukemia causes frequent immune-mediated hepatotoxicity

Author

Lampson, Benjamin L., Kasar, Siddha N., Matos, Tiago R., Morgan, Elizabeth A., Rassenti, Laura, Davids, Matthew S., Fisher, David C., Freedman, Arnold S., Jacobson, Caron A., Armand, Philippe, Abramson, Jeremy S., Arnason, Jon E., Kipps, Thomas J., Fein, Joshua, Fernandes, Stacey, Hanna, John, Ritz, Jerome, Kim, Haesook T., and Brown, Jennifer R.

Published
2016
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34. Systemic Anticancer Therapy and Thromboembolic Outcomes in Hospitalized Patients With Cancer and COVID-19

Author

Gulati, Shuchi, Hsu, Chih-Yuan, Shah, Surbhi, Shah, Pankil K., Zon, Rebecca, Alsamarai, Susan, Awosika, Joy, El-Bakouny, Ziad, Bashir, Babar, Beeghly, Alicia, Berg, Stephanie, de-la-Rosa-Martinez, Daniel, Doroshow, Deborah B., Egan, Pamela C., Fein, Joshua, Flora, Daniel B., Friese, Christopher R., Fromowitz, Ariel, Griffiths, Elizabeth A., Hwang, Clara, Jani, Chinmay, Joshi, Monika, Khan, Hina, Klein, Elizabeth J., Heater, Natalie Knox, Koshkin, Vadim S., Kwon, Daniel H., Labaki, Chris, Latif, Tahir, McKay, Rana R., Nagaraj, Gayathri, Nakasone, Elizabeth S., Nonato, Taylor, Polimera, Hyma V., Puc, Matthew, Razavi, Pedram, Ruiz-Garcia, Erika, Saliby, Renee Maria, Shastri, Aditi, Singh, Sunny R.K., Tagalakis, Vicky, Vilar-Compte, Diana, Weissmann, Lisa B., Wilkins, Cy R., Wise-Draper, Trisha M., Wotman, Michael T., Yoon, James J., Mishra, Sanjay, Grivas, Petros, Shyr, Yu, Warner, Jeremy L., Connors, Jean M., Shah, Dimpy P., Rosovsky, Rachel P., Gulati, Shuchi, Hsu, Chih-Yuan, Shah, Surbhi, Shah, Pankil K., Zon, Rebecca, Alsamarai, Susan, Awosika, Joy, El-Bakouny, Ziad, Bashir, Babar, Beeghly, Alicia, Berg, Stephanie, de-la-Rosa-Martinez, Daniel, Doroshow, Deborah B., Egan, Pamela C., Fein, Joshua, Flora, Daniel B., Friese, Christopher R., Fromowitz, Ariel, Griffiths, Elizabeth A., Hwang, Clara, Jani, Chinmay, Joshi, Monika, Khan, Hina, Klein, Elizabeth J., Heater, Natalie Knox, Koshkin, Vadim S., Kwon, Daniel H., Labaki, Chris, Latif, Tahir, McKay, Rana R., Nagaraj, Gayathri, Nakasone, Elizabeth S., Nonato, Taylor, Polimera, Hyma V., Puc, Matthew, Razavi, Pedram, Ruiz-Garcia, Erika, Saliby, Renee Maria, Shastri, Aditi, Singh, Sunny R.K., Tagalakis, Vicky, Vilar-Compte, Diana, Weissmann, Lisa B., Wilkins, Cy R., Wise-Draper, Trisha M., Wotman, Michael T., Yoon, James J., Mishra, Sanjay, Grivas, Petros, Shyr, Yu, Warner, Jeremy L., Connors, Jean M., Shah, Dimpy P., and Rosovsky, Rachel P.

Abstract

IMPORTANCE: Systematic data on the association between anticancer therapies and thromboembolic events (TEEs) in patients with COVID-19 are lacking. OBJECTIVE: To assess the association between anticancer therapy exposure within 3 months prior to COVID-19 and TEEs following COVID-19 diagnosis in patients with cancer. DESIGN, SETTING, AND PARTICIPANTS: This registry-based retrospective cohort study included patients who were hospitalized and had active cancer and laboratory-confirmed SARS-CoV-2 infection. Data were accrued from March 2020 to December 2021 and analyzed from December 2021 to October 2022. EXPOSURE: Treatments of interest (TOIs) (endocrine therapy, vascular endothelial growth factor inhibitors/tyrosine kinase inhibitors [VEGFis/TKIs], immunomodulators [IMiDs], immune checkpoint inhibitors [ICIs], chemotherapy) vs reference (no systemic therapy) in 3 months prior to COVID-19. MAIN OUTCOMES AND MEASURES: Main outcomes were (1) venous thromboembolism (VTE) and (2) arterial thromboembolism (ATE). Secondary outcome was severity of COVID-19 (rates of intensive care unit admission, mechanical ventilation, 30-day all-cause mortality following TEEs in TOI vs reference group) at 30-day follow-up. RESULTS: Of 4988 hospitalized patients with cancer (median [IQR] age, 69 [59-78] years; 2608 [52%] male), 1869 had received 1 or more TOIs. Incidence of VTE was higher in all TOI groups: endocrine therapy, 7%; VEGFis/TKIs, 10%; IMiDs, 8%; ICIs, 12%; and chemotherapy, 10%, compared with patients not receiving systemic therapies (6%). In multivariable log-binomial regression analyses, relative risk of VTE (adjusted risk ratio [aRR], 1.33; 95% CI, 1.04-1.69) but not ATE (aRR, 0.81; 95% CI, 0.56-1.16) was significantly higher in those exposed to all TOIs pooled together vs those with no exposure. Among individual drugs, ICIs were significantly associated with VTE (aRR, 1.45; 95% CI, 1.01-2.07). Also noted were significant associations between VTE and active and progressing ca

Published
2023

35. Comorbidities in transplant recipients with acute myeloid leukemia receiving low-intensity conditioning regimens:an ALWP EBMT study

Author

Fein, Joshua A., Shouval, Roni, Galimard, Jacques Emmanuel, Labopin, Myriam, Socié, Gérard, Finke, Jürgen, Cornelissen, Jan J., Malladi, Ram, Itälä-Remes, Maija, Chevallier, Patrice, Orchard, Kim H., Bunjes, Donald, Aljurf, Mahmoud, Rubio, Marie Thérèse, Versluis, Jurjen, Mohty, Mohamad, Nagler, Arnon, Fein, Joshua A., Shouval, Roni, Galimard, Jacques Emmanuel, Labopin, Myriam, Socié, Gérard, Finke, Jürgen, Cornelissen, Jan J., Malladi, Ram, Itälä-Remes, Maija, Chevallier, Patrice, Orchard, Kim H., Bunjes, Donald, Aljurf, Mahmoud, Rubio, Marie Thérèse, Versluis, Jurjen, Mohty, Mohamad, and Nagler, Arnon

Abstract

Older age and a high burden of comorbidities often drive the selection of low-intensity conditioning regimens in allogeneic hematopoietic stem cell transplantation recipients. However, the impact of comorbidities in the low-intensity conditioning setting is unclear. We sought to determine the contribution of individual comorbidities and their cumulative burden on the risk of nonrelapse mortality (NRM) among patients receiving low-intensity regimens. In a retrospective analysis of adults (≥18 years) who underwent transplantation for acute myeloid leukemia in the first complete remission between 2008 and 2018, we studied recipients of low-intensity regimens as defined by the transplantation conditioning intensity (TCI) scale. Multivariable Cox models were constructed to study associations of comorbidities with NRM. Comorbidities identified as putative risk factors in the low-TCI setting were included in combined multivariable regression models assessed for overall survival, NRM, and relapse. A total of 1663 patients with a median age of 61 years received low-TCI regimens. Cardiac comorbidity (including arrhythmia/valvular disease) and psychiatric disease were associated with increased NRM risk (hazard ratio [HR], 1.54; 95% confidence interval [CI], 1.13-2.09 and HR, 1.69; 95% CI, 1.02-2.82, respectively). Moderate pulmonary dysfunction, though prevalent, was not associated with increased NRM. In a combined model, cardiac, psychiatric, renal, and inflammatory bowel diseases were independently associated with adverse transplantation outcomes. These findings may inform patient and regimen selection and reinforce the need for further investigation of cardioprotective transplantation approaches.

Published
2023

36. Supplementary Table 1-4, Supplementary Figures 1-3 from An Integrative Scoring System for Survival Prediction Following Umbilical Cord Blood Transplantation in Acute Leukemia

Author

Shouval, Roni, primary, Ruggeri, Annalisa, primary, Labopin, Myriam, primary, Mohty, Mohamad, primary, Sanz, Guillermo, primary, Michel, Gerard, primary, Kuball, Jürgen, primary, Chevallier, Patrice, primary, Al-Seraihy, Amal, primary, Milpied, Noel-Jean, primary, de Heredia, Cristina Diaz, primary, Arcese, William, primary, Blaise, Didier, primary, Rocha, Vanderson, primary, Fein, Joshua, primary, Unger, Ron, primary, Baron, Frederic, primary, Bader, Peter, primary, Gluckman, Eliane, primary, and Nagler, Arnon, primary

Published
2023
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37. Allogeneic Hematopoietic Cell Transplantation after Chimeric Antigen Receptor T Cell Therapy in Large B Cell Lymphoma

Author

Fried, Shalev, primary, Shouval, Roni, additional, Walji, Moneeza, additional, Flynn, Jessica R., additional, Yerushalmi, Ronit, additional, Shem-Tov, Noga, additional, Danylesko, Ivetta, additional, Tomas, Ana Alarcon, additional, Fein, Joshua A., additional, Devlin, Sean M., additional, Sauter, Craig S., additional, Shah, Gunjan L., additional, Kedmi, Meirav, additional, Jacoby, Elad, additional, Shargian, Liat, additional, Raanani, Pia, additional, Yeshurun, Moshe, additional, Perales, Miguel-Angel, additional, Nagler, Arnon, additional, Avigdor, Abraham, additional, and Shimoni, Avichai, additional

Published
2023
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38. Comorbidities in recipients of low transplant conditioning intensity regimens for acute myeloid leukemia: an ALWP EBMT study

Author

Fein, Joshua Alexander, primary, Shouval, Roni, additional, Galimard, Jacques-Emmanuel, additional, Labopin, Myriam, additional, Socié, Gerard, additional, Finke, Jürgen, additional, Cornelissen, Jan J, additional, Malladi, Ram, additional, Itälä-Remes, Maija, additional, Chevallier, Patrice, additional, Orchard, Kim, additional, Bunjes, Donald, additional, Aljurf, Mahmoud, additional, Rubio, Marie-Thérèse, additional, Versluis, Jurjen, additional, Mohty, Mohamad, additional, and Nagler, Arnon, additional

Published
2023
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39. Severe Persistent Cytopenias Following CAR T-Cell Therapy in Patients with Large B-Cell Lymphoma

Author

Corona De Lapuerta, Magdalena, primary, Shouval, Roni, additional, Alarcon Tomas, Ana, additional, Flynn, Jessica R., additional, Devlin, Sean M., additional, Batlevi, Connie Lee, additional, Fein, Joshua A, additional, Giralt, Sergio A, additional, Lin, Richard J., additional, Nath, Karthik, additional, Palomba, Maria Lia, additional, Parascondola, Allison, additional, Shah, Gunjan L., additional, Salles, Gilles, additional, Scordo, Michael, additional, Walji, Moneeza, additional, Perales, Miguel-Angel, additional, and Dahi, Parastoo B, additional

Published
2022
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40. Inflammatory Biomarker Clusters Are Predictive of Response and Toxicity in Large B-Cell Lymphoma Treated with CD19 CAR-T Cell Therapy

Author

Raj, Sandeep, primary, Perales, Miguel-Angel, additional, Fein, Joshua A, additional, Alarcon Tomas, Ana, additional, Batlevi, Connie Lee, additional, Corona De Lapuerta, Magdalena, additional, Dahi, Parastoo B, additional, Danylesko, Ivetta, additional, Fried, Shalev, additional, Funnell, Tyler, additional, Giralt, Sergio A., additional, Jacoby, Elad, additional, Kedmi, Meirav, additional, Lin, Richard J., additional, Nagler, Arnon, additional, Nath, Karthik, additional, Parascondola, Allison, additional, Palomba, M.Lia, additional, Salles, Gilles, additional, Scordo, Michael, additional, Shah, Gunjan L., additional, Shem-Tov, Noga, additional, Shimoni, Avichai, additional, Slingerland, John, additional, Walji, Moneeza, additional, Yerushalmi, Ronit, additional, Avigdor, Abraham, additional, van den Brink, Marcel R M, additional, and Shouval, Roni, additional

Published
2022
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41. Predictors and Implications of Renal Injury in Large Cell Lymphoma Patients Receiving CD19 CAR T Cell Therapy

Author

Boardman, Alexander P., primary, Gutgarts, Victoria, additional, Flynn, Jessica R., additional, Devlin, Sean M., additional, Alarcon Tomas, Ana, additional, Fein, Joshua A., additional, Slingerland, John, additional, Parascondola, Allison, additional, Lin, Richard J., additional, Scordo, Michael, additional, Batlevi, Connie Lee, additional, Dahi, Parastoo B., additional, Giralt, Sergio A., additional, Palomba, M.Lia, additional, Salles, Gilles, additional, Nath, Karthik, additional, Walji, Moneeza, additional, Corona De Lapuerta, Magdalena, additional, Shah, Gunjan L., additional, Perales, Miguel-Angel, additional, Jaffer-Sathick, Insara, additional, and Shouval, Roni, additional

Published
2022
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42. Outcomes of first therapy after CD19-CAR-T treatment failure in large B-cell lymphoma

Author

Alarcon Tomas, Ana, primary, Fein, Joshua A., additional, Fried, Shalev, additional, Flynn, Jessica R., additional, Devlin, Sean M., additional, Fingrut, Warren B., additional, Anagnostou, Theodora, additional, Alperovich, Anna, additional, Shah, Nishi, additional, Fraint, Ellen, additional, Lin, Richard J., additional, Scordo, Michael, additional, Batlevi, Connie Lee, additional, Besser, Michal J., additional, Dahi, Parastoo B., additional, Danylesko, Ivetta, additional, Giralt, Sergio, additional, Imber, Brandon S., additional, Jacoby, Elad, additional, Kedmi, Meirav, additional, Nagler, Arnon, additional, Palomba, M. Lia, additional, Roshal, Mikhail, additional, Salles, Gilles A., additional, Sauter, Craig, additional, Shem-Tov, Noga, additional, Shimoni, Avichai, additional, Yahalom, Joachim, additional, Yerushalmi, Ronit, additional, Shah, Gunjan L., additional, Avigdor, Abraham, additional, Perales, Miguel-Angel, additional, and Shouval, Roni, additional

Published
2022
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43. Point-of-care CAR T-cell therapy as salvage strategy for out-of-specification tisagenlecleucel

Author

Fried, Shalev, primary, Shouval, Roni, additional, Varda-Bloom, Nira, additional, Besser, Michal J., additional, Yerushalmi, Ronit, additional, Shem-Tov, Noga, additional, Danylesko, Ivetta, additional, Jacoby, Elad, additional, Teihman, Shlomit, additional, Itzhaki, Orit, additional, Fein, Joshua A., additional, Kedmi, Meirav, additional, Shimoni, Avichai, additional, Nagler, Arnon, additional, and Avigdor, Abraham, additional

Published
2022
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44. Impact of a shared-care model between community and academic centers for facilitating access to allogeneic and autologous stem cell transplantation.

Author

Fein, Joshua Alexander, primary, McAuliffe, Agnes, additional, Fischer, Kimberly, additional, Brady, Owen, additional, Devlin, Sean M., additional, Willumsen, Silvia, additional, Ozcan, Gonca, additional, Montanaro, Pat, additional, Pristyazhnyuk, Yelena, additional, Digiuseppe, Joseph, additional, Perales, Miguel-Angel, additional, Pfister, David G., additional, Giralt, Sergio, additional, Dailey, Mark, additional, Yu, Peter Paul, additional, and Sauter, Craig Steven, additional

Published
2022
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45. Vitamin D Deficiency Is Associated with Inferior Clinical Outcomes in Patients with Large B-Cell Lymphoma Receiving Anti-CD19 CAR T-Cell Therapy

Author

Nath, Karthik, primary, Tomas, Ana Alarcon, additional, Flynn, Jessica, additional, Fein, Joshua A, additional, Alperovich, Anna, additional, Anagnostou, Theodora, additional, Batlevi, Connie W, additional, Dahi, Parastoo B., additional, Fingrut, Warren, additional, Giralt, Sergio A, additional, Lin, Richard J., additional, Palomba, M. Lia, additional, Peled, Jonathan U., additional, Salles, Gilles, additional, Sauter, Craig S., additional, Scordo, Michael, additional, Shah, Nishi, additional, Slingerland, John, additional, Devlin, Sean M., additional, Shah, Gunjan, additional, Perales, Miguel-Angel, additional, and Shouval, Roni, additional

Published
2022
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46. Impact of TP53 Genomic Alterations in Large B-Cell Lymphoma Treated With CD19-Chimeric Antigen Receptor T-Cell Therapy

Author

Shouval, Roni, primary, Alarcon Tomas, Ana, additional, Fein, Joshua A., additional, Flynn, Jessica R., additional, Markovits, Ettai, additional, Mayer, Shimrit, additional, Olaide Afuye, Aishat, additional, Alperovich, Anna, additional, Anagnostou, Theodora, additional, Besser, Michal J., additional, Batlevi, Connie Lee, additional, Dahi, Parastoo B., additional, Devlin, Sean M., additional, Fingrut, Warren B., additional, Giralt, Sergio A., additional, Lin, Richard J., additional, Markel, Gal, additional, Salles, Gilles, additional, Sauter, Craig S., additional, Scordo, Michael, additional, Shah, Gunjan L., additional, Shah, Nishi, additional, Scherz-Shouval, Ruth, additional, van den Brink, Marcel, additional, Perales, Miguel-Angel, additional, and Palomba, Maria Lia, additional

Published
2022
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47. Encouraging Survival and High Rates of Toxicity: Allogeneic Hematopoietic Cell Transplantation after Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy in Aggressive Lymphoma Patients

Author

Fried, Shalev, primary, Danylesko, Ivetta, additional, Yerushalmi, Ronit, additional, Shem-Tov, Noga, additional, Shouval, Roni, additional, Fein, Joshua A, additional, Cohen, Zachary, additional, Jacoby, Elad, additional, Besser, Michal, additional, Nagler, Arnon, additional, Shimoni, Avichai, additional, and Avigdor, Abraham, additional

Published
2021
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48. TP53 and CD19-Directed Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in Large B-Cell Lymphoma

Author

Shouval, Roni, primary, Alarcon Tomas, Ana, additional, Fein, Joshua A, additional, Flynn, Jessica, additional, Markovits, Ettai, additional, Mayer, Shimrit, additional, Afuye, Aishat Olaide, additional, Alperovich, Anna, additional, Anagnostou, Theodora, additional, Batlevi, Connie Lee, additional, Dahi, Parastoo B., additional, Devlin, Sean M, additional, Fingrut, Warren, additional, Giralt, Sergio A, additional, Lin, Richard J, additional, Salles, Gilles, additional, Sauter, Craig S., additional, Scordo, Michael, additional, Shah, Gunjan L, additional, Shah, Nishi, additional, Scherz Shouval, Ruth, additional, van den Brink, Marcel, additional, Perales, Miguel-Angel, additional, and Palomba, Maria Lia, additional

Published
2021
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49. KIR-HLA Interactions Lack Clinical Utility in Matched Unrelated Donor Transplantation for AML: An Analysis of the CIBMTR and DRST Registries

Author

Fein, Joshua A, primary, Shouval, Roni, additional, Krieger, Elizabeth, additional, Baldauf, Henning, additional, Fleischhauer, Katharina, additional, Kroeger, Nicolaus, additional, Horowitz, Mary M., additional, Maiers, Martin, additional, Malmberg, Karl-Johan, additional, Miller, Jeffrey S., additional, Mohty, Mohamad, additional, Nagler, Arnon, additional, Romee, Rizwan, additional, Schetelig, Johannes, additional, Spellman, Stephen R., additional, Toor, Amir Ahmed, additional, Wang, Tao, additional, Weisdorf, Daniel J., additional, and Koreth, John, additional

Published
2021
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50. Novel Agents May be Preferable to Chemotherapy for Large B-Cell Lymphoma Progressing after CD19-CAR-T: A Multicenter Observational Study

Author

Alarcon Tomas, Ana, primary, Fein, Joshua A, additional, Fried, Shalev, additional, Fingrut, Warren, additional, Anagnostou, Theodora, additional, Alperovich, Anna, additional, Shah, Nishi, additional, Fraint, Ellen, additional, Lin, Richard J, additional, Scordo, Michael, additional, Afuye, Aishat Olaide, additional, Batlevi, Connie Lee, additional, Besser, Michal, additional, Dahi, Parastoo B, additional, Danylesko, Ivetta, additional, Giralt, Sergio, additional, Imber, Brandon S., additional, Jacobi, Elad, additional, Nagler, Arnon, additional, Palomba, M. Lia, additional, Salles, Gilles, additional, Sauter, Craig S., additional, Shah, Gunjan L, additional, Shem-Tov, Noga, additional, Shimoni, Avichai, additional, Yahalom, Joachim, additional, Yerushalmi, Ronit, additional, Avigdor, Abraham, additional, Perales, Miguel-Angel, additional, and Shouval, Roni, additional

Published
2021
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