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1. Bioética de la investigación biomédica con población mapuche

Author

Ana Alarcón

Subjects
Bioética y cultura, Pueblos indígenas e investigación, Sociedad mapuche, Social sciences (General), H1-99, Anthropology, GN1-890
Abstract

Este trabajo presenta un análisis meta-etnográfico de las investigaciones biomédicas realizadas con población mapuche durante los años 1993 a 2003, con el objeto de examinar la pertinencia cultural de los aspectos éticos involucrados en el proceso de investigación. Los principios bioéticos de autonomía, justicia y beneficencia orientan desde hace largo tiempo los procedimientos de investigación biomédica con seres humanos. Sin embargo, la aplicación universal de principios filosóficos occidentales aparece cuestionable y a veces inapropiada en sociedades multiculturales o pluriétnicas. Por ejemplo, el considerar preponderante el ejercicio de la autonomía individual en sociedades basadas en sistemas familiares y religiosos, obtener un consentimiento informado en lengua distinta a la materna, la configuración estereotipada del sujeto de investigación, aplicar procedimientos que excluyen la idea cultural de daño a través de la manipulación corporal, y la omisión del principio de justicia en los resultados de investigación, son aspectos resultantes de este trabajo, y que denotan la ausencia de una bioética aplicada al contexto, situación y cultura de los sujetos de estudio. En consecuencia un análisis que vincule bioética y cultura en los procesos de investigación podrían contribuir a diseñar, en conjunto con la sociedad mapuche y otros grupos étnicos, un marco de regulaciones éticas culturalmente pertinentes para la ejecución de estudios biomédicos.

Published
2024
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2. P1401: IDENTIFICATION OF BIOMARKERS AND RISK FACTORS FOR IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS) IN CD19-DIRECTED CAR T-CELL THERAPY: A RETROSPECTIVE MACHINE LEARNING-BASED ANALYSIS.

Author

Marina Gómez-Llobell, María Martínez García, Carlos Serra Smith, Daniel Gómez Costas, Gillen Oarbeascoa Royuela, Diego Carbonell, Javier Anguita Velasco, Ana María Pérez Corral, Marjorie Pion, Veronica Astrid Pérez-Fernández, Isabel Fernández García, Mariana Bastos Oreiro, Paula Fernández-Caldas González, Ignacio Gómez-Centurión, Ana Alarcón, Eva Catalá, Diego Conde, Jorge Gayoso, Pablo Olmos, Carolina Martínez Laperche, Jose García-Domínguez, Yolanda Fernández, Rebeca Bailen, and MI Kwon

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2023
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3. Subsequent Malignancies After CD19-Targeted Chimeric Antigen Receptor T Cells in Patients With Lymphoma

Author

Lorenc, Rachel, Shouval, Roni, Flynn, Jessica R., Devlin, Sean M., Saldia, Amethyst, De Abia, Alejandro Luna, De Lapuerta, Magdalena Corona, Tomas, Ana Alarcon, Cassanello, Giulio, Leslie, Lori A., Rejeski, Kai, Lin, Richard J., Scordo, Michael, Shah, Gunjan L., Palomba, M. Lia, Salles, Gilles, Park, Jae, Giralt, Sergio A., Perales, Miguel-Angel, Ip, Andrew, and Dahi, Parastoo B.

Published
2024
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4. Identifying an optimal fludarabine exposure for improved outcomes after axi-cel therapy for aggressive B-cell non-Hodgkin lymphoma

Author

Scordo, Michael, Flynn, Jessica R., Gonen, Mithat, Devlin, Sean M., Parascondola, Allison, Tomas, Ana Alarcon, Shouval, Roni, Brower, Jamie, Porter, David L., Schuster, Stephen J., Bachanova, Veronika, Maakaron, Joseph, Maziarz, Richard T., Chen, Andy I., Nastoupil, Loretta J., McGuirk, Joseph P., Oluwole, Olalekan O., Ip, Andrew, Leslie, Lori A., Bishop, Michael R., Riedell, Peter A., and Perales, Miguel-Angel

Published
2023
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7. 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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8. Site-Specific Response Rates in Large B-Cell Lymphomas Treated with CD19-CART Therapy.

Author

Luna, Alejandro, primary, Corona, Magdalena, additional, Flynn, Jessica, additional, Devlin, Sean M., additional, Luttwak, Efrat, additional, Landego, Ivan, additional, Dahi, Parastoo B., additional, Lin, Dr. Richard J., additional, Parascondola, Allison, additional, Palomba, M. Lia, additional, Shah, Gunjan L., additional, Scordo, Michael, additional, Imber, Brandon S., additional, Tomas, Ana Alarcón, additional, Salles, Gilles, additional, Park, Jae H., additional, Perales, Miguel-Angel, additional, and Shouval, Roni, additional

Published
2024
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9. 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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11. Intensive parenting and elective bilingualism English/Spanish in Spanish monolingual families: From language ideologies to practice

Author

Esther Nieto Moreno de Diezmas and Ana Alarcón Utrera

Subjects
Linguistics and Language, Language and Linguistics, Education
Abstract

In our globalised economy, English proficiency is currently a priority for Spanish families, as it is fundamental for ensuring their children’s future economic and personal welfare. As a sign of good parenting, families are increasingly acting as linguistic entrepreneurs and adopting family language policies oriented to provide their children with the best methodologies to enhance English learning, thereby investing their personal and financial capital in extracurricular classes, local English camps, and stays abroad. In searching for more natural learning environments, those parents with knowledge of English emulate native bi/multilingual families and raise their children in English and Spanish. This type of non-native elective bilingualism upbringing is gaining momentum in Spain and deserves further scrutiny. Therefore, this paper is devoted to better understand this phenomenon by means of the study of 16 Spanish families who are raising their children in English and Spanish. Their family language policy (FLP) will be analysed in terms of language beliefs, language management and language practices. Results reflect parents’ desires and imagined identities with English as a metaphor of accomplishment, as well as their emotional implications, disruptions and negotiations to bring to fruition this complex socialization practice.

Published
2022
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12. Prospective geriatric assessment and geriatric consultation in CAR T-cell therapy for older patients with lymphoma

Author

Lin, Richard J., Kim, Soo Jung, Brown, Samantha, Elko, Theresa A., Ruiz, Josel D., Hanley, Danielle M., Lia Palomba, M., Perales, Miguel-Angel, Shah, Gunjan L., Dahi, Parastoo B., Scordo, Michael, Sauter, Craig S., Batlevi, Connie L., Tomas, Ana Alarcon, Shouval, Roni, Lee, Nicole, Pavkovic, Emma A., Engstler, Danielle E., Park, Jae H., Salles, Gilles A., Devlin, Sean M., Korc-Grodzicki, Beatriz, Hamlin, Paul A., and Giralt, Sergio A.

Published
2023
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14. Management of prolonged cytopenia following CAR T-cell therapy

Author

Magdalena Corona, Roni Shouval, Ana Alarcón, Jessica Flynn, Sean Devlin, Connie Batlevi, Simon Mantha, Maria Lia Palomba, Michael Scordo, Gunjan Shah, Craig Sauter, Miguel-Ángel Perales, and Parastoo B. Dahi

Subjects
Transplantation, Humans, Hematology, Immunotherapy, Adoptive, Thrombocytopenia
Published
2022

15. Predictors and implications of renal injury after CD19 chimeric antigen receptor T-cell therapy

Author

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

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Chimeric Antigen Receptor (CAR) T cells targeting CD19 induce durable remissions in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), but many patients experience treatmentrelated toxicity. Cytokine release syndrome and immune effector cell-associated neurologic syndrome are extensively characterized. However, limited data exist on the burden, predictors, and implications of acute kidney injury (AKI) after CAR T cell therapy. On initial screening of the FDA adverse event reporting system, we identified a disproportionately high rate of renal adverse events among nearly 6,000 CAR T adverse event reports, suggesting it is clinically important in this patient population. In a subsequent single-center analysis of 399 NHL patients treated with CD19 CAR T cells, we found a substantial burden of AKI after CAR T infusion (10% and 5% of any grade and grade ≥2 AKI) with pre-renal causes being predominant (72%). Evolution to chronic kidney disease was rare, however, 3 patients required hemodialysis. Importantly, patients experiencing cytokine release syndrome and/or neurotoxicity as well as those with low serum albumin and high inflammatory cytokines, including IL-6 and TNF-alpha, were more likely to develop AKI. While pre-CAR T renal dysfunction was not associated with adverse outcomes, patients developing post-CAR T AKI had lower overall survival compared to their counterparts. Our findings indicate that renal dysfunction is a common toxicity of CAR T cell therapy with meaningful prognostic impact. Notably, the link between systemic inflammation and renal dysfunction, suggests that readily available biomarkers may inform on renal injury risk after CAR T cell therapy.

Published
2024
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16. Conventional and novel [18F]FDG PET/CT features as predictors of CAR-T cell therapy outcome in large B-cell lymphoma

Author

Doris Leithner, Jessica R. Flynn, Sean M. Devlin, Audrey Mauguen, Teng Fei, Shang Zeng, Junting Zheng, Brandon S. Imber, Harper Hubbeling, Marius E. Mayerhoefer, Akshay Bedmutha, Efrat Luttwak, Magdalena Corona, Parastoo B. Dahi, Alejandro Luna de Abia, Ivan Landego, Richard J. Lin, M. Lia Palomba, Michael Scordo, Jae H. Park, Ana Alarcon Tomas, Gilles Salles, Daniel Lafontaine, Laure Michaud, Gunjan L. Shah, Miguel-Angel Perales, Roni Shouval, and Heiko Schöder

Subjects
Lymphoma, Positron emission tomography, Biomarker, Immunotherapy, CAR-T, Radiomics, Diseases of the blood and blood-forming organs, RC633-647.5, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Relapse and toxicity limit the effectiveness of chimeric antigen receptor T-cell (CAR-T) therapy for large B-cell lymphoma (LBCL), yet biomarkers that predict outcomes and toxicity are lacking. We examined radiomic features extracted from pre-CAR-T 18F-fluorodeoxyglucose positron emission tomography/computed tomography ([18F]FDG PET/CT) scans (n = 341) of 180 patients (121 male; median age, 66 years). Three conventional (maximum standardized uptake value [SUVmax], metabolic tumor volume [MTV], total lesion glycolysis [TLG]) and 116 novel radiomic features were assessed, along with inflammatory markers, toxicities, and outcomes. At both pre-apheresis and pre-infusion time points, conventional PET features of disease correlated with elevated inflammatory markers. At pre-infusion, MTV was associated with grade ≥ 2 cytokine release syndrome (odds ratio [OR] for 100 mL increase: 1.08 [95% confidence interval (CI), 1.01–1.20], P = 0.031), and SUVmax was associated with failure to achieve complete response (CR) (OR 1.72 [95% CI, 1.24–2.43], P

Published
2024
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17. Consensus recommendation for prenatal, neonatal and postnatal management of congenital cytomegalovirus infection from the European congenital infection initiative (ECCI)

Author

Marianne Leruez-Ville, Christos Chatzakis, Daniele Lilleri, Daniel Blazquez-Gamero, Ana Alarcon, Nicolas Bourgon, Ina Foulon, Jacques Fourgeaud, Anna Gonce, Christine E. Jones, Paul Klapper, André Krom, Tiziana Lazzarotto, Hermione Lyall, Paulo Paixao, Vassiliki Papaevangelou, Elisabeth Puchhammer, George Sourvinos, Pamela Vallely, Yves Ville, and Ann Vossen

Subjects
Congenital cytomegalovirus infection, Guidelines, Prenatal, Neonatal, Postnatal, Public aspects of medicine, RA1-1270
Abstract

Summary: Congenital cytomegalovirus (cCMV) infection carries a significant burden with a 0.64% global prevalence and a 17–20% chance of serious long-term effects in children. Since the last guidelines, our understanding, particularly regarding primary maternal infections, has improved. A cCMV guidelines group was convened under the patronage of the European Society of Clinical Virology in April 2023 to refine these insights. The quality and validity of selected studies were assessed for potential biases and the GRADE framework was employed to evaluate quality of evidence across key domains. The resulting recommendations address managing cCMV, spanning prevention to postnatal care. Emphasizing early and accurate maternal diagnosis through serological tests enhances risk management and prevention strategies, including using valaciclovir to prevent vertical transmission. The guidelines also strive to refine personalized postnatal care based on risk assessments, ensuring targeted interventions for affected families.

Published
2024
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18. 544 - Lesion Characteristics and Patterns of Failure in Diffuse Large B Cell Lymphoma Patients Treated with Bridging Radiotherapy Prior to Chimeric Antigen Receptor T Cell Therapy

Author

Hubbeling, Harper, Silverman, Emily, Wijetunga, Neil Ari, Palomba, M. Lia, Tomas, Ana Alarcon, Shouval, Roni, Batlevi, Connie W, Dahi, Parastoo B., Giralt, Sergio A, Lin, Richard J., Park, Jae H, Scordo, Michael, Sauter, Craig S., Shah, Gunjan, Perales, Miguel-Angel, Hajj, Carla, Yahalom, Joachim, and Imber, Brandon S.

Published
2022
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19. 262 - Five-Year Experience Using Bridging Radiotherapy Prior to Chimeric Antigen Receptor (CAR) T-Cell Therapies for B-Cell Malignancies

Author

Imber, Brandon S., Hubbeling, Harper, Silverman, Emily, Wijetunga, Neil Ari, Palomba, M. Lia, Tomas, Ana Alarcon, Shouval, Roni, Batlevi, Connie W, Dahi, Parastoo B., Giralt, Sergio A, Lin, Richard J., Park, Jae H, Scordo, Michael, Sauter, Craig S., Shah, Gunjan, Perales, Miguel-Angel, Hajj, Carla, and Yahalom, Joachim

Published
2022
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20. 216 - 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, Tomas, Ana Alarcon, Flynn, Jessica, Fein, Joshua A, Alperovich, Anna, Anagnostou, Theodora, Batlevi, Connie W, Dahi, Parastoo B., Fingrut, Warren, Giralt, Sergio A, Lin, Richard J., Palomba, M. Lia, Peled, Jonathan U., Salles, Gilles, Sauter, Craig S., Scordo, Michael, Shah, Nishi, Slingerland, John, Devlin, Sean M., Shah, Gunjan, Perales, Miguel-Angel, and Shouval, Roni

Published
2022
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21. Allogeneic transplant following CAR T-cell therapy for large B-cell lymphoma

Author

Joanna Zurko, Jeremy Ramdial, Mazyar Shadman, Sairah Ahmed, Aniko Szabo, Lorenzo Iovino, Ana Alarcon Tomas, Craig Sauter, Miguel-Angel Perales, Nirav. N. Shah, Utkarsh H. Acharya, Caron Jacobson, Robert J. Soiffer, Trent Wang, Krishna V. Komanduri, Samantha Jaglowski, Adam S. Kittai, Nathan Denlinger, Madiha Iqbal, Mohamed A. Kharfan-Dabaja, Ernesto Ayala, Julio Chavez, Michael Jain, Frederick L. Locke, Yazeed Samara, Lihua E. Budde, Matthew G. Mei, Alexandra Della Pia, Tatyana Feldman, Nausheen Ahmed, Ryan Jacobs, Nilanjan Ghosh, Bhagirathbhai Dholaria, Olalekan O. Oluwole, Brian Hess, Ayesha Hassan, Vaishalee P. Kenkre, Patrick Reagan, Farrukh Awan, Yago Nieto, Mehdi Hamadani, and Alex F. Herrera

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Allogeneic hematopoietic cell transplantation (alloHCT) can potentially salvage large B-cell lymphoma (LBCL) patients experiencing treatment failure after chimeric antigen receptor T-cell therapy (CAR T). Nonetheless, data on the efficacy and toxicities of alloHCT after receipt of CAR T are limited. We report a multicenter retrospective study assessing the safety, toxicities, and outcomes of alloHCT in LBCL patients following CAR T failure. Eighty-eight patients with relapsed, refractory LBCL received an alloHCT following anti-CD19 CAR T failure. The median number of lines of therapy between CAR T infusion and alloHCT was one (range, 0-7). Low intensity conditioning was used in 77% (n=68) and peripheral blood was the most common graft source (86%, n=76). The most common donor types were matched unrelated donor (39%), followed by haploidentical (30%) and matched related donor (26%). Median follow-up of survivors was 15 months (range, 1-72). One-year overall survival, progression-free survival, and graft-versus-host disease-free relapse-free survival were 59%, 45%, and 39% respectively. One-year non-relapse mortality and progression/relapse were 22% and 33% respectively. On multivariate analysis,

Published
2022
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