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2. T cell lymphoma and secondary primary malignancy risk after commercial CAR T cell therapy

Author

Ghilardi, Guido, Fraietta, Joseph A., Gerson, James N., Van Deerlin, Vivianna M., Morrissette, Jennifer J. D., Caponetti, Gabriel C., Paruzzo, Luca, Harris, Jaryse C., Chong, Elise A., Susanibar Adaniya, Sandra P., Svoboda, Jakub, Nasta, Sunita D., Ugwuanyi, Ositadimma H., Landsburg, Daniel J., Fardella, Eugenio, Waxman, Adam J., Chong, Emeline R., Patel, Vrutti, Pajarillo, Raymone, Kulikovskaya, Irina, Lieberman, David B., Cohen, Adam D., Levine, Bruce L., Stadtmauer, Edward A., Frey, Noelle V., Vogl, Dan T., Hexner, Elizabeth O., Barta, Stefan K., Porter, David L., Garfall, Alfred L., Schuster, Stephen J., June, Carl H., and Ruella, Marco

Published
2024
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6. Bendamustine lymphodepletion before axicabtagene ciloleucel is safe and associates with reduced inflammatory cytokines

Author

Ghilardi, Guido, Paruzzo, Luca, Svoboda, Jakub, Chong, Elise A., Shestov, Alexander A., Chen, Linhui, Cohen, Ivan J., Gabrielli, Giulia, Nasta, Sunita D., Porazzi, Patrizia, Landsburg, Daniel J., Gerson, James N., Carter, Jordan, Barta, Stefan K., Yelton, Rebecca, Pajarillo, Raymone, Patel, Vrutti, White, Griffin, Ballard, Hatcher J., Weber, Elizabeth, Napier, Ellen, Chong, Emeline R., Fraietta, Joseph A., Garfall, Alfred L., Porter, David L., Milone, Michael C., O’Connor, Roderick, Schuster, Stephen J., and Ruella, Marco

Published
2024
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7. Deletion of the inhibitory co-receptor CTLA-4 enhances and invigorates chimeric antigen receptor T cells

Author

Agarwal, Sangya, Aznar, M. Angela, Rech, Andrew J., Good, Charly R., Kuramitsu, Shunichiro, Da, Tong, Gohil, Mercy, Chen, Linhui, Hong, Seok-Jae Albert, Ravikumar, Pranali, Rennels, Austin K., Salas-Mckee, January, Kong, Weimin, Ruella, Marco, Davis, Megan M., Plesa, Gabriela, Fraietta, Joseph A., Porter, David L., Young, Regina M., and June, Carl H.

Published
2023
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8. 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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10. Survival Outcomes for Patients with Relapsed/ Refractory Aggressive B Cell Lymphomas Following Receipt of High-Dose Chemotherapy/Autologous Stem Transplantation and/or Chimeric Antigen Receptor-Modified T Cells

Author

Landsburg, Daniel J., Nasta, Sunita D., Svoboda, Jakub, Gerson, James N., Schuster, Stephen J., Barta, Stefan K., Chong, Elise A., Difilippo, Heather, Weber, Elizabeth, Cunningham, Kathleen, Catania, Christopher, Garfall, Alfred L., Stadtmauer, Edward A., Frey, Noelle V., and Porter, David L.

Published
2023
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11. Author Correction: Gut microbiome correlates of response and toxicity following anti-CD19 CAR T cell therapy

Author

Smith, Melody, Dai, Anqi, Ghilardi, Guido, Amelsberg, Kimberly V., Devlin, Sean M., Pajarillo, Raymone, Slingerland, John B., Beghi, Silvia, Herrera, Pamela S., Giardina, Paul, Clurman, Annelie, Dwomoh, Emmanuel, Armijo, Gabriel, Gomes, Antonio L. C., Littmann, Eric R., Schluter, Jonas, Fontana, Emily, Taur, Ying, Park, Jae H., Palomba, Maria Lia, Halton, Elizabeth, Ruiz, Josel, Jain, Tania, Pennisi, Martina, Afuye, Aishat Olaide, Perales, Miguel-Angel, Freyer, Craig W., Garfall, Alfred, Gier, Shannon, Nasta, Sunita, Landsburg, Daniel, Gerson, James, Svoboda, Jakub, Cross, Justin, Chong, Elise A., Giralt, Sergio, Gill, Saar I., Riviere, Isabelle, Porter, David L., Schuster, Stephen J., Sadelain, Michel, Frey, Noelle, Brentjens, Renier J., June, Carl H., Pamer, Eric G., Peled, Jonathan U., Facciabene, Andrea, van den Brink, Marcel R. M., and Ruella, Marco

Published
2023
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13. Clinical utilization of Chimeric Antigen Receptor T-cells (CAR-T) in B-cell acute lymphoblastic leukemia (ALL)–an expert opinion from the European Society for Blood and Marrow Transplantation (EBMT) and the American Society for Blood and Marrow Transplantation (ASBMT)

Author

Kansagra, Ankit J, Frey, Noelle V, Bar, Merav, Laetsch, Theodore W, Carpenter, Paul A, Savani, Bipin N, Heslop, Helen E, Bollard, Catherine M, Komanduri, Krishna V, Gastineau, Dennis A, Chabannon, Christian, Perales, Miguel A, Hudecek, Michael, Aljurf, Mahmoud, Andritsos, Leslie, Barrett, John A, Bachanova, Veronika, Bonini, Chiara, Ghobadi, Armin, Gill, Saar I, Hill, Joshua A, Kenderian, Saad, Kebriaei, Partow, Nagler, Arnon, Maloney, David, Liu, Hien D, Shah, Nirali N, Kharfan-Dabaja, Mohamed A, Shpall, Elizabeth J, Mufti, Ghulam J, Johnston, Laura, Jacoby, Elad, Bazarbachi, Ali, DiPersio, John F, Pavletic, Steven Z, Porter, David L, Grupp, Stephan A, Sadelain, Michel, Litzow, Mark R, Mohty, Mohamad, and Hashmi, Shahrukh K

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Cancer, Pediatric, Childhood Leukemia, Immunization, Genetics, Transplantation, Biotechnology, Gene Therapy, Pediatric Cancer, Pediatric Research Initiative, Hematology, Orphan Drug, Rare Diseases, Development of treatments and therapeutic interventions, 5.2 Cellular and gene therapies, Good Health and Well Being, Clinical Sciences, Cardiovascular medicine and haematology, Oncology and carcinogenesis
Abstract

On August 30, 2017, the U.S. Food and Drug Administration (US-FDA) approved tisagenlecleucel (KYMRIAH, Novartis, Basel, Switzerland), a synthetic bioimmune product of anti-CD19 chimeric antigen receptor-T cells (CAR-T), for the treatment of children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). With this new era of personalized cancer immunotherapy, multiple challenges are present ranging from implementation of a CAR-T program to safe delivery of the drug, long-term toxicity monitoring and disease assessments. To address these issues, experts representing the American Society for Blood and Marrow Transplant (ASBMT), the European Group for Blood and Marrow Transplantation (EBMT), the International Society of Cell and Gene Therapy (ISCT), and the Foundation for the Accreditation of Cellular Therapy (FACT), formed a global CAR-T task force to identify and address key questions pertinent for hematologists and transplant physicians regarding the clinical use of anti CD19 CAR-T therapy in patients with B-ALL. This article presents an initial roadmap for navigating common clinical practice scenarios that will become more prevalent now that the first commercially available CAR-T product for B-ALL has been approved.

Published
2019

14. Modulation of the gut microbiota engages antigen cross-presentation to enhance antitumor effects of CAR T cell immunotherapy

Author

Uribe-Herranz, Mireia, Beghi, Silvia, Ruella, Marco, Parvathaneni, Kalpana, Salaris, Silvano, Kostopoulos, Nektarios, George, Subin S., Pierini, Stefano, Krimitza, Elisavet, Costabile, Francesca, Ghilardi, Guido, Amelsberg, Kimberly V., Lee, Yong Gu, Pajarillo, Raymone, Markmann, Caroline, McGettigan-Croce, Bevin, Agarwal, Divyansh, Frey, Noelle, Lacey, Simon F., Scholler, John, Gabunia, Khatuna, Wu, Gary, Chong, Elise, Porter, David L., June, Carl H., Schuster, Stephen J., Bhoj, Vijay, and Facciabene, Andrea

Published
2023
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15. Clofarabine and Busulfan Myeloablative Conditioning in Allogeneic Hematopoietic Cell Transplantation for Patients With Active Myeloid Malignancies

Author

Connor, Matthew P., Loren, Alison W., Hexner, Elizabeth O., Martin, Mary Ellen, Gill, Saar I., Luger, Selina M., Mangan, James K., Perl, Alexander E., McCurdy, Shannon R., Pratz, Keith W., Timlin, Colleen, Freyer, Craig W., Carulli, Alison, Catania, Christopher, Smith, Jacqueline, Hollander, Lauren, Zebrowski, Alexis M., Stadtmauer, Edward A., Porter, David L., and Frey, Noelle V.

Published
2023
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16. Impact of late immune effector cell associated hematotoxicity (ICAHT) and prolonged neutropenia after CAR-T therapy on infection and survival outcomes.

Author

Zenner, Morgan, primary, Lessans, Spencer, additional, Rejeski, Kai, additional, Perales, Miguel-Angel, additional, Maziarz, Richard T., additional, Chen, Andy I., additional, Porter, David L., additional, Schuster, Stephen J., additional, McGuirk, Joseph, additional, Bishop, Michael Russell, additional, Bachanova, Veronika, additional, Nastoupil, Loretta J., additional, Riedell, Peter A., additional, Oluwole, Olalekan O., additional, Bhaskar, Shakthi, additional, and Patel, Vivek, additional

Published
2024
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17. Anti-CD19 CAR T cells in combination with ibrutinib for the treatment of chronic lymphocytic leukemia

Author

Gill, Saar, Vides, Vanessa, Frey, Noelle V., Hexner, Elizabeth O., Metzger, Susan, O'Brien, Megan, Hwang, Wei-Ting, Brogdon, Jennifer L., Davis, Megan M., Fraietta, Joseph A., Gaymon, Avery L., Gladney, Whitney L., Lacey, Simon F., Lamontagne, Anne, Mato, Anthony R., Maus, Marcela V., Melenhorst, J. Joseph, Pequignot, Edward, Ruella, Marco, Shestov, Maksim, Byrd, John C., Schuster, Stephen J., Siegel, Donald L., Levine, Bruce L., June, Carl H., and Porter, David L.

Published
2022
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18. Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Transplantation and Cellular Therapy

Author

Kansagra, Ankit J, Frey, Noelle V, Bar, Merav, Laetsch, Theodore W, Carpenter, Paul A, Savani, Bipin N, Heslop, Helen E, Bollard, Catherine M, Komanduri, Krishna V, Gastineau, Dennis A, Chabannon, Christian, Perales, Miguel A, Hudecek, Michael, Aljurf, Mahmoud, Andritsos, Leslie, Barrett, John A, Bachanova, Veronika, Bonini, Chiara, Ghobadi, Armin, Gill, Saar I, Hill, Joshua, Kenderian, Saad, Kebriaei, Partow, Nagler, Arnon, Maloney, David, Liu, Hien D, Shah, Nirali N, Kharfan-Dabaja, Mohamed A, Shpall, Elizabeth J, Mufti, Ghulam J, Johnston, Laura, Jacoby, Elad, Bazarbachi, Ali, DiPersio, John F, Pavletic, Steven Z, Porter, David L, Grupp, Stephan A, Sadelain, Michel, Litzow, Mark R, Mohty, Mohamad, and Hashmi, Shahrukh K

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Transplantation, Childhood Leukemia, Pediatric Cancer, Pediatric, Biotechnology, Orphan Drug, Genetics, Pediatric Research Initiative, Cancer, Rare Diseases, Gene Therapy, Immunization, Hematology, Development of treatments and therapeutic interventions, 5.2 Cellular and gene therapies, Good Health and Well Being, Antigens, CD19, Child, Critical Pathways, Drug Approval, Expert Testimony, Humans, Immunotherapy, Adoptive, Practice Patterns, Physicians', Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Receptors, Antigen, T-Cell, Societies, Medical, United States, Young Adult, Chimeric antigen receptor, Leukemia, T cell, Clinical Sciences, Cardiovascular medicine and haematology
Abstract

On August 30, 2017 the US Food and Drug Administration approved tisagenlecleucel (Kymriah; Novartis, Basel, Switzerland), a synthetic bioimmune product of anti-CD19 chimeric antigen receptor T cells (CAR-T), for the treatment of children and young adults with relapsed/refractory B cell acute lymphoblastic leukemia (B-ALL). With this new era of personalized cancer immunotherapy, multiple challenges are present, ranging from implementation of a CAR-T program to safe delivery of the drug, long-term toxicity monitoring, and disease assessments. To address these issues experts representing the American Society for Blood and Marrow Transplant, the European Society for Blood and Marrow Transplantation, the International Society of Cell and Gene Therapy, and the Foundation for the Accreditation of Cellular Therapy formed a global CAR-T task force to identify and address key questions pertinent for hematologists and transplant physicians regarding the clinical use of anti CD19 CAR-T therapy in patients with B-ALL. This article presents an initial roadmap for navigating common clinical practice scenarios that will become more prevalent now that the first commercially available CAR-T product for B-ALL has been approved.

Published
2019

19. Three prophylaxis regimens (tacrolimus, mycophenolate mofetil, and cyclophosphamide; tacrolimus, methotrexate, and bortezomib; or tacrolimus, methotrexate, and maraviroc) versus tacrolimus and methotrexate for prevention of graft-versus-host disease with haemopoietic cell transplantation with reduced-intensity conditioning: a randomised phase 2 trial with a non-randomised contemporaneous control group (BMT CTN 1203)

Author

Bolaños-Meade, Javier, Reshef, Ran, Fraser, Raphael, Fei, Mingwei, Abhyankar, Sunil, Al-Kadhimi, Zaid, Alousi, Amin M, Antin, Joseph H, Arai, Sally, Bickett, Kate, Chen, Yi-Bin, Damon, Lloyd E, Efebera, Yvonne A, Geller, Nancy L, Giralt, Sergio A, Hari, Parameswaran, Holtan, Shernan G, Horowitz, Mary M, Jacobsohn, David A, Jones, Richard J, Liesveld, Jane L, Logan, Brent R, MacMillan, Margaret L, Mielcarek, Marco, Noel, Pierre, Pidala, Joseph, Porter, David L, Pusic, Iskra, Sobecks, Ronald, Solomon, Scott R, Weisdorf, Daniel J, Wu, Juan, Pasquini, Marcelo C, and Koreth, John

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Trials and Supportive Activities, Hematology, Transplantation, Cancer, Rare Diseases, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Aged, Bortezomib, Cyclophosphamide, Drug Interactions, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Male, Maraviroc, Methotrexate, Middle Aged, Mycophenolic Acid, Tacrolimus, Transplantation Conditioning, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular medicine and haematology
Abstract

BackgroundPrevention of graft-versus-host disease (GvHD) without malignant relapse is the overall goal of allogeneic haemopoietic cell transplantation (HCT). We aimed to evaluate regimens using either maraviroc, bortezomib, or post-transplantation cyclophosphamide for GvHD prophylaxis compared with controls receiving the combination of tacrolimus and methotrexate using a novel composite primary endpoint to identify the most promising intervention to be further tested in a phase 3 trial.MethodsIn this prospective multicentre phase 2 trial, adult patients aged 18-75 years who received reduced-intensity conditioning HCT were randomly assigned (1:1:1) by random block sizes to tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide (cyclophosphamide 50 mg/kg on days 3 and 4, followed by tacrolimus starting on day 5 and mycophenolate mofetil starting on day 5 at 15 mg/kg three times daily not to exceed 1 g from day 5 to day 35); tacrolimus, methotrexate, and bortezomib (bortezomib 1·3 mg/m2 intravenously on days 1, 4, and 7 after HCT); or tacrolimus, methotrexate, and maraviroc (maraviroc 300 mg orally twice daily from day -3 to day 30 after HCT). Methotrexate was administered as a 15 mg/m2 intravenous bolus on day 1 and 10 mg/m2 intravenous bolus on days 3, 6, and 11 after HCT; tacrolimus was given intravenously at a dose of 0·05 mg/kg twice daily (or oral equivalent) starting on day -3 (except the post-transplantation cyclophosphamide, as indicated), with a target level of 5-15 ng/mL. Tacrolimus was continued at least until day 90 and was tapered off by day 180. Each study group was compared separately to a contemporary non-randomised prospective cohort of patients (control group) who fulfilled the same eligibility criteria as the trial, but who were treated with tacrolimus and methotrexate at centres not participating in the trial. The primary endpoint (GvHD-free, relapse-free survival [GRFS]) was defined as the time from HCT to onset of grade 3-4 acute GvHD, chronic GvHD requiring systemic immunosuppression, disease relapse, or death. The study was analysed by modified intention to treat. The study is closed to accrual and this is the planned analysis. This trial is registered with ClinicalTrials.gov, number NCT02208037.FindingsBetween Nov 17, 2014, and May 18, 2016, 273 patients from 31 US centres were randomly assigned to the three study arms: 89 to tacrolimus, methotrexate, and bortezomib; 92 to tacrolimus, methotrexate, and maraviroc; 92 to tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide; and six were excluded. Between Aug 1, 2014, and Sept 14, 2016, 224 controls received tacrolimus and methotrexate. Controls were generally well matched except for more frequent comorbidities than the intervention groups and a different distribution of types of conditioning regimens used. Compared with controls, the hazard ratio for GRFS was 0·72 (90% CI 0·54-0·94; p=0·044) for tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide, 0·98 (0·76-1·27; p=0·92) for tacrolimus, methotrexate, and bortezomib, and 1·10 (0·86-1·41; p=0·49) for tacrolimus, methotrexate, and maraviroc. 238 patients experienced grade 3 or 4 toxicities: 12 (13%) had grade 3 and 67 (73%) grade 4 events with tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide; ten (11%) had grade 3 and 68 (76%) had grade 4 events with tacrolimus, methotrexate, and bortezomib; and 18 (20%) had grade 3 and 63 (68%) had grade 4 events with tacrolimus, methotrexate, and maraviroc. The most common toxicities were haematological (77 [84%] for tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide; 73 [82%] for tacrolimus, methotrexate, and bortezomib; and 78 [85%] for tacrolimus, methotrexate, and maraviroc) and cardiac (43 [47%], 44 [49%], and 43 [47%], respectively).InterpretationTacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide was the most promising intervention, yielding the best GRFS; this regimen is thus being prospectively compared with tacrolimus and methotrexate in a phase 3 randomised trial.FundingUS National Health, Lung, and Blood Institute; National Cancer Institute; National Institute of Allergy and Infectious Disease; and Millennium Pharmaceuticals.

Published
2019

20. Patterns of Use, Outcomes, and Resource Utilization among Recipients of Commercial Axicabtagene Ciloleucel and Tisagenlecleucel for Relapsed/Refractory Aggressive B Cell Lymphomas

Author

Riedell, Peter A., Hwang, Wei-Ting, Nastoupil, Loretta J., Pennisi, Martina, McGuirk, Joseph P., Maziarz, Richard T., Bachanova, Veronika, Oluwole, Olalekan O., Brower, Jamie, Flores, Oscar A., Ahmed, Nausheen, Schachter, Levanto, Bharucha, Kharmen, Dholaria, Bhagirathbhai R., Schuster, Stephen J., Perales, Miguel-Angel, Bishop, Michael R., and Porter, David L.

Published
2022
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23. Real-world effectiveness of CPX-351 vs venetoclax and azacitidine in acute myeloid leukemia

Author

Matthews, Andrew H., Perl, Alexander E., Luger, Selina M., Loren, Alison W., Gill, Saar I., Porter, David L., Babushok, Daria V., Maillard, Ivan P., Carroll, Martin P., Frey, Noelle V., Hexner, Elizabeth O., Martin, Mary Ellen, McCurdy, Shannon R., Stadtmauer, Edward A., Paralkar, Vikram R., Bruno, Ximena Jordan, Hwang, Wei-Ting, Margolis, David, and Pratz, Keith W.

Published
2022
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24. Gut microbiome correlates of response and toxicity following anti-CD19 CAR T cell therapy

Author

Smith, Melody, Dai, Anqi, Ghilardi, Guido, Amelsberg, Kimberly V., Devlin, Sean M., Pajarillo, Raymone, Slingerland, John B., Beghi, Silvia, Herrera, Pamela S., Giardina, Paul, Clurman, Annelie, Dwomoh, Emmanuel, Armijo, Gabriel, Gomes, Antonio L. C., Littmann, Eric R., Schluter, Jonas, Fontana, Emily, Taur, Ying, Park, Jae H., Palomba, Maria Lia, Halton, Elizabeth, Ruiz, Josel, Jain, Tania, Pennisi, Martina, Afuye, Aishat Olaide, Perales, Miguel-Angel, Freyer, Craig W., Garfall, Alfred, Gier, Shannon, Nasta, Sunita, Landsburg, Daniel, Gerson, James, Svoboda, Jakub, Cross, Justin, Chong, Elise A., Giralt, Sergio, Gill, Saar I., Riviere, Isabelle, Porter, David L., Schuster, Stephen J., Sadelain, Michel, Frey, Noelle, Brentjens, Renier J., June, Carl H., Pamer, Eric G., Peled, Jonathan U., Facciabene, Andrea, van den Brink, Marcel R. M., and Ruella, Marco

Published
2022
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25. Decade-long leukaemia remissions with persistence of CD4+ CAR T cells

Author

Melenhorst, J. Joseph, Chen, Gregory M., Wang, Meng, Porter, David L., Chen, Changya, Collins, McKensie A., Gao, Peng, Bandyopadhyay, Shovik, Sun, Hongxing, Zhao, Ziran, Lundh, Stefan, Pruteanu-Malinici, Iulian, Nobles, Christopher L., Maji, Sayantan, Frey, Noelle V., Gill, Saar I., Loren, Alison W., Tian, Lifeng, Kulikovskaya, Irina, Gupta, Minnal, Ambrose, David E., Davis, Megan M., Fraietta, Joseph A., Brogdon, Jennifer L., Young, Regina M., Chew, Anne, Levine, Bruce L., Siegel, Donald L., Alanio, Cécile, Wherry, E. John, Bushman, Frederic D., Lacey, Simon F., Tan, Kai, and June, Carl H.

Published
2022
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28. Preconditioning Frailty Phenotype Influences Survival and Relapse for Older Allogeneic Transplantation Recipients

Author

Sung, Anthony D., Koll, Thuy, Gier, Shannon H., Racioppi, Alessandro, White, Griffin, Lew, Meagan, Free, Marcia, Agarwal, Priyal, Bohannon, Lauren M., Johnson, Ernaya J., Selvan, Bharathi, Babushok, Daria V., Frey, Noelle V., Gill, Saar I., Hexner, Elizabeth O., Martin, MaryEllen, Perl, Alexander E., Pratz, Keith W., Luger, Selina M., Chao, Nelson J., Fisher, Alfred L., Stadtmauer, Edward A., Porter, David L., Loren, Alison W., Bhatt, Vijaya R., Gimotty, Phyllis A., and McCurdy, Shannon R.

Published
2024
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29. TET2 regulates early and late transitions in exhausted CD8+T-cell differentiation and limits CAR T-cell function

Author

Dimitri, Alexander J, primary, Baxter, Amy E, additional, Chen, Gregory M, additional, Hopkins, Caitlin R, additional, Rouin, Geoffrey T, additional, Huang, Hua, additional, Kong, Weimin, additional, Holliday, Christopher H, additional, Wiebking, Volker, additional, Bartoszek, Robert, additional, Drury, Sydney, additional, Dalton, Katherine, additional, Koucky, Owen M, additional, Chen, Zeyu, additional, Giles, Josephine R, additional, Jung, In-Young, additional, O'Connor, Roddy, additional, Collins, Sierra, additional, Everett, John K, additional, Amses, Kevin, additional, Sherrill-Mix, Scott, additional, Chandra, Aditi, additional, Goldman, Naomi, additional, Vahedi, Golnaz, additional, Jadlowsky, Julie K, additional, Young, Regina M, additional, Melenhorst, Jan Joseph, additional, Maude, Shannon L, additional, Levine, Bruce L, additional, Frey, Noelle V, additional, Berger, Shelley L, additional, Grupp, Stephan A, additional, Porter, David L, additional, Herbst, Friederike, additional, Porteus, Matthew H, additional, Bushman, Frederic D, additional, Weber, Evan W, additional, Wherry, E. John, additional, Jordan, Martha S, additional, and Fraietta, Joseph A, additional

Published
2024
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30. CAR T-Cell Immunotherapy in Minority Patients with Lymphoma

Author

Ghilardi, Guido, primary, Williamson, Staci, additional, Pajarillo, Raymone, additional, Paruzzo, Luca, additional, Chen, Linhui, additional, Grady, Connor, additional, Doucette, Abigail, additional, Nemecek, Eneida, additional, Gabrielli, Giulia, additional, Barta, Stefan K., additional, Svoboda, Jakub, additional, Chong, Elise A., additional, Yelton, Rebecca, additional, Nasta, Sunita D., additional, Landsburg, Daniel J., additional, Ugwuanyi, Ositadimma, additional, Chen, Andy I., additional, Schachter, Levanto, additional, White, Griffin, additional, Ballard, Hatcher J., additional, Weber, Elizabeth, additional, Curley, Cara, additional, Porter, David L., additional, Garfall, Alfred L., additional, Hwang, Wei-Ting, additional, Guerra, Carmen E., additional, Maziarz, Richard T., additional, Schuster, Stephen J., additional, and Ruella, Marco, additional

Published
2024
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31. Bendamustine as Lymphodepletion for Brexucabtagene Autoleucel Therapy of Mantle Cell Lymphoma

Author

Chong, Elise A., primary, Chong, Emeline R., additional, Therwhanger, Dylan, additional, Nasta, Sunita D., additional, Landsburg, Daniel J., additional, Barta, Stefan K., additional, Svoboda, Jakub, additional, Gerson, James N., additional, Ghilardi, Guido, additional, Paruzzo, Luca, additional, Fraietta, Joseph A., additional, Weber, Elizabeth, additional, Stefano, Natalie, additional, Porter, David L., additional, Frey, Noelle V., additional, Garfall, Alfred L., additional, Ruella, Marco, additional, and Schuster, Stephen J., additional

Published
2024
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32. Interim Results of a Phase I/II Trial of Intermediate-Dose Post-Transplantation Cyclophosphamide after Reduced Intensity Conditioned HLA-Mismatched Bone Marrow Transplantation for Older or Unfit Patients

Author

McCurdy, Shannon R., primary, Hyder, Mustafa A., additional, Sabina, Ruby, additional, DeVries, Ashley, additional, Chalupa, Kirstin, additional, Berryman, Natasha, additional, Bernhardt, Jessica, additional, Cusmano, Alison Christina, additional, Chai, Amy, additional, Schwartz, Rebecca, additional, Dimitrova, Dimana, additional, Rechache, Kamil, additional, McKeown, Christi, additional, Stokes, Anita, additional, Sponaugle, Jennifer, additional, Frey, Noelle V., additional, Gill, Saar I., additional, Hexner, Elizabeth O, additional, Martin, Mary Ellen, additional, Hossain, Nasheed, additional, Porter, David L., additional, Loren, Alison W., additional, Kanakry, Jennifer A., additional, and Kanakry, Christopher G., additional

Published
2024
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33. Defining the Optimal Post-CART Monitoring Period in Recipients of Axicabtagene Ciloleucel, Tisagenlecleucel, and Lisocabtagene Maraleucel: A Cell Therapy Consortium Study

Author

Wesson, William, primary, Riedell, Peter A., additional, Porter, David L., additional, Lutfi, Forat, additional, Bachanova, Veronika, additional, Nastoupil, Loretta J., additional, Maziarz, Richard T., additional, DeJarnette, Shaun, additional, Brower, Jamie, additional, Shah, Gunjan L., additional, Chen, Andy I., additional, Oluwole, Olalekan O., additional, Schuster, Stephen J., additional, Perales, Miguel-Angel, additional, Bishop, Michael R., additional, McGuirk, Joseph P, additional, and Ahmed, Nausheen, additional

Published
2024
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34. Post-Transplant Frailty Phenotype Predicts Survival

Author

Hadjis, Ashley D., primary, White, Griffin W., additional, Gill, Saar I., additional, Hossain, Nasheed, additional, Frey, Noelle V., additional, Hexner, Elizabeth O, additional, Bruno, Ximena Jordan, additional, Lai, Catherine E, additional, Matthews, Andrew H., additional, Martin, Mary Ellen, additional, Babushok, Daria V., additional, Perl, Alexander E., additional, Pratz, Keith W., additional, Luger, Selina M., additional, Porter, David L., additional, Loren, Alison W., additional, and McCurdy, Shannon R., additional

Published
2024
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35. Risk Factors for Solid Organ Graft Failure and Death in Solid Organ Transplant Recipients Undergoing Hematopoietic Cell Transplantation: A Center for International Blood and Marrow Transplant Research Study

Author

Schoettler, Michelle Long, primary, Bo-Subait, Stephanie, additional, Brazauskas, Ruta, additional, Abt, Peter L., additional, Hamilton, Betty K., additional, Levine, Matthew, additional, Orozco, Gabriel, additional, Porter, David L., additional, Savani, Bipin N., additional, Schoemans, Prof. Helene M., additional, Shaw, Bronwen E., additional, Sorror, Mohamed L., additional, Phelan, Rachel, additional, and Gupta, Meera, additional

Published
2024
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36. One versus two sets of busulfan therapeutic drug monitoring in myeloablative allogeneic hematopoietic cell transplant.

Author

Chippendale, Lindsey, Freyer, Craig W, Carulli, Alison, Babushok, Daria V, Frey, Noelle V, Gill, Saar I, Hexner, Elizabeth O, Luger, Selina M, Martin, Mary Ellen, Porter, David L, Stadtmauer, Edward A, and Loren, Alison W

Subjects
HEMATOPOIETIC stem cell transplantation, GRAFT versus host disease, STOMATITIS, BUSULFAN, TREATMENT effectiveness, DRUG monitoring, DISEASE relapse, HEPATIC veno-occlusive disease, PROGRESSION-free survival, OVERALL survival
Abstract

Introduction: Busulfan is a common component of allogeneic hematopoietic cell transplant (alloHCT) conditioning, however interpatient pharmacokinetic variability can result in enhanced toxicity or increased relapse risk. Therapeutic drug monitoring (TDM) can minimize variability, yet the optimal frequency of TDM is unknown. We compared outcomes for patients with one versus two sets of busulfan TDM during myeloablative conditioning (MAC) prior to alloHCT. Methods: We analyzed the impact of busulfan TDM frequency and dose adjustments, with the primary outcome being relapse-free survival (RFS). Other outcomes included the incidence of acute and chronic graft versus host disease (GVHD), oral mucositis, pulmonary toxicity, sinusoidal obstruction syndrome (SOS), the cumulative incidence of relapse (CIR), and overall survival (OS). Results: Twenty-two patients underwent one set of sampling while 53 patients underwent two sets. Similar baseline characteristics were observed between the groups. There were no significant differences observed in RFS by day +180 (77.3% vs. 79.2%, p = 1.0), CIR by day +180 (18.2% vs. 17.8%, p = 0.74), or OS (p = 0.73). The incidences of acute GVHD, chronic GVHD, SOS, and severe mucositis were also similar. In each group, 63% received busulfan dose adjustments after one set, with 52.8% receiving further dose adjustments following the second set. Conclusion: We observed no significant difference in alloHCT outcomes between patients who underwent one versus two sets of busulfan TDM sampling, suggesting that a single-time TDM and dose adjustment may be adequate to maximize outcomes after MAC alloHCT. [ABSTRACT FROM AUTHOR]

Published
2024
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37. Author Correction: Decade-long leukaemia remissions with persistence of CD4+ CAR T cells

Author

Melenhorst, J. Joseph, Chen, Gregory M., Wang, Meng, Porter, David L., Chen, Changya, Collins, McKensie A., Gao, Peng, Bandyopadhyay, Shovik, Sun, Hongxing, Zhao, Ziran, Lundh, Stefan, Pruteanu-Malinici, Iulian, Nobles, Christopher L., Maji, Sayantan, Frey, Noelle V., Gill, Saar I., Loren, Alison W., Tian, Lifeng, Kulikovskaya, Irina, Gupta, Minnal, Ambrose, David E., Davis, Megan M., Fraietta, Joseph A., Brogdon, Jennifer L., Young, Regina M., Chew, Anne, Levine, Bruce L., Siegel, Donald L., Alanio, Cécile, Wherry, E. John, Bushman, Frederic D., Lacey, Simon F., Tan, Kai, and June, Carl H.

Published
2022
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38. Diagnostic biomarkers to differentiate sepsis from cytokine release syndrome in critically ill children

Author

Diorio, Caroline, Shaw, Pamela A., Pequignot, Edward, Orlenko, Alena, Chen, Fang, Aplenc, Richard, Barrett, David M., Bassiri, Hamid, Behrens, Edward, DiNofia, Amanda M., Gonzalez, Vanessa, Koterba, Natalka, Levine, Bruce L., Maude, Shannon L., Meyer, Nuala J., Moore, Jason H., Paessler, Michele, Porter, David L., Bush, Jenny L., Siegel, Don L., Davis, Megan M., Zhang, Donglan, June, Carl H., Grupp, Stephan A., Melenhorst, J. Joseph, Lacey, Simon F., Weiss, Scott L., and Teachey, David T.

Published
2020
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41. Bendamustine Lymphodepletion Before Axicabtagene Ciloleucel Is Safe and Associates with Reduced Inflammatory Cytokines

Author

Ghilardi, Guido, primary, Paruzzo, Luca, additional, Svoboda, Jakub, additional, Chong, Elise A., additional, Shestov, Alexander A, additional, Chen, Linhui, additional, Cohen, Ivan J, additional, Gabrielli, Giulia, additional, Nasta, Sunita D., additional, Porazzi, Patrizia, additional, Landsburg, Daniel J., additional, Gerson, James N., additional, Carter, Jordan, additional, Barta, Stefan K., additional, Yelton, Rebecca Dawn, additional, Pajarillo, Raymone, additional, Patel, Vrutti, additional, White, Griffin, additional, Ballard, Hatcher, additional, Weber, Elizabeth, additional, Napier, Ellen B, additional, Chong, Emeline R, additional, Fraietta, Joseph A., additional, Garfall, Alfred, additional, Porter, David L., additional, Milone, Michael C, additional, O'Connor, Roddy S, additional, Schuster, Stephen J., additional, and Ruella, Marco, additional

Published
2023
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43. Patient Characteristics and Outcomes of Outpatient Tisagenlecleucel Recipients for B Cell Non-Hodgkin Lymphoma

Author

Ahmed, Nausheen, Wesson, William, Mushtaq, Muhammad Umair, Porter, David L., Nasta, Sunita D., Brower, Jamie, Bachanova, Veronika, Hu, Marie, Nastoupil, Loretta J., Oluwole, Olalekan O., Patel, Vivek G., Oliai, Caspian, Riedell, Peter A., Bishop, Michael R., Shah, Gunjan L., Perales, Miguel-Angel, Schachter, Levanto, Maziarz, Richard T., and McGuirk, Joseph P.

Published
2023
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44. CD19-targeting CAR T cell immunotherapy outcomes correlate with genomic modification by vector integration

Author

Nobles, Christopher L., Sherrill-Mix, Scott, Everett, John K., Reddy, Shantan, Fraietta, Joseph A., Porter, David L., Frey, Noelle, Gill, Saar I., Grupp, Stephan A., Maude, Shannon L., Siegel, Donald L., Levine, Bruce L., June, Carl H., Lacey, Simon F., Melenhorst, J. Joseph, and Bushman, Frederic D.

Subjects
Genes, Chromatin, Immunotherapy, Genomes, Genomics, T cells, Lymphocytic leukemia, Antigens, Chronic lymphocytic leukemia, Acute lymphocytic leukemia, Pediatrics, Health care industry
Abstract

Chimeric antigen receptor-engineered T cells targeting CD19 (CART19) provide an effective treatment for pediatric acute lymphoblastic leukemia but are less effective for chronic lymphocytic leukemia (CLL), focusing attention on improving efficacy. CART19 harbor an engineered receptor, which is delivered through lentiviral vector integration, thereby marking cell lineages and modifying the cellular genome by insertional mutagenesis. We recently reported that vector integration within the host TET2 gene was associated with CLL remission. Here, we investigated clonal population structure and therapeutic outcomes in another 39 patients by high-throughput sequencing of vector-integration sites. Genes at integration sites enriched in responders were commonly found in cell-signaling and chromatin modification pathways, suggesting that insertional mutagenesis in these genes promoted therapeutic T cell proliferation. We also developed a multivariate model based on integration-site distributions and found that data from preinfusion products forecasted response in CLL successfully in discovery and validation cohorts and, in day 28 samples, reported responders to CLL therapy with high accuracy. These data clarify how insertional mutagenesis can modulate cell proliferation in CART19 therapy and how data on integration- site distributions can be linked to treatment outcomes., Introduction Patient T cells engineered to express a CD19-specific chimeric antigen receptor (CART19) have proven effective in inducing long-term remissions in pediatric acute lymphoblastic leukemia (ALL), with complete response rates [...]

Published
2020
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46. Characterization of the calcineurin inhibitor pain syndrome in patients undergoing allogeneic hematopoietic cell transplantation.

Author

Freyer, Craig W., Carulli, Alison, Frey, Noelle V., Gill, Saar I., Hexner, Elizabeth O., Martin, Mary Ellen, Luger, Selina M., Porter, David L., Stadtmauer, Edward A., and Loren, Alison W.

Subjects
HEMATOPOIETIC stem cell transplantation, CALCINEURIN, LEG pain, TOTAL body irradiation, CALCIUM antagonists
Abstract

Calcineurin inhibitor pain syndrome (CIPS) is a rare complication of graft-vs-host disease prophylaxis following allogeneic hematopoietic cell transplant (alloHCT). CIPS presents as severe bilateral lower extremity pain, and the incidence, risk factors, and management of CIPS are poorly characterized. This is a single center retrospective study of patients who received tacrolimus (TAC) following alloHCT to describe the characteristics and management of CIPS and compare to a cohort who did not develop CIPS. Fifteen of 585 alloHCT patients (2.6%) developed CIPS at a median of 5 days following TAC initiation and a median level of 10.5 ng/mL. Severe bilateral foot, ankle, or leg pain were the primary symptoms. Patients with CIPS were younger and more frequently received myeloablative conditioning and total body irradiation compared to patients without CIPS. Analgesic regimens included dihydropyridine calcium channel blockers, gabapentinoids, topical diclofenac, and opioids. Clinicians should be aware of this uncommon but severe adverse effect. [ABSTRACT FROM AUTHOR]

Published
2024
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47. Deletion of the inhibitory co-receptor CTLA4 enhances and invigorates chimeric antigen receptor T cells

Author

Agarwal, Sangya, primary, Aznar, M. Angela, additional, Rech, Andrew J., additional, Good, Charly R., additional, Kuramitsu, Shunichiro, additional, Da, Tong, additional, Gohil, Mercy, additional, Chen, Linhui, additional, Hong, Seok-Jae Albert, additional, Ravikumar, Pranali, additional, Rennels, Austin K., additional, Salas-Mckee, January, additional, Kong, Weimin, additional, Ruella, Marco, additional, Davis, Megan M., additional, Plesa, Gabriela, additional, Fraietta, Joseph A., additional, Porter, David L., additional, Young, Regina M., additional, and June, Carl H., additional

Published
2023
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48. One versus two sets of busulfan therapeutic drug monitoring in myeloablative allogeneic hematopoietic cell transplant

Author

Chippendale, Lindsey, primary, Freyer, Craig W, additional, Carulli, Alison, additional, Babushok, Daria V, additional, Frey, Noelle V, additional, Gill, Saar I, additional, Hexner, Elizabeth O, additional, Luger, Selina M, additional, Martin, Mary Ellen, additional, Porter, David L, additional, Stadtmauer, Edward A, additional, and Loren, Alison W, additional

Published
2023
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