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1. Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials.

Author

Lin, Chenyu, Schwarzbach, Aurelie, Sanz, Jaime, Montesinos, Pau, Stiff, Patrick, Parikh, Suhag, Brunstein, Claudio, Cutler, Corey, Lindemans, Caroline, Hanna, Rabi, Koh, Liang, Jagasia, Madan, Valcarcel, David, Maziarz, Richard, Keating, Amy, Hwang, William, Rezvani, Andrew, Karras, Nicole, Fernandes, Juliana, Rocha, Vanderson, Badell, Isabel, Ram, Ron, Schiller, Gary, Volodin, Leonid, Walters, Mark, Hamerschlak, Nelson, Cilloni, Daniela, Frankfurt, Olga, McGuirk, Joseph, Kurtzberg, Joanne, Sanz, Guillermo, Simantov, Ronit, and Horwitz, Mitchell

Subjects
Allogeneic stem cell transplantation, Clinical trial, Cord blood, Ex vivo expansion, Long-term follow-up, Humans, Follow-Up Studies, Prospective Studies, Hematopoietic Stem Cell Transplantation, Disease-Free Survival, Multicenter Studies as Topic
Abstract

Omidubicel is an umbilical cord blood (UCB)-derived ex vivo-expanded cellular therapy product that has demonstrated faster engraftment and fewer infections compared with unmanipulated UCB in allogeneic hematopoietic cell transplantation. Although the early benefits of omidubicel have been established, long-term outcomes remain unknown. We report on a planned pooled analysis of 5 multicenter clinical trials including 105 patients with hematologic malignancies or sickle cell hemoglobinopathy who underwent omidubicel transplantation at 26 academic transplantation centers worldwide. With a median follow-up of 22 months (range, .3 to 122 months), the 3-year estimated overall survival and disease-free survival were 62.5% and 54.0%, respectively. With up to 10 years of follow-up, omidubicel showed durable trilineage hematopoiesis. Serial quantitative assessments of CD3+, CD4+, CD8+, CD19+, CD116+CD56+, and CD123+ immune subsets revealed median counts remaining within normal ranges through up to 8 years of follow-up. Secondary graft failure occurred in 5 patients (5%) in the first year, with no late cases reported. One case of donor-derived myeloid neoplasm was reported at 40 months post-transplantation. This was also observed in a control arm patient who received only unmanipulated UCB. Overall, omidubicel demonstrated stable trilineage hematopoiesis, immune competence, and graft durability in extended follow-up.

Published
2023

3. Paving the Road for Chimeric Antigen Receptor T Cells: American Society for Transplantation and Cellular Therapy 80/20 Task Force Consensus on Challenges and Solutions to Improving Efficiency of Clinical Center Certification and Maintenance of Operations for Commercially Approved Immune Effector Cell Therapies

Author

Nikiforow, Sarah, Frigault, Matthew J., Frey, Noelle V., Gardner, Rebecca A., Komanduri, Krishna V., Perales, Miguel-Angel, Kebriaei, Partow, Warkentin, Phyllis Irene, Pasquini, Marcelo, Aho, Joy Lynn, Levine, Bruce L., Heslop, Helen E., Hlucky, Tracey L., Habucky, Karen, Gharibo, Mecide, Jagasia, Madan, and Locke, Frederick L.

Published
2023
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4. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Sandhu, Irwindeep, Podhorecka, Monika, Palumbo, Antonio, Shacham-Abulafia, Adi, Vaxman, Iuliana, Shpilberg, Ofer, Besemer, Britta, Martelli, Maurizio, Foà, Roberto, De Fabritiis, Paolo, Caravita di Toritto, Tommaso, Gheorghita, Emanuil, Oriol, Albert, Rowlings, Philip, Emanuele, Angelucci, Carella, Angelo M, Offidani, Massimo, Bladé, Joan, Casado, Luis F, Oakervee, Heather, Panelli, Victoria, Meza, Luis, Kühr, Thomas, Granell, Miguel, Benson, Don, Nair, Rajesh, Holden, Viran, Reeves, James, Jr., Eek, Richard W, Walker, Patricia A, Catalano, John, Rosta, András, Lech-Marańda, Ewa, Samaras, Christy, Reiman, Anthony, Weaver, Robert, Acs, Peter, Grigg, Andrew, De Prijck, Bernard, Louzada, Martha, Minuk, Leonard, Sebag, Michael, Klausmann, Martine, Welslau, Manfred, Hellmann, Andrzej, Danaila, Catalin, Becker, Pamela, Bensinger, William, Porterfield, Bruce, Modiano, Manuel, Schultz, Stephen M, Manges, Robert, Lee, Huey-Shin Cindy, Gray, James X, Wright, Matthew P, Vekemans, Marie-Christine, Hamed, Aryan, Gasztonyi, Zoltán, Mikala, Gábor, Masszi, Tamás, Gamberi, Barbara, Kuliczkowski, Kazimierz, Usnarska-Zubkiewicz, Lidia, Bengoechea, Enrique, Gutiérrez, María AE, García, Miguel TH, San-Miguel, Jesús, Driessen, Christoph, Behl, Rajesh, Brenner, Warren, Gray, Carl, Hansen, Vincent, Moezi, Mehdi, Cortes, Hector V, Yen, Charles, Gressot, Laurent, Horvath, Noemi, D'Rozario, James M, Latimer, Maya, Kyrtsonis, Maria-Christine, Chubar, Evgeni, Mittelman, Moshe, Baldini, Luca, Tosi, Patrizia, Vacca, Angelo, Jędrzejczak, Wiesław W, Robak, Tadeusz, Lahuerta, Juan J, Carney, Jennifer, Chen, Franklin, Hirsch, Robert, Ruiz, Marco, Alencar, Alvaro, Jagasia, Madan, Kasbari, Samer, Kuriakose, Philip, Mahmood, Aftab, Chaudhry, Madhu, Cohen, Gary, Noga, Stephen, Roa, Sch, Jakubowiak, Andrzej, Rosenbaum, Cara, Delforge, Michel, Delrieu, Vanessa, Doyen, Chantal, Dries, Deeren, Demuynck, Hilde, Schots, Rik, Maisnar, Vladimir, Blau, Igor W, Dürk, Heinz A, Kerkhoff, Andrea, Kropff, Martin, Munder, Markus, Röllig, Christoph, Scheid, Christof, Symeonidis, Argiris S, Illés, Árpád, Coyne, Mark, O'Gorman, Peter, Hayden, Patrick, O'Dwyer, Michael, Ben-Yehuda, Dina, Braester, Andrei, Nemets, Anatoly, Lugassy, Gilles, Cohen, Yossi, Rahimi-Levene, Naomi, Bosi, Alberto, Pezzatti, Sara, Rossini, Fausto, Pogliani, Enrico M, Pinto, Antonello, Komarnicki, Mieczysław, Borsaru, Gabriela, Stoia, Razvan, Afanasyev, Boris, Goñi, María A, Carboneras, Ana V, Ali, Sarah, Rubenstein, S. Eric, Caputto, Salvador, Cosgriff, Thomas, Fanning, Suzanne, Khojasteh, Ali, Liman, Andrew, Malcolm, Albert, Vrindavanam, Nandagopal, Patel, Ravindranath, Belani, Rajesh, Shieh, Marie, Stockerl-Goldstein, Keith, Strnad, Charles, Stuart, Robert, Chhabra, Saurabh, Costa, Luciano, Jhangiani, Haresh, Augustson, Bradley, Filshie, Robin, Johnston, Amanda, Hertzberg, Mark S, Mineur, Philippe, Fox, Susan, Kotb, Rami, Dao, Vi, LeBlanc, Richard, Gregora, Evzen, Brioli, Annamaria, Mügge, Lars-Olof, Hänel, Mathias, Langer, Christian, Kapsali, Eleni, Briasoulis, Evangelos, Kyriakou, Despoina, Hardan, Izhar, Horowitz, Netanel A, Clotilde, Cangialosi, Fabbiano, Francesco, Castagnari, Barbara, Ciceri, Fabio, Musuraca, Gerardo, Deptała, Andrzej, Kłoczko, Janusz, Balea, Marius, Vladareanu, Ana-Maria, Rossiev, Victor, Alegre, Adrián, Encinas, Cristina, Gayoso, Jorge, Pabst, Thomas, Rabin, Neil, Arledge, Sherri, Cabanillas, Fernando, Catlett, Joseph, Chidiac, Tarek, Clarkson, David, Dhodapkar, Madhav, Geils, George, Jr., Khan, Cyrus MA, Sahovic, Entezam, Khasawneh, Mohamad, Sehgal, Rajesh, Ballester, Oscar, Levy, Moshe, Fay, Joseph, Liem, Kiem, Lunning, Matthew, Vose, Julie, Faber, Edward, Jr., MacFarlane, Donald, Hohl, Raymond, Mahmood, Tariq, Bhaskar, Birbal, Mims, Martha, Oliff, Ira, Paner, Agne, Maciejewski, John, Padmanabhan, Arvinda, Richard, Robert, Sanyal, Amit, Schiller, Gary, Staszewski, Harry, Stevens, Don, Vaughn, Christopher, and Windsor, Kevin

Published
2022
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7. CT-314 Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation With Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials

Author

Lin, Chenyu, Schwarzbach, Aurelie, Montesinos, Pau, Stiff, Patrick, Cutler, Corey, Parikh, Suhag, Brunstein, Claudio, Lindemans, Caroline A., Hanna, Rabi, Koh, Liang Piu, Maziarz, Richard T., Keating, Amy K., Huang, William Y.K., Rezvani, Andrew R., Valcarcel, David, Fernandes, Juliana F., Badell, Isabell S., Jagasia, Madan H., Frankfurt, Olga, Ram, Ron, McGuirk, Joseph P., Kurtzberg, Joanne, Sanz, Guillermo, Simantov, Ronit, and Horwitz, Mitchell E.

Published
2022
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8. Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials

Author

Lin, Chenyu, primary, Schwarzbach, Aurelie, additional, Sanz, Jaime, additional, Montesinos, Pau, additional, Stiff, Patrick, additional, Parikh, Suhag, additional, Brunstein, Claudio, additional, Cutler, Corey, additional, Lindemans, Caroline A., additional, Hanna, Rabi, additional, Koh, Liang Piu, additional, Jagasia, Madan H., additional, Valcarcel, David, additional, Maziarz, Richard T., additional, Keating, Amy K., additional, Hwang, William Y.K., additional, Rezvani, Andrew R., additional, Karras, Nicole A., additional, Fernandes, Juliana F., additional, Rocha, Vanderson, additional, Badell, Isabel, additional, Ram, Ron, additional, Schiller, Gary J., additional, Volodin, Leonid, additional, Walters, Mark C., additional, Hamerschlak, Nelson, additional, Cilloni, Daniela, additional, Frankfurt, Olga, additional, McGuirk, Joseph P., additional, Kurtzberg, Joanne, additional, Sanz, Guillermo, additional, Simantov, Ronit, additional, and Horwitz, Mitchell E., additional

Published
2023
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9. Supplemental Table 1 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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10. Supplemental Figure 1 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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11. supplemental figure legend from A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation

Author

Arai, Sally, primary, Pidala, Joseph, primary, Pusic, Iskra, primary, Chai, Xiaoyu, primary, Jaglowski, Samantha, primary, Khera, Nandita, primary, Palmer, Jeanne, primary, Chen, George L., primary, Jagasia, Madan H., primary, Mayer, Sebastian A., primary, Wood, William A., primary, Green, Michael, primary, Hyun, Teresa S., primary, Inamoto, Yoshihiro, primary, Storer, Barry E., primary, Miklos, David B., primary, Shulman, Howard M., primary, Martin, Paul J., primary, Sarantopoulos, Stefanie, primary, Lee, Stephanie J., primary, and Flowers, Mary E.D., primary

Published
2023
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12. Supplemental Table 2 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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13. Supplemental Table 3 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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14. Supplemental Table 4 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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15. Supplementary Figure 2 from Dysregulated Human Myeloid Nuclear Differentiation Antigen Expression in Myelodysplastic Syndromes: Evidence for a Role in Apoptosis

Author

Briggs, Robert C., primary, Shults, Keith E., primary, Flye, Leanne A., primary, McClintock-Treep, Sara A., primary, Jagasia, Madan H., primary, Goodman, Stacey A., primary, Boulos, Fouad I., primary, Jacobberger, James W., primary, Stelzer, Greg T., primary, and Head, David R., primary

Published
2023
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16. Supplementary Figure 1 from Dysregulated Human Myeloid Nuclear Differentiation Antigen Expression in Myelodysplastic Syndromes: Evidence for a Role in Apoptosis

Author

Briggs, Robert C., primary, Shults, Keith E., primary, Flye, Leanne A., primary, McClintock-Treep, Sara A., primary, Jagasia, Madan H., primary, Goodman, Stacey A., primary, Boulos, Fouad I., primary, Jacobberger, James W., primary, Stelzer, Greg T., primary, and Head, David R., primary

Published
2023
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17. Paving the Road for CAR-Ts: ASTCT 80/20 Task Force consensus on challenges and solutions to improving efficiency of clinical center certification and maintenance of operations for commercially approved immune effector cell therapies

Author

Nikiforow, Sarah, primary, Frigault, Matthew J, additional, Frey, Noelle V, additional, Gardner, Rebecca A, additional, Komanduri, Krishna V, additional, Perales, Miguel-Angel, additional, Kebriaei, Partow, additional, Warkentin, Phyllis Irene, additional, Pasquini, Marcelo, additional, Aho, Joy Lynn, additional, Levine, Bruce L, additional, Heslop, Helen E, additional, Hlucky, Tracey L, additional, Habucky, Karen, additional, Gharibo, Mecide, additional, Jagasia, Madan, additional, and Locke, Frederick L, additional

Published
2023
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18. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study

Author

Kitko, Carrie L., primary, Arora, Mukta, additional, DeFilipp, Zachariah, additional, Zaid, Mohammad Abu, additional, Di Stasi, Antonio, additional, Radojcic, Vedran, additional, Betts, Courtney B., additional, Coussens, Lisa M., additional, Meyers, Michael L., additional, Qamoos, Hope, additional, Ordentlich, Peter, additional, Kumar, Vinit, additional, Quaranto, Christine, additional, Schmitt, Aaron, additional, Gu, Yu, additional, Blazar, Bruce R., additional, Wang, Trent P., additional, Salhotra, Amandeep, additional, Pusic, Iskra, additional, Jagasia, Madan, additional, and Lee, Stephanie J., additional

Published
2022
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19. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study

Author

Chesney, Jason, primary, Lewis, Karl D, additional, Kluger, Harriet, additional, Hamid, Omid, additional, Whitman, Eric, additional, Thomas, Sajeve, additional, Wermke, Martin, additional, Cusnir, Mike, additional, Domingo-Musibay, Evidio, additional, Phan, Giao Q, additional, Kirkwood, John M, additional, Hassel, Jessica C, additional, Orloff, Marlana, additional, Larkin, James, additional, Weber, Jeffrey, additional, Furness, Andrew J S, additional, Khushalani, Nikhil I, additional, Medina, Theresa, additional, Egger, Michael E, additional, Graf Finckenstein, Friedrich, additional, Jagasia, Madan, additional, Hari, Parameswaran, additional, Sulur, Giri, additional, Shi, Wen, additional, Wu, Xiao, additional, and Sarnaik, Amod, additional

Published
2022
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20. 789 Lifileucel TIL cell monotherapy in patients with advanced melanoma after progression on immune checkpoint inhibitors (ICI) and targeted therapy: pooled analysis of consecutive cohorts (C-144–01 study)

Author

Sarnaik, Amod, primary, Lewis, Karl, additional, Kluger, Harriet, additional, Hamid, Omid, additional, Whitman, Eric, additional, Thomas, Sajeve, additional, Wermke, Martin, additional, Cusnir, Mike, additional, Domingo-Musibay, Evidio, additional, Phan, Giao, additional, Kirkwood, John, additional, Hassel, Jessica, additional, Orloff, Marlana, additional, Larkin, James, additional, Weber, Jeffrey, additional, Furness, Andrew, additional, Khushalani, Nikhil, additional, Medina, Theresa, additional, Finckenstein, Friedrich, additional, Jagasia, Madan, additional, Hari, Parameswaran, additional, Sulur, Giri, additional, Shi, Wen, additional, Wu, Xiao, additional, and Chesney, Jason, additional

Published
2022
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21. 783 Trial in progress: a phase 1/2 open-label study (IOV-GM1–201) of TALEN-mediated PD-1–inactivated autologous tumor-infiltrating lymphocytes (TIL; IOV-4001) in patients with advanced melanoma and NSCLC

Author

Betof, Allison, primary, Wise-Draper, Trisha, additional, He, Kai, additional, Sarnaik, Amod, additional, Thompson, Jonathan, additional, Finckenstein, Friedrich, additional, Hari, Parameswaran, additional, Jagasia, Madan, additional, Desai, Anjali, additional, Suzuki, Akiko, additional, Wu, Xiao, additional, and Chesney, Jason, additional

Published
2022
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22. Poster: CT-314 Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation With Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials

Author

Lin, Chenyu, primary, Schwarzbach, Aurelie, additional, Montesinos, Pau, additional, Stiff, Patrick, additional, Cutler, Corey, additional, Parikh, Suhag, additional, Brunstein, Claudio, additional, Lindemans, Caroline A., additional, Hanna, Rabi, additional, Koh, Liang Piu, additional, Maziarz, Richard T., additional, Keating, Amy K., additional, Huang, William Y.K., additional, Rezvani, Andrew R., additional, Valcarcel, David, additional, Fernandes, Juliana F., additional, Badell, Isabell S., additional, Jagasia, Madan H., additional, Frankfurt, Olga, additional, Ram, Ron, additional, McGuirk, Joseph P., additional, Kurtzberg, Joanne, additional, Sanz, Guillermo, additional, Simantov, Ronit, additional, and Horwitz, Mitchell E., additional

Published
2022
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24. Abstract CT130: Trial in progress: A phase 2 multicenter study (IOV-LUN-202) of autologous tumor-infiltrating lymphocyte (TIL) cell therapy (LN-145) in patients with metastatic non-small cell lung cancer (mNSCLC)

Author

Chesney, Jason Alan, primary, Schoenfeld, Adam J., additional, Wise-Draper, Trisha, additional, Sukari, Ammar, additional, He, Kai, additional, Finckenstein, Friedrich Graf, additional, Hari, Parameswaran, additional, Jagasia, Madan, additional, Samakoglu, Selda, additional, Leighton-Swayze, Ann, additional, Chen, Guang, additional, and Hong, Yong Ki, additional

Published
2022
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25. Tumor mutational burden (TMB) in immune checkpoint inhibitor (ICI)-naïve and -experienced patients with metastatic melanoma treated with lifileucel, a tumor-infiltrating lymphocyte (TIL) cell therapy.

Author

Kluger, Harriet M., primary, Sarnaik, Amod, additional, Chesney, Jason Alan, additional, Lewis, Karl D., additional, Weber, Jeffrey S., additional, Gogas, Helen, additional, In, Gino Kim, additional, Terheyden, Patrick Andres Maximilian, additional, Lee, Sylvia, additional, Jagasia, Madan H., additional, Masteller, Emma, additional, Qi, Rongsu, additional, Gontcharova, Viktoria, additional, Shi, Wen, additional, Fiaz, Rana, additional, Sulur, Giri, additional, Wu, Renee Xiao, additional, Chen, Guang, additional, and Thomas, Sajeve Samuel, additional

Published
2022
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27. Efficacy and Safety of Lifileucel, a One-Time Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy, in Patients With Advanced Melanoma After Progression on Immune Checkpoint Inhibitors and Targeted Therapies: Pooled Analysis of Consecutive Cohorts of the C-144-01 Study

Author

Chesney, Jason, Lewis, Karl D, Kluger, Harriet, Hamid, Omid, Whitman, Eric, Thomas, Sajeve, Wermke, Martin, Cusnir, Mike, Domingo-Musibay, Evidio, Phan, Giao Q, Kirkwood, John M, Hassel, Jessica C, Orloff, Marlana, Larkin, James, Weber, Jeffrey, Furness, Andrew J S, Khushalani, Nikhil I, Medina, Theresa, Egger, Michael E, Graf Finckenstein, Friedrich, Jagasia, Madan, Hari, Parameswaran, Sulur, Giri, Shi, Wen, Wu, Xiao, Sarnaik, Amod, Chesney, Jason, Lewis, Karl D, Kluger, Harriet, Hamid, Omid, Whitman, Eric, Thomas, Sajeve, Wermke, Martin, Cusnir, Mike, Domingo-Musibay, Evidio, Phan, Giao Q, Kirkwood, John M, Hassel, Jessica C, Orloff, Marlana, Larkin, James, Weber, Jeffrey, Furness, Andrew J S, Khushalani, Nikhil I, Medina, Theresa, Egger, Michael E, Graf Finckenstein, Friedrich, Jagasia, Madan, Hari, Parameswaran, Sulur, Giri, Shi, Wen, Wu, Xiao, and Sarnaik, Amod

Abstract

Background: Patients with advanced melanoma have limited treatment options after progression on immune checkpoint inhibitors (ICI). Lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, demonstrated an investigator-assessed objective response rate (ORR) of 36% in 66 patients who progressed after ICI and targeted therapy. Herein, we report independent review committee (IRC)-assessed outcomes of 153 patients treated with lifileucel in a large multicenter Phase 2 cell therapy trial in melanoma. Methods: Eligible patients had advanced melanoma that progressed after ICI and targeted therapy, where appropriate. Melanoma lesions were resected (resected tumor diameter ≥1.5 cm) and shipped to a central good manufacturing practice facility for 22-day lifileucel manufacturing. Patients received a non-myeloablative lymphodepletion regimen, a single lifileucel infusion, and up to six doses of high-dose interleukin-2. The primary endpoint was IRC-assessed ORR (Response Evaluation Criteria in Solid Tumors V.1.1). Results: The Full Analysis Set consisted of 153 patients treated with lifileucel, including longer-term follow-up on the 66 patients previously reported. Patients had received a median of 3.0 lines of prior therapy (81.7% received both anti-programmed cell death protein 1 and anti-cytotoxic lymphocyte-associated protein 4) and had high disease burden at baseline (median target lesion sum of diameters (SOD): 97.8 mm; lactate dehydrogenase (LDH) >upper limit of normal: 54.2%). ORR was 31.4% (95% CI: 24.1% to 39.4%), with 8 complete responses and 40 partial responses. Median duration of response was not reached at a median study follow-up of 27.6 months, with 41.7% of the responses maintained for ≥18 months. Median overall survival and progression-free survival were 13.9 and 4.1 months, respectively. Multivariable analyses adjusted for Eastern Cooperative Oncology Group performance status demonstrated that elevated LDH and target lesion SOD >med

Published
2022

28. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study.

Author

Kitko, Carrie L., Arora, Mukta, DeFilipp, Zachariah, Zaid, Mohammad Abu, Di Stasi, Antonio, Radojcic, Vedran, Betts, Courtney B., Coussens, Lisa M., Meyers, Michael L., Qamoos, Hope, Ordentlich, Peter, Kumar, Vinit, Quaranto, Christine, Schmitt, Aaron, Gu, Yu, Blazar, Bruce R., Wang, Trent P., Salhotra, Amandeep, Pusic, Iskra, and Jagasia, Madan

Published
2023
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29. Successful Manufacturing of Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy from Cryopreserved Melanoma Tumors Shipped from Australia

Author

Onimus, Kenneth, primary, Wells, Adrian, additional, Herman, Courtney, additional, Tawashi, Ahmed, additional, Long, Georgina V, additional, Scolyer, Richard A, additional, Velickovic, Rebecca, additional, Saw, Robyn PM, additional, Pennington, Thomas E, additional, Menzies, Alexander M, additional, Jagasia, Madan, additional, Natarajan, Arvind, additional, and Veerapathran, Anandaraman, additional

Published
2022
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31. CMV exposure drives long-term CD57+ CD4 memory T-cell inflation following allogeneic stem cell transplant

Author

Yeh, Albert C., primary, Varelias, Antiopi, additional, Reddy, Anupama, additional, Barone, Sierra M., additional, Olver, Stuart D., additional, Chilson, Kate, additional, Onstad, Lynn E., additional, Ensbey, Kathleen S., additional, Henden, Andrea S, additional, Samson, Luke, additional, Jaeger, Carla A, additional, Bi, Timothy, additional, Dahlman, Kimberly B., additional, Kim, Tae Kon, additional, Zhang, Ping, additional, Degli-Esposti, Mariapia A., additional, Newell, Evan W., additional, Jagasia, Madan H., additional, Irish, Jonathan M., additional, Lee, Stephanie J., additional, and Hill, Geoffrey R., additional

Published
2021
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32. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study

Author

Cutler, Corey, primary, Lee, Stephanie J., additional, Arai, Sally, additional, Rotta, Marcello, additional, Zoghi, Behyar, additional, Lazaryan, Aleksandr, additional, Ramakrishnan, Aravind, additional, DeFilipp, Zachariah, additional, Salhotra, Amandeep, additional, Chai-Ho, Wanxing, additional, Mehta, Rohtesh, additional, Wang, Trent, additional, Arora, Mukta, additional, Pusic, Iskra, additional, Saad, Ayman, additional, Shah, Nirav N., additional, Abhyankar, Sunil, additional, Bachier, Carlos, additional, Galvin, John, additional, Im, Annie, additional, Langston, Amelia, additional, Liesveld, Jane, additional, Juckett, Mark, additional, Logan, Aaron, additional, Schachter, Levanto, additional, Alavi, Asif, additional, Howard, Dianna, additional, Waksal, Harlan W., additional, Ryan, John, additional, Eiznhamer, David, additional, Aggarwal, Sanjay K., additional, Ieyoub, Jonathan, additional, Schueller, Olivier, additional, Green, Laurie, additional, Yang, Zhongming, additional, Krenz, Heidi, additional, Jagasia, Madan, additional, Blazar, Bruce R., additional, and Pavletic, Steven, additional

Published
2021
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35. Trial in Progress: Phase 1/2 Study Evaluating the Safety and Efficacy of Iov-2001, an Autologous, Non-Genetically Modified, Polyclonal T-Cell Product, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Author

Pinilla Ibarz, Javier, primary, Long, Meixiao, additional, Lister, John, additional, Woyach, Jennifer A., additional, Graf Finckenstein, Friedrich, additional, Jagasia, Madan, additional, Samakoglu, Selda, additional, Yadav, Bhagyashree, additional, Li, Huiling, additional, and Byrd, John C., additional

Published
2021
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36. 492 Phase 2 efficacy and safety of autologous tumor-infiltrating lymphocyte (TIL) cell therapy in combination with pembrolizumab in immune checkpoint inhibitor-naïve patients with advanced cancers

Author

O’Malley, David, primary, Lee, Sylvia, additional, Psyrri, Amanda, additional, Sukari, Ammar, additional, Thomas, Sajeve, additional, Wenham, Robert, additional, Gogas, Helen, additional, Jazaeri, Amir, additional, Monk, Bradley, additional, Rose, Peter, additional, Reuda, Antonio, additional, Finckenstein, Friedrich Graf, additional, Jagasia, Madan, additional, Fiaz, Rana, additional, Garelik, Brigid, additional, Shi, Wen, additional, Desai, Anjali, additional, Sulur, Giri, additional, Chen, Guang, additional, Wu, Xiao, additional, and Jimeno, Antonio, additional

Published
2021
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37. 458 First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)

Author

Schoenfeld, Adam, primary, Lee, Sylvia, additional, Paz-Ares, Luis, additional, Doger, Bernard, additional, Gettinger, Scott, additional, Haefliger, Simon, additional, Orcurto, Angela, additional, Sukari, Ammar, additional, Papa, Sophie, additional, Rodriguez Moreno, Juan Francisco, additional, Finckenstein, Friedrich Graf, additional, Jagasia, Madan, additional, Fiaz, Rana, additional, Sulur, Giri, additional, Chen, Guang, additional, Gontcharova, Viktoria, additional, and He, Kai, additional

Published
2021
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39. Cost and quality issues in establishing hematopoietic cell transplant program in developing countries

Author

Hashmi, Shahrukh K., Srivastava, Alok, Rasheed, Walid, Adil, Salman, Wu, Tong, Jagasia, Madan, Nassar, Amr, Hwang, William Y.K., Hamidieh, Amir Ali, Greinix, Hildegard T., Pasquini, Marcelo C., Apperley, Jane F., and Aljurf, Mahmoud

Abstract

The hematopoietic cell transplant (HCT) activity has grown significantly over the past two decades in both developing and developed countries. Many challenges arise in establishing new HCT programs in developing countries, due to scarcity of resources and manpower in expertise in HCT. While cost issues can potentially hinder establishment of new HCT programs in certain regions, the focus on quality and value should be included in the general vision of leadership before establishing an HCT program. The main challenge in most developing countries is the lack of trained/qualified personnel, enormous start-up costs for a tertiary care center, and quality maintenance. Herein, we discuss the main challenges from a cost and quality perspective which occur at initiation of a new HCT program. We give real world examples of two developing countries that have recently started new HCT programs despite significant financial constraints. We also portray recommendations from the Worldwide Network of Blood and Marrow Transplantation for levels of requirements for a new HCT program. We hope that this review will serve as a general guide for new transplant program leadership with respect to the concerns of balancing high quality with concurrently lowering costs.

Published
2024
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40. NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: II. The 2014 Pathology Working Group Report

Author

Shulman, Howard M., Cardona, Diana M., Greenson, Joel K., Hingorani, Sangeeta, Horn, Thomas, Huber, Elisabeth, Kreft, Andreas, Longerich, Thomas, Morton, Thomas, Myerson, David, Prieto, Victor G., Rosenberg, Avi, Treister, Nathaniel, Washington, Kay, Ziemer, Mirjana, Pavletic, Steven Z., Lee, Stephanie J., Flowers, Mary E.D., Schultz, Kirk R., Jagasia, Madan, Martin, Paul J., Vogelsang, Georgia B., and Kleiner, David E.

Abstract

The 2005 National Institute of Health (NIH) Consensus Conference outlined histopathological diagnostic criteria for the major organ systems affected by both acute and chronic graft-versus-host disease (GVHD). The 2014 Consensus Conference led to this updated document with new information from histopathological studies of GVHD in the gut, liver, skin, and oral mucosa and an expanded discussion of GVHD in the lungs and kidneys. The recommendations for final histological diagnostic categories have been simplified from 4 categories to 3: no GVHD, possible GVHD, and likely GVHD, based on better reproducibility achieved by combining the previous categories of “consistent with GVHD” and “definite GVHD” into the single category of “likely GVHD.” Issues remain in the histopathological characterization of GVHD, particularly with respect to the threshold of histological changes required for diagnostic certainty. Guidance is provided for the incorporation of biopsy information into prospective clinical studies of GVHD, particularly with respect to biomarker validation.

Published
2024
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