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2. Higher doses of tisagenlecleucel associate with improved outcomes: a report from the pediatric real-world CAR consortium

Author

Stefanski, Heather, Eaton, Anne, Baggott, Christina, Rossoff, Jenna, Verneris, Michael R, Keating, Amy K, Prabhu, Snehit, Pacenta, Holly L, Phillips, Christine L, Talano, Julie-An, Moskop, Amy, Margossian, Steven P, Myers, Gary Doug, Karras, Nicole A, Brown, Patrick A, Qayed, Muna, Hermiston, Michelle L, Satwani, Prakash, Krupski, Christa, Wilcox, Rachel, rabik, cara A, Fabrizio, Vanessa A, Chinnabhandar, Vasant, Goksenin, A Yasemin, Egeler, Emily, Mavroukakis, Sharon, Curran, Kevin J, Mackall, Crystal L, Laetsch, Theodore W, and Schultz, Liora M

Subjects
Rare Diseases, Pediatric, Pediatric Cancer, Cancer, Pediatric Research Initiative, Childhood Leukemia, Hematology, Clinical Research, United States, Humans, Child, Adult, Retrospective Studies, Receptors, Antigen, T-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma, T-Lymphocytes, Recurrence, Chronic Disease
Abstract

Remarkable complete response rates have been shown with tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy targeting CD19, in patients up to age 26 years with refractory/relapsed B-cell acute lymphoblastic leukemia; it is US Food and Drug Administration approved for this indication. Currently, patients receive a single dose of tisagenlecleucel across a wide dose range of 0.2 to 5.0 × 106 and 0.1 to 2.5 × 108 CAR T cells per kg for patients ≤50 and >50 kg, respectively. The effect of cell dose on survival and remission is not yet well established. Our primary goal was to determine if CAR T-cell dose affects overall survival (OS), event-free survival (EFS), or relapse-free-survival (RFS) in tisagenlecleucel recipients. Retrospective data were collected from Pediatric Real World CAR Consortium member institutions and included 185 patients infused with commercial tisagenlecleucel. The median dose of viable transduced CAR T cells was 1.7 × 106 CAR T cells per kg. To assess the impact of cell dose, we divided responders into dose quartiles: 0.134 to 1.300 × 106 (n = 48 [27%]), 1.301 to 1.700 × 106 (n = 46 [26%]), 1.701 to 2.400 × 106 (n = 43 [24%]), and 2.401 to 5.100 × 106 (n = 43 [24%]). OS, EFS, and RFS were improved in patients who received higher doses of tisagenlecleucel (P = .031, .0079, and .0045, respectively). Higher doses of tisagenlecleucel were not associated with increased toxicity. Because the current tisagenlecleucel package insert dose range remains broad, this work has implications in regard to targeting higher cell doses, within the approved dose range, to optimize patients' potential for long-standing remission.

Published
2023

3. Outcomes After Nonresponse and Relapse Post-Tisagenlecleucel in Children, Adolescents, and Young Adults With B-Cell Acute Lymphoblastic Leukemia.

Author

Schultz, Liora, Eaton, Anne, Baggott, Christina, Rossoff, Jenna, Prabhu, Snehit, Keating, Amy, Krupski, Christa, Pacenta, Holly, Philips, Christine, Talano, Julie-An, Moskop, Amy, Baumeister, Susanne, Myers, Gary, Karras, Nicole, Brown, Patrick, Qayed, Muna, Satwani, Prakash, Wilcox, Rachel, Rabik, Cara, Fabrizio, Vanessa, Chinnabhandar, Vasant, Kunicki, Michael, Mavroukakis, Sharon, Egeler, Emily, Li, Yimei, Mackall, Crystal, Curran, Kevin, Verneris, Michael, Laetsch, Theodore, Stefanski, Heather, and Hermiston, Michelle

Subjects
Humans, Child, Young Adult, Adolescent, Retrospective Studies, Receptors, Antigen, T-Cell, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Immunotherapy, Adoptive, Recurrence, Antigens, CD19, Chronic Disease
Abstract

PURPOSE: Nonresponse and relapse after CD19-chimeric antigen receptor (CAR) T-cell therapy continue to challenge survival outcomes. Phase II landmark data from the ELIANA trial demonstrated nonresponse and relapse rates of 14.5% and 28%, respectively, whereas use in the real-world setting showed nonresponse and relapse rates of 15% and 37%. Outcome analyses describing fate after post-CAR nonresponse and relapse remain limited. Here, we aim to establish survival outcomes after nonresponse and both CD19+ and CD19- relapses and explore treatment variables associated with inferior survival. METHODS: We conducted a retrospective multi-institutional study of 80 children and young adults with B-cell acute lymphoblastic leukemia experiencing nonresponse (n = 23) or relapse (n = 57) after tisagenlecleucel. We analyze associations between baseline characteristics and these outcomes and establish survival rates and salvage approaches. RESULTS: The overall survival (OS) at 12 months was 19% across nonresponders (n = 23; 95% CI, 7 to 50). Ninety-five percent of patients with nonresponse had high preinfusion disease burden. Among 156 morphologic responders, the cumulative incidence of relapse was 37% (95% CI, 30 to 47) at 12 months (CD19+; 21% [15 to 29], CD19-; 16% [11 to 24], median follow-up; 380 days). Across 57 patients experiencing relapse, the OS was 52% (95% CI, 38 to 71) at 12 months after time of relapse. Notably, CD19- relapse was associated with significantly decreased OS as compared with patients who relapsed with conserved CD19 expression (CD19- 12-month OS; 30% [14 to 66], CD19+ 12-month OS; 68% [49 to 92], P = .0068). Inotuzumab, CAR reinfusion, and chemotherapy were used as postrelapse salvage therapy with greatest frequency, yet high variability in treatment sequencing and responses limits efficacy analysis across salvage approaches. CONCLUSION: We describe poor survival across patients experiencing nonresponse to tisagenlecleucel. In the post-tisagenlecleucel relapse setting, patients can be salvaged; however, CD19- relapse is distinctly associated with decreased survival outcomes.

Published
2023

4. Nutritional Risks in Patients Undergoing Total Pancreatectomy Islet AutoTransplantation in the POST Consortium

Author

Downs, Elissa M., Eaton, Anne, Witkowski, Piotr, Wijkstrom, Martin, Walsh, Matthew, Trikudanathan, Guru, Singh, Vikesh K., Schwarzenberg, Sarah J., Pruett, Timothy L., Posselt, Andrew, Naziruddin, Bashoo, Nathan, Jaimie D., Mokshagundam, Sri Prakash, Morgan, Katherine, Lara, Luis F., Gardner, Timothy B., Freeman, Martin L., Ellery, Kate, Chinnakotla, Srinath, Beilman, Gregory J., Adams, David, Ahmad, Syed, Abu-El-Haija, Maisam, and Bellin, Melena D.

Published
2023
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13. Higher doses of tisagenlecleucel are associated with improved outcomes: a report from the pediatric real-world CAR consortium

Author

Stefanski, Heather E., Eaton, Anne, Baggott, Christina, Rossoff, Jenna, Verneris, Michael R., Prabhu, Snehit, Pacenta, Holly L., Phillips, Christine L., Talano, Julie-An, Moskop, Amy, Margossian, Steven P., Myers, Gary Douglas, Karras, Nicole A., Brown, Patrick A., Qayed, Muna, Hermiston, Michelle, Satwani, Prakash, Krupski, M. Christa, Keating, Amy K., Wilcox, Rachel, Rabik, Cara A., Fabrizio, Vanessa A., Chinnabhandar, Vasant, Goksenin, A. Yasemin, Curran, Kevin J., Mackall, Crystal L., Laetsch, Theodore W., and Schultz, Liora M.

Published
2023
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14. Surgical approach and short-term outcomes in adults and children undergoing total pancreatectomy with islet autotransplantation: A report from the Prospective Observational Study of TPIAT

Author

Nathan, Jaimie D., Yang, Yi, Eaton, Anne, Witkowski, Piotr, Wijkstrom, Martin, Walsh, Matthew, Trikudanathan, Guru, Singh, Vikesh K., Schwarzenberg, Sarah J., Pruett, Timothy L., Posselt, Andrew, Naziruddin, Bashoo, Mokshagundam, Sri Prakash, Morgan, Katherine, Lara, Luis F., Kirchner, Varvara, He, Jin, Gardner, Timothy B., Freeman, Martin L., Ellery, Kate, Conwell, Darwin L., Chinnakotla, Srinath, Beilman, Gregory J., Ahmad, Syed, Abu-El-Haija, Maisam, Hodges, James S., and Bellin, Melena D.

Published
2022
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16. TPIAT improves pain burden and quality of life at 1 year: Results from the Prospective Observational Study of TPIAT (POST) cohort

Author

Trikudanathan, Guru, primary, Eaton, Anne, additional, Abu-El-Haija, Maisam, additional, Adams, David, additional, Ahmad, Syed, additional, Beilman, Gregory J., additional, Chinnakotla, Srinath, additional, Downs, Elissa M., additional, Freeman, Martin L., additional, B. Gardner, Timothy, additional, Lara, Luis F., additional, Morgan, Katherine, additional, Mokshagundam, Sri Prakash, additional, Nathan, Jaimie D., additional, Naziruddin, Bashoo, additional, Posselt, Andrew, additional, Pruett, Timothy L., additional, Schwarzenberg, Sarah J., additional, Singh, Vikesh K., additional, Wijkstrom, Martin, additional, Witkowski, Piotr, additional, and Bellin, Melena D., additional

Published
2023
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22. Supplementary Figure S2 from Human Effectors of Acute and Chronic GVHD Overexpress CD83 and Predict Mortality

Author

Holtan, Shernan G., primary, Savid-Frontera, Constanza, primary, Walton, Kelly, primary, Eaton, Anne A., primary, Demorest, Connor, primary, Hoeschen, Andrea, primary, Zhang, Ling, primary, Reid, Kayla, primary, Kurian, Tony, primary, Sayegh, Zena, primary, Julia, Estefania, primary, Maakaron, Joseph, primary, Bachanova, Veronika, primary, Jurdi, Najla El, primary, MacMillan, Margaret L., primary, Weisdorf, Daniel J., primary, Felices, Martin, primary, Miller, Jeffrey S., primary, Blazar, Bruce R., primary, Davila, Marco L., primary, and Betts, Brian C., primary

Published
2023
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23. Supplementary Table S1 from Human Effectors of Acute and Chronic GVHD Overexpress CD83 and Predict Mortality

Author

Holtan, Shernan G., primary, Savid-Frontera, Constanza, primary, Walton, Kelly, primary, Eaton, Anne A., primary, Demorest, Connor, primary, Hoeschen, Andrea, primary, Zhang, Ling, primary, Reid, Kayla, primary, Kurian, Tony, primary, Sayegh, Zena, primary, Julia, Estefania, primary, Maakaron, Joseph, primary, Bachanova, Veronika, primary, Jurdi, Najla El, primary, MacMillan, Margaret L., primary, Weisdorf, Daniel J., primary, Felices, Martin, primary, Miller, Jeffrey S., primary, Blazar, Bruce R., primary, Davila, Marco L., primary, and Betts, Brian C., primary

Published
2023
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28. Higher doses of tisagenlecleucel are associated with improved outcomes: a report from the pediatric real-world CAR consortium.

Author

Stefanski, Heather E, Stefanski, Heather E, Eaton, Anne, Baggott, Christina, Rossoff, Jenna, Verneris, Michael R, Prabhu, Snehit, Pacenta, Holly L, Phillips, Christine L, Talano, Julie-An, Moskop, Amy, Margossian, Steven P, Myers, Gary Douglas, Karras, Nicole A, Brown, Patrick A, Qayed, Muna, Hermiston, Michelle, Satwani, Prakash, Krupski, M Christa, Keating, Amy K, Wilcox, Rachel, Rabik, Cara A, Fabrizio, Vanessa A, Chinnabhandar, Vasant, Goksenin, A Yasemin, Curran, Kevin J, Mackall, Crystal L, Laetsch, Theodore W, Schultz, Liora M, Stefanski, Heather E, Stefanski, Heather E, Eaton, Anne, Baggott, Christina, Rossoff, Jenna, Verneris, Michael R, Prabhu, Snehit, Pacenta, Holly L, Phillips, Christine L, Talano, Julie-An, Moskop, Amy, Margossian, Steven P, Myers, Gary Douglas, Karras, Nicole A, Brown, Patrick A, Qayed, Muna, Hermiston, Michelle, Satwani, Prakash, Krupski, M Christa, Keating, Amy K, Wilcox, Rachel, Rabik, Cara A, Fabrizio, Vanessa A, Chinnabhandar, Vasant, Goksenin, A Yasemin, Curran, Kevin J, Mackall, Crystal L, Laetsch, Theodore W, and Schultz, Liora M

Abstract

Remarkable complete response rates have been shown with tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy targeting CD19, in patients up to age 26 years with refractory/relapsed B-cell acute lymphoblastic leukemia; it is US Food and Drug Administration approved for this indication. Currently, patients receive a single dose of tisagenlecleucel across a wide dose range of 0.2 to 5.0 × 106 and 0.1 to 2.5 × 108 CAR T cells per kg for patients ≤50 and >50 kg, respectively. The effect of cell dose on survival and remission is not yet well established. Our primary goal was to determine if CAR T-cell dose affects overall survival (OS), event-free survival (EFS), or relapse-free-survival (RFS) in tisagenlecleucel recipients. Retrospective data were collected from Pediatric Real World CAR Consortium member institutions and included 185 patients infused with commercial tisagenlecleucel. The median dose of viable transduced CAR T cells was 1.7 × 106 CAR T cells per kg. To assess the impact of cell dose, we divided responders into dose quartiles: 0.134 to 1.300 × 106 (n = 48 [27%]), 1.301 to 1.700 × 106 (n = 46 [26%]), 1.701 to 2.400 × 106 (n = 43 [24%]), and 2.401 to 5.100 × 106 (n = 43 [24%]). OS, EFS, and RFS were improved in patients who received higher doses of tisagenlecleucel (P = .031, .0079, and .0045, respectively). Higher doses of tisagenlecleucel were not associated with increased toxicity. Because the current tisagenlecleucel package insert dose range remains broad, this work has implications in regard to targeting higher cell doses, within the approved dose range, to optimize patients' potential for long-standing remission.

Published
2023

29. Changes in patterns of traumatic brain injury in the Michigan Trauma Quality Improvement Program database early in the COVID-19 pandemic

Author

Johnson, Reid A., primary, Eaton, Anne, additional, Tignanelli, Christopher J., additional, Carrabre, Kailey J., additional, Gerges, Christina, additional, Yang, George L., additional, Hemmila, Mark R., additional, Ngwenya, Laura B., additional, Wright, James M., additional, Parr, Ann M., additional, and _, _, additional

Published
2023
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30. Human Effectors of Acute and Chronic GVHD Overexpress CD83 and Predict Mortality

Author

Holtan, Shernan G., primary, Savid-Frontera, Constanza, additional, Walton, Kelly, additional, Eaton, Anne A., additional, Demorest, Connor, additional, Hoeschen, Andrea, additional, Zhang, Ling, additional, Reid, Kayla, additional, Kurian, Tony, additional, Sayegh, Zena, additional, Julia, Estefania, additional, Maakaron, Joseph, additional, Bachanova, Veronika, additional, Jurdi, Najla El, additional, MacMillan, Margaret L., additional, Weisdorf, Daniel J., additional, Felices, Martin, additional, Miller, Jeffrey S., additional, Blazar, Bruce R., additional, Davila, Marco L., additional, and Betts, Brian C., additional

Published
2023
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36. Multi-institutional Validation Study of Pancreatic Cyst Fluid Protein Analysis for Prediction of High-risk Intraductal Papillary Mucinous Neoplasms of the Pancreas

Author

Al Efishat, Mohammad A., Attiyeh, Marc A., Eaton, Anne A., Gönen, Mithat, Prosser, Denise, Lokshin, Anna E., Castillo, Carlos Fernández-del, Lillemoe, Keith D., Ferrone, Cristina R., Pergolini, Ilaria, Mino-Kenudson, Mari, Rezaee, Neda, Dal Molin, Marco, Weiss, Matthew J., Cameron, John L., Hruban, Ralph H., D’Angelica, Michael I., Kingham, T. Peter, DeMatteo, Ronald P., Jarnagin, William R., Wolfgang, Christopher L., and Allen, Peter J.

Published
2018
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37. Development and Validation of a Multi-institutional Preoperative Nomogram for Predicting Grade of Dysplasia in Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas: A Report from The Pancreatic Surgery Consortium

Author

Attiyeh, Marc A., Fernández-del Castillo, Carlos, Al Efishat, Mohammad, Eaton, Anne A., Gönen, Mithat, Batts, Ruqayyah, Pergolini, Ilaria, Rezaee, Neda, Lillemoe, Keith D., Ferrone, Cristina R., Mino-Kenudson, Mari, Weiss, Matthew J., Cameron, John L., Hruban, Ralph H., D’Angelica, Michael I., DeMatteo, Ronald P., Kingham, T. Peter, Jarnagin, William R., Wolfgang, Christopher L., and Allen, Peter J.

Published
2018
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