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4. Recombinant Erwinia asparaginase (JZP458) in acute lymphoblastic leukemia/lymphoblastic lymphoma (ALL/LBL): Post hoc analysis of adverse events of interest from AALL1931.

Author

Aoki, Etsuko, primary, Maese, Luke Devon, additional, Loh, Mignon, additional, Agarwal, Shirali, additional, Chandrasekaran, Vijayalakshmi, additional, Liang, Yali, additional, Dronamraju, Nalina, additional, Iannone, Robert, additional, Silverman, Lewis B., additional, Raetz, Elizabeth A., additional, and Rau, Rachel, additional

Published
2024
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7. Supplementary Appendix 2 from Repeatability of Quantitative FDG-PET/CT and Contrast-Enhanced CT in Recurrent Ovarian Carcinoma: Test–Retest Measurements for Tumor FDG Uptake, Diameter, and Volume

Author

Rockall, Andrea G., primary, Avril, Norbert, primary, Lam, Raymond, primary, Iannone, Robert, primary, Mozley, P. David, primary, Parkinson, Christine, primary, Bergstrom, Donald, primary, Sala, Evis, primary, Sarker, Shah-Jalal, primary, McNeish, Iain A., primary, and Brenton, James D., primary

Published
2023
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8. Figure S1 from Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors

Author

Patnaik, Amita, primary, Kang, S. Peter, primary, Rasco, Drew, primary, Papadopoulos, Kyriakos P., primary, Elassaiss-Schaap, Jeroen, primary, Beeram, Muralidhar, primary, Drengler, Ronald, primary, Chen, Cong, primary, Smith, Lon, primary, Espino, Guillermo, primary, Gergich, Kevin, primary, Delgado, Liliana, primary, Daud, Adil, primary, Lindia, Jill A., primary, Li, Xiaoyun Nicole, primary, Pierce, Robert H., primary, Yearley, Jennifer H., primary, Wu, Dianna, primary, Laterza, Omar, primary, Lehnert, Manfred, primary, Iannone, Robert, primary, and Tolcher, Anthony W., primary

Published
2023
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9. Supplementary Tables S1-2, Figure 1 from Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors

Author

Patnaik, Amita, primary, Kang, S. Peter, primary, Rasco, Drew, primary, Papadopoulos, Kyriakos P., primary, Elassaiss-Schaap, Jeroen, primary, Beeram, Muralidhar, primary, Drengler, Ronald, primary, Chen, Cong, primary, Smith, Lon, primary, Espino, Guillermo, primary, Gergich, Kevin, primary, Delgado, Liliana, primary, Daud, Adil, primary, Lindia, Jill A., primary, Li, Xiaoyun Nicole, primary, Pierce, Robert H., primary, Yearley, Jennifer H., primary, Wu, Dianna, primary, Laterza, Omar, primary, Lehnert, Manfred, primary, Iannone, Robert, primary, and Tolcher, Anthony W., primary

Published
2023
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10. Supplementary Appendix 1 from Repeatability of Quantitative FDG-PET/CT and Contrast-Enhanced CT in Recurrent Ovarian Carcinoma: Test–Retest Measurements for Tumor FDG Uptake, Diameter, and Volume

Author

Rockall, Andrea G., primary, Avril, Norbert, primary, Lam, Raymond, primary, Iannone, Robert, primary, Mozley, P. David, primary, Parkinson, Christine, primary, Bergstrom, Donald, primary, Sala, Evis, primary, Sarker, Shah-Jalal, primary, McNeish, Iain A., primary, and Brenton, James D., primary

Published
2023
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11. RecombinantErwiniaasparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study

Author

Maese, Luke, primary, Loh, Mignon L., additional, Choi, Mi Rim, additional, Lin, Tong, additional, Aoki, Etsuko, additional, Zanette, Michelle, additional, Agarwal, Shirali, additional, Iannone, Robert, additional, Silverman, Jeffrey A., additional, Silverman, Lewis B., additional, Raetz, Elizabeth A., additional, and Rau, Rachel E., additional

Published
2023
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12. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial

Author

Robert, Caroline, Ribas, Antoni, Wolchok, Jedd D, Hodi, F Stephen, Hamid, Omid, Kefford, Richard, Weber, Jeffrey S, Joshua, Anthony M, Hwu, Wen-Jen, Gangadhar, Tara C, Patnaik, Amita, Dronca, Roxana, Zarour, Hassane, Joseph, Richard W, Boasberg, Peter, Chmielowski, Bartosz, Mateus, Christine, Postow, Michael A, Gergich, Kevin, Elassaiss-Schaap, Jeroen, Li, Xiaoyun Nicole, Iannone, Robert, Ebbinghaus, Scot W, Kang, S Peter, and Daud, Adil

Published
2014
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13. Efficacy, Safety, and Population Pharmacokinetic Modeling of Intravenous Recombinant Erwinia Asparaginase (JZP458) in Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma: Results from Study AALL1931

Author

Maese, Luke, primary, Loh, Mignon L., additional, Choi, Mi Rim, additional, Lin, Tong, additional, Aoki, Etsuko, additional, Agarwal, Shirali, additional, Wu, Xiaotian, additional, Iannone, Robert, additional, Silverman, Jeffrey A., additional, Silverman, Lewis B., additional, Raetz, Elizabeth A., additional, and Rau, Rachel E., additional

Published
2022
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14. The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial

Author

Sandhu, Shahneen K, Schelman, William R, Wilding, George, Moreno, Victor, Baird, Richard D, Miranda, Susana, Hylands, Lucy, Riisnaes, Ruth, Forster, Martin, Omlin, Aurelius, Kreischer, Nathan, Thway, Khin, Gevensleben, Heidrun, Sun, Linda, Loughney, John, Chatterjee, Manash, Toniatti, Carlo, Carpenter, Christopher L, Iannone, Robert, Kaye, Stan B, de Bono, Johann S, and Wenham, Robert M

Published
2013
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17. Efficacy and Safety of Recombinant Erwinia Asparaginase (JZP458) in Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL): Complete Follow-up of the Children's Oncology Group (COG) AALL1931 Study

Author

Maese, Luke, Loh, Mignon L., Choi, Mi Rim, Lin, Tong, Aoki, Etsuko, Agarwal, Shirali, Chandrasekaran, Vijayalakshmi, Liang, Yali, Girgis, Suzette, Chen, Cuiping, Iannone, Robert, Silverman, Lewis B., Raetz, Elizabeth A., and Rau, Rachel E.

Published
2023
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18. Acknowledgments

Author

Iannone, Robert B., primary, Long, Lennart E., additional, Opolot, James S.E., additional, Rennard, Chelsey, additional, Rojas, Rafael, additional, Sondej, Allen R., additional, and Witt, Michael H., additional

Published
2013
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19. Recombinant Erwiniaasparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study

Author

Maese, Luke, Loh, Mignon L., Choi, Mi Rim, Lin, Tong, Aoki, Etsuko, Zanette, Michelle, Agarwal, Shirali, Iannone, Robert, Silverman, Jeffrey A., Silverman, Lewis B., Raetz, Elizabeth A., and Rau, Rachel E.

Abstract

•Intramuscular JZP458 at 25/25/50 mg/m2M/W/F was effective in patients with ALL/LBL, with a safety profile similar to other asparaginases.•JZP458 overcomes one of the most significant drug shortage issues facing patients with ALL/LBL.

Published
2023
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21. AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia: A report from the Childrenʼs Oncology Group

Author

Cooper, Todd M., Franklin, Janet, Gerbing, Robert B., Alonzo, Todd A., Hurwitz, Craig, Raimondi, Susana C., Hirsch, Betsy, Smith, Franklin O., Mathew, Prasad, Arceci, Robert J., Feusner, James, Iannone, Robert, Lavey, Robert S., Meshinchi, Soheil, and Gamis, Alan

Published
2012
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23. A Phase 2 Trial of KIR Mismatched Unrelated Donor Transplantation Using In Vivo T-cell Depletion with ATG in AML: Children’s Oncology Group AAML05P1 Study

Author

Davies, Stella M, Iannone, Robert, Alonzo, Todd A., Wang, Yi-Cheng, Gerbing, Robert, Soni, Sandeep, Kolb, E. Anders, Meshinchi, Soheil, Orchard, Paul J, Burns, Linda J, Shenoy, Shalini, and Leung, Wing

Subjects
Adult, T-Lymphocytes, Hematopoietic Stem Cell Transplantation, Graft vs Host Disease, chemical and pharmacologic phenomena, Article, Leukemia, Myeloid, Acute, Receptors, KIR, immune system diseases, otorhinolaryngologic diseases, Humans, Prospective Studies, Child, Unrelated Donors, Antilymphocyte Serum
Abstract

Patients with acute myelogenous leukemia (AML) who undergo killer immunoglobulin-like receptor (KIR)-mismatched haploidentical hematopoietic stem cell transplantation (HSCT) have improved survival. Children's Oncology Group AAML05P1 is a prospective phase 2 trial of unrelated donor (URD) HSCT in which KIR typing of donors was available to the treating physician at donor selection, aiming to determine feasibility (defined as the ability to obtain donor samples from URDs and obtain KIR data before transplantation) of prospective selection of KIR-mismatched donors and effect on outcomes. Patients age ≤30 years with high-risk AML at presentation or relapsed AML were eligible; the study accrued 90 evaluable patients. After enrollment, as many as 5 potential URD samples were KIR-typed (including gene expression) in a central laboratory and results reported to the treating physician, who made the final donor selection. Cases were categorized as KIR-matched or KIR-mismatched using different published strategies. Overall survival (OS), disease-free survival (DFS), and relapse did not differ significantly by KIR mismatch status. Acute graft-versus-host disease (GVHD) was significantly lower in recipients of KIR-mismatched stem cells (35% versus 60%; P = .027). We examined DFS according to time to natural killer (NK) receptor recovery after HSCT. NK p44 recovery was significantly associated with KIR mismatch and with decreased DFS and increased relapse risk in multivariate Cox analysis (P = .006 and .009, respectively). We show that prospective selection of URD according to KIR type was feasible, acute GVHD was reduced, but survival did not differ using any model of KIR mismatch. However, the study enrolled mostly matched transplants, so ligand-ligand mismatch was rare, and thus the sample size was insufficient to determine potential benefit according to this model. Cord blood recipients demonstrated a trend toward improved DFS with KIR mismatch, but the study was not powered to detect a difference in this small subset of patients. Our data suggest that recovery of NK receptor expression might influence DFS after HSCT.

Published
2019

31. HTLV-I DNA sequences in CNS tissue of a patient with tropical spastic paraparesis and HTLV-I associated myelopathy

Author

Iannone, Robert, Sherman, Michael P., Rodgers-Johnson, Pamela E.B., Beilke, Mark A., Mora, Carlos A., Amin, Rajnikant M., Tinsley, Susan R., Papsidero, Laurence D., Poiesz, Bernard J., and Gibbs, Clarence J., Jr.

Subjects
HTLV-I infections -- Complications, Paraparesis, Tropical spastic -- Physiological aspects, Myeloproliferative disorders -- Physiological aspects, Health
Published
1992

32. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer

Author

Bardia, Aditya, primary, Mayer, Ingrid A., additional, Vahdat, Linda T., additional, Tolaney, Sara M., additional, Isakoff, Steven J., additional, Diamond, Jennifer R., additional, O’Shaughnessy, Joyce, additional, Moroose, Rebecca L., additional, Santin, Alessandro D., additional, Abramson, Vandana G., additional, Shah, Nikita C., additional, Rugo, Hope S., additional, Goldenberg, David M., additional, Sweidan, Ala M., additional, Iannone, Robert, additional, Washkowitz, Sarah, additional, Sharkey, Robert M., additional, Wegener, William A., additional, and Kalinsky, Kevin, additional

Published
2019
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33. A Prospective Phase 2 Clinical Trial of KIR Mismatched Unrelated Donor Transplantation for Children and Young Adults with High Risk AML: A Report of Children's Oncology Group AAML05P1 Study

Author

Davies, Stella M., primary, Iannone, Robert, additional, Alonzo, Todd, additional, Wang, Jim, additional, Gerbing, Robert, additional, Soni, Sandeep, additional, Kolb, E. Anders, additional, Meshinchi, Soheil, additional, Orchard, Paul, additional, Burns, Linda J., additional, Shenoy, Shalini, additional, and Leung, Wing H., additional

Published
2017
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36. Recombinant Erwiniaasparaginase (JZP458) in ALL/LBL: complete follow-up of the Children’s Oncology Group AALL1931 study

Author

Maese, Luke, Loh, Mignon L., Choi, Mi Rim, Agarwal, Shirali, Aoki, Etsuko, Liang, Yali, Lin, Tong, Girgis, Suzette, Chen, Cuiping, Roller, Shane, Chandrasekaran, Vijayalakshmi, Iannone, Robert, Silverman, Lewis B., Raetz, Elizabeth A., and Rau, Rachel E.

Abstract

•Recombinant Erwiniaasparaginase JZP458 maintains therapeutic serum asparaginase activity levels via multiple IM and IV dosing schedules.•The safety profile of JZP458 is consistent with other asparaginases, with no new adverse safety signals identified at study completion.

Published
2024
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37. Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors

Author

Patnaik, Amita, primary, Kang, S. Peter, additional, Rasco, Drew, additional, Papadopoulos, Kyriakos P., additional, Elassaiss-Schaap, Jeroen, additional, Beeram, Muralidhar, additional, Drengler, Ronald, additional, Chen, Cong, additional, Smith, Lon, additional, Espino, Guillermo, additional, Gergich, Kevin, additional, Delgado, Liliana, additional, Daud, Adil, additional, Lindia, Jill A., additional, Li, Xiaoyun Nicole, additional, Pierce, Robert H., additional, Yearley, Jennifer H., additional, Wu, Dianna, additional, Laterza, Omar, additional, Lehnert, Manfred, additional, Iannone, Robert, additional, and Tolcher, Anthony W., additional

Published
2015
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38. Correlation between Circulating Fungal Biomarkers and Clinical Outcome in Invasive Aspergillosis

Author

Neofytos, Dionysios, primary, Railkar, Radha, additional, Mullane, Kathleen M., additional, Fredricks, David N., additional, Granwehr, Bruno, additional, Marr, Kieren A., additional, Almyroudis, Nikolaos G., additional, Kontoyiannis, Dimitrios P., additional, Maertens, Johan, additional, Fox, Rebecca, additional, Douglas, Cameron, additional, Iannone, Robert, additional, Kauh, Eunkyung, additional, and Shire, Norah, additional

Published
2015
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39. Abstract S1-09: A phase Ib study of pembrolizumab (MK-3475) in patients with advanced triple-negative breast cancer

Author

Nanda, Rita, primary, Chow, Laura Q, additional, Dees, E Claire, additional, Berger, Raanan, additional, Gupta, Shilpa, additional, Geva, Ravit, additional, Pusztai, Lajos, additional, Dolled-Filhart, Marisa, additional, Emancipator, Kenneth, additional, Gonzalez, Edward J, additional, Houp, Jennifer, additional, Pathiraja, Kumudu, additional, Karantza, Vassiliki, additional, Iannone, Robert, additional, Gause, Christine K, additional, Cheng, Johnathan D, additional, and Buisseret, Laurence, additional

Published
2015
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40. Tumorigenic Properties of a HTLV-1 Transformed Human PBL in SCID Mice

Author

Venkateshan, C.N. | Rodgers-Johnson, P. | Liberski, P. P. | Mora, C.A. | Iannone, Robert | Stone, G. A. | Sulima, M. P. | Johnson, B. K. | Gibbs Jr., C. J., Venkateshan, C.N. | Rodgers-Johnson, P. | Liberski, P. P. | Mora, C.A. | Iannone, Robert | Stone, G. A. | Sulima, M. P. | Johnson, B. K. | Gibbs Jr., C. J., Venkateshan, C.N. | Rodgers-Johnson, P. | Liberski, P. P. | Mora, C.A. | Iannone, Robert | Stone, G. A. | Sulima, M. P. | Johnson, B. K. | Gibbs Jr., C. J., and Venkateshan, C.N. | Rodgers-Johnson, P. | Liberski, P. P. | Mora, C.A. | Iannone, Robert | Stone, G. A. | Sulima, M. P. | Johnson, B. K. | Gibbs Jr., C. J.

Abstract

(DLPS) 5571095.0054.011, http://name.umdl.umich.edu/5571095.0054.011, http://quod.lib.umich.edu/t/text/accesspolicy.html, Where applicable, subject to copyright. Other restrictions on distribution may apply. Please go to http://www.umdl.umich.edu/ for more information.

Published
1992

42. Efficacy and safety of the anti-PD-1 monoclonal antibody MK-3475 in 411 patients (pts) with melanoma (MEL).

Author

Ribas, Antoni, primary, Hodi, F. Stephen, additional, Kefford, Richard, additional, Hamid, Omid, additional, Daud, Adil, additional, Wolchok, Jedd D., additional, Hwu, Wen-Jen, additional, Gangadhar, Tara C., additional, Patnaik, Amita, additional, Joshua, Anthony M., additional, Hersey, Peter, additional, Weber, Jeffrey S., additional, Dronca, Roxana Stefania, additional, Zarour, Hassane M., additional, Gergich, Kevin, additional, Li, Xiaoyun (Nicole), additional, Iannone, Robert, additional, Kang, Soonmo Peter, additional, Ebbinghaus, Scot, additional, and Robert, Caroline, additional

Published
2014
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43. A phase I/II study to assess the safety and efficacy of pazopanib and MK-3475 in subjects with advanced renal cell carcinoma.

Author

McDermott, David F., primary, Infante, Jeffrey R., additional, Voss, Martin Henner, additional, Motzer, Robert J., additional, Haanen, John B. A. G., additional, Chowdhury, Simon, additional, Perini, Rodolfo F., additional, Iannone, Robert, additional, Hodge, Rachel, additional, Figueroa, David, additional, Suttle, Benjamin B., additional, Allred, Alicia, additional, Rubin, Stephen D., additional, and Rini, Brian I., additional

Published
2014
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44. A phase Ib study of MK-3475 in patients with human papillomavirus (HPV)-associated and non-HPV–associated head and neck (H/N) cancer.

Author

Seiwert, Tanguy Y., primary, Burtness, Barbara, additional, Weiss, Jared, additional, Gluck, Iris, additional, Eder, Joseph Paul, additional, Pai, Sara I, additional, Dolled-Filhart, Marisa, additional, Emancipator, Kenneth, additional, Pathiraja, Kumudu, additional, Gause, Christine, additional, Iannone, Robert, additional, Brown, Holly, additional, Houp, Jennifer, additional, Cheng, Jonathan D., additional, and Chow, Laura Quan Man, additional

Published
2014
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45. Phase 2 study of programmed death-1 antibody (anti-PD-1, MK-3475) in patients with microsatellite unstable (MSI) tumors.

Author

Le, Dung T., primary, Azad, Nilofer Saba, additional, Laheru, Dan, additional, Browner, Ilene S., additional, Wang, Hao, additional, Uram, Jennifer N., additional, Kemberling, Holly, additional, Zheng, Lei, additional, Iannone, Robert, additional, Friedman, Evan, additional, Meister, Amy, additional, Donehower, Ross C., additional, De Jesus-Acosta, Ana, additional, and Diaz, Luis A., additional

Published
2014
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46. A phase Ib multicohort study of MK-3475 in patients with advanced solid tumors.

Author

Nanda, Rita, primary, Plimack, Elizabeth R., additional, Dees, Elizabeth Claire, additional, Gupta, Shilpa, additional, Berger, Raanan, additional, Elfiky, Aymen, additional, Pusztai, Lajos, additional, Buisseret, Laurence, additional, Geva, Ravit, additional, Pai, Sara I, additional, Pathiraja, Kumudu, additional, Iannone, Robert, additional, Gause, Christine, additional, Brown, Holly, additional, Houp, Jennifer, additional, Cheng, Jonathan D., additional, and Chow, Laura Quan Man, additional

Published
2014
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47. A phase 1 (Ph1) trial of MK-3475 combined with lenalidomide (Len) and low-dose dexamethasone (Dex) in patients (pts) with relapsed/refractory multiple myeloma (RRMM).

Author

Siegel, David Samuel DiCapua, primary, Moreau, Philippe, additional, Avigan, David, additional, Anderson, Kenneth Carl, additional, Reece, Donna Ellen, additional, San Miguel, Jesus, additional, Mateos, María-Victoria, additional, Wu, Dianna, additional, Emancipator, Kenneth, additional, Dolled-Filhart, Marisa, additional, Gause, Christine, additional, Brown, Holly, additional, Heath, Karl, additional, Iannone, Robert, additional, Rose, Shelonitda, additional, and Orlowski, Robert Z., additional

Published
2014
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48. A multicohort trial of the safety and efficacy of the PD-1 inhibitor MK-3475 in patients with hematologic malignancies.

Author

Garcia-Manero, Guillermo, primary, Martinelli, Giovanni, additional, Zeidner, Joshua F., additional, Avigan, David, additional, Anderson, Kenneth Carl, additional, Ribrag, Vincent, additional, Moskowitz, Craig, additional, Zinzani, Pier Luigi, additional, Wu, Dianna, additional, Emancipator, Kenneth, additional, Dolled-Filhart, Marisa, additional, Gause, Christine, additional, Brown, Holly, additional, Geschwindt, Ryan D., additional, Iannone, Robert, additional, Rose, Shelonitda, additional, and Armand, Phillippe, additional

Published
2014
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49. Repeatability of Quantitative FDG-PET/CT and Contrast-Enhanced CT in Recurrent Ovarian Carcinoma: Test–Retest Measurements for Tumor FDG Uptake, Diameter, and Volume

Author

Rockall, Andrea G., primary, Avril, Norbert, additional, Lam, Raymond, additional, Iannone, Robert, additional, Mozley, P. David, additional, Parkinson, Christine, additional, Bergstrom, Donald, additional, Sala, Evis, additional, Sarker, Shah-Jalal, additional, McNeish, Iain A., additional, and Brenton, James D., additional

Published
2014
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50. Immunogenicity of Recombinant Erwiniaasparaginase (JZP458) for Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)

Author

Maese, Luke, Loh, Mignon L., Choi, Mi Rim, Liang, Yali, Aoki, Etsuko, Roller, Shane, Lin, Tong, Agarwal, Shirali, Chandrasekaran, Vijayalakshmi, Iannone, Robert, Silverman, Lewis B., Raetz, Elizabeth A., and Rau, Rachel E.

Abstract

Introduction:L-asparaginase is important in multi-agent treatment regimens for pediatric and adult patients (pts) with ALL/LBL. However, hypersensitivity reactions (HSRs) to E. coli-derived asparaginases (ASP) often lead to treatment delay or discontinuation. JZP458, a recombinant ErwiniaASP derived from a Pseudomonas fluorescensexpression platform, is indicated as part of multi-agent chemotherapy regimens for ALL/LBL in adult and pediatric pts ≥1 month old who developed HSRs to E. coli-derived ASP. Here we report the immunogenicity profile of JZP458 based on study AALL1931.

Published
2023
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