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4. Three-Year Update of Tisagenlecleucel in Pediatric and Young Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia in the ELIANA Trial

Author

Laetsch, T, Maude, S, Rives, S, Hiramatsu, H, Bittencourt, H, Bader, P, Baruchel, A, Boyer, M, De Moerloose, B, Qayed, M, Buechner, J, Pulsipher, M, Myers, G, Stefanski, H, Martin, P, Nemecek, E, Peters, C, Yanik, G, Khaw, S, Davis, K, Krueger, J, Balduzzi, A, Boissel, N, Tiwari, R, O'Donovan, D, Grupp, S, Laetsch, Theodore W, Maude, Shannon L, Rives, Susana, Hiramatsu, Hidefumi, Bittencourt, Henrique, Bader, Peter, Baruchel, André, Boyer, Michael, De Moerloose, Barbara, Qayed, Muna, Buechner, Jochen, Pulsipher, Michael A, Myers, Gary Douglas, Stefanski, Heather E, Martin, Paul L, Nemecek, Eneida, Peters, Christina, Yanik, Gregory, Khaw, Seong Lin, Davis, Kara L, Krueger, Joerg, Balduzzi, Adriana, Boissel, Nicolas, Tiwari, Ranjan, O'Donovan, Darragh, Grupp, Stephan A, Laetsch, T, Maude, S, Rives, S, Hiramatsu, H, Bittencourt, H, Bader, P, Baruchel, A, Boyer, M, De Moerloose, B, Qayed, M, Buechner, J, Pulsipher, M, Myers, G, Stefanski, H, Martin, P, Nemecek, E, Peters, C, Yanik, G, Khaw, S, Davis, K, Krueger, J, Balduzzi, A, Boissel, N, Tiwari, R, O'Donovan, D, Grupp, S, Laetsch, Theodore W, Maude, Shannon L, Rives, Susana, Hiramatsu, Hidefumi, Bittencourt, Henrique, Bader, Peter, Baruchel, André, Boyer, Michael, De Moerloose, Barbara, Qayed, Muna, Buechner, Jochen, Pulsipher, Michael A, Myers, Gary Douglas, Stefanski, Heather E, Martin, Paul L, Nemecek, Eneida, Peters, Christina, Yanik, Gregory, Khaw, Seong Lin, Davis, Kara L, Krueger, Joerg, Balduzzi, Adriana, Boissel, Nicolas, Tiwari, Ranjan, O'Donovan, Darragh, and Grupp, Stephan A

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.In the primary analysis of the global phase II ELIANA trial (ClinicalTrials.gov identifier: NCT02435849), tisagenlecleucel provided an overall remission rate of 81% in pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), with 59% of responders remaining relapse-free at 12 months. Here, we report an update on efficacy, safety, and patient-reported quality of life in 79 pediatric and young adult patients with R/R B-ALL following a median follow-up of 38.8 months. The overall remission rate was 82%. The median event-free survival was 24 months, and the median overall survival was not reached. Event-free survival was 44% (95% CI, 31 to 57) and overall survival was 63% (95% CI, 51 to 73) at 3 years overall (most events occur within the first 2 years). The estimated 3-year relapse-free survival with and without censoring for subsequent therapy was 52% (95% CI, 37 to 66) and 48% (95% CI, 34 to 60), respectively. No new or unexpected long-term adverse events were reported. Grade 3/4 adverse events were reported in 29% of patients > 1 year after infusion; grade 3/4 infection rate did not increase > 1 year after infusion. Patients reported improvements in quality of life up to 36 months after infusion. These findings demonstrate favorable long-term safety and suggest tisagenlecleucel as a curative treatment option for heavily pretreated pediatric and young adult patients with R/R B-ALL.

Published
2023

9. S112: TISAGENLECLEUCEL IN PEDIATRIC AND YOUNG ADULT PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL): FINAL ANALYSES FROM THE ELIANA STUDY

Author

Rives, S., primary, Maude, S. L., additional, Hiramatsu, H., additional, Baruchel, A., additional, Bader, P., additional, Bittencourt, H., additional, Buechner, J., additional, Laetsch, T., additional, De Moerloose, B., additional, Qayed, M., additional, Stefanski, H. E., additional, Davis, K. L., additional, Martin, P. L., additional, Nemecek, E., additional, Peters, C., additional, Yanik, G., additional, Balduzzi, A., additional, Boissel, N., additional, Khaw, S. L., additional, Krueger, J., additional, Levine, J., additional, Davies, S., additional, Myers, G. D., additional, Yeo, A., additional, O’Donovan, D., additional, Ramos, R., additional, Pulsipher, M., additional, and Grupp, S., additional

Published
2022
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13. Defibrotide: potential for treating endothelial dysfunction related to viral and post-infectious syndromes

Author

Richardson, E, Garcia-Bernal, D, Calabretta, E, Jara, R, Palomo, M, Baron, RM, Yanik, G, Fareed, J, Vlodavsky, I, Iacobelli, M, Diaz-Ricart, M, Richardson, PG, Carlo-Stella, C, and Moraleda, JM

Subjects
Defibrotide, Ebola, coronavirus, COVID-19, viral hemorrhagic fever, influenza A, complement cascade, endothelial dysfunction
Abstract

Introduction Defibrotide (DF) is a polyribonucleotide with antithrombotic, pro-fibrinolytic, and anti-inflammatory effects on endothelium. These effects and the established safety of DF present DF as a strong candidate to treat viral and post-infectious syndromes involving endothelial dysfunction. Areas Covered We discuss DF and other therapeutic agents that have the potential to target endothelial components of pathogenesis in viral and post-infectious syndromes. We introduce defibrotide (DF), describe its mechanisms of action, and explore its established pleiotropic effects on the endothelium. We describe the established pathophysiology of Coronavirus Disease 2019 (COVID-19) and highlight the processes specific to COVID-19 potentially modulated by DF. We also present influenza A and viral hemorrhagic fevers, especially those caused by hantavirus, Ebola virus, and dengue virus, as viral syndromes in which DF might serve therapeutic benefit. Finally, we offer our opinion on novel treatment strategies targeting endothelial dysfunction in viral infections and their severe manifestations. Expert Opinion Given the critical role of endothelial dysfunction in numerous infectious syndromes, in particular COVID-19, therapeutic pharmacology for these conditions should increasingly prioritize endothelial stabilization. Several agents with endothelial protective properties should be further studied as treatments for severe viral infections and vasculitides, especially where other therapeutic modalities have failed.

Published
2021

24. S1618 TISAGENLECLEUCEL APPEARS EFFECTIVE AND SAFE IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA WITH HIGH-RISK CYTOGENETIC ABNORMALITIES

Author

Grupp, S., primary, Maude, S., additional, Baruchel, A., additional, Laetsch, T.W., additional, Driscoll, T., additional, Qayed, M., additional, Levine, J., additional, Boyer, M., additional, Krueger, J., additional, Myers, G. D., additional, Peters, C., additional, Rives, S., additional, Bader, P., additional, Boissel, N., additional, Davies, S., additional, Davis, K., additional, Nemecek, E., additional, Yanik, G., additional, Tiwari, R., additional, Konduri, S., additional, Eldjerou, L., additional, Chassot Agostinho, A., additional, Hunger, S., additional, and Pulsipher, M., additional

Published
2019
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25. Sickle cell disease: An international survey of results of HLA-identical sibling hematopoietic stem cell transplantation

Author

Gluckman, E., Cappelli, B., Bernaudin, F., Labopin, M., Volt, F., Carreras, J., Simoes, B. P., Ferster, A., Dupont, S., De La Fuente, J., Dalle, J. -H., Zecca, M., Walters, M. C., Krishnamurti, L., Bhatia, M., Leung, K., Yanik, G., Kurtzberg, J., Dhedin, N., Kuentz, M., Michel, G., Apperley, J., Lutz, P., Neven, B., Bertrand, Y., Vannier, J. P., Ayas, M., Cavazzana, M., Matthes-Martin, S., Rocha, V., Elayoubi, H., Kenzey, C., Bader, P., Locatelli, Franco, Ruggeri, A., Eapen, M., Bordon, V., Labarque, V., Pereira, M., Bittencourt, H., Petersen, H., Deconninck, E., Jubert, C., Perrin, J., Cahn, J. Y., Bruno, B., Bordigoni, P., Mechinaud, F., Vernant, J. P., Stephan, J. L., Suttorp, M., Strahm, B., Da Cunha, C. B., Garwer, B., Rothmayer, M., Wendelin, K., Graphakos, S., Tbakhi, A., Naeimi, N., Zuckerman, T., Sharon, P. B., Yaniv, I., Amos, T., Prete, A., Lo Nigro, L., Lanino, E., Faraci, M., Ciceri, F., Marktel, S., De Simone, G., Messina, C., Bartolomeo, P. D. I., Santarone, S., Vallisa, D., Bertaina, A., Arcese, W., Foa, R., Berger, M., Maximova, N., Wallet, S., Bazuaye, G. N., Maschan, A., De Heredia, C. D., Bieler, C. B., Pato, J. R., Heras, I., Trevor, R., Abayomi, K., Thomson, J., Fasth, A., Frodin, U., Ljugman, P., Ansari, M., Gungor, T., Unal, E., Pehlivan, M., Anak, S., Ozturk, G., Unal, A., Lawson, S., Keshani, J., Drake, A., Wynn, R., Williams, J., Jagsia, M., Leung, W., Abraham, A., Sahdey, I., Margolis, D., Eames, G., Horwitz, E., Cowan, M., Kapoor, N., Rowley, S., Megason, G., Rogers, Z., Bolanos-Meade, J., Hudspeth, M., Rosenthal, J., Olson, T., Kassow, K., Selby, G., Haines, H., Chaudhury, S., Gluckman, E., Cappelli, B., Bernaudin, F., Labopin, M., Volt, F., Carreras, J., Simoes, B. P., Ferster, A., Dupont, S., De La Fuente, J., Dalle, J. -H., Zecca, M., Walters, M. C., Krishnamurti, L., Bhatia, M., Leung, K., Yanik, G., Kurtzberg, J., Dhedin, N., Kuentz, M., Michel, G., Apperley, J., Lutz, P., Neven, B., Bertrand, Y., Vannier, J. P., Ayas, M., Cavazzana, M., Matthes-Martin, S., Rocha, V., Elayoubi, H., Kenzey, C., Bader, P., Locatelli, F., Ruggeri, A., Eapen, M., Bordon, V., Labarque, V., Pereira, M., Bittencourt, H., Petersen, H., Deconninck, E., Jubert, C., Perrin, J., Cahn, J. Y., Bruno, B., Bordigoni, P., Mechinaud, F., Vernant, J. P., Stephan, J. L., Suttorp, M., Strahm, B., Da Cunha, C. B., Garwer, B., Rothmayer, M., Wendelin, K., Graphakos, S., Tbakhi, A., Naeimi, N., Zuckerman, T., Sharon, P. B., Yaniv, I., Amos, T., Prete, A., Lo Nigro, L., Lanino, E., Faraci, M., Ciceri, F., Marktel, S., De Simone, G., Messina, C., Bartolomeo, P. D. I., Santarone, S., Vallisa, D., Bertaina, A., Arcese, W., Foa, R., Berger, M., Maximova, N., Wallet, S., Bazuaye, G. N., Maschan, A., De Heredia, C. D., Bieler, C. B., Pato, J. R., Heras, I., Trevor, R., Abayomi, K., Thomson, J., Fasth, A., Frodin, U., Ljugman, P., Ansari, M., Gungor, T., Unal, E., Pehlivan, M., Anak, S., Ozturk, G., Unal, A., Lawson, S., Keshani, J., Drake, A., Wynn, R., Williams, J., Jagsia, M., Leung, W., Abraham, A., Sahdey, I., Margolis, D., Eames, G., Horwitz, E., Cowan, M., Kapoor, N., Rowley, S., Megason, G., Rogers, Z., Bolanos-Meade, J., Hudspeth, M., Rosenthal, J., Olson, T., Kassow, K., Selby, G., Haines, H., Chaudhury, S., France Monacord, Centre Scientifique de Monaco (CSM), CHI Créteil, Centre de Recherche Saint-Antoine (CR Saint-Antoine), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), Eurocord, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Institut Universitaire d'Hématologie (IUH), Université Paris Diderot - Paris 7 (UPD7)-Université Paris Diderot - Paris 7 (UPD7), Hôpital Universitaire des Enfants - Reine Fabiola, Université Libre de Bruxelles, Equipe NEMESIS - Centre de Recherches de l'Institut du Cerveau et de la Moelle épinière (NEMESIS-CRICM), Centre de Recherche de l'Institut du Cerveau et de la Moelle épinière (CRICM), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), Unité d'Hémato-Immunologie pédiatrique [Hôpital Robert Debré, Paris], Service d'Immuno-hématologie pédiatrique [Hôpital Robert Debré, Paris], Hôpital Robert Debré-Hôpital Robert Debré, Duke University Medical Center, Service de Greffe de Moelle - Unité AJA, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service d'hématologie clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Hôpital de la Timone [CHU - APHM] (TIMONE), Department of Haematology, Hôpital Civil, Hopital Civil, Département d'Immunologie, hématologie et rhumatologie pédiatriques [Hôpital Necker-Enfants malades - APHP], CHU Necker - Enfants Malades [AP-HP], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Hemostase, Endothelium, Angiogenese (UMR_S_553), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Physiopathologie, Autoimmunité, maladies Neuromusculaires et THErapies Régénératrices (PANTHER), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Imagine - Institut des maladies génétiques (IMAGINE - U1163), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Churchill Hospital [Breast Care Unit], Churchill Hospital Oxford Centre for Haematology, Santa Lucia Foundation, IRCSS, Rome, Medical College of Wisconsin, National Institute for Health Research, Centre de Recherche Saint-Antoine (UMRS893), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut Universitaire d'Hématologie (IUH), Hôpital Universitaire des Enfants Reine Fabiola [Bruxelles, Belgique] (HUDERF), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, and UCL - (SLuc) Service d'hématologie et d'oncologie pédiatrique

Subjects
Male, HYDROXYUREA, Transplantation Conditioning, [SDV]Life Sciences [q-bio], medicine.medical_treatment, CHILDREN, Hematopoietic stem cell transplantation, Biochemistry, THALASSEMIA, 0302 clinical medicine, HLA Antigens, Surveys and Questionnaires, 1114 Paediatrics And Reproductive Medicine, Child, ComputingMilieux_MISCELLANEOUS, CÉLULAS-TRONCO, Hazard ratio, Graft Survival, BONE-MARROW TRANSPLANT, Hematopoietic Stem Cell Transplantation, Hematology, Sickle cell anemia, 3. Good health, Survival Rate, medicine.anatomical_structure, Treatment Outcome, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, 030220 oncology & carcinogenesis, Child, Preschool, Histocompatibility, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, Life Sciences & Biomedicine, medicine.medical_specialty, Adolescent, Anemia, Immunology, Anemia, Sickle Cell, 1102 Cardiovascular Medicine And Haematology, Disease-Free Survival, 03 medical and health sciences, Internal medicine, MANAGEMENT, medicine, Humans, ANEMIA, Survival rate, Transplantation, Science & Technology, business.industry, Siblings, Sickle cell disease, Infant, 1103 Clinical Sciences, ADULTS, Cell Biology, medicine.disease, LIFE, EXPERT PANEL, Bone marrow, FOLLOW-UP, business, 030215 immunology
Abstract

Despite advances in supportive therapy to prevent complications of sickle cell disease (SCD), access to care is not universal. Hematopoietic cell transplantation is, to date, the only curative therapy for SCD, but its application is limited by availability of a suitable HLA-matched donor and lack of awareness of the benefits of transplant. Included in this study are 1000 recipients of HLA-identical sibling transplants performed between 1986 and 2013 and reported to the European Society for Blood and Marrow Transplantation, Eurocord, and the Center for International Blood and Marrow Transplant Research. The primary endpoint was event-free survival, defined as being alive without graft failure; risk factors were studied using a Cox regression models. The median age at transplantation was 9 years, and the median follow-up was longer than 5 years. Most patients received a myeloablative conditioning regimen (n = 873; 87%); the remainder received reduced-intensity conditioning regimens (n = 125; 13%). Bone marrow was the predominant stem cell source (n = 839; 84%); peripheral blood and cord blood progenitors were used in 73 (7%) and 88 (9%) patients, respectively. The 5-year event-free survival and overall survival were 91.4% (95% confidence interval, 89.6%-93.3%) and 92.9% (95% confidence interval, 91.1%-94.6%), respectively. Event-free survival was lower with increasing age at transplantation (hazard ratio [HR], 1.09; P < .001) and higher for transplantations performed after 2006 (HR, 0.95; P = .013). Twenty-three patients experienced graft failure, and 70 patients (7%) died, with the most common cause of death being infection. The excellent outcome of a cohort transplanted over the course of 3 decades confirms the role of HLA-identical sibling transplantation for children and adults with SCD.

Published
2017
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26. Contribution of in vivo proliferation/differentiation studies toward the development of a combined functional and morphologic system of classification of neoplastic diseases

Author

Raza, Azra, Yousuf, N., Bokhari, S.A.J., Mehdi, A., Masterson, M., Lampkin, B., Yanik, G., Mazewski, C., Khan, S., and Preisler, H.

Subjects
Tumor staging -- Methods, Tumors -- Identification and classification, Cancer -- Molecular aspects, Health
Abstract

Proliferation kinetics of both leukemia and a variety of solid tumors have been assessed after in vivo infusions of the thymidine analogues, iododeoxyuridine (IUdR) and bromodeoxyuridine (BrdU). In acute myeloid leukemia (AML), these data indicate that the pretherapy cell cycle time (Tc) of myeloblasts is a prognostic indicator for remission duration since patients with slowly cycling myeloblasts had more durable remissions. The presence of in vivo differentiation detected from the day 7 biopsy after chemotherapy was also of favorable prognosis as these individuals had statistically significant improvement in their remission duration. The data in solid tumors are not mature enough for determining their clinical significance. Since cell kinetic information is readily available in a prompt fashion using these novel techniques, data can be used to plan therapeutic strategies for patients. This review discusses the state-of-the-art techniques available for cell cycle kinetic studies and the clinical and prognostic utility of data that have been generated thus far. Cancer 1992; 69:1557-1566.

Published
1992

27. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia

Author

Maude, S, Laetsch, T, Buechner, J, Rives, S, Boyer, M, Bittencourt, H, Bader, P, Verneris, M, Stefanski, H, Myers, G, Qayed, M, De Moerloose, B, Hiramatsu, H, Schlis, K, Davis, K, Martin, P, Nemecek, E, Yanik, G, Peters, C, Baruchel, A, Boissel, N, Mechinaud, F, Balduzzi, A, Krueger, J, June, C, Levine, B, Wood, P, Taran, T, Leung, M, Mueller, K, Zhang, Y, Sen, K, Lebwohl, D, Pulsipher, M, Grupp, S, Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, Grupp SA, Maude, S, Laetsch, T, Buechner, J, Rives, S, Boyer, M, Bittencourt, H, Bader, P, Verneris, M, Stefanski, H, Myers, G, Qayed, M, De Moerloose, B, Hiramatsu, H, Schlis, K, Davis, K, Martin, P, Nemecek, E, Yanik, G, Peters, C, Baruchel, A, Boissel, N, Mechinaud, F, Balduzzi, A, Krueger, J, June, C, Levine, B, Wood, P, Taran, T, Leung, M, Mueller, K, Zhang, Y, Sen, K, Lebwohl, D, Pulsipher, M, Grupp, S, Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, and Grupp SA

Abstract

BACKGROUND In a single-center phase 1-2a study, the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel produced high rates of complete remission and was associated with serious but mainly reversible toxic effects in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). METHODS We conducted a phase 2, single-cohort, 25-center, global study of tisagenlecleucel in pediatric and young adult patients with CD19+ relapsed or refractory B-cell ALL. The primary end point was the overall remission rate (the rate of complete remission or complete remission with incomplete hematologic recovery) within 3 months. RESULTS For this planned analysis, 75 patients received an infusion of tisagenlecleucel and could be evaluated for efficacy. The overall remission rate within 3 months was 81%, with all patients who had a response to treatment found to be negative for minimal residual disease, as assessed by means of flow cytometry. The rates of event-free survival and overall survival were 73% (95% confidence interval [CI], 60 to 82) and 90% (95% CI, 81 to 95), respectively, at 6 months and 50% (95% CI, 35 to 64) and 76% (95% CI, 63 to 86) at 12 months. The median duration of remission was not reached. Persistence of tisagenlecleucel in the blood was observed for as long as 20 months. Grade 3 or 4 adverse events that were suspected to be related to tisagenlecleucel occurred in 73% of patients. The cytokine release syndrome occurred in 77% of patients, 48% of whom received tocilizumab. Neurologic events occurred in 40% of patients and were managed with supportive care, and no cerebral edema was reported. CONCLUSIONS In this global study of CAR T-cell therapy, a single infusion of tisagenlecleucel provided durable remission with long-term persistence in pediatric and young adult patients with relapsed or refractory B-cell ALL, with transient high-grade toxic effects.

Published
2018

29. An early-biomarker algorithm predicts lethal graft-versus-host disease and survival

Author

Hartwell, M. J., Ozbek, U., Holler, E., Renteria, A. S., Major-Monfried, H., Reddy, P., Aziz, M., Hogan, W. J., Ayuk, F., Efebera, Y. A., Hexner, E. O., Bunworasate, U., Qayed, M., Ordemann, R., Wolfl, M., Mielke, S., Pawarode, A., Chen, Y. -B., Devine, S., Harris, A. C., Jagasia, M., Kitko, C. L., Litzow, M. R., Kroger, N., Locatelli, Franco, Morales, G., Nakamura, R., Reshef, R., Rosler, W., Weber, D., Wudhikarn, K., Yanik, G. A., Levine, J. E., Ferrara, J. L. M., Locatelli F. (ORCID:0000-0002-7976-3654), Hartwell, M. J., Ozbek, U., Holler, E., Renteria, A. S., Major-Monfried, H., Reddy, P., Aziz, M., Hogan, W. J., Ayuk, F., Efebera, Y. A., Hexner, E. O., Bunworasate, U., Qayed, M., Ordemann, R., Wolfl, M., Mielke, S., Pawarode, A., Chen, Y. -B., Devine, S., Harris, A. C., Jagasia, M., Kitko, C. L., Litzow, M. R., Kroger, N., Locatelli, Franco, Morales, G., Nakamura, R., Reshef, R., Rosler, W., Weber, D., Wudhikarn, K., Yanik, G. A., Levine, J. E., Ferrara, J. L. M., and Locatelli F. (ORCID:0000-0002-7976-3654)

Published
2017

30. Vorinostat plus tacrolimus/methotrexate to prevent GVHD after myeloablative conditioning, unrelated donor HCT

Author

Choi, S.W., Braun, T., Henig, I., Gatza, E., Magenau, J., Parkin, B., Pawarode, A., Riwes, M., Yanik, G., Dinarello, C.A., Reddy, P., Choi, S.W., Braun, T., Henig, I., Gatza, E., Magenau, J., Parkin, B., Pawarode, A., Riwes, M., Yanik, G., Dinarello, C.A., and Reddy, P.

Abstract

Contains fulltext : 182594.pdf (publisher's version ) (Closed access), The oral histone deacetylase (HDAC) inhibitor (vorinostat) is safe and results in low incidence of acute graft-versus-host disease (GVHD) after reduced-intensity conditioning, related donor hematopoietic cell transplantation (HCT). However, its safety and efficacy in preventing acute GVHD in settings of heightened clinical risk that use myeloablative conditioning, unrelated donor (URD), and methotrexate are not known. We conducted a prospective, phase 2 study in this higher-risk setting. We enrolled 37 patients to provide 80% power to detect a significant difference in grade 2 to 4 acute GVHD of 50% compared with a reduction in target to 28%. Eligibility included adults with a hematological malignancy to receive myeloablative HCT from an available 8/8-HLA matched URD. Patients received GVHD prophylaxis with tacrolimus and methotrexate. Vorinostat (100 mg twice daily) was started on day -10 and continued through day +100 post-HCT. Median age was 56 years (range, 18-69 years), and 95% had acute myelogenous leukemia or high-risk myelodysplastic syndrome. Vorinostat was safe and tolerable. The cumulative incidence of grade 2 to 4 acute GVHD at day 100 was 22%, and for grade 3 to 4 it was 8%. The cumulative incidence of chronic GVHD was 29%; relapse, nonrelapse mortality, GVHD-free relapse-free survival, and overall survival at 1 year were 19%, 16%, 47%, and 76%, respectively. Correlative analyses showed enhanced histone (H3) acetylation in peripheral blood mononuclear cells and reduced interleukin 6 (P = .028) and GVHD biomarkers (Reg3, P = .041; ST2, P = .002) at day 30 post-HCT in vorinostat-treated subjects compared with similarly treated patients who did not receive vorinostat. Vorinostat for GVHD prevention is an effective strategy that should be confirmed in a randomized phase 3 study. This trial was registered at www.clinicaltrials.gov as #NCT01790568.

Published
2017

31. Quasi-Resonant Full-Wave Zero-Current Switching Buck Converter Design, Simulation and Application

Author

YANİK, G. and ISEN, E.

Subjects
Hardware_GENERAL
Abstract

—This paper presents a full wave quasi-resonant zerocurrent switching buck converter design, simulation and application. The converter control uses with zero-current switching (ZCS) technique to decrease the switching losses. Comparing to conventional buck converter, resonant buck converter includes a resonant tank equipped with resonant inductor and capacitor. The converter is analyzed in mathematical for each subintervals. Depending on the desired input and output electrical quantities, converter is designed with subinterval equations. The converter is simulated in PSIM with design parameters. The simulation results are verified with experimental setup. The converter is controlled by UC3867N integrated resonant mode power supply controller

Published
2015

32. Production of translucent ceramics containing diopside-akermanite phases by fast firing

Author

Ceylantekin, R., Uz, V., Yanik, G., Sirin, M., and Kadioglu, H.

Subjects
Translucent ceramic, Akermanite, Fast firing, Sepiolite, Diopside
Abstract

WOS: 000308569300011, In this study, research was made on the production of white and translucent ceramics with a low water absorption and high resistance using waste dolomitic sepiolite, cullet and calcite through fast firing under operational conditions. For this purpose, 4 different recipes were prepared. The recipes were first dry ground and shaped with a dry pressing method. The shaped samples were then fired in a fast firing kiln at 1140 degrees C for 70 minutes. Strength, water absorption, porosity and color measurements were made on the fired samples as well as mineralogical and microstructural examinations. Consequently, diopside and amorphous phases and diopside and akermanite based ceramic structures were produced using the waste materials through fast firing at 1140 degrees C. L* values of the fired samples were found to be between 92.30 and 95.40. In the samples with the akermanite and diopside phases, the ratio of dissolution was found to be higher in acids than samples containing the diopside and amorphous phases. Consequently, highly white and translucent ceramics with a low water absorption capacity were obtained using the waste materials used through fast firing.

Published
2012

33. Characterization of underclays from Agacli-Kemerburgaz region of Istanbul/Turkey and their evaluation for porcelain tile production

Author

Yavuz O., Kayaci K., Kucuker A.S., Ozdamar S., Uzun M., Yanik G., Tarcan M., Anadolu Üniversitesi, Mühendislik Fakültesi, Malzeme Bilimi ve Mühendisliği Bölümü, and Kara, Alpagut

Abstract

WOS: 000297454600003, gacli-Kemerburgaz area, NW of Istanbul, is one of the most important underclay deposits of Turkey This area is composed of Paleozoic sedimentary sequence, Upper Cretaceous volcanic rocks, Neogene sediments and Quaternary alluvium deposits. The calc-alkaline volcanic rocks are the parent rocks of the underclays in this area. In this work, mineralogical and chemical analyses and relevant technological tests were conducted in order to assess the potential of selected underclays of this region. The technological properties were characterized by firing shrinkage, water absorption and breaking strength after firing. The chemical analyses generally showed the characteristics of typical kaolinized materials. Underclays containing (up to 33 wt. %) porcelain stoneware formulations were prepared and standard tests were applied to the porcelain tiles after single fast firing under industrial conditions. The densification behaviour and phase evolution of the bodies upon firing were evaluated. Physical, thermal and optical properties and chromatic coordinates were also measured. The results revealed that it was possible to employ the underclays to replace more expensive clay in porcelain tile production without deterioration of the required properties.

Published
2011

34. MIBG scans in patients with stage 4 neuroblastoma reveal two metastatic patterns, one is associated with MYCN amplification and in MYCN-amplified tumours correlates with a better prognosis

Author

Bleeker, G, van Eck-Smit, BL, Zwinderman, KH, Versteeg, R, Noesel, MM, Kam, BLR, Kaspers, GJ, van Schie, A, Kreissman, SG, Yanik, G, Hero, B, Schmidt, M, Laureys, G, Lambert, B, Ora, I, Schulte, JH, Caron, HN, Tytgat, GA, Bleeker, G, van Eck-Smit, BL, Zwinderman, KH, Versteeg, R, Noesel, MM, Kam, BLR, Kaspers, GJ, van Schie, A, Kreissman, SG, Yanik, G, Hero, B, Schmidt, M, Laureys, G, Lambert, B, Ora, I, Schulte, JH, Caron, HN, and Tytgat, GA

Published
2015

35. Analytic morphomics: a novel CT imaging approach to quantify adipose tissue and muscle composition in allogeneic hematopoietic cell transplantation

Author

Chughtai, K, primary, Song, Y, additional, Zhang, P, additional, Derstine, B, additional, Gatza, E, additional, Friedman, J, additional, Hully, L, additional, Inglis, C, additional, Goldstein, S, additional, Magenau, J, additional, Pawarode, A, additional, Reddy, P, additional, Riwes, M, additional, Yanik, G, additional, Wang, S C, additional, and Choi, S W, additional

Published
2015
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36. FLT3 mutational status is an independent risk factor for adverse outcomes after allogeneic transplantation in AML

Author

Song, Y, primary, Magenau, J, additional, Li, Y, additional, Braun, T, additional, Chang, L, additional, Bixby, D, additional, Hanauer, D A, additional, Chughtai, K A, additional, Gatza, E, additional, Couriel, D, additional, Goldstein, S, additional, Pawarode, A, additional, Reddy, P, additional, Riwes, M, additional, Connelly, J, additional, Harris, A, additional, Kitko, C, additional, Levine, J, additional, Yanik, G, additional, Parkin, B, additional, and Choi, S W, additional

Published
2015
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37. MIBG scans in patients with stage 4 neuroblastoma reveal two metastatic patterns, one is associated with MYCN amplification and in MYCN-amplified tumours correlates with a better prognosis

Author

Bleeker, G. (Gitta), Eck-Smit, B.L.F. (Berthe) van, Zwinderman, K. (Koos), Versteeg, R. (Rogier), Noesel, M.M. (Max) van, Kam, B.L. (Boen), Kaspers, G.J. (Gertjan J.), van Schie, A. (Annelies), Kreissman, S.G. (Susan G.), Yanik, G. (Gregory), Hero, B. (Barbara), Schmidt, M. (Matthias), Laureys, G. (Geneviève), Lambert, B. (Bieke), Øra, I. (Ingrid), Schulte, J.H. (Johannes), Caron, H.N. (Huib), Tytgat, G.A.M. (Godelieve ), Bleeker, G. (Gitta), Eck-Smit, B.L.F. (Berthe) van, Zwinderman, K. (Koos), Versteeg, R. (Rogier), Noesel, M.M. (Max) van, Kam, B.L. (Boen), Kaspers, G.J. (Gertjan J.), van Schie, A. (Annelies), Kreissman, S.G. (Susan G.), Yanik, G. (Gregory), Hero, B. (Barbara), Schmidt, M. (Matthias), Laureys, G. (Geneviève), Lambert, B. (Bieke), Øra, I. (Ingrid), Schulte, J.H. (Johannes), Caron, H.N. (Huib), and Tytgat, G.A.M. (Godelieve )

Abstract

Methods: Diagnostic 123I-MIBG scans from 249 patients (123 from a European and 126 from the COG cohort) were assessed for metastatic spread in 14 body segments and the form of the lesions: “focal” (clear margins distinguishable from adjacent background) or “diffuse” (indistinct margins, dispersed throughout the body segment). The total numbers of diffuse and focal lesions were recorded. Patients were then categorized as having lesions exclusively focal, lesions more focal than diffuse, lesions more diffuse than focal, or lesions exclusively diffuse.Results: Diffuse lesions affected a median of seven body segments and focal lesions a median of two body segments (P < 0.001, both cohorts). Patients with a focal pattern had a median of 2 affected body segments and those with a diffuse pattern a median of 11 affected body segments (P < 0.001, both cohorts). Thus, two MIBG-avid metastatic patterns emerged: “limited-focal” and “extensive-diffuse”. The median numbers of affected body segments in MYCN-amplified (MNA) tumours were 5 (European cohort) and 4 (COG cohort) compared to 9 and 11, respectively, in single-copy MYCN (MYCNsc) tumours (P < 0.001). Patients with exclusively focal metastases were more likely to have a MNA tumour (60 % and 70 %, respectively) than patients with the other types of metastases (23 % and 28 %, respectively; P < 0.001). In a multivariate Cox regression analysis, focal metastases were associated with a better event-free and overall survival than the other types of metastases in patients with MNA tumours in the COG cohort (P < 0.01).Conclusion: Two metastatic patterns were found: a “limited and focal” pattern found mainly in patients with MNA neuroblastoma that correlated with prognosis, and an “extensive and diffuse” pattern found mainly in patients with MYCNsc neuroblastoma.Purpose: The aim of this study was to find clinically relevant MIBG-avid metastatic patterns in patients with newly diagnosed stage 4 neuroblastoma.

Published
2014
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46. Phase I study of vincristine, irinotecan, and 131I-MIBG for patients with relapsed or refractory neuroblastoma: A New Approach to Neuroblastoma Therapy (NANT) study.

Author

DuBois, S. G., primary, Chesler, L., additional, Groshen, S. G., additional, Hawkins, R., additional, Goodarzian, F., additional, Yanik, G. A., additional, Stewart, C. F., additional, Mosse, Y. P., additional, Maris, J. M., additional, Villablanca, J., additional, and Matthay, K. K., additional

Published
2011
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47. Dosimetry, toxicity, and response in a phase IIa trial of no-carrier added iobenguane I-131 (nca-MIBG): A New Approach to Neuroblastoma Therapy (NANT) study.

Author

Matthay, K. K., primary, Weiss, B. D., additional, Villablanca, J., additional, Maris, J. M., additional, Yanik, G. A., additional, Groshen, S. G., additional, Jackson, H., additional, Hawkins, R., additional, Goodarzian, F., additional, Panigrahy, A., additional, DuBois, S. G., additional, Stubbs, J., additional, Towbin, A., additional, Barrett, J. A., additional, LaFrance, N. D., additional, and Babich, J. W., additional

Published
2011
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48. Reg3α Is a Biomarker of Graft Versus Host Disease of the Gastrointestinal Tract

Author

Harris, A.C., primary, Ferrara, J.L.M., additional, Levine, J.E., additional, Braun, T., additional, Hogan, J., additional, Crawford, J., additional, Pitteri, S., additional, Wang, H., additional, Chin, A., additional, Zhang, Q., additional, Granger, J., additional, Vander Lugt, M., additional, Byersdorfer, C., additional, Magenau, J., additional, Gomez, A., additional, Choi, S., additional, Kitko, C., additional, Yanik, G., additional, Peres, E., additional, Pawarode, A., additional, Mineishi, S., additional, Reddy, P., additional, Couriel, D.R., additional, Hanash, S., additional, and Paczesny, S., additional

Published
2011
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49. A Three Biomarker Panel at Days 7 and 14 Can Predict Development of Grade II-IV Acute Graft-Versus-Host Disease

Author

Paczesny, S., primary, Braun, T., additional, Vander Lugt, M., additional, Harris, A., additional, Fiema, B., additional, Hernandez, J., additional, Choi, S.W., additional, Kitko, C., additional, Magenau, J., additional, Yanik, G., additional, Peres, E.M., additional, Pawarode, A., additional, Mineishi, S., additional, Whitfield, J., additional, Jones, D., additional, Couriel, D., additional, Pavan, R., additional, Hanash, S., additional, Ferrara, J.L.M., additional, and Levine, J.E., additional

Published
2011
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