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Impact of COVID-19 in Paediatric Early Phase Cancer Clinical Trials in Europe: A report from the Innovative Therapies for Children with Cancer consortium (ITCC)

Alba Rubio-San-Simón, Nicolas André, Maria Giuseppina Cefalo, Isabelle Aerts, Alicia Castañeda, Sarah Benezech, Guy Makin, Natasha van Eijkelenburg, Karsten Nysom, Lynley Marshall, Marion Gambart, Raquel Hladun, Claudia Rossig, Luca Bergamaschi, Franca Fagioli, Ben Carpenter, Stephane Ducassou, Cormac Owens, Ingrid Øra, Antonio Juan Ribelles, Bram De Wilde, Pilar Guerra-García, Marion Strullu, Carmelo Rizzari, Torben Ek, Simone Hettmer, Nicolas U. Gerber, Christine Rawlings, Manuel Diezi, Sauli Palmu, Antonio Ruggiero, Jaime Verdú, Teresa de Rojas, Gilles Vassal, Birgit Geoerger, Lucas Moreno, Francisco Bautista,

Introduction Data regarding real-world impact on cancer clinical research during COVID-19 are scarce. We analysed the impact of the COVID-19 pandemic on the conduct of paediatric cancer phase I-II trials in Europe through the experience of the Innovative Therapies for Children with Cancer (ITCC). Methods A survey was sent to ... Read more >>

Eur J Cancer (European journal of cancer (Oxford, England : 1990))
[2020, :]

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Increasing completion of asparaginase treatment in childhood acute lymphoblastic leukaemia (ALL): summary of an expert panel discussion.

André Baruchel, Patrick Brown, Carmelo Rizzari, Lewis Silverman, Inge van der Sluis, Benjamin Ole Wolthers, Kjeld Schmiegelow,

Insufficient exposure to asparaginase therapy is a barrier to optimal treatment and survival in childhood acute lymphoblastic leukaemia (ALL). Three important reasons for inactivity or discontinuation of asparaginase therapy are infusion related reactions (IRRs), pancreatitis and life-threatening central nervous system (CNS). For IRRs, real-time therapeutic drug monitoring (TDM) and premedication ... Read more >>

ESMO Open (ESMO open)
[2020, 5(5):]

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Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children.

Véronique Minard-Colin, Anne Aupérin, Marta Pillon, G A Amos Burke, Donald A Barkauskas, Keith Wheatley, Rafael F Delgado, Sarah Alexander, Anne Uyttebroeck, Catherine M Bollard, József Zsiros, Monika Csoka, Bernarda Kazanowska, Alan K Chiang, Rodney R Miles, Andrew Wotherspoon, Peter C Adamson, Gilles Vassal, Catherine Patte, Thomas G Gross, , ,

BACKGROUND:Rituximab added to chemotherapy prolongs survival among adults with B-cell cancer. Data on its efficacy and safety in children with high-grade, mature B-cell non-Hodgkin's lymphoma are limited. METHODS:We conducted an open-label, international, randomized, phase 3 trial involving patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma ... Read more >>

N Engl J Med (The New England journal of medicine)
[2020, 382(23):2207-2219]

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Therapeutic Drug Monitoring of Asparaginase: Intra-individual Variability and Predictivity in Children With Acute Lymphoblastic Leukemia Treated With PEG-Asparaginase in the AIEOP-BFM Acute Lymphoblastic Leukemia 2009 Study.

Gudrun Würthwein, Claudia Lanvers-Kaminsky, Joachim Gerss, Anja Möricke, Martin Zimmermann, Jan Stary, Petr Smisek, Andishe Attarbaschi, Christa Nath, Massimo Zucchetti, Carmelo Rizzari, Martin Schrappe, Joachim Boos,

BACKGROUND:Therapeutic drug monitoring (TDM) can identify patients with subtherapeutic asparaginase (ASNase) activity [silent inactivation (SI)] and prospectively guide therapeutic adaptation. However, limited intra-individual variability is a precondition for targeted dosing and the diagnosis of SI. METHODS:In the AIEOP-BFM acute lymphoblastic leukemia (ALL) 2009 trial, 2771 children with ALL were included ... Read more >>

Ther Drug Monit (Therapeutic drug monitoring)
[2020, 42(3):435-444]

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Children with cancer in the time of COVID-19: An 8-week report from the six pediatric onco-hematology centers in Lombardia, Italy.

Andrea Ferrari, Marco Zecca, Carmelo Rizzari, Fulvio Porta, Massimo Provenzi, Maddalena Marinoni, Richard Fabian Schumacher, Roberto Luksch, Monica Terenziani, Michela Casanova, Filippo Spreafico, Stefano Chiaravalli, Francesca Compagno, Federica Bruni, Chiara Piccolo, Laura Bettini, Mariella D'Angiò, Giulia Maria Ferrari, Andrea Biondi, Maura Massimino, Adriana Balduzzi,

Pediatr Blood Cancer (Pediatric blood & cancer)
[2020, 67(8):e28410]

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Emapalumab in Children with Primary Hemophagocytic Lymphohistiocytosis.

Franco Locatelli, Michael B Jordan, Carl Allen, Simone Cesaro, Carmelo Rizzari, Anupama Rao, Barbara Degar, Timothy P Garrington, Julian Sevilla, Maria-Caterina Putti, Franca Fagioli, Martina Ahlmann, Jose-Luis Dapena Diaz, Michael Henry, Fabrizio De Benedetti, Alexei Grom, Genevieve Lapeyre, Philippe Jacqmin, Maria Ballabio, Cristina de Min,

BACKGROUND:Primary hemophagocytic lymphohistiocytosis is a rare syndrome characterized by immune dysregulation and hyperinflammation. It typically manifests in infancy and is associated with high mortality. METHODS:We investigated the efficacy and safety of emapalumab (a human anti-interferon-γ antibody), administered with dexamethasone, in an open-label, single-group, phase 2-3 study involving patients who had ... Read more >>

N Engl J Med (The New England journal of medicine)
[2020, 382(19):1811-1822]

Cited: 3 times

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Lessons after the early management of the COVID-19 outbreak in a pediatric transplant and hemato-oncology center embedded within a COVID-19 dedicated hospital in Lombardia, Italy. Estote parati.

Adriana Balduzzi, Erica Brivio, Attilio Rovelli, Carmelo Rizzari, Serena Gasperini, Maria Luisa Melzi, Valentino Conter, Andrea Biondi,

Italy is the second exposed country worldwide, after China, and Lombardia is the most affected region in Italy, with more than half of the national cases, with 13% of whom being healthcare professionals. The Clinica Pediatrica Università degli Studi di Milano Bicocca is a general pediatric and hematology oncology and ... Read more >>

Bone Marrow Transplant (Bone marrow transplantation)
[2020, 55(10):1900-1905]

Cited: 10 times

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Flash survey on severe acute respiratory syndrome coronavirus-2 infections in paediatric patients on anticancer treatment.

Ondrej Hrusak, Tomas Kalina, Joshua Wolf, Adriana Balduzzi, Massimo Provenzi, Carmelo Rizzari, Susana Rives, María Del Pozo Carlavilla, Maria E V Alonso, Nerea Domínguez-Pinilla, Jean-Pierre Bourquin, Kjeld Schmiegelow, Andishe Attarbaschi, Pernilla Grillner, Karin Mellgren, Jutte van der Werff Ten Bosch, Rob Pieters, Triantafyllia Brozou, Arndt Borkhardt, Gabriele Escherich, Melchior Lauten, Martin Stanulla, Owen Smith, Allen E J Yeoh, Sarah Elitzur, Ajay Vora, Chi-Kong Li, Hany Ariffin, Alexandra Kolenova, Luciano Dallapozza, Roula Farah, Jelena Lazic, Atsushi Manabe, Jan Styczynski, Gabor Kovacs, Gabor Ottoffy, Maria S Felice, Barbara Buldini, Valentino Conter, Jan Stary, Martin Schrappe,

INTRODUCTION:Since the beginning of COVID-19 pandemic, it is known that the severe course of the disease occurs mostly among the elderly, whereas it is rare among children and young adults. Comorbidities, in particular, diabetes and hypertension, clearly associated with age, besides obesity and smoke, are strongly associated with the need ... Read more >>

Eur J Cancer (European journal of cancer (Oxford, England : 1990))
[2020, 132:11-16]

Cited: 16 times

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Randomized post-induction and delayed intensification therapy in high-risk pediatric acute lymphoblastic leukemia: long-term results of the international AIEOP-BFM ALL 2000 trial.

Andishe Attarbaschi, Georg Mann, Martin Zimmermann, Peter Bader, Elena Barisone, Giuseppe Basso, Andrea Biondi, Gunnar Cario, Gianni Cazzaniga, Antonella Colombini, Christian Flotho, Michaela Kuhlen, Peter Lang, Melchior Lauten, Christin Linderkamp, Franco Locatelli, Luca Lo Nigro, Anja Möricke, Felix Niggli, Renate Panzer-Grümayer, Rosanna Parasole, Christina Peters, Maria Caterina Putti, Carmelo Rizzari, Meinolf Suttorp, Maria Grazia Valsecchi, Valentino Conter, Martin Schrappe, ,

Leukemia (Leukemia)
[2020, 34(6):1694-1700]

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Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia.

Nobuko Hijiya, Alexey Maschan, Carmelo Rizzari, Hiroyuki Shimada, Carlo Dufour, Hiroaki Goto, Hyoung Jin Kang, Terri Guinipero, Zeynep Karakas, Francisco Bautista, Stéphane Ducassou, Keon Hee Yoo, Christian Michel Zwaan, Frédéric Millot, Paola Aimone, Alex Allepuz, Sara Quenet, Florence Hourcade-Potelleret, Sabine Hertle, Darintr Sosothikul,

Chronic myeloid leukemia (CML) is rare in children and accounts for ≤15% of all myeloid leukemia cases. When we initiated this study with nilotinib, imatinib was the only tyrosine kinase inhibitor indicated for pediatric patients with Philadelphia chromosome-positive (Ph+) CML in chronic phase (CP); alternative treatment options were needed, particularly ... Read more >>

Blood (Blood)
[2019, 134(23):2036-2045]

Cited: 1 time

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Pharmacokinetics of Nilotinib in Pediatric Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia or Acute Lymphoblastic Leukemia.

Nobuko Hijiya, C Michel Zwaan, Carmelo Rizzari, Robin Foà, Floor Abbink, Donna Lancaster, Judith Landman-Parker, Frédéric Millot, John Moppett, Brigitte Nelken, Maria Caterina Putti, Xianbin Tian, Karen Sinclair, Helene Santanastasio, Aby Buchbinder, Pamela Kearns,

PURPOSE:We investigated nilotinib exposure in pediatric patients with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) resistant to, relapsed on, refractory to, or intolerant of previous treatment. PATIENTS AND METHODS:Fifteen patients (aged 1-<18 years) with CML resistant to or intolerant of imatinib and/or dasatinib (n = ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2020, 26(4):812-820]

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Pharmacokinetics and Pharmacodynamics of Conventional-Dose vs Triple-Dose Oseltamivir in Severely Immunocompromised Children With Influenza.

Francisco Bautista, Dan Engelhard, Carmelo Rizzari, Margarita Baka, Jesús Saavedra-Lozano, Eduardo Lopez-Medina, Clare Nasmyth-Miller, Jules Hernández-Sánchez, Stefan Sturm,

This randomized phase 1b study evaluated the pharmacokinetics/pharmacodynamics of conventional-dose (30-75 mg twice daily [BID]) vs triple-dose (90-225 mg BID; weight-adjusted) oseltamivir for treatment of influenza in severely immunocompromised children <13 years. Oseltamivir carboxylate (OC) Cmax and AUC0-12h were ~2-fold higher with triple-dose vs conventional-dose oseltamivir. Increased dose/exposure of oseltamivir/OC ... Read more >>

(Open forum infectious diseases)
[2019, 6(10):ofz430]

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Outcome of adolescent patients with acute lymphoblastic leukaemia aged 10-14 years as compared with those aged 15-17 years: Long-term results of 1094 patients of the AIEOP-BFM ALL 2000 study.

Anna Maria Testi, Andishe Attarbaschi, Maria Grazia Valsecchi, Anja Möricke, Gunnar Cario, Felix Niggli, Daniela Silvestri, Peter Bader, Michaela Kuhlen, Rosanna Parasole, Maria Caterina Putti, Peter Lang, Christian Flotho, Georg Mann, Carmelo Rizzari, Elena Barisone, Franco Locatelli, Christin Linderkamp, Melchior Lauten, Meinolf Suttorp, Martin Zimmermann, Guiseppe Basso, Andrea Biondi, Valentino Conter, Martin Schrappe, ,

BACKGROUND:Adolescents (aged 10-17 years) with acute lymphoblastic leukaemia (ALL) have unfavourable disease features and an inferior outcome when compared with younger children, but it is still unclear if differences in disease biology and prognosis exist between adolescents older or younger than 15 years. METHODS:We retrospectively analysed outcomes of 1094 adolescents ... Read more >>

Eur. J. Cancer (European journal of cancer (Oxford, England : 1990))
[2019, 122:61-71]

Cited: 1 time

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Combination Antifungal Therapy for Invasive Mold Infections Among Pediatric Patients with Hematological Malignancies: Data from A Real-Life Case-Series.

Anna Maria Peri, Marta Verna, Stefano Biffi, Laura Alagna, Benedetta Longhi, Guglielmo Marco Migliorino, Sergio Foresti, Alessandra Bandera, Attilio Rovelli, Carmelo Rizzari, Andrea Gori, Antonella Colombini,

Background:Invasive mold infections in children with hematological malignancies are associated with high mortality rates. The use of combination antifungal therapy in cases with a severe clinical course is increasing, although information on the efficacy and safety of this approach is limited. Methods:We present a case series of 13 children affected ... Read more >>

(Pathogens & immunity)
[2019, 4(2):180-194]

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Nationwide central diagnosis review for childhood solid tumors: From concept to realization of an Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) integrated project.

Filippo Spreafico, Paola Quarello, Rita Alaggio, Paola Collini, Riccardo Haupt, Angela Mastronuzzi, Arcangelo Prete, Marco Rabusin, Carmelo Rizzari, Fabian Schumacher, Marco Zecca, Andrea Pession, Franca Fagioli,

Pediatr Blood Cancer (Pediatric blood & cancer)
[2019, 66(8):e27749]

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Acute myeloid leukaemia niche regulates response to L-asparaginase.

Ilaria M Michelozzi, Valentina Granata, Giada De Ponti, Gaia Alberti, Chiara Tomasoni, Laura Antolini, Carlo Gambacorti-Passerini, Bernhard Gentner, Francesco Dazzi, Andrea Biondi, Tiziana Coliva, Carmelo Rizzari, Alice Pievani, Marta Serafini,

Eradicating the malignant stem cell is the ultimate challenge in the treatment of leukaemia. Leukaemic stem cells (LSC) hijack the normal haemopoietic niche, where they are mainly protected from cytotoxic drugs. The anti-leukaemic effect of L-asparaginase (ASNase) has been extensively investigated in acute lymphoblastic leukaemia, but only partially in acute ... Read more >>

Br. J. Haematol. (British journal of haematology)
[2019, 186(3):420-430]

Cited: 2 times

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Human Fibrinogen Concentrate and Fresh Frozen Plasma in the Management of Severe Acquired Hypofibrinogenemia in Children With Acute Lymphoblastic Leukemia: Results of a Retrospective Survey.

Paola Giordano, Massimo Grassi, Paola Saracco, Matteo Luciani, Antonella Colombini, Anna M Testi, Concetta Micalizzi, Fara Petruzziello, Maria C Putti, Fiorina Casale, Caterina Consarino, Rosa M Mura, Elena Mastrodicasa, Lucia D Notarangelo, Daniela Onofrillo, Berardino Pollio, Carmelo Rizzari, Silvio Tafuri, Francesco De Leonardis, Paola C Corallo, Nicola Santoro,

OBJECTIVE OF THE STUDY:In this study we aimed to retrospectively evaluate how centers, belonging to the Associazione Italiana Ematologia e Oncologia Pediatrica (AIEOP), manage severe acquired hypofibrinogenemia in children with acute lymphoblastic leukemia, particularly evaluating the therapeutic role of human fibrinogen concentrate (HFC) and fresh frozen plasma (FFP). METHODS:We conducted ... Read more >>

J. Pediatr. Hematol. Oncol. (Journal of pediatric hematology/oncology)
[2019, 41(4):275-279]

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Hermansky-Pudlak syndrome type II and lethal hemophagocytic lymphohistiocytosis: Case description and review of the literature.

Fabiola Dell'Acqua, Francesco Saettini, Ilaria Castelli, Raffaele Badolato, Lucia Dora Notarangelo, Carmelo Rizzari,

J Allergy Clin Immunol Pract (The journal of allergy and clinical immunology. In practice)
[2019, 7(7):2476-2478.e5]

Cited: 1 time

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First evidence of a paediatric patient with Cornelia de Lange syndrome with acute lymphoblastic leukaemia.

Grazia Fazio, Valentina Massa, Andrea Grioni, Vojtech Bystry, Silvia Rigamonti, Claudia Saitta, Marta Galbiati, Carmelo Rizzari, Caterina Consarino, Andrea Biondi, Angelo Selicorni, Giovanni Cazzaniga,

Cornelia de Lange syndrome (CdLS) is a rare autosomal-dominant genetic disorder characterised by prenatal and postnatal growth and mental retardation, facial dysmorphism and upper limb abnormalities. Germline mutations of cohesin complex genes SMC1A, SMC3, RAD21 or their regulators NIPBL and HDAC8 have been identified in CdLS as well as somatic ... Read more >>

J Clin Pathol (Journal of clinical pathology)
[2019, 72(8):558-561]

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Asparagine levels in the cerebrospinal fluid of children with acute lymphoblastic leukemia treated with pegylated-asparaginase in the induction phase of the AIEOP-BFM ALL 2009 study.

Carmelo Rizzari, Claudia Lanvers-Kaminsky, Maria Grazia Valsecchi, Andrea Ballerini, Cristina Matteo, Joachim Gerss, Gudrun Wuerthwein, Daniela Silvestri, Antonella Colombini, Valentino Conter, Andrea Biondi, Martin Schrappe, Anja Moericke, Martin Zimmermann, Arend von Stackelberg, Christin Linderkamp, Michael C Frühwald, Sabine Legien, Andishe Attarbaschi, Bettina Reismüller, David Kasper, Petr Smisek, Jan Stary, Luciana Vinti, Elena Barisone, Rosanna Parasole, Concetta Micalizzi, Massimo Zucchetti, Joachim Boos,

Asparagine levels in cerebrospinal fluid and serum asparaginase activity were monitored in children with acute lymphoblastic leukemia treated with pegylated-asparaginase. The drug was given intravenously at a dose of 2,500 IU/m2 on days 12 and 26. Serum and cerebrospinal fluid samples obtained on days 33 and 45 were analyzed centrally. ... Read more >>

Haematologica (Haematologica)
[2019, 104(9):1812-1821]

Cited: 1 time

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Correspondence: Osteonecrosis in childhood acute lymphoblastic leukemia: a retrospective cohort study of the Italian Association of Pediatric Haemato-Oncology (AIEOP).

Rosanna Parasole, Maria G Valsecchi, Daniela Silvestri, Franco Locatelli, Elena Barisone, Fara Petruzziello, M Caterina Putti, Concetta Micalizzi, Antonella Colombini, Rossella Mura, Tommaso Mina, Anna M Testi, Lucia D Notarangelo, Nicola Santoro, Tommaso Casini, Caterina Consarino, Luca Lo Nigro, Ottavio Ziino, Giovanna Giagnuolo, Carmelo Rizzari, Valentino Conter,

Blood Cancer J (Blood cancer journal)
[2018, 8(12):115]

Cited: 1 time

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A novel EP300 mutation associated with Rubinstein-Taybi syndrome type 2 presenting as combined immunodeficiency.

Francesco Saettini, Daniele Moratto, Andrea Grioni, Silvia Maitz, Maria Iascone, Carmelo Rizzari, Fabio Pavan, Marco Spinelli, Laura Rachele Bettini, Andrea Biondi, Raffaele Badolato,

Pediatr Allergy Immunol (Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology)
[2018, 29(7):776-781]

Cited: 0 times

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ActivinA: a new leukemia-promoting factor conferring migratory advantage to B-cell precursor-acute lymphoblastic leukemic cells.

Federica Portale, Giulia Cricrì, Silvia Bresolin, Monica Lupi, Stefania Gaspari, Daniela Silvestri, Barbara Russo, Noemi Marino, Paolo Ubezio, Fabio Pagni, Patrizia Vergani, Geertruy Te Kronnie, Maria Grazia Valsecchi, Franco Locatelli, Carmelo Rizzari, Andrea Biondi, Erica Dander, Giovanna D'Amico,

B-cell precursor-acute lymphoblastic leukemia modulates the bone marrow (BM) niche to become leukemia-supporting and chemo-protective by reprogramming the stromal microenvironment. New therapies targeting the interplay between leukemia and stroma can help improve disease outcome. We identified ActivinA, a TGF-β family member with a well-described role in promoting several solid malignancies, ... Read more >>

Haematologica (Haematologica)
[2019, 104(3):533-545]

Cited: 2 times

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A phase 1/2, open-label, dose-escalation study of midostaurin in children with relapsed or refractory acute leukaemia.

C Michel Zwaan, Stefan Söderhäll, Benoit Brethon, Matteo Luciani, Carmelo Rizzari, Ronald W Stam, Emmanuelle Besse, Catherine Dutreix, Franca Fagioli, Phoenix A Ho, Carlo Dufour, Rob Pieters,

Br J Haematol (British journal of haematology)
[2019, 185(3):623-627]

Cited: 4 times

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Therapeutic Drug Monitoring of Asparaginase Activity-Method Comparison of MAAT and AHA Test Used in the International AIEOP-BFM ALL 2009 Trial.

Claudia Lanvers-Kaminsky, Andrea Rüffer, Gudrun Würthwein, Joachim Gerss, Massimo Zucchetti, Andrea Ballerini, Andishe Attarbaschi, Petr Smisek, Christa Nath, Samiuela Lee, Sara Elitzur, Martin Zimmermann, Anja Möricke, Martin Schrappe, Carmelo Rizzari, Joachim Boos,

BACKGROUND:In the international AIEOP-BFM ALL 2009 trial, asparaginase (ASE) activity was monitored after each dose of pegylated Escherichia coli ASE (PEG-ASE). Two methods were used: the aspartic acid β-hydroxamate (AHA) test and medac asparaginase activity test (MAAT). As the latter method overestimates PEG-ASE activity because it calibrates using E. coli ... Read more >>

Ther Drug Monit (Therapeutic drug monitoring)
[2018, 40(1):93-102]

Cited: 2 times

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