Siebel, Christian http://orcid.org/0000-0003-3518-9483
Lanvers-Kaminsky, Claudia http://orcid.org/0000-0002-9764-8035
Alten, Julia
Smisek, Petr http://orcid.org/0000-0003-3158-7484
Nath, Christa E. http://orcid.org/0000-0002-1013-3646
Rizzari, Carmelo http://orcid.org/0000-0002-4828-3893
Boos, Joachim http://orcid.org/0000-0003-2954-2025
Würthwein, Gudrun http://orcid.org/0000-0002-7617-183X
Funding for this research was provided by:
Servier Deutschland GmbH
José Carreras Leukämie-Stiftung (DJCLSR13/01)
Westfälische Wilhelms-Universität Münster
Article History
Accepted: 21 November 2021
First Online: 8 December 2021
Declarations
:
: Assay development and monitoring of anti-PEG antibodies within the AIEOP-BFM ALL 2009 trial was supported by Deutsche José Carreras Leukämie-Stiftung e.V. (DJCLSR 13/01). Additional funding was provided by Servier Deutschland GmbH to perform the population pharmacokinetic analysis described here. Christa E. Nath is supported by the Sydney Children’s Hospital Network Foundation. Asparaginase monitoring in Australia was supported by funding from the Kids Cancer Alliance, a translational cancer research centre of the Cancer Institute of NSW.
: CLK held invited talks for Sigma Tau, Erytech, Jazz Pharmaceuticals and Servier and received honoraria for consultancy from Erytech. CR received honoraria for consultancy and fees for invited lectures from Jazz Pharmaceuticals and Servier. JB serves as a consultant for Servier, held invited lectures and received a research grant—always in the form of an institutional grant in the context of ASNase drug monitoring. CS, JA, PS, CN and GW declare no conflicts of interest.
: The AIEOP-BFM ALL 2009 trial (EudraCT No: 2007-004270-43) was approved by each national and local review board and was conducted in accordance with the Declaration of Helsinki and applicable national legislation. Informed consent was obtained from the parents or guardians of each patient included in the study, as required by ethical standards and national guidelines. For the pharmacokinetic analysis described here, an additional vote of the Ethics Committee of the Westfalen-Lippe Medical Association and the University of Münster was obtained (reference number 2021-071-f-S).
: Informed consent was obtained from the parents or legal representative of each patient included in the study, as required by ethical standards and national guidelines.
: Not applicable.
: The datasets generated and/or analysed during the current study are not publicly available due to data protection rules and the fact that the complexity of the data does not allow for full anonymization.
: The NONMEM code for the final anti-PEG antibody covariate model is provided in the ESM.
: JB, CLK, CS and GW designed the research. JA and PS collected the data. CS and GW performed the pharmacokinetic analysis. Results were discussed and interpreted by all authors. CS and GW wrote the draft manuscript; all authors reviewed the manuscript and approved the final version of the manuscript.