Würthwein, Gudrun
Lanvers-Kaminsky, Claudia
Hempel, Georg
Gastine, Silke
Möricke, Anja
Schrappe, Martin
Karlsson, Mats O.
Boos, Joachim http://orcid.org/0000-0003-2954-2025
Clinical trials referenced in this document:
Documents that mention this clinical trial
Population Pharmacokinetics to Model the Time-Varying Clearance of the PEGylated Asparaginase Oncaspar® in Children with Acute Lymphoblastic Leukemia
https://doi.org/10.1007/s13318-017-0410-5
Article History
First Online: 27 March 2017
Compliance with Ethical Standards
:
: Limited research support (for data collection and safety reporting) for the ALL-BFM study center in Kiel (Germany) has been received from medac GmbH, Sigma-Tau, Baxter and Jazz Pharmaceuticals. The pharmacological laboratory at the department of Paediatric Haematology and Oncology at the University Hospital Münster received limited research support for drug monitoring from medac GmbH, Sigma-Tau and Baxter. No sources of funding were used to assist with the preparation of this manuscript.
: J Boos served personally as a consultant and participated in advisory as well as in safety boards for the medac GmbH. He received support for travel from Eusa Pharma, Jazz Pharmaceuticals, Baxalta and Shire. For medac GmbH, Eusa Pharma, Jazz Pharmaceuticals, Baxalta, Shire and Sigma-Tau he held invited lectures. In addition, institutional grants in the context of ASNase drug monitoring from more or less all ASNase providers contributed to the therapeutic drug monitoring program, including the medac GmbH, Eusa Pharma, Jazz Pharmaceuticals, Baxalta, Shire, Sigma-Tau (all representing the varying marketing authorization holders of <i>E. coli</i> ASNase, PEG-ASNase and Erwinase). G. Hempel received research grants from the medac GmbH, the former distributor of PEG-ASNase in Germany, for analyzing the pharmacokinetics of different ASNase formulations. C. Lanvers-Kaminsky received consulting fees from ERYTECH. G. Würthwein, S. Gastine, A. Möricke and M. O. Karlsson have no potential conflicts of interest to declare.
: The AIEOP-BFM ALL 2009 trial (EudraCT Number 2007-004270-43) was approved by the competent ethics committees of the national coordinating centers. This trial was registered at ExternalRef removed with the identifier NCT01117441. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Informed consent was obtained from the parents or guardians of each patient included in the study.