v. Stackelberg, Arend http://orcid.org/0000-0002-8103-2631
Jäschke, Katja
Jousseaume, Etienne
Templin, Corinna
Jeratsch, Ulli
Kosmides, Daniela
Steffen, Ingo
Gökbuget, Nicola
Peters, Christina http://orcid.org/0000-0003-0369-8515
Article History
Received: 10 May 2023
Revised: 10 August 2023
Accepted: 19 September 2023
First Online: 25 October 2023
Competing interests
: This study was funded by Novartis Pharma GmbH. Medical writing was provided by Daniela Skalt, Stephanie Sussmann and Fabian Berkemeier. Statistical analyses were provided by Heidi Kulas and Guido Schiffhorst. These are employed by IGES Institut GmbH, which received financial support from Novartis Pharma GmbH for this research project. Katja Jäschke, Corinna Templin, Ulli Jeratsch and Daniela Kosmides are employees from Novartis GmbH and Etienne Jousseaume from Novartis Pharma AG which sponsored the studies ELIANA, ENSIGN and CCTL019B2001X.
: The current manuscript describes analyses using patient-level data from the ELIANA (NCT02435849), ENSIGN (NCT02228096) and CCTL019B2001X (NCT03123939) single arm studies, which have been previously published. This manuscript also uses data from the registries ALL-REZ BFM (Berlin), ALL-SCT BFM (Vienna) and GMALL (Frankfurt). This study was approved by the institutional review board of each participating institution.
: Written informed consent was obtained by the patients/guardians participating in the registries for participation in research projects. The data from the registries have been shared with the involved institute conducting the analyses for this study in a fully anonymized form.