Study population
ALL
T(9;22)
A total of 6136 children enrolled as study patients in the international, multi-center prospective randomized Phase III clinical trial AIEOP-BFM ALL2009 (EudraCT 2007-004270-43) were included in the analysis. Patients were eligible if they were older than 1 year, younger than 18 years, and were not Ph-positive (BCR/ABL or t(9;22)). The study started June 1, 2010 and ended February 28, 2017 (manuscript submitted). The median time of follow-up was 6 years (1. and 3. quartile, 4.7 and 7.6). Whereas diagnostic procedures (e.g., evaluation of treatment response) and treatment for ALL was prescribed and monitored, supportive care including diagnostics of suspected IFD and antifungal prophylaxis and treatment was at the discretion of the responsible physician. The study was approved by the appropriate national and local review boards, and was conducted in accordance with the Declaration of Helsinki and national laws. Informed consent was obtained from the parents or guardians of each patient included in the study as required by ethical standards and national guidelines.