Trial reportJournal of hematology & oncology2026
Improved outcomes of the refined risk-stratification and risk-adapted therapy in children with acute myeloid leukemia: final results of the AIEOP AML 2013.
Trial report in Journal of hematology & oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Olive Leaf Extract Health-Promoting and Anti-Tumor Properties: An Adjunct Therapy in Pediatric Oncology?Nutrients · 2026Review
- CD84 is a specific target for acute myeloid leukemia CAR-T cell therapy.Nature communications · 2026Article
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21 authors.
Funding
Abstract
backgroundThe previous Italian national trial (AIEOP-AML-2002/01) on children with acute myeloid leukemia (AML) achieved a 3-year overall (OS) and event-free survival (EFS) of 72.3% and 59.1%, respectively. In this study (AIEOP-AML-2013), we evaluated if refined patient's stratification in 3 groups and a second induction with randomization could improve outcomes.
methodsIn the new AIEOP-AML-2013, patients were stratified into 3 groups [standard-(SR), intermediate-(IR) and high-risk (HR)] mainly according to genetic criteria and centralized assessment of multiparametric flow-cytometry measurable residual disease (MFC-MRD). The 1st induction course was common for all patients [idarubicin-cytarabine-etoposide (ICE)]. IR and HR patients were then randomized to receive either a 2nd ICE or the fludarabine-cytarabine- liposomal-doxorubicin (FLA-My) scheme as second induction. IR patients with HLA-compatible sibling, and all HR patients were consolidated with allogeneic hematopoietic stem cell transplantation (allo-HSCT), while the remaining IR and SR patients were consolidated with chemotherapy only. Data cut-off was February 1, 2024.
resultsFrom June/2015 to June/2022, 371 patients were enrolled in the trial. Twenty-six children (7%) experienced primary induction failure, while only 3 patients died during the 2 induction courses. The cumulative incidence of 3-year non-relapse mortality in continuous complete remission was 6.8%. The proportion of patients allocated to the SR, IR, and HR groups were 19.5%, 22%, and 58.5%, respectively. Three-year cumulative incidence of relapse was 18.9%. The 3-year probabilities of OS and EFS were 83.9% and 68.5%, respectively, both values being significantly better (p = 0.001) than those of the AIEOP-AML-2002/01 study. The 3-year OS of SR, IR, and HR patients were 97.0%, 84.2%, and 79.4%, respectively, (p = 0.01). The probability of EFS did not differ in IR and HR randomized to receive either a 2nd ICE or the FLA-My scheme course. Levels of MRD after the 1st and 2nd induction course strongly influenced the EFS probability.
conclusionsA significant improvement in the outcomes of children with de novo AML was obtained with refined risk-stratification and risk-adapted therapy. FLA-My did not offer any advantage over repeating a 2nd ICE as 2nd induction course.
trial registrationThis study was registered in the European Clinical Trials Database (EudraCT 2014-000652-28).
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