IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)

Inclusion Criteria: * Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria * 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022 * Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician * Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice * No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to: i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization * Male or Female, aged\>18 years * Eastern Cooperative Oncology Group (ECOG) performance status \