This protocol addresses patients with acute myeloid leukaemia characterised by ELN adverse-risk genetics — a group defined by complex cytogenetics and other poor-risk genetic aberrations — who have undergone standard induction chemotherapy without achieving the expected remission.
The preceding induction regimen — cytarabine plus daunorubicin (7+3), with or without the addition of cladribine or fludarabine in patients up to 60 years — did not achieve complete remission or complete remission with incomplete haematologic recovery (CR/CRi), defined as fewer than 5% blasts in the bone marrow on assessment between day 14 and day 21. Non-achievement of this goal is the trigger for this consolidation protocol.
The next step centres on consolidation, with allogeneic haematopoietic cell transplantation as the preferred pathway where the patient is eligible. Where transplantation is not feasible, consolidation chemotherapy options exist for certain younger patients. The full eligibility criteria, treatment sequence, and individual regimen details are in the complete protocol.
In the remaining patients with ELN adverse risk, 7 + 3 ChT is recommended [II, A] with the option to add cladribine or fludarabine to induction ChT in patients up to 60 years (though cladribine and fludarabine are not approved for this indication) [II, C].
The adverse-risk AML group includes patients with complex cytogenetics and other poor-risk genetic aberrations.
Patients in CR with ELN intermediate- or adverse-risk AML should undergo alloHCT, if feasible [II, A].
If alloHCT is not feasible in younger patients with adverse-risk cytogenetics, consolidation with amsacrine, cytarabine, etoposide/mitoxantrone, cytarabine (MACE/MidAC) may be considered (OS 39% versus 0% after a median follow-up of 5.6 years) [II, B].
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