This protocol covers fit patients with primary refractory or relapsed acute myeloid leukaemia who remain eligible for intensive chemotherapy and allogeneic haematopoietic cell transplantation, following a prior salvage chemotherapy course.
Patients with primary refractory AML — who did not achieve complete remission with initial induction — or with relapsed AML, whose performance status and organ function support continuation of intensive treatment including allogeneic transplantation.
The preceding line was salvage chemotherapy — such as FLAG-Ida or comparable regimens combining high- or intermediate-dose cytarabine with an anthracycline, with or without a purine analogue. The goal of that line was achievement of second complete remission. For patients with primary refractory disease, allogeneic transplantation represents the most effective option regardless; for relapsed patients who achieved second CR, this protocol defines the next therapeutic step.
For fit, eligible patients, the recommended approach centres on allogeneic haematopoietic cell transplantation — with specific guidance on donor selection and further options covered in the full protocol.
For fit patients with relapsed AML, the recommended treatment is salvage ChT followed by alloHCT [III, B].
The outcome of patients with primary refractory AML is dismal, with no realistic prospect of long-term survival after salvage ChT; thus, alloHCT is the most effective treatment option providing long-term survival in 20%–30% of patients [III, B].
AlloHCT should be considered for all fit, eligible patients who entered second CR [III, B], as it represents the only chance for long-term survival.
If a family or unrelated donor is not immediately available, either a haploidentical or cord blood donor alloHCT should be offered promptly.
A second alloHCT or DLI may induce long-term survival in patients with relapse after the first alloHCT, particularly for those relapsing later than 5 months [IV, C].
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