Treatment of AML with FLT3-ITD or FLT3-TKD Mutation

Clinical scenario

This protocol covers newly diagnosed acute myeloid leukaemia in patients confirmed to carry a FLT3-ITD or FLT3-TKD mutation with an allelic ratio of ≥0.05. It applies specifically where the AML is not therapy-related and does not have myelodysplasia-related changes.

Treatment goal

Induction aims to achieve complete remission (CR) or complete remission with incomplete haematological recovery (CRi) — defined as fewer than 5% blasts in the bone marrow — with response assessed between day 14 and day 21 of the first induction cycle.

Induction approach

For FLT3-ITD– or FLT3-TKD–positive AML, induction incorporates midostaurin in addition to standard chemotherapy. The complete regimen structure, sequencing, and all decision criteria are detailed in the full protocol.

Full regimen — agents, schedule, and clinical decision points — available via the structured protocol below.

Instant Access to Structured Evidence-Based Regimens

References

For the remaining patients, 7 + 3 + midostaurin is recommended if they are FLT3-ITD or FLT3-TKD positive [I, A].
Midostaurin is approved for patients with a FLT3-ITD or FLT3-TKD mutation (defined by an AR ≥0.05) in combination with 7 + 3 induction ChT.
After the first induction cycle, response should be assessed between day 14 and day 21.
As soon as patients achieve CR/CRi after 1 or 2 induction cycles, they should proceed to consolidation treatment [II, B].

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