Treatment of Primary Refractory or Relapsed AML with FLT3-ITD or FLT3-TKD Mutation When Standard Chemotherapy Is Not Eligible
This protocol applies to patients with acute myeloid leukaemia that is either primary refractory (no response to initial induction) or has relapsed after prior remission, in the specific context of a confirmed FLT3-ITD or FLT3-TKD mutation and exclusion from standard chemotherapy.
The patient carries a FLT3-ITD or FLT3-TKD activating mutation — confirmed or re-tested at the time of relapse — and is not a candidate for standard chemotherapy. FLT3 mutation status should be reassessed at relapse, as it may differ from diagnosis.
A targeted monotherapy directed against the FLT3 mutation is central to management in this setting. Full regimen details, selection criteria, and sequencing guidance are available in the complete protocol.
Achievement of complete remission is the primary clinical target. Eligibility for transplantation should be re-evaluated in patients who attain remission.
References
Mutation analysis for FLT3 should be repeated in relapsed patients, as gilteritinib has been approved in Europe and the United States in the relapse setting of FLT3-ITD- and FLT3-TKD-mutated patients.
In FLT3-mutated patients, the authors recommend treatment with gilteritinib, which showed a favourable response rate and improved OS compared with ChT (mOS 9.3 versus 5.6 months) [I, A].
Eligibility for RIC alloHCT should be re-evaluated for patients who achieved CR.
View source ↗