Relapsed or Primary Refractory FLT3-Mutated AML When Gilteritinib Did Not Achieve Complete Remission

This protocol addresses patients with primary refractory or relapsed acute myeloid leukemia harboring a FLT3-ITD or FLT3-TKD mutation who are not eligible for standard chemotherapy and in whom gilteritinib monotherapy did not result in complete remission (CR).

Clinical scenario

Primary refractory or relapsed AML with confirmed FLT3-ITD or FLT3-TKD mutation; patient not eligible for standard chemotherapy. FLT3 mutation status should be re-confirmed at relapse, as mutational profiles can evolve over time.

Previous line — failure condition

The prior regimen, gilteritinib monotherapy, did not achieve the primary goal of complete remission. This failure is the trigger for escalation to the current protocol.

Next step — partial overview

The protocol for this situation addresses whether patients who achieved CR may be candidates for a specific form of transplant-based consolidation. The full eligibility criteria, sequencing, and additional options are detailed in the complete protocol.

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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.

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