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Two years of the FLT3 blocker gilteritinib after a stem-cell transplant did not significantly reduce relapses across all patients, but it clearly did in the half whose highly sensitive blood tests still found traces of the leukaemia, one of the first results to support choosing post-transplant treatment by residual disease.
Randomised, double-blind, placebo-controlled phase 3 trial (BMT CTN 1506) in 356 adults with FLT3-ITD acute myeloid leukaemia in first remission after allogeneic transplant, assigned to gilteritinib 120 mg daily or placebo for 24 months. The primary endpoint was relapse-free survival; measurable residual disease for FLT3-ITD was assessed before and after transplant.
Relapse-free survival favoured gilteritinib but was not statistically significant (hazard ratio 0.679, p 0.0518). In the prespecified 50.5 percent of participants with detectable residual disease the hazard ratio was 0.515 (p 0.0065); those without detectable disease showed no benefit (hazard ratio 1.213).
Post-transplant FLT3 inhibitor maintenance helps patients with detectable FLT3-ITD residual disease and can probably be spared in those without it; guidelines now describe maintenance for MRD-positive disease on this evidence.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.