NOTE

🌱 created from: gilteritinib

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Gilteritinib Maintenance after Allogeneic Hematopoietic Cell Transplantation in FLT3-ITD AML

Information

• Design: Randomized, double-blind, placebo-controlled, multi-center
• Number of patients: 356
• Patients characteristics: Adults with FLT3-ITD AML in first remission who underwent allogeneic hematopoietic cell transplantation (HCT)
• Agent: Gilteritinib (120 mg once daily) vs placebo
• Treatment line: Post-HCT maintenance therapy
• Trial Name or NCT Number: NCT02997202

Comparison of two groups

Endpoint	Gilteritinib	Placebo
Relapse-Free Survival (RFS)	Hazard ratio (HR) 0.679 (95% CI, 0.459 to 1.005); P = .0518	-
RFS in patients with detectable MRD	HR 0.515 (95% CI, 0.316 to 0.838); P = .0065	-
RFS in patients without detectable MRD	HR 1.213 (95% CI, 0.616 to 2.387); P = .575	-

Other findings

• 50.5% of participants had measurable residual disease (MRD) detectable pre- or post-HCT
• Gilteritinib was beneficial in patients with detectable MRD, but not in those without detectable MRD

Summary In this randomized trial, gilteritinib maintenance therapy after allogeneic HCT in FLT3-ITD AML patients did not show a statistically significant improvement in relapse-free survival overall. However, a prespecified subgroup analysis revealed that gilteritinib was beneficial in patients with detectable measurable residual disease (MRD) pre- or post-HCT, supporting the use of MRD-based post-HCT therapy.