Health-Related Quality of Life with Gilteritinib Versus Placebo Post-Transplant Maintenance for FLT3-ITD+ Acute Myeloid Leukemia (AML): A Quality of Life Analysis from BMT CTN 1506

The Blood and Marrow Transplant Clinical Trials Network study 1506 (NCT02997202) was a multi-center phase III randomized trial comparing gilteritinib versus placebo after allogeneic hematopoietic cell transplantation (HCT) in patients with FLT3-ITD-positive AML. The primary analysis comparing relapse-free survival (RFS) did not reach statistical significance, with higher treatment-emergent adverse events (TEAE) with gilteritinib. In patients with detectable FLT3-ITDmeasurable residual disease (MRD) peri-HCT, gilteritinib was associated with significantly longer RFS, demonstrating efficacy of MRD monitoring and intervention with FLT3 inhibition in MRD positive patients. The impact of gilteritinib maintenance on health-related quality of life (HRQoL) is not known; and the aim of this prespecified exploratory analysis is to describe the effect of gilteritinib versus placebo on HRQoL.