Trial design and regimes
AML, Cancer
ADVERSE EVENTS, RECRUITMENT, AML, CANCER
Results of an open-label, single-arm, first in man multicenter trial (recruitment period February 2017 to March 2020) evaluating safety/tolerability and efficacy of FLYSYN in AML patients with persistent or increasing MRD are reported.Dose escalation followed a standard 3 + 3 design. Patients were enrolled in six dosing cohorts, with cohorts 1–5 evaluating a single FLYSYN application and up to three mAb treatments in cohort 6. FLYSYN was administered i.v. over 3 h with a fixed dose on day 1 (0.5 mg/mTreatment-emergent adverse events (AEs) and treatment-related AEs were summarized as per the Medical Dictionary for Regulatory Activities and the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) version 4.03. Safety data are summarized by counting every respective AE (SOC and lowest level term) that occurred in a patient only once. If the same AE occurred more than once, only the highest graded AE was counted. Details on trial methods are provided in Additional file 