Statistical analysis
toxicities
The clinical data cut-off date was February 2022. The number of patients in each cohort was based on toxicities observed as the trial progressed. Up to 31 patients were planned for enrolment. Safety, pharmacokinetics, and anti-leukemic activity analyses were done per protocol on all patients who received at least one dose of FLYSYN. All patients with drop-outs prior to end of study visit were assessed until last scheduled visit. Demographics were analyzed by descriptive statistics. Time to EPD between groups was compared using a logrank test. 95% CIs for median survival were calculated based on a log–log transform of the survival function estimate. All statistical analyses were done with SAS 9.4.