Fig. 1

Consort flow diagram. Seventeen patients did not meet the inclusion criteria at screening and accordingly were not enrolled in the trial. Three patients underwent screening procedures twice prior to enrollment. 31 enrolled patients received FLYSYN at the indicated dose level of the assigned cohort. Safety oversight to proceed to the next higher dose cohort was performed by an independent data and safety monitoring board after an interim safety analysis of the first three study patients included in a dose level, evaluated on day 15 (cohorts 1–5) or day 43 (cohort 6) after FLYSYN application. Assessment of DLT could be done for all dose levels, whereas single patients of each cohort were not assessable at the primary safety endpoint, and 15 patients left follow-up during the assessment of efficacy for the secondary endpoint analysis. In cohort 6, one patient (asterisk) dropped out prior to third application of FLYSYN due to hematologic relapse. One patient was lost to follow-up. n number