Secondary objectives
toxicity
BLOOD
Blood samples for determination of AFM11 serum concentration were drawn pre-dose and at regular intervals after the start of the infusion until 72, 72 and 48 h after the end of the 4-, 24- and 48-h infusions, respectively, in weeks 1 and 4 of cycle 1.Pharmacodynamic analysis included a modified standard panel for lymphocyte analysis by flow cytometry to characterise the basic lymphocyte subset (absolute and relative CD3 + , CD4 + , CD8 + T cells and the CD4:CD8 ratio, as well as CD20 + B cells). Inclusion of absolute and relative CD16 + /CD56 + and CD3 − natural killer (NK) cells was optional. In Germany, and optionally in other centres, the expression of activation and memory markers on T cell subsets was assessed by flow cytometry.Other pharmacodynamic assays included systemic cytokine release, assessed by multiplex analysis of a panel of proinflammatory cytokinesThe safety population included all patients who had received at least one dose of AFM11. The dose determination set comprised all patients who had received at least 4 weeks of treatment or had stopped treatment for reasons of toxicity. The DLT analysis set included all patients in the dose determination set. The PK population was defined as all patients who received at least one dose of AFM11 and for whom serum concentrations of AFM11 were measured.