Study endpoints
toxicity
EVENTS, TRANSFUSION REACTION
The primary endpoint of this first-in-human study was toxicity assessed by the incidence of acute transfusion reaction related to the T cell product and/or late toxicity manifested by the development of acute GvHD due to the infusion of activated T cells. As shown previously, the T-cell products can substantially expand in the host and persist long term (Secondary endpoints of the study included the incidence of CMV and EBV reactivation, the use of antiviral drugs such as ganciclovir, valganciclovir, foscavir or cidofovir, and the use of rituximab for the treatment of EBV. T-cell reconstitution was assessed in both groups throughout the observation period and was started before the first transfusion of the T cell product. CMV and EBV DNA in peripheral blood plasma or PBMCs was determined by PCR in the laboratory used by the transplant center. Reactivation was defined as a single positive result in a PCR-based test. As shown in Reactivation of CMV and EBV. Secondary endpoints.Secondary endpoints included number of patients with CMV and/or EBV reactivation, number of patients treated with Ganciclovir, Valganciclovir, Foscavir, Cidofovir and Rituximab. Cumulative drug dosing was assessed throughout the study for all antiviral drugs including Rituximab. For comparison of events among the groups, Chi-Square test was used. For comparisons of means non-parametric Mann-Whitney-U test was used.None of the patients received Foscarnet or Cidovovir as a treatment. There was no statistically significant difference in the use of Ganciclovir (3 out of 23 cases). The most frequent drug used for the treatment of CMV was Valganciclovir. There was no difference regarding the number of patients treated, the duration of treatment and cumulative dose applied in each patient (