The RIALTO study is a trial in which we included patients with a B-cell precursor relapsed refractory acute lymphoblastic leukaemia substantially with the scope of confirming the results of the original 205 trial in which we demonstrated a good efficacy of the drug product as well as relevant safety. A difference with the original trial – we were allowed to recruit patients with a lower leukaemia burden and this resulted into a better complete remission rate with a negativity of minimal residual disease in many of these patients.
The RIALTO trial is based on a novel monoclonal antibody called blinatumomab; it belongs to the class of bispecific T-cell engager. Through this monoclonal antibody there is an immunologic synapsis between leukaemia cells and T-lymphocytes of the patients, the latter being able to kill the leukaemia cells. When we treat these patients we must be careful during the first 3-4 days of treatment to monitor potential toxicity, in particular related to the dramatic destruction of the leukaemia cells and a potential cytokine release syndrome must be carefully monitored. If it occurs it must be timely treated.
The drug otherwise is very well tolerated and this represents a further advantage because these patients are candidates then to receive an allogeneic bone marrow transplantation to consolidate the state of remission that we have obtained and sparing the toxicity associated with conventional chemotherapy can also translate into a better post-transplant outcome.