In the EHA meeting we have presented our first preliminary data of this trial that consisted of the inclusion of blinatumomab in consolidation of patients with high-risk ALL in substitution of one cycle of early consolidation, one out of three, and one out of three cycles of delayed consolidation therapy. The novelty of this trial is that we applied this trial to patients who had a good MRD clearance after induction, or pretty good, so less than 1x10-3.
Our results showed that after the first consolidation cycle that consisted of two chemotherapy cycles and one blinatumomab cycle we have reached a one log depletion of MRD level compared to post-induction levels. Most importantly, after the delayed consolidation part of the trial that consisted, again, with two cycles of chemotherapy and one additional cycle of blinatumomab, we achieved a further new one log reduction of MRD.
So, in summary, including blinatumomab in consolidation cycles we have reached a two log reduction in the MRD level after consolidation. This is the efficacy part: the safety part was good so we could include blinatumomab between chemotherapy cycles without any unexpected toxicity. So we have some neurological toxicities, some cytopenias but they were in the frequency as expected with the use of blinatumomab. But no additional unexpected toxicities were seen.
This trial is ongoing; we have included eleven patients to date and today ten out of these eleven patients are disease free at the moment with more than one year median follow-up. So we have to follow this study but the preliminary results in terms of efficacy and safety are promising.