Outcomes
death
RECURRENCE, ADVERSE EVENT, DISEASE, EVENT, REMISSION, SOMATIC MUTATIONS, EVENTS, RELAPSE
The primary endpoints of the analysis were overall response rate (including complete remission [CR], CR with incomplete platelet recovery [CRp], and CR with incomplete hematologic recovery [CRi]) and OS. Landmark analysis for OS was reported at the 2 months and 4 months cutoffs for patients receiving blinatumomab (the median time to receiving blinatumomab was 2 months) and allogeneic SCT (the median time to allogeneic SCT was 4 months), respectively. Secondary endpoints included safety measures, relapse-free survival (RFS), the rate of subsequent allogeneic SCT, and the MRD negativity rate. Response to therapy was by bone marrow evaluations after Course 1 then after every 2–4 courses of consolidation and every 3–6 months during maintenance. CR was defined as the presence of ≤ 5% blasts in the bone marrow, with more than 1 × 10We performed in situ hybridization (FISH) technique using a CRLF2 dual color, breakapart DNA probe from Cytocell Ltd. The probe hybridized to band Xp22.33/Yp11.32 to detect CRLF2 rearrangement. We performed a next-generation sequencing-based analysis for the detection of somatic mutations in the coding sequence of the Relapse was defined as recurrence of more than 5% lymphoblasts in a bone marrow aspirate unrelated to recovery, or by the presence of extramedullary disease. RFS was calculated from the time of CR until relapse or death. OS was calculated from the time of treatment initiation until death.Adverse events were defined as any event that occurred between the first dose and 2 months after the last dose, all treatment-related events that occurred after the last dose, and all cases of SOS (of any cause) that occurred within 2 years after inotuzumab therapy. SOS was assessed, diagnosed and evaluated according to previously defined clinical criteria [