Study participants
cancer, malignancy, infection, ALL, abnormal renal or hepatic function, coronary artery disease
GRAFT VERSUS HOST DISEASE, CANCER, DISEASE, INFECTION, PATHOLOGY, CORONARY ARTERY DISEASE
The study included men or women aged ≥ 18 years with a diagnosis of R/R CD19 + B-precursor Philadelphia-chromosome negative ALL who were not candidates for bone marrow transplantation with curative intent. CD19 expression must have been confirmed by either staining or flow cytometry of a recent bone marrow biopsy. Patients were required to have failed or be intolerant to therapy with at least two tyrosine kinase inhibitors, > 5% blasts in their bone marrow, an ECOG performance status of ≤ 2 and a life expectancy of ≥ 3 months.Patients were excluded from the study if they had received autologous or allogeneic haematopoietic stem cell transplant within the previous 3 months; had active graft versus host disease; had received prior treatment with blinatumomab or other CD19 targeting T-cell engager; had been treated with a donor lymphocyte infusion, cancer chemotherapy, an antibody or antibody construct or any investigational agent; or had received regular corticosteroids or other immunosuppressive in the 4 weeks prior to study entry. Patients with CNS involvement, a history of CNS pathology, abnormal renal or hepatic function, history of malignancy other than ALL, uncontrolled infection, clinically relevant coronary artery disease or other relevant disease were also excluded.A total of 50 patients were estimated to be enrolled based on the number of dose cohorts; the actual number of enrolled patients was dependent upon the number of dose levels assessed and the number of DLTs observed at each dose level.