Official websites use. Share sensitive information only on official, secure websites. Qualified researchers may request data from Amgen clinical studies. The primary end point was incidence of adverse events. Secondary end points included complete response CR and measurable residual disease MRD response within the first 2 cycles and relapse-free survival RFS , overall survival OS , and allogeneic hematopoietic stem cell transplant alloHSCT after treatment.
At final data cutoff 10 January , patients were enrolled median age, 8. Median OS was Of patients achieving CR after 2 cycles, This trial was registered at www.
We previously described findings of the primary analysis 16 ; herein the final follow-up data are presented. In this multicenter, open-label, expanded access study, investigators at 16 centers in Europe and the United States supplemental Table 1 enrolled patients from January to July Exclusion criteria included presence of clinically relevant central nervous system CNS pathology, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, with the exception of CNS leukemia that is well controlled with intrathecal therapy; chemotherapy within 2 weeks, radiotherapy within 4 weeks, or immunotherapy within 6 weeks; grade 2 to 4 active acute graft-versus-host disease GVHD or active chronic GVHD requiring systemic treatment; and immunosuppressive agents to prevent or treat GVHD within 2 weeks before blinatumomab treatment except for topical corticosteroids.
The trial protocol was approved by an independent ethics committee or institutional review board at each participating center. Patients above the age of 12 years provided assent to participate in the study. Eligible patients received blinatumomab by continuous IV infusion in a 6-week cycle 4 weeks on, 2 weeks off for up to 5 cycles 2 induction cycles and 3 consolidation cycles.
Only patients achieving CR as defined by M1 marrow after induction could receive up to 3 consolidation cycles of blinatumomab. To prevent first-dose adverse events AEs , dexamethasone was administered at a dose up to 24 mg per day for up to 4 days before the start of blinatumomab treatment. A TEAE is defined as any AE occurring between the start of the first infusion of blinatumomab until 30 days after the end of the infusion.
