A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphobl

While outcomes in Standard Risk (SR) B-lymphoblastic leukemia (B-ALL) have improved significantly, this population still accounts for approximately half of the overall burden of relapse among children with ALL. Despite contemporary intensive chemotherapy, the outcomes for children with relapsed ALL remain dismal, with 5-year overall survival (OS) of approximately 38%.1 Interventions that further reduce the number of SR ALL relapses will therefore significantly improve the long-term survival of the overall ALL population. AALL1731 is a group-wide risk-stratified trial for children with newly diagnosed B-ALL and localized B-lymphoblastic lymphoma (B-LLy) that will test if the addition of blinatumomab to standard chemotherapy in patients with NCI SR B-ALL at highest risk for relapse will improve disease-free survival (DFS). Risk stratification will be determined by traditional prognosticators (tumor genetics, extent of extramedullary involvement, early response to therapy as determined by flow cytometry) combined with the new DNA-based MRD detection technology of high throughput sequencing (HTS) of the immunoglobulin heavy chain (IgH).