Blinatumomab Versus Standard of Care Chemotherapy in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

- Subjects with Philadelphia negative B-precursor ALL, with any of the following: • refractory to primary induction therapy or refractory to salvage therapy, • in untreated first relapse with first remission duration <12 months • in untreated second or greater relapse • relapse at any time after allogeneic HSCT - Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy. - Greater than 5% blasts in the bone marrow - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria - Malignancy other than ALL within 5 years before blinatumomab treatment, except for adequately treated selected cancers without evidence of disease - Diagnosis of Burkitt’s leukemia according to World Health Organization classification, or human immunodeficiency virus (HIV), Hepatitis B or C, or other clinically significant disorder - Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement - Isolated extramedullary disease - Current autoimmune disease or history of autoimmune disease with potential CNS involvement - Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment - Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment - Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert) - Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy - Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min.