Multicenter phase 3 trial of blinatumomab for standard-risk B-cell acute lymphoblastic leukemia in children

The multicenter phase 3 AALL1731 trial in the USA evaluated addition of the bispecific T-cell engager blinatumomab to chemotherapy for standard risk B-cell acute lymphoblastic leukemia (B-cell ALL) in children at average or high risk of relapse. Patients were randomized to chemotherapy alone or chemotherapy plus blinatumomab during two non-sequential cycles. Primary endpoint was disease-free survival (DFS). At the first interim analysis, the data and safety monitoring committee recommended early termination of randomization. The estimated 3-year DFS was 96.0±1.2% with blinatumomab plus chemotherapy versus 87.9±2.1% with chemotherapy alone; among patients with average relapse risk the estimated 3-year DFS was 97.5±1.3% versus 90.2±2.3%; and among patients with high relapse risk 94.1±2,5% versus 84.8± 3.8%. The overall incidence of nonfatal sepsis and catheter-related infections was higher among patients with average relapse risk receiving blinatumomab. The authors conclude that adding blinatumomab to chemotherapy in patients with newly diagnosed childhood standard-risk B-cell ALL of average or high risk of relapse significantly improved disease-free survival.