Effect of Blinatumomab vs Chemotherapy on Event-Free Survival Among Children With High-risk First-Relapse B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial
RCT (n=108) terminated early as found blinatumomab was superior to chemotherapy for the third consolidation therapy prior to allogeneic hematopoietic stem cell transplant for event free survival (incidence of events in 31% vs. 57%, respectively, HR 0.33, 95%CI 0.18-0.61).
Source:
Journal of the American Medical Association
SPS commentary:
Event free survival was defined as absence of relapse, death, second malignancy, or failure to achieve complete remission.
A related study in paediatric and young adult patients with first relapse of B-cell acute lymphoblastic leukaemia did not find a statistically significant improvement in disease free survival for 2 cycles of blinatumomab vs chemotherapy prior to transplant (54.4% vs 39.0%, HR 0.70, 95%CI 0.47-1.03), though 2 year overall survival was superior (71.3% vs 58.4%, 0.62, 0.39-0.98).
A related commentary discusses these studies. It concludes that they represent the first randomised trials to show a clear benefit of blinatumomab for children with high-risk relapsed B-ALL. The improved outcomes, coupled with a favourable toxicity profile, support investigating the inclusion of blinatumomab and other immunotherapies in future clinical trials of frontline treatment and therapy for relapse among patients with childhood ALL.