AALL1731 — A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (Children's Oncology Group AALL1731)

Phase III · 2024 · Acute Lymphoblastic Leukemia

Design

Randomized phase III trial assigning children with newly diagnosed standard-risk B-cell ALL of average or higher relapse risk to chemotherapy alone versus chemotherapy plus two cycles of blinatumomab.

Population

Children with newly diagnosed National Cancer Institute standard-risk B-cell acute lymphoblastic leukemia of average or higher risk of relapse.

Primary Endpoint

Disease-free survival

Key Result

At a median follow-up of 2.5 years, adding blinatumomab improved estimated 3-year disease-free survival to 96.0±1.2% versus 87.9±2.1% with chemotherapy alone (difference in restricted mean survival time, 72 days; 95% CI, 36-108; P<0.001), prompting early termination of randomization.

Guideline Impact

Supports incorporating blinatumomab into frontline standard-risk pediatric B-ALL therapy