Swapping Chemo for Blincyto Helped More Kids With High-Risk Leukemia

For children with high-risk B-cell acute lymphoblastic leukemia (ALL), replacing part of their intensive chemotherapy with the immunotherapy Blincyto (blinatumomab) kept more of them free of leukemia and caused far fewer infections, according to a large international trial.

The results of the phase 3 AIEOP-BFM ALL 2017 trial were published online Sept. 17, 2026, in The New England Journal of Medicine. The trial was led by Dr. Martin Schrappe of University Hospital Schleswig-Holstein in Kiel, Germany, with researchers from Europe, Israel and Australia.

What the Trial Tested

ALL is the most common childhood cancer. Children whose leukemia is considered high risk usually receive several cycles of very intensive chemotherapy, which can cause serious infections and other complications.

The trial included 709 children and teens younger than 18 with high-risk, Philadelphia chromosome-negative B-cell ALL. After the early phases of treatment and one cycle of intensive chemotherapy, they were randomly assigned to one of two paths:

• Blincyto: 358 children received Blincyto in place of the next two cycles of intensive chemotherapy.
• Chemotherapy: 351 children received the standard two cycles of intensive chemotherapy.

Blincyto is a type of immunotherapy called a bispecific T-cell engager. It acts like a bridge, connecting the body's T cells (a type of immune cell) to leukemia cells that carry a marker called CD19 so the immune system can attack them.

What the Study Found

After four years:

• More children were event-free: 83% of children in the Blincyto group were alive without their leukemia coming back or other major events, compared with 70.3% in the chemotherapy group. That is a 49% lower risk of such events.
• Fewer relapses: Leukemia returned in 11.8% of children who got Blincyto, compared with 21.4% of those who got chemotherapy.
• Survival was high in both groups: 93.6% of children who received Blincyto were alive at four years, compared with 91% of those who received chemotherapy.
• Deeper responses: After one cycle of Blincyto, 69.2% of children had leukemia that was undetectable on sensitive tests (called minimal residual disease, or MRD), compared with 32.3% after two cycles of chemotherapy.

Side Effects to Know

Treatment-related infections were much less common with Blincyto: 23.9% of children, compared with 69.4% of those who received chemotherapy.

Blincyto has its own side effects. Nervous system problems such as headache, confusion, tremors or seizures occurred in 12% of children who got Blincyto, compared with 3.2% with chemotherapy. Cytokine release syndrome, an immune reaction that can cause fever and low blood pressure, was rare, affecting 1.1% of children at a moderate or higher level.

Why This Matters

Blincyto is already approved by the FDA for the consolidation phase of treatment in adults and children 1 month and older with CD19-positive, Philadelphia chromosome-negative B-cell ALL, an approval granted in June 2024 (read more here). Another trial, published in December 2024, found that adding Blincyto to chemotherapy helped children with standard-risk B-cell ALL.

This new trial goes a step further. Instead of adding Blincyto on top of chemotherapy, it replaced some of the hardest chemotherapy for children at high risk. The researchers concluded that Blincyto "can safely replace chemotherapy" as part of first-line treatment for these children.

What It Means for You

If your child has been diagnosed with high-risk B-cell ALL, ask whether Blincyto could be part of their treatment plan. Treatment protocols vary by hospital and study group, and the right approach depends on the leukemia's genetic features and how well it responds to early treatment. Children who receive Blincyto usually get it as a continuous infusion through a small portable pump, sometimes for weeks at a time, and need close monitoring for nervous system side effects.

Questions to Ask Your Child's Care Team

• Is my child's leukemia considered high risk, and why?
• Could Blincyto replace any of the intensive chemotherapy in my child's plan?
• How would the infusion pump work at home and at school?
• Which side effects should we watch for, and when should we call you?

References

1. "Blinatumomab for Replacing Chemotherapy in Pediatric Acute Lymphoblastic Leukemia." Schrappe M, et al. The New England Journal of Medicine. Sept. 17, 2026.

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