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AIEOP-BFM ALL 2017

International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

Phase 3N = 709NCT03643276

Population
Children with newly diagnosed high-risk B-cell acute lymphoblastic leukemia
Design
Phase 3 randomised comparison within a larger protocol: after consolidation, children with high-risk B-cell ALL were assigned 1:1 to two cycles of blinatumomab or two cycles of chemotherapy. Primary objective: to test whether 4-year EFS would be 10 percentage points higher with blinatumomab. Results shown are a planned interim analysis, with 709 of 768 eligible patients randomised.
Primary endpoint
EFS
Arms
  • Chemotherapy cycles (control, n = 351): Two cycles of conventional chemotherapy after consolidation
  • Blinatumomab cycles (experimental, n = 358): Two cycles of blinatumomab in place of the two chemotherapy cycles, after consolidation
People
Schrappe M, AIEOP-BFM ALL 2017 Consortium
EFSHR 0.51 (95% CI 0.35–0.73)Δ 48-month EFS+12.7 points
Show the numbers
Results reported for AIEOP-BFM ALL 2017
EndpointAnalysisBlinatumomab cyclesChemotherapy cyclesEffect
EFSITT (709 randomised)Time from randomization to the first of resistance to protocol treatment, relapse, second cancer or death from any causeinterimmedian follow-up 2.9 yearsSchrappe 202683% at 4 y (77.4–87.4%)70.3% at 4 y (63.8–75.9%)HR 0.51 (95% CI 0.35–0.73)P=0.0002Planned interim analysis. Hazard ratio is blinatumomab versus control, from a Cox model; the P value is from the intention-to-treat analysis.
Results reported for AIEOP-BFM ALL 2017
EndpointAnalysisBlinatumomab cyclesChemotherapy cyclesEffect
EFSITT (709 randomised)Time from randomization to the first of resistance to protocol treatment, relapse, second cancer or death from any causeinterimmedian follow-up 2.9 yearsSchrappe 202683% at 4 y (77.4–87.4%)70.3% at 4 y (63.8–75.9%)HR 0.51 (95% CI 0.35–0.73)P=0.0002Planned interim analysis. Hazard ratio is blinatumomab versus control, from a Cox model; the P value is from the intention-to-treat analysis.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS0.510.35–0.73
Primary publication: Schrappe M, Locatelli F, Valsecchi MG, Zugmaier G, Vossen-Gajcy M, Starý J, et al. Blinatumomab for Replacing Chemotherapy in Pediatric Acute Lymphoblastic Leukemia. N Engl J Med. 2026;395(11):1075-1089. PubMedDOI

Appears in

Sources

  1. Schrappe M, Locatelli F, Valsecchi MG, Zugmaier G, Vossen-Gajcy M, Starý J, et al. Blinatumomab for Replacing Chemotherapy in Pediatric Acute Lymphoblastic Leukemia. N Engl J Med. 2026;395(11):1075-1089.

    PubMedDOI