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EndRAD Trial Finds TBI-Free Conditioning Matches 2-Year Outcomes in MRD-Negative Pediatric and Young Adult B-ALL

Presented at ASH 2025, the phase 2 data suggest NGS-MRD testing can steer radiation-sparing transplant conditioning for carefully selected patients.

Overview

  • Fifty-one next-generation sequencing MRD–negative patients aged 1–30 received myeloablative non–total body irradiation conditioning across 45 North American centers.
  • With a median follow-up of 2.3 years, the 2-year event-free survival was 76.3% and overall survival was 82.0%, comparable with historical TBI-based benchmarks.
  • Most participants (86%) received busulfan, fludarabine, and thiotepa, with graft sources including bone marrow (71%), peripheral blood (21%), and cord blood (8%).
  • Reported outcomes included one early transplant-related death (2%), 12% non-relapse mortality, six relapses, acute GVHD in 39%, and chronic GVHD in 25% with most requiring systemic therapy.
  • Investigators said NGS-MRD–negative patients may consider TBI-free conditioning, while emphasizing the need for longer follow-up, broader validation, and refined risk stratification.