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EndRAD Phase 2 Finds Non-TBI Conditioning Matches Outcomes in MRD-Negative Young B-ALL

Researchers used highly sensitive NGS-MRD to select transplant candidates for radiation-free regimens.

Overview

  • The phase 2 EndRAD treatment arm (n=51) achieved 2-year event-free survival of 76.3% and overall survival of 82.0% after myeloablative, TBI-free conditioning.
  • Outcomes were comparable to an observational cohort of TBI-treated patients (n=151) with a median follow-up of 2.3 years.
  • Non-relapse mortality and relapse each occurred in 12% of patients, with grade 3–4 acute GVHD in 10% and chronic GVHD requiring systemic therapy in 21%.
  • Most participants (86%) received busulfan, fludarabine and thiotepa, and the study enrolled across 45 North American centers with varied donors and graft sources.
  • Investigators described the findings as potentially practice-changing for NGS-MRD–negative patients and said further analyses will refine selection and assess durability.