eligibility_summary
Eligibility: Pediatric ALL diagnosed age 1–19 with one+: Ph+ t(9,22), induction failure (>5% marrow blasts post-induction), hypodiploidy (<44 chromosomes), E2A-HLF+, high-risk NGS-MRD: B-ALL MRD ≥0.01% post-consolidation and during interim maintenance, or T-ALL MRD >0.01% post-consolidation. Exclusions: med contraindications, consent withdrawn, pregnancy/lactation (use contraception), investigator deems unsuitable, in other interventional trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06257394 tests MRD-guided therapy for pediatric very high-risk ALL in two arms: Ph+ ALL uses a dasatinib backbone, non‑Ph+ VHR ALL uses chemo with possible blinatumomab and HSCT. Interventions/mechanisms: • Dasatinib (small‑molecule ATP‑competitive TKI) inhibits BCR‑ABL1 and SRC family kinases. • Blinatumomab (bispecific T‑cell engager, BiTE) links CD3 on T cells to CD19 on B‑cell blasts, triggering T‑cell cytotoxicity. • High‑dose methotrexate (antifolate antimetabolite) blocks DHFR and thymidylate/purine synthesis. • High‑dose cytarabine/Ara‑C (nucleoside analog antimetabolite) inhibits DNA polymerase/chain elongation. • Allogeneic HSCT (cellular therapy) provides graft‑versus‑leukemia immunity. Targets/pathways: BCR‑ABL signaling in Ph+ blasts, CD19 on B‑precursor ALL with T‑cell engagement, S‑phase DNA synthesis in rapidly dividing blasts, donor immune GVL effect. MRD status guides blinatumomab vs HD MTX/Ara‑C and HSCT.