eligibility_summary
Eligibility: age at relapse <=1 or >22 yrs, histologic ALL (B-ALL/T-ALL), first relapse with marrow involvement (+/- extramedullary, blasts <5% allowed), no prior allo-HSCT or blinatumomab, adequate renal/liver/cardiac function, PS >=60, life expectancy >=1 yr, consent/compliance. Exclude: Burkitt/mature B-cell, Ph+ ALL, CD19- B-ALL, relapse <1 mo post same induction, mixed phenotype, genetic syndromes, HIV, pregnancy/non-infertile females, other trials, unstable/CNS disease, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label pediatric first-relapse ALL using NGS-MRD–guided risk groups. Interventions: multi-agent chemotherapy—prednisolone/dexamethasone (glucocorticoids inducing lymphoblast apoptosis), vincristine (vinca microtubule inhibitor), L-asparaginase (asparagine depletion), idarubicin (anthracycline DNA intercalator/topo II inhibitor), cytarabine (antimetabolite inhibiting DNA polymerase), methotrexate (antifolate DHFR inhibitor), ifosfamide (alkylator DNA crosslinks), etoposide (topo II inhibitor), 6-mercaptopurine (purine analog), intrathecal MTX/Ara-C ± steroid for CNS, blinatumomab (BiTE antibody construct) linking CD3 on T cells to CD19 on B-ALL, hematopoietic stem cell transplant (graft-versus-leukemia). Target cells/pathways: CD19+ B lymphoblasts via T-cell engagement, microtubules, asparagine metabolism, folate/purine synthesis, DNA replication/repair (polymerase/topo II) and crosslinking, CNS sanctuary sites. High/very-high B-ALL get blinatumomab then HSCT, T-ALL proceeds to HSCT after chemo.