eligibility_summary
Eligible: ages 15–65 with newly diagnosed Ph– (BCR-ABL1–) B-ALL (WHO), no prior induction (except ≤5 days hydroxyurea or steroids), ECOG 0–3, bilirubin/AST/ALT ≤3× ULN (unless due to leukemic infiltration), CrCl ≥30 mL/min, consent. Exclude: Ph+ ALL, T-ALL, mature B-cell leukemia/lymphoma (incl. B-cell lymphoma with extramedullary disease), acute mixed-cell leukemia, CNS leukemia, HIV, HBV/HCV viremia, ≥grade 2 heart failure/other unsuitable, pregnant/breastfeeding, refusal.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 trial in newly diagnosed Ph− B-ALL compares: 1) Reduced-dose chemotherapy (idarubicin—anthracycline/topoisomerase II inhibitor, vincristine—vinca alkaloid/microtubule inhibitor, dexamethasone—glucocorticoid inducing lymphoblast apoptosis) followed by blinatumomab (BiTE, bispecific antibody immunotherapy linking CD3 on T cells to CD19 on B cells to trigger T cell–mediated cytotoxicity), vs 2) hyperCVAD (cyclophosphamide—alkylating DNA crosslinker, vincristine—microtubule inhibitor, anthracycline [doxorubicin/daunorubicin]—topo II/ROS, dexamethasone—glucocorticoid). Targets/pathways: CD19+ B-ALL blasts, CD3/TCR activation and cytolysis, DNA replication/crosslinking (alkylator), topoisomerase II, mitotic spindle, glucocorticoid receptor. Consolidation may include methotrexate (DHFR), cytarabine (DNA polymerase), asparaginase (asparagine depletion).