eligibility_summary
Eligible: age 15–59 with de novo Ph− precursor B‑ALL (2022 WHO), ECOG 0–2, life expectancy ≥2 months, adequate organ function, consent, and effective contraception during treatment and 12 months after. Exclude: CNS leukemia, significant cardiac/respiratory/hepatic/renal disease or severe infection, LVEF <45%, other cancer ≤5 years (except localized thyroid/in situ skin), bilirubin >1.5×ULN, ALT/AST >2.5×ULN, creatinine >1.5×ULN, HIV, contraindications, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial in Ph‑negative precursor B‑ALL tests induction with blinatumomab plus reduced-dose chemotherapy (vindesine, cyclophosphamide, dexamethasone), then blinatumomab + venetoclax, HSCT is suggested for consolidation. Drug types/mechanisms: blinatumomab (bispecific T‑cell engager, BiTE) links CD3 on T cells to CD19 on B‑cell blasts, driving T‑cell–mediated cytotoxicity, venetoclax (oral BH3‑mimetic) inhibits BCL‑2 to induce apoptosis, vindesine (vinca alkaloid) blocks microtubule polymerization/mitosis, cyclophosphamide (alkylating agent) crosslinks DNA, dexamethasone (glucocorticoid) is lympholytic/pro‑apoptotic. Targets/pathways: CD19+ B‑ALL blasts, CD3+ T‑cell activation, intrinsic apoptosis via BCL‑2, microtubules/mitotic spindle, DNA damage/crosslinking, glucocorticoid receptor signaling. Primary endpoint: MRD‑negative complete remission.