eligibility_summary
Adults ≥18 with newly diagnosed CD19+ Ph− B‑ALL, unsuitable for pediatric‑inspired regimens, marrow/blood involvement by MFC, bilirubin ≤2× ULN (≤4× if Gilbert’s, ≤5× with hepatic ALL), AST/ALT ≤5× ULN (≤8× with hepatic ALL), CrCl >30 mL/min, ECOG 0–2 (3 if due to ALL), able to consent, expected survival ≥3 mo. Exclude: Burkitt, prior ALL therapy beyond emergent, isolated extramedullary/parenchymal CNS disease, drug intolerance, unsafe comorbidity, pregnancy/nursing.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm study adding tafasitamab to DA-EPOCH±rituximab for newly diagnosed Ph– B-ALL. Drugs/mechanisms (type): tafasitamab-cxix (humanized, Fc-engineered anti-CD19 IgG1 monoclonal antibody, enhances ADCC/ADCP and induces apoptosis), rituximab (chimeric anti-CD20 mAb, CDC/ADCC/apoptosis, given only if CD20+), etoposide (epipodophyllotoxin, topoisomerase II inhibitor), doxorubicin (anthracycline, DNA intercalation, topoisomerase II inhibition, ROS), vincristine (vinca alkaloid, microtubule polymerization inhibitor), cyclophosphamide (alkylating agent, DNA crosslinking), prednisone (glucocorticoid, GR-mediated lympholysis). Targets/pathways: CD19 on B-lymphoblasts, CD20 on a subset of B-ALL cells, immune effector pathways via Fcγ receptors and complement, DNA replication/repair and mitotic spindle, glucocorticoid signaling–induced apoptosis.