eligibility_summary
Pre-reg: first-pull BM/PB mandatory for baseline MRD. Eligible: B‑cell ALL/LBL with ≥5% blasts, CD22+ ≥20%, age ≥50, ECOG ≤2 (3 if disease-related), only limited prior therapy, leukapheresis, ≤24 Gy RT allowed. Labs: Cr ≤2.0, bili ≤1.5×ULN (≤2× if Gilbert/infiltration), AST/ALT ≤2.5×ULN, EF >40%, no sig liver dz, HBV/HCV suppressed ok, HIV on ART ok. Exclude T‑ALL/LBL, Ph+ B‑ALL, Burkitt-like, symptomatic CNS, uncontrolled illness, active 2nd cancer. Contraception required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Randomized phase II in adults ≥50 with Ph− B‑ALL/B‑LBL testing inotuzumab ozogamicin plus multi‑agent chemo vs standard chemo. Drugs/mechanisms (type): inotuzumab ozogamicin—anti‑CD22 antibody‑drug conjugate delivering calicheamicin to induce DNA double‑strand breaks, rituximab—anti‑CD20 monoclonal antibody (ADCC/CDC) for CD20+ blasts, cyclophosphamide—alkylating agent (DNA crosslinks), vincristine—vinca alkaloid (microtubule inhibitor), methotrexate—antifolate (DHFR inhibition), cytarabine—nucleoside analog (DNA polymerase inhibitor), doxorubicin—anthracycline (topo II inhibition, ROS), mercaptopurine—purine analog antimetabolite, dexamethasone/prednisone/methylpred—glucocorticoids (lymphoid apoptosis). Targets/pathways: CD22 (primary) and CD20 on B‑cell lymphoblasts, DNA replication/repair, nucleotide synthesis (folate/purine), mitotic spindle, topoisomerase II, and glucocorticoid signaling.