eligibility_summary
Eligible: men/women 15–65 with untreated newly diagnosed Ph– B-ALL (MICM, ≥20% blasts, Ph/BCR-ABL–), ECOG 0–2, adequate organ function, LVEF ≥45%, women need negative pregnancy test. Exclude: prior ALL therapy, CNS/extramedullary disease, other trials, significant comorbidities/neuro-psych disorders, recent major surgery, active other cancers, inadequate contraception/pregnancy/lactation, serious heart disease, HIV+, uncontrolled infection, drug allergy, non-ALL bleeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Reduced-dose multi-agent chemotherapy followed by 14-day blinatumomab for induction, consolidation alternates chemotherapy with blinatumomab (3 cycles total), maintenance POMP (6-mercaptopurine, vincristine, methotrexate, prednisone) ± one blinatumomab cycle every 6 months, ≥12 prophylactic intrathecal doses. Mechanisms/type: Blinatumomab is a bispecific T-cell engager (BiTE) antibody construct (immunotherapy/biologic) that binds CD19 on B-lineage blasts and CD3 on T cells, redirecting T-cell cytotoxicity to CD19+ cells. Cytotoxic chemotherapy (antimetabolites, vinca alkaloid, corticosteroid) inhibits DNA synthesis and mitosis and is lymphotoxic, intrathecal methotrexate/cytarabine protect CNS. Targets/pathways: CD19+ B-ALL blasts, T-cell activation via CD3/immune synapse, cell-cycle/DNA replication and microtubule pathways, CNS leukemic reservoirs. Population: newly diagnosed Ph-negative B-ALL (15–65).