eligibility_summary
Eligible: adults starting first blinatumomab for R/R or MRD+ B-ALL, adequate renal/hepatic function, HIV-negative, negative pregnancy test if applicable, ECOG 0-2. Exclude: CNS ALL, CNS disorders (seizure, paresis, aphasia, stroke/ICH, severe brain injury, dementia, Parkinsons, cerebellar disease, psychosis, coordination/movement disorder), contraindication to intrathecal methotrexate, prior blinatumomab, other active cancer, active infection or other interfering condition.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm prevention trial in adult B-ALL (R/R or MRD+): intrathecal methotrexate (12 mg, antimetabolite antifolate chemotherapy, DHFR inhibitor) is given within 24 h before blinatumomab (28 μg/day continuous infusion x4 weeks, bispecific T-cell engager antibody). Goal: preserve anti-leukemic efficacy while reducing CNS neurotoxicity from cytokine release. Mechanisms/targets: blinatumomab links CD3 on T cells to CD19 on B-lineage ALL blasts, activating T-cell cytotoxicity and cytokine release, methotrexate inhibits folate/DHFR-dependent DNA synthesis to control CNS leukemic cells and may blunt inflammatory responses. Targeted cells/pathways: CD19+ B-cell blasts, CD3+ T-cell activation, folate/DHFR, CNS cytokine/inflammation.