eligibility_summary
Eligible: adults (>18) with relapsed/refractory DLBCL, FL, PMBCL, MCL, or B-ALL, planned for CAR-T at the Hematology division of Policlinico Universitario Agostino Gemelli, Rome, and LVEF >50%. Exclude: age <18, refusal to participate, or LVEF <50%.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Design: Prospective observational study in adults with relapsed/refractory B‑cell malignancies receiving CAR‑T. Interventions: autologous anti‑CD19 CAR‑T products—tisagenlecleucel (4‑1BB costimulation), axicabtagene ciloleucel (CD28), brexucabtagene autoleucel (CD28). Mechanism: patient T cells engineered with a chimeric antigen receptor bind CD19 on B cells, triggering T‑cell activation/cytolysis and cytokine release. Targets/pathways: CD19+ malignant B cells, CAR signaling in T cells (CD3ζ with 4‑1BB or CD28 costimulation), inflammatory cytokine pathways (notably IL‑6, IL‑6 inhibitor use recorded). Aim: quantify CAR‑T–associated cardiac dysfunction via echocardiography and biomarkers at baseline, day 7, and 1 month.