San Sisto

Researchers are conducting a multinational clinical trial called LBL 2018 to study treatment approaches for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial aims to see if replacing prednisone with dexamethasone in induction therapy can reduce relapse involving the central nervous system (CNS) and if intensified treatment improves event-free survival in high-risk patients. Participants are grouped into high risk and standard risk categories based on disease characteristics to guide treatment and randomization. The study compares standard chemotherapy treatment using prednisone to an experimental approach using dexamethasone during induction. Patients in standard risk groups receive induction, consolidation, extra-compartment phases, reintensification (for some), and maintenance therapy over 24 months. High-risk patients can be randomized again after induction to receive either standard or intensified chemotherapy including additional PEG asparaginase and alternating high-risk courses. Patients with CNS involvement receive intensified intrathecal therapy and additional doses during maintenance without cranial irradiation. Participants undergo treatment phases lasting up to 24 months with follow-up for up to 7.25 years to monitor relapse rates and event-free survival. Evaluations include disease status, CNS involvement, and response to therapy. The trial collects pathology and genetic samples for risk stratification and monitors safety and treatment effects across multiple international centers. This comprehensive study seeks to improve outcomes while reducing CNS relapses in young patients with lymphoblastic lymphoma.