Biological Analysis of MABs in NHL in a Translational Prospective Observational Study Within Italian Clinical Practice

Multilayer Biological Analysis of Novel Monoclonal Antibodies (MABs) in B-Cell Non-Hodgkin Lymphoma (NHL): A Translational and Prospective Observational Study Within Italian Clinical Practice (BIO-FIL_MAB Trial)

This a prospective, multicenter, observational pharmacological translational study designed to investigate the biological and imaging correlates of treatment with novel monoclonal antibodies (NMABs) in patients with B-cell non-Hodgkin lymphoma (NHL), enrolled in the observationa FIL_MAB study. Patients enrolled in BIO FIL-MAB are concurrently participating in the FIL-MAB clinical cohort, ensuring that all clinical data-including treatment details, outcomes, and safety-are captured within the main observational study.

Patients will undergo systematic collection of biological specimens including tumor tissue, peripheral blood integrated with advanced imaging data. Biological analyses will encompass molecular, cellular, and immunological assessments, while imaging evaluations will include standardized functional and metabolic imaging techniques. All biological and imaging assessments will be performed as routine clinical visits, without requiring modifications to treatment or additional procedures beyond standard-of-care.

Inclusion Criteria:

• Adults (≥18 years old) are diagnosed with B-cell Non-Hodgkin Lymphoma;
• Patients enrolled in the FIL_MAB trial (provided by Informed Consent Form (ICF) signature) who are scheduled to receive treatment with novel monoclonal antibodies (NMABs), either as monotherapy or in combination with other therapies;
• Written informed consent to participate in this study.

Exclusion Criteria:

• Patients not enrolled in the FIL_MAB study.

• Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

  • Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARSCoV-2;
  • Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA;
  • HIV seropositivity;

• Refusal or inability to provide informed consent.

• Refusal or inability to provide biological specimens.