Bispecific antibodies have demonstrated high efficacy in the treatment of Refractory/relapsed b-cell non-Hodgkin lymphomas. However, a non-negligible percentage of patients do not respond to therapy and/or develop significant treatment toxicity.
Age≥18 years
Patients with histologically documented non-Hodgkin B lymphoma, with relapsed/refractory disease and candidates for BsAbs therapy (glofitamab, epcoritamab, mosunetuzumab) according to clinical indication and AIFA reimbursement criteria
obtaining signed and dated informed consent before the start of any screening or study-specific procedure
Evidence of concomitant and uncontrolled diseases that could affect protocol compliance or interpretation of results.
Concomitant secondary neoplasm.
This is a single-center, observational pharmacological, non-profit study with a tissue component and collection of biological samples, which involves a prospective enrollment of patients treated with BsAbs who will be followed for a period of at least 18 months. All patients will be treated according to clinical practice and will follow the clinical care pathway required by the standard operating procedures of the IRCCS AOUBO Hospital Authority. The search for biomarkers predictive of response and toxicity, as well as the description of potential resistance mechanisms to BsAbs treatment, will be conducted by a multidisciplinary team involving several Operational Units (UOs) of the IRCCS AOUBO. In particular, the units involved in the specific study analyses will be the Nuclear Medicine Operational Unit, Hemolymphopathology, Gastroenterology and Digestive Endoscopy, Internal Medicine and Digestive Pathophysiology and the Biology and Molecular Medicine Platform, Intestinal Microbiomics.
Cohort
Prospective
Not listed
Identify potential predictors of toxicity to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma
Therapy toxicity defined as the occurrence of at least one of the following conditions: * hematological toxicity of degree \> 3 * extra-hematological toxicity of degree \> 2 * CRS and ICANS of any degree
Identify potential predictors of response to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma
Response to therapy defined as the occurrence of any of the following conditions: * CR * PR * stable response (SD, stable disease) * disease progression (PD, progression disease) assessed by performing PET/CT radiological examination and measured by the Deauville score
Identify and describe potential mechanisms of resistance (ongoing metabolic progression or at the end of BsAbs treatment/metabolic relapse) to BsAbs treatment
Presence (yes/no) of resistance to the treatment, identified by PET (Deauville Score) in patients undergoing at least 1 course of treatment, in case of SD \>3, through: * Histological examination and characterization in IHC of lymphomatous cells and their TME pre therapy and at relapse/progression * Characterization longitudinal of the GM and the intestinal permeability and of their changes in the time * Parameter analysis semi-quantitative in PET
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