Identification of the Best Treatment Pathway for Patients With Relapsed/Refractory Lymphocytic B-derived Non-Hodgkin Lymphoma

N/ANot Yet RecruitingNCT07614035

IRCCS Azienda Ospedaliero-Universitaria di Bologna70 enrolled

Overview

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.

This exploratory study aims to obtain a first identification of clinical and biological characteristics related to response and toxicity to bispecific antibodies. Having this information, currently not available in the scientific literature and to be validated in further studies, therapies with BsAbs can be addressed only to patients for whom they have proven useful, improving the results of the therapy pharmacological (more responses and less toxicity) and consequently the sustainability and efficiency of the healthcare system.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-Hodgkin Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Evidence of concomitant and uncontrolled diseases that could affect protocol compliance or interpretation of results. * Concomitant secondary neoplasm.

Locations (1)

IRCCS Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, Italy

Outcomes

Primary Outcomes

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

Time frame: During the entire duration of treatment and up to 12 months after the last administration

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

Time frame: At the end of treatment, approximately 1 month after last cycle treatment (up to 12 months from baseline). Indiviadual cycle lengths range from 21 to 28 days depending on the specific drug regimen, with a maximum treatment duration of 12 months.

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

Time frame: Through study completion, up to 12 months

Central Contacts

Beatrice Casadei, MD

CONTACT

+39 051 2143480 beatrice.casadei10@unibo.it

Data from ClinicalTrials.gov

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