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

NCT07614035 | Not Yet Recruiting

• 2 other identifiers: ASCLEPIORC-2025-2794601
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Hodgkin Lymphoma

Keywords

Non-Hodgkin Lymphoma; bispecific antibodies

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Through study completion, up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Evidence of concomitant and uncontrolled diseases that could affect protocol compliance or interpretation of results.
• Concomitant secondary neoplasm.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, faeces, lymph nodes

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Beatrice Casadei, MD

CONTACT

+39 051 2143480; beatrice.casadei10@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

IT (1)