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

22 mai 2026 mis à jour par: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Identification of the Best Treatment Pathway for Patients With Relapsed/Refractory Lymphocytic B-derived Non-Hodgkin Lymphoma, Through the Identification of Prognostic Factors and Mechanisms of Resistance to Bispecific Antibody Therapy

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Lymphome non hodgkinien

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Beatrice Casadei, MD
Numéro de téléphone: +39 051 2143480
E-mail: beatrice.casadei10@unibo.it

Lieux d'étude

Italie
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italie, 40138
    - IRCCS Policlinico di Sant'Orsola
    - Contact:
      
      Beatrice Casadei, MD
      
      Numéro de téléphone: +39 051 2143480
      
      E-mail: beatrice.casadei10@unibo.it

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

N/A

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Identify potential predictors of toxicity to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma Délai: During the entire duration of treatment and up to 12 months after the last administration	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 Délai: 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.	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 Délai: Through study completion, up to 12 months	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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 juin 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

22 mai 2026

Première publication (Réel)

29 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)