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INfections in Patients Treated With CAR-T (IN-CART)

17 juillet 2026 mis à jour par: IRCCS Azienda Ospedaliero-Universitaria di Bologna

INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies

This study includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their causes, and factors that may increase the risk. The study will use information from patients treated in the past and from newly enrolled patients. For some patients who develop fever after CAR-T therapy, a rapid molecular blood test will be used alongside standard tests to help identify bloodstream infections more quickly and support timely clinical care.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

This is a single-center observational study involving adult patients with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who received/will receive CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The study aims to evaluate how often infections occur during the first 12 months after CAR-T infusion and to describe their main characteristics and risk factors. Both patients treated since 2019 (retrospective cohort) and newly enrolled patients during the year following study approval (prospective cohort) will be included, with one year of follow-up after infusion.

The study will investigate factors associated with infection risk, the impact of preventive and therapeutic anti-infective strategies, the distinction between infection-related fever and cytokine release syndrome (CRS), post-discharge infections, and immune recovery after CAR-T therapy. In the prospective cohort, patients who develop their first fever episode after CAR-T infusion will also undergo a validated rapid molecular blood test (PilotGene ddPCR Blood System), alongside standard blood cultures, to improve the speed of bloodstream infection diagnosis. The test is already used in clinical practice and will serve as a complementary diagnostic tool without changing standard patient management. Approximately 290 patients are expected to be included, most of whom with lymphoma.

Type d'étude

Observationnel

Inscription (Estimé)

290

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: Maddalena Giannella, MD, PhD
Numéro de téléphone: +39 051 2143199
E-mail: maddalena.giannella@unibo.it

Sauvegarde des contacts de l'étude

Nom: Zeno Adrien Igor Pasquini, MD
Numéro de téléphone: +39 051 214 3752
E-mail: zeno.pasquini@aosp.bo.it

Lieux d'étude

Italie
- Italy
  - Bologna, Italy, Italie, 40138
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
    - Contact:
      
      Maddalena Giannella, MD, PhD
      
      Numéro de téléphone: +39 051 2143199
      
      E-mail: maddalena.giannella@unibo.it
    - Contact:
      
      Zeno Adrien Igor Pasquini, MD
      
      Numéro de téléphone: +39 051 214 3752
      
      E-mail: zeno.pasquini@aosp.bo.it
    - Chercheur principal:
      
      Zeno Adrien Igor Pasquini, MD

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

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods

La description

Inclusion Criteria:

Diagnosis of relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL)
Receipt of CAR-T infusion at IRCCS AOUBo
Age ≥18 years at the time of CAR-T infusion
Signed informed consent

Exclusion Criteria:

None

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

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Adult patients (≥18 years old) undergoing CAR-T cell therapy at IRCCS AOUBo Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion. Délai: Within 12 months after CAR-T infusion	Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.	Within 12 months after CAR-T infusion

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications. Délai: Within 12 months after CAR-T infusion	Adjusted odds ratios with 95% confidence intervals for the association between predefined pre-infusion and post-infusion variables and the occurrence of at least one infectious complication after CAR-T infusion.	Within 12 months after CAR-T infusion
Classification of the first febrile episode within 30 days after CAR-T infusion. Délai: Within the first 30 days after CAR-T infusion	Classification of each participant's first febrile episode as no fever, infection-related fever, indeterminate fever, or cytokine release syndrome (CRS)-related fever.	Within the first 30 days after CAR-T infusion
Participants with microbiologically documented infection at the first febrile episode. Délai: Within the first 30 days after CAR-T infusion.	Number (or percentage) of participants with a microbiologically documented infection identified at the time of the first febrile episode.	Within the first 30 days after CAR-T infusion.
Post-Discharge Infectious Complications. Délai: From hospital discharge up to 12 months after CAR-T infusion.	Percentage of participants with at least one infectious complication occurring after hospital discharge.	From hospital discharge up to 12 months after CAR-T infusion.
Diagnostic Yield of the Pilot Gene ddPCR Blood Test. Délai: Up to 12 months after enrollment (at the first febrile episode)	Percentage of first febrile episodes with at least one pathogen and/or antimicrobial resistance marker detected by the Pilot Gene droplet digital polymerase chain reaction blood test.	Up to 12 months after enrollment (at the first febrile episode)

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

Les enquêteurs

Chercheur principal: Zeno Adrien Igor Pasquini, 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)

1 novembre 2026

Achèvement primaire (Estimé)

31 octobre 2027

Achèvement de l'étude (Estimé)

30 avril 2029

Dates d'inscription aux études

Première soumission

19 juin 2026

Première soumission répondant aux critères de contrôle qualité

17 juillet 2026

Première publication (Réel)

20 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)