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

17. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

290

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Maddalena Giannella, MD, PhD
Telefonnummer: +39 051 2143199
E-post: maddalena.giannella@unibo.it

Studer Kontakt Backup

Navn: Zeno Adrien Igor Pasquini, MD
Telefonnummer: +39 051 214 3752
E-post: zeno.pasquini@aosp.bo.it

Studiesteder

Italia
- Italy
  - Bologna, Italy, Italia, 40138
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
    - Ta kontakt med:
      
      Maddalena Giannella, MD, PhD
      
      Telefonnummer: +39 051 2143199
      
      E-post: maddalena.giannella@unibo.it
    - Ta kontakt med:
      
      Zeno Adrien Igor Pasquini, MD
      
      Telefonnummer: +39 051 214 3752
      
      E-post: zeno.pasquini@aosp.bo.it
    - Hovedetterforsker:
      
      Zeno Adrien Igor Pasquini, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion. Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications. Tidsramme: 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. Tidsramme: 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. Tidsramme: 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. Tidsramme: 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. Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Etterforskere

Hovedetterforsker: Zeno Adrien Igor Pasquini, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

31. oktober 2027

Studiet fullført (Antatt)

30. april 2029

Datoer for studieregistrering

Først innsendt

19. juni 2026

Først innsendt som oppfylte QC-kriteriene

17. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)