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

17 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Geschat)

290

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Maddalena Giannella, MD, PhD
Telefoonnummer: +39 051 2143199
E-mail: maddalena.giannella@unibo.it

Studie Contact Back-up

Naam: Zeno Adrien Igor Pasquini, MD
Telefoonnummer: +39 051 214 3752
E-mail: zeno.pasquini@aosp.bo.it

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion. Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications. Tijdsspanne: 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. Tijdsspanne: 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. Tijdsspanne: 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. Tijdsspanne: 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. Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

31 oktober 2027

Studie voltooiing (Geschat)

30 april 2029

Studieregistratiedata

Eerst ingediend

19 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2026

Eerst geplaatst (Werkelijk)

20 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)