INfections in Patients Treated With CAR-T

N/ANot Yet RecruitingNCT07713511

IRCCS Azienda Ospedaliero-Universitaria di Bologna290 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

290

Conditions

Relapsed Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.

Time frame: Within 12 months after CAR-T infusion

Secondary Outcomes

Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.

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.

Time frame: Within 12 months after CAR-T infusion

Classification of the first febrile episode within 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.

Time frame: Within the first 30 days after CAR-T infusion

Participants with microbiologically documented infection at the first febrile episode.

Number (or percentage) of participants with a microbiologically documented infection identified at the time of the first febrile episode.

Time frame: Within the first 30 days after CAR-T infusion.

Post-Discharge Infectious Complications.

Percentage of participants with at least one infectious complication occurring after hospital discharge.

Time frame: From hospital discharge up to 12 months after CAR-T infusion.

Diagnostic Yield of the Pilot Gene ddPCR Blood Test.

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.

Time frame: Up to 12 months after enrollment (at the first febrile episode)