INfections in Patients Treated With CAR-T
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Relapsed Multiple Myeloma, Refractory Multiple Myeloma, B-Cell Non-Hodgkin Lymphoma, Bloodstream Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies
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.
Detailed description
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.
Primary outcome measures
- Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion. [Time frame: Within 12 months after CAR-T infusion]
Secondary outcome measures (5)
- Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications. [Time frame: Within 12 months after CAR-T infusion]
- Classification of the first febrile episode within 30 days after CAR-T infusion. [Time frame: Within the first 30 days after CAR-T infusion]
- Participants with microbiologically documented infection at the first febrile episode. [Time frame: Within the first 30 days after CAR-T infusion.]
- Post-Discharge Infectious Complications. [Time frame: From hospital discharge up to 12 months after CAR-T infusion.]
- Diagnostic Yield of the Pilot Gene ddPCR Blood Test. [Time frame: Up to 12 months after enrollment (at the first febrile episode)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT07713511 · IN-CART · RC-2026-2802107