Clinical trial · Observational
INfections in Patients Treated With CAR-T
INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Bloodstream Infections | — | UNRESOLVED | — |
| CAR-T Cell Therapy | — | UNRESOLVED | — |
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Adult patients (≥18 years old) undergoing CAR-T cell therapy at IRCCS AOUBo
- description
- 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
Primary outcomes (1)
- measure
- Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
- timeFrame
- Within 12 months after CAR-T infusion
- description
- Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.
Secondary outcomes (5)
- measure
- Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.
- timeFrame
- Within 12 months after CAR-T infusion
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available