INfections in Patients Treated With CAR-T

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

290 Participants
are grouped into 1 trial group
Group A: Adult patients (≥18 years old) undergoing CAR-T cell therapy at IRCCS AOUBo

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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.
4

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.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: