INfections in Patients Treated With CAR-T

Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study ID
NCT07713511
Status
Not Yet Recruiting

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Conditions

  • B-Cell Non-Hodgkin Lymphoma
  • Bloodstream Infections
  • CAR-T Cell Therapy
  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Nov 1, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
290 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion. [ Time Frame: Within 12 months after CAR-T infusion ]

Central Contacts

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