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 AOUBoAdult 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
- Zeno Adrien Igor Pasquini, MD+39 051 214 3752
- Maddalena Giannella, MD, PhD+39 051 2143199
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