INfections in Patients Treated With CAR-T (IN-CART)
INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Maddalena Giannella, MD, PhD
- 전화번호: +39 051 2143199
- 이메일: maddalena.giannella@unibo.it
연구 연락처 백업
- 이름: Zeno Adrien Igor Pasquini, MD
- 전화번호: +39 051 214 3752
- 이메일: zeno.pasquini@aosp.bo.it
연구 장소
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Italy
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Bologna, Italy, 이탈리아, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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연락하다:
- Maddalena Giannella, MD, PhD
- 전화번호: +39 051 2143199
- 이메일: maddalena.giannella@unibo.it
-
연락하다:
- Zeno Adrien Igor Pasquini, MD
- 전화번호: +39 051 214 3752
- 이메일: zeno.pasquini@aosp.bo.it
-
수석 연구원:
- Zeno Adrien Igor Pasquini, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
기간: Within 12 months after CAR-T infusion
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Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.
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Within 12 months after CAR-T infusion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.
기간: Within 12 months after CAR-T infusion
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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.
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Within 12 months after CAR-T infusion
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Classification of the first febrile episode within 30 days after CAR-T infusion.
기간: Within the first 30 days after CAR-T infusion
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Classification of each participant's first febrile episode as no fever, infection-related fever, indeterminate fever, or cytokine release syndrome (CRS)-related fever.
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Within the first 30 days after CAR-T infusion
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Participants with microbiologically documented infection at the first febrile episode.
기간: Within the first 30 days after CAR-T infusion.
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Number (or percentage) of participants with a microbiologically documented infection identified at the time of the first febrile episode.
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Within the first 30 days after CAR-T infusion.
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Post-Discharge Infectious Complications.
기간: From hospital discharge up to 12 months after CAR-T infusion.
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Percentage of participants with at least one infectious complication occurring after hospital discharge.
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From hospital discharge up to 12 months after CAR-T infusion.
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Diagnostic Yield of the Pilot Gene ddPCR Blood Test.
기간: Up to 12 months after enrollment (at the first febrile episode)
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Percentage of first febrile episodes with at least one pathogen and/or antimicrobial resistance marker detected by the Pilot Gene droplet digital polymerase chain reaction blood test.
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Up to 12 months after enrollment (at the first febrile episode)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Zeno Adrien Igor Pasquini, IRCCS Azienda Ospedaliero-Universitaria di Bologna
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IN-CART
- RC-2026-2802107 (기타 보조금/기금 번호: Italian Ministry of Health)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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