INfections in Patients Treated With CAR-T (IN-CART)
INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Maddalena Giannella, MD, PhD
- 電話番号：+39 051 2143199
- メール：maddalena.giannella@unibo.it
研究連絡先のバックアップ
- 名前：Zeno Adrien Igor Pasquini, MD
- 電話番号：+39 051 214 3752
- メール：zeno.pasquini@aosp.bo.it
研究場所
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Italy
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Bologna、Italy、イタリア、40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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コンタクト：
- Maddalena Giannella, MD, PhD
- 電話番号：+39 051 2143199
- メール：maddalena.giannella@unibo.it
-
コンタクト：
- Zeno Adrien Igor Pasquini, MD
- 電話番号：+39 051 214 3752
- メール：zeno.pasquini@aosp.bo.it
-
主任研究者：
- Zeno Adrien Igor Pasquini, MD
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Zeno Adrien Igor Pasquini、IRCCS Azienda Ospedaliero-Universitaria di Bologna
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IN-CART
- RC-2026-2802107 (その他の助成金/資金番号：Italian Ministry of Health)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。