CMV-CMI in csCMVi After HSCT
Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
Cytomegalovirus (CMV) reactivation is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and the reconstitution of CMV-specific cell-mediated immunity (CMV-CMI) plays a key role in viral control.
This prospective, exploratory study will enroll 40 adult CMV-seropositive patients who experience their first CMV reactivation after allo-HSCT. CMV-specific T cell levels (IFN-γ-producing T cells stimulated by IE-1 and pp65 antigens) will be measured using ELISPOT at four time points: at diagnosis of CMV viremia, 3 weeks after initiating preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients will be followed for 12 weeks after stopping treatment.
The primary objective is to describe the changes in CMV-specific T cell levels over the therapy. Secondary objectives are to explore the relationship between these levels and the occurrence of refractory CMV infection, recurrent CMV infection, and CMV disease. Findings may help identify patients at high risk of progressing to severe or persistent CMV infection at an early stage of preemptive therapy, enabling personalized intervention strategies.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Feng Chen, MD
- 電話番号：+8613584861215
- メール：13584861215@163.com
研究場所
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Jiangsu
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Suzhou、Jiangsu、中国
- 募集
- The First Affiliated Hospital of Soochow University
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コンタクト：
- The First Affiliated Hospital of Soochow University
- 電話番号：+86 512 67972861
- メール：sdfyec@163.com
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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:
- ≥18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- First CMV reactivation after transplantation;
- Life expectancy of ≥8 weeks;
- The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial.
Exclusion Criteria:
- Recurrence of CMV infection;
- primary CMV infection in CMV-seronegative recipients (R-);
- Resistance to known anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, maribavir, etc.);
- Currently receiving CMV-CTL treatment or lymphocyte infusion.
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 |
介入・治療 |
|---|---|
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CMV Reactivation Cohort
Adult CMV-seropositive patients (≥18 years) who experience first CMV reactivation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Therapy with anti-CMV drugs (mono- or combination therapy, at investigator's discretion) is initiated upon diagnosis of CMV viremia and continued until two consecutive negative CMV DNA tests separated by ≥5 days.
CMV-specific T cell levels are measured by ELISPOT at four time points: at CMV viremia diagnosis, 3 weeks after starting preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation.
Patients are followed for 12 weeks after treatment cessation.
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The choice of agent (monotherapy or combination) is at the investigator's discretion and may include ganciclovir, valganciclovir, foscarnet, maribavir, or other approved anti-CMV medications.
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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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CMV-specific T cells
時間枠：from baseline to 4 weeks after end of treatment, an average of 8 weeks
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Number of IFN-γ-producing T cells per 250,000 PBMCs measured by ELISPOT
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from baseline to 4 weeks after end of treatment, an average of 8 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Cumulative incidence of refractory CMV infection
時間枠：From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks
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From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks
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Cumulative incidence of CMV disease
時間枠：From EOT+1 day through 12 weeks after EOT(end of follow-up)
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From EOT+1 day through 12 weeks after EOT(end of follow-up)
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Cumulative incidence of recurrent CMV infection
時間枠：From EOT+1 day through 12 weeks after EOT (end of follow-up)
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From EOT+1 day through 12 weeks after EOT (end of follow-up)
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Cumulative incidence of acute graft-versus-host disease (aGVHD)
時間枠：From Day 1 through 12 weeks after EOT (end of follow-up)
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From Day 1 through 12 weeks after EOT (end of follow-up)
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Overall survival
時間枠：From Day 1 through 12 weeks after EOT (end of follow-up).
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From Day 1 through 12 weeks after EOT (end of follow-up).
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Cumulative incidence of non-relapse mortality (NRM)
時間枠：From Day 1 through 12 weeks after EOT (end of follow-up).
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From Day 1 through 12 weeks after EOT (end of follow-up).
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
- CMV-CMI in csCMVi
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
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