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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Feng Chen, MD
- 전화번호: +8613584861215
- 이메일: 13584861215@163.com
연구 장소
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Jiangsu
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Suzhou, Jiangsu, 중국
- 모병
- The First Affiliated Hospital of Soochow University
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연락하다:
- The First Affiliated Hospital of Soochow University
- 전화번호: +86 512 67972861
- 이메일: sdfyec@163.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CMV-specific T cells
기간: 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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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Cumulative incidence of refractory CMV infection
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Cumulative incidence of non-relapse mortality (NRM)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CMV-CMI in csCMVi
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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