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Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.

RecruitingPhase 4Ages 18 Years - anyAllWeiShi
NCT07569653 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the efficacy and safety of a personalized strategy for discontinuing Letermovir (a drug used to prevent Cytomegalovirus \[CMV\] infection) based on the recovery of the patient's own immune system. Cytomegalovirus (CMV) is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, Letermovir is typically given as a standard prevention for about 100 days post-transplant. However, some patients may recover their CMV-specific immunity earlier, while others may need longer protection. In this study, researchers will use a dynamic monitoring technology (QuantiFERON-CMV) to detect the level of CMV-specific T-cells in patients. Participants will be randomly assigned to either the experimental group or the control group: Experimental Group: Letermovir discontinuation will be guided by T-cell recove

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT). 2. CMV serostatus of the recipient is positive (R+). 3. Aged 18 years or older. 4. Expected survival \> 6 months. 5. Provision of signed informed consent. Exclusion Criteria: * 1.Active CMV infection or CMV disease at the time of screening. 2.Known hypersensitivity to Letermovir or its excipients. 3.Severe hepatic or renal impairment. 4.Pregnant or breastfeeding women.
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What it tests

  • CMV-Specific T-cell Guided Letermovir Discontinuation
  • Standard Letermovir Prophylaxis
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Where

12 sites
Chinese PLA General Hospital
Beijing, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Jingzhou First People's Hospital
Jingzhou, China
Jingzhou Central Hospital
Jingzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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