T-cell–guided letermovir stopping after allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 4 trial compares a personalized approach using QuantiFERON-CMV T-cell monitoring to guide letermovir discontinuation versus standard-duration letermovir prophylaxis after allogeneic hematopoietic stem cell transplant. Participants who are CMV-seropositive (R+) are randomly assigned to have letermovir stopped when CMV-specific T-cell recovery is documented or to receive routine prophylaxis for the standard period. The study will track CMV infection/disease rates and safety outcomes to determine whether the T-cell–guided strategy maintains protection while shortening prophylaxis for some patients. The intervention is implemented at a single center in Wuhan with regular blood testing and clinical follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• The Second Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Not yet recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Not yet recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Not yet recruiting
• Jingzhou First People's Hospital
  Jingzhou, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: wei MD, PhD
• Email: shiwei076@hust.edu.cn
• Phone: +86 027-85726003

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.