Extended antiviral therapy may shield transplant patients from dangerous virus
NCT ID NCT06812598
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving letermovir for a longer time (up to 28 weeks) can prevent cytomegalovirus (CMV) infection in Chinese adults who have a high risk of reactivation after a stem cell transplant. Participants must be at least 18, have had a stem cell transplant, and have certain risk factors like a mismatched donor or cord blood. The goal is to see if extended treatment reduces CMV-related complications without increasing side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The patients have decided to undergo an initial allogeneic hematopoietic stem cell transplantation (allo-HSCT). 2. The patients are ≥18 years old. 3. The patients are CMV seropositive prior to transplantation. 4. The patients have at least one high-risk factor for CMV reactivation, including: (1) Haploidentical transplantation, HLA-mismatched transplantation, or unrelated donor transplantation. (2) The primary source of stem cells is cord blood. (3) A conditioning regimen including total body irradiation (TBI). (4) A GVHD prophylaxis regimen containing alemtuzumab or high-dose anti-thymocyte globulin (ATG). 5\. The patients are able to comply with the study visit schedule, understand and agree to adhere to all protocol requirements, and have voluntarily signed the informed consent form to participate in the study. 6\. The patients have no plans for reproduction from the date of consent until 90 days after the last dose of the study treatment. Exclusion Criteria: 1. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT). 2. Patients with evidence of CMV viremia at any time prior to enrollment. 3. Patients with a history of CMV end-organ disease within 6 months prior to enrollment. 4. Patients with suspected or known allergy to letermovir or any active or inactive components of similar drugs. 5. Patients with severe hepatic impairment (defined as Child-Pugh Class C). 6. Patients with end-stage renal disease with a creatinine clearance \< 10 mL/min. 7. Patients requiring mechanical ventilation or experiencing hemodynamic instability at the time of enrollment. 8. Patients who received any investigational drug therapy within 28 days prior to enrollment. 9. Patients who received or plan to receive any of the following treatments within 28 days prior to enrollment or during the study: cidofovir, CMV immune globulin, or any experimental CMV antiviral drugs/biological therapies. 10. Patients who previously participated or are currently participating in any study involving a CMV vaccine or other CMV investigational drugs, or who plan to participate in such studies during this trial. 11. Patients who are pregnant or breastfeeding at the time of enrollment or planning to become pregnant within 90 days after the last dose of study medication. 12. Patients who test positive for human immunodeficiency virus antibodies (HIV-Ab) at any time prior to randomization, or who test positive for hepatitis C virus antibodies (HCV-Ab) with detectable HCV RNA, or for hepatitis B surface antigen (HBsAg) within 90 days prior to randomization. Laboratory testing for HIV, HBV, or HCV is allowed using locally acceptable methods. 13. Patients with active solid malignancies, except for localized basal cell or squamous cell carcinoma of the skin or a condition currently under treatment (e.g., lymphoma).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hematology Department, The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Banked t cells target four viruses at once in children after transplant
- Can an antiviral drug protect hearing in infants with congenital CMV?
- Can we outsmart Drug-Resistant CMV in transplant patients?
- Can we map CMV's spread in daycares to shield future pregnancies?
- Can immune cells predict herpesvirus danger in transplant patients?
- Can specially grown immune cells from donors beat viruses that won't go away?