Cytomegalovirus InfectionsNCT06812598
Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic HSCT
A study testing Letermovir (0-24w） and Letermovir (0-14w） in people with Cytomegalovirus Infections and CMV, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
After allogeneic hematopoietic stem cell transplantation (allo-HSCT), recipients are immunocompromised and at increased risk of complications, including cytomegalovirus (CMV) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections, CMV
- What is being tested?
- Letermovir (0-24w） and Letermovir (0-14w）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients have decided to undergo an initial allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- The patients are ≥18 years old.
- The patients are CMV seropositive prior to transplantation.
- The patients have at least one high-risk factor for CMV reactivation, including:
- Haploidentical transplantation, HLA-mismatched transplantation, or unrelated donor transplantation.
- 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.
Who cannot join
- Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Patients with evidence of CMV viremia at any time prior to enrollment.
- Patients with a history of CMV end-organ disease within 6 months prior to enrollment.
- Patients with suspected or known allergy to letermovir or any active or inactive components of similar drugs.
- Patients with severe hepatic impairment (defined as Child-Pugh Class C).
- Patients with end-stage renal disease with a creatinine clearance < 10 mL/min.
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- Patients requiring mechanical ventilation or experiencing hemodynamic instability at the time of enrollment.
- Patients who received any investigational drug therapy within 28 days prior to enrollment.
- 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.
- 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.
- 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.
- 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.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hematology Department, The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaojin Wu, Prof., 13057493105, wuxiaojin@suda.edu.cn
About this study
Official title: A Clinical Study on the Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
After allogeneic hematopoietic stem cell transplantation (allo-HSCT), recipients are immunocompromised and at increased risk of complications, including cytomegalovirus (CMV) infection. International clinical guidelines for the management of CMV infection post-allo-HSCT recommend three main strategies: minimizing infection risk, prevention, and preemptive therapy. However, traditional antiviral agents have not been approved for CMV prophylaxis in allo-HSCT recipients and are associated with significant adverse effects and the development of resistance, leaving the CMV prevention needs of this patient population unmet. Recent studies have demonstrated that letermovir prevents potent and highly specific antiviral activity against CMV, and it has been approved for CMV prophylaxis within the first 100 days post-allo-HSCT. Furthermore, evidence suggests that extending letermovir administration up to 28 weeks further reduces the risk of CMV infection in the later post-transplant period without increasing drug-related mortality. In China, the post-allo-HSCT CMV prevention strategy faces challenges such as limited treatment options, unclear guideline recommendations, non-standardized drug usage in certain medical institutions, and insufficient monitoring. This study aims to provide robust, evidence-based support for the use of letermovir in high-risk CMV reactivation among adult allo-HSCT recipients, thereby broadening clinical treatment choices.
Read the detailed description
CMV late-onset infections following the discontinuation of letermovir have been reported in numerous clinical studies. During this period, transplant recipients remain in the critical phase of immune reconstitution, and further reducing the occurrence of CMV late-onset infections is crucial for improving transplant outcomes. International data have shown that extending the duration of letermovir prophylaxis can further reduce the risk of CMV infection.
In high-risk populations for CMV reactivation and recurrence, the risk of CMV viremia remains elevated even beyond 100 days post-transplant, with incidence rates ranging from 36% to 54%. Consequently, clinical guidelines recommend extending prophylaxis duration, monitoring periods, and shortening the intervals between tests for these high-risk groups. The Chinese Expert Consensus on the Management of CMV Infection in Allogeneic Hematopoietic Stem Cell Transplantation (2022 Edition) suggests that for high-risk populations, particularly those with acute or chronic GVHD, consideration should be given to extending the treatment course or reinitiating CMV reactivation prevention until immunosuppressive therapy is reduced.
Currently, in China, there are no prospective clinical studies or high-level evidence regarding the extension of prophylactic therapy to reduce CMV late-onset infections in adult allo-HSCT recipients at high risk for CMV reactivation. This study aims to investigate the efficacy and safety of extending letermovir prophylaxis from week 14 to week 24 post-HSCT in patients at high risk of CMV reactivation, thereby offering additional therapeutic options for these patients.
- Conditions
- Cytomegalovirus Infections, CMV
- Being tested
- Letermovir (0-24w）, Letermovir (0-14w）
- Keywords
- Letermovir, Allogeneic Hematopoietic Stem Cell Transplantation
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letermovir (0-24w）Drug
Patients will begin receiving prophylactic treatment with domestically produced letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg, administered orally once daily. If used in combination with cyclosporine, the dose should be reduced to 240 mg once daily. The treatment will continue until 24 weeks post-transplant (approximately 170 days).
Letermovir (0-14w）Drug
Patients will begin receiving prophylactic treatment with domestically produced letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg, administered orally once daily. If used in combination with cyclosporine, the dose should be reduced to 240 mg once daily. The treatment will continue until 14 weeks post-transplant (approximately 100 days).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The patient will begin receiving prophylactic treatment with letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg orally once daily. If administered in combination with cyclosporine, the letermovir dose should be reduced to 240 mg orally once daily. Treatment will continue until 24 weeks post-transplant (approximately 170 days). During hospitalization, the study nurse will distribute the medication to the patient according to the treatment protocol and provide guidance on proper administration. The nurse will ensure the patient adheres to the prescribed dosing schedule and will document both the medication distribution and adherence. Receives: Drug: Letermovir (0-24w） |
| Control Group | Other | The patient will begin prophylactic treatment with letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg orally once daily. If used in combination with cyclosporine, the letermovir dose should be reduced to 240 mg orally once daily. The treatment will continue for up to 14 weeks post-transplant (approximately 100 days). In addition, the usage of the medication will be carefully monitored and documented. Receives: Drug: Letermovir (0-14w） |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of clinically significant CMV infection (csCMVi) within 24 weeks post-transplant
csCMVi: the occurrence of CMV disease or CMV viremia requiring preemptive therapy
Measured: within 24 weeks following HSCT
Secondary outcomes (7)
Incidence of resistant or refractory CMV infection within 24 weeks post-transplant
Refractory CMV viremia: CMV viral load remains unchanged or increases after 2 weeks of appropriate anti-CMV treatment. Refractory CMV disease: Symptoms or signs of CMV disease show no improvement or continue to progress after 2 weeks of appropriate anti-CMV treatment.
Measured: within 24 weeks following HSCT
Time to initiation of preemptive therapy and duration of treatment for CMV infection within 24 weeks post-transplant
Preemptive Therapy for CMV: A treatment strategy where antiviral medications are administered early, based on the detection of CMV reactivation (e.g., through viral load monitoring) before symptoms or disease develop, to prevent the progression to CMV disease.
Measured: within 24 weeks following HSCT
Incidence and severity of acute graft-versus-host disease (GVHD) within 100 days post-transplant
Acute GVHD: A complication that occurs shortly after allogeneic stem cell transplantation, where the donor's immune cells attack the recipient's tissues, typically affecting the skin, liver, and gastrointestinal tract. It usually develops within the first 100 days post-transplant and can range from mild to severe.
Measured: within 100 days following HSCT
Incidence and severity of chronic GVHD within 24 weeks post-transplant
Chronic GVHD: A long-term complication following allogeneic stem cell transplantation, where the donor's immune cells attack the recipient's healthy tissues, affecting organs such as the skin, liver, lungs, and eyes. It can range from mild to severe and may require prolonged immunosuppressive therapy.
Measured: within 24 weeks following HSCT
Incidence and severity of all adverse events (AEs) within 24 weeks post-transplant
Adverse Events (AEs) with letermovir: Refers to any unwanted or harmful effects experienced by patients using letermovir, such as nausea, vomiting, diarrhea, headaches, or elevated liver enzymes. These events can vary in severity and may or may not be related to the medication.
Measured: within 24 weeks following HSCT
CMV disease-related mortality within 24 weeks post-transplant
CMV disease-related mortality: Refers to deaths directly caused by complications of CMV (cytomegalovirus) infection, such as CMV viremia, organ damage, or CMV-related immunosuppression, leading to fatal outcomes.
Measured: within 24 weeks following HSCT
All-cause mortality and non-relapse mortality within 24 weeks post-transplant
All-cause mortality: Refers to deaths from any cause, including disease relapse, treatment complications, or unrelated factors, providing an overall measure of survival. Non-Relapse Mortality (NRM): Refers to deaths unrelated to disease relapse or progression, typically caused by treatment complications such as infections, organ failure, or graft-versus-host disease (GVHD).
Non-relapse mortality (NRM): Refers to deaths unrelated to disease relapse or progression, typically caused by treatment complications such as infections, organ failure, or graft-versus-host disease (GVHD).
Measured: within 24 weeks following HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start16 Dec 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojin Wu, Prof., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812598
- Sponsor's protocol ID
- SOOCHOW-WXJ-2024-505
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06812598
- Acronym / sponsor ID
- SOOCHOW-WXJ-2024-505
- Conditions
- Cytomegalovirus Infections, CMV
- Keywords
- Letermovir, Allogeneic Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After allogeneic hematopoietic stem cell transplantation (allo-HSCT), recipients are immunocompromised and at increased risk of complications, including cytomegalovirus (CMV) infection. International clinical guidelines for the management of CMV infection post-allo-HSCT recommend three main strategies: minimizing infection risk, prevention, and preemptive therapy. However, traditional antiviral agents have not been approved for CMV prophylaxis in allo-HSCT recipients and are associated with significant adverse effects and the development of resistance, leaving the CMV prevention needs of this patient population unmet. Recent studies have demonstrated that letermovir prevents potent and highly specific antiviral activity against CMV, and it has been approved for CMV prophylaxis within the first 100 days post-allo-HSCT. Furthermore, evidence suggests that extending letermovir administration up to 28 weeks further reduces the risk of CMV infection in the later post-transplant period without increasing drug-related mortality. In China, the post-allo-HSCT CMV prevention strategy faces challenges such as limited treatment options, unclear guideline recommendations, non-standardized drug usage in certain medical institutions, and insufficient monitoring. This study aims to provide robust, evidence-based support for the use of letermovir in high-risk CMV reactivation among adult allo-HSCT recipients, thereby broadening clinical treatment choices.
Detailed description
CMV late-onset infections following the discontinuation of letermovir have been reported in numerous clinical studies. During this period, transplant recipients remain in the critical phase of immune reconstitution, and further reducing the occurrence of CMV late-onset infections is crucial for improving transplant outcomes. International data have shown that extending the duration of letermovir prophylaxis can further reduce the risk of CMV infection.
In high-risk populations for CMV reactivation and recurrence, the risk of CMV viremia remains elevated even beyond 100 days post-transplant, with incidence rates ranging from 36% to 54%. Consequently, clinical guidelines recommend extending prophylaxis duration, monitoring periods, and shortening the intervals between tests for these high-risk groups. The Chinese Expert Consensus on the Management of CMV Infection in Allogeneic Hematopoietic Stem Cell Transplantation (2022 Edition) suggests that for high-risk populations, particularly those with acute or chronic GVHD, consideration should be given to extending the treatment course or reinitiating CMV reactivation prevention until immunosuppressive therapy is reduced.
Currently, in China, there are no prospective clinical studies or high-level evidence regarding the extension of prophylactic therapy to reduce CMV late-onset infections in adult allo-HSCT recipients at high risk for CMV reactivation. This study aims to investigate the efficacy and safety of extending letermovir prophylaxis from week 14 to week 24 post-HSCT in patients at high risk of CMV reactivation, thereby offering additional therapeutic options for these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Letermovir (0-24w）The patient will begin receiving prophylactic treatment with letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg orally once daily. If administered in combination with cyclosporine, the letermovir dose should be reduced to 240 mg orally once daily. Treatment will continue until 24 weeks post-transplant (approximately 170 days). During hospitalization, the study nurse will distribute the medication to the patient according to the treatment protocol and provide guidance on proper administration. The nurse will ensure the patient adheres to the prescribed dosing schedule and will document both the medication distribution and adherence. |
| Control Group | Other | Drug: Letermovir (0-14w）The patient will begin prophylactic treatment with letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg orally once daily. If used in combination with cyclosporine, the letermovir dose should be reduced to 240 mg orally once daily. The treatment will continue for up to 14 weeks post-transplant (approximately 100 days). In addition, the usage of the medication will be carefully monitored and documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patients have decided to undergo an initial allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- The patients are ≥18 years old.
- The patients are CMV seropositive prior to transplantation.
- The patients have at least one high-risk factor for CMV reactivation, including:
- Haploidentical transplantation, HLA-mismatched transplantation, or unrelated donor transplantation.
Key exclusion criteria (13 listed)
- Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Patients with evidence of CMV viremia at any time prior to enrollment.
- Patients with a history of CMV end-organ disease within 6 months prior to enrollment.
- Patients with suspected or known allergy to letermovir or any active or inactive components of similar drugs.
- Patients with severe hepatic impairment (defined as Child-Pugh Class C).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letermovir (0-24w）Patients will begin receiving prophylactic treatment with domestically produced letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg, administered orally once daily. If used in combination with cyclosporine, the dose should be reduced to 240 mg once daily. The treatment will continue until 24 weeks post-transplant (approximately 170 days). | Drug | Intervention Group |
| Letermovir (0-14w）Patients will begin receiving prophylactic treatment with domestically produced letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg, administered orally once daily. If used in combination with cyclosporine, the dose should be reduced to 240 mg once daily. The treatment will continue until 14 weeks post-transplant (approximately 100 days). | Drug | Control Group |
Primary outcome
The incidence of clinically significant CMV infection (csCMVi) within 24 weeks post-transplant
Time frame: within 24 weeks following HSCT
csCMVi: the occurrence of CMV disease or CMV viremia requiring preemptive therapy
7 secondary outcomes
Incidence of resistant or refractory CMV infection within 24 weeks post-transplant
Time frame: within 24 weeks following HSCT
Time to initiation of preemptive therapy and duration of treatment for CMV infection within 24 weeks post-transplant
Time frame: within 24 weeks following HSCT
Incidence and severity of acute graft-versus-host disease (GVHD) within 100 days post-transplant
Time frame: within 100 days following HSCT
Incidence and severity of chronic GVHD within 24 weeks post-transplant
Time frame: within 24 weeks following HSCT
Incidence and severity of all adverse events (AEs) within 24 weeks post-transplant
Time frame: within 24 weeks following HSCT
CMV disease-related mortality within 24 weeks post-transplant
Time frame: within 24 weeks following HSCT
All-cause mortality and non-relapse mortality within 24 weeks post-transplant
Time frame: within 24 weeks following HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaojin Wu, Prof. principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letermovir (0-24w） and Letermovir (0-14w） in people with Cytomegalovirus Infections and CMV, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojin Wu, Prof. (13057493105, wuxiaojin@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of clinically significant CMV infection (csCMVi) within 24 weeks post-transplant (time frame: within 24 weeks following HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.