Cytomegalovirus InfectionsPhase 4NCT07569653
Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.
A Phase 4 study testing CMV-Specific T-cell Guided Letermovir Discontinuation and Standard Letermovir Prophylaxis in people with Cytomegalovirus Infections and Cytomegalovirus Disease, run by WeiShi at 12 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections, Cytomegalovirus Disease, Hematopoietic Stem Cell Transplantation
- What is being tested?
- CMV-Specific T-cell Guided Letermovir Discontinuation and Standard Letermovir Prophylaxis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 12 sitesChina
- Study dates
- 30 Oct 2025to Dec 2027
- Phase
- Phase 4
- 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
- Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- CMV serostatus of the recipient is positive (R+).
- Aged 18 years or older.
- Expected survival > 6 months.
- Provision of signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Fei Li, +86 18611406860, 847982123@qq.com
- Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050
Da Gao, +86 13947130473, gaoda72@163.com
- Not yet recruiting
Jingzhou First People's Hospital
Jingzhou, Hubei, 434000
Jie Tan, +86 18163137226, Tanjie@yangtzeu.edu.cn
- Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Yuanyan Tang, +86 18107168243, 343665915@qq.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xianbao Huang, +86 18679119505, huangxianbao2017@163.com
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Fuxu Wang, +86 13931100360, 827064030@qq.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Lan Sun Sun, +86 13587685726, sunlan91@126.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wei Shi, M.D., +86 027-85726003, shiwei076@hust.edu.cn
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Yang Cao, +86 13986142606, caoyangemma@163.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Fei Chen, +86 13545297071, chenfeiwhu@whu.edu.cn
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Jian Zhou, +86 13623822347, zhoujiandoctor@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Weijie Cao, +86 15093360671, caoweijie2003@126.com
About this study
Official title: A Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Letermovir Prophylaxis Duration Guided by Dynamic Monitoring of Specific T-cells for Preventing Cytomegalovirus Infection in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation in China.
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.
Read more
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 recovery. If the test shows that the patient's CMV-specific T-cells have recovered, Letermovir may be stopped earlier than the standard 100 days.
Control Group: Patients will receive the standard Letermovir prophylaxis for approximately 100 days, regardless of T-cell status.
The study aims to determine if this immune-guided strategy can effectively prevent CMV infection while potentially reducing the duration of medication and associated costs, without increasing the risk of CMV disease.
- Conditions
- Cytomegalovirus Infections, Cytomegalovirus Disease, Hematopoietic Stem Cell Transplantation, Graft vs Host Disease
- Being tested
- CMV-Specific T-cell Guided Letermovir Discontinuation, Standard Letermovir Prophylaxis
- Medical subject headings
- Cytomegalovirus Infections, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV-Specific T-cell Guided Letermovir DiscontinuationDrug
Patients receive Letermovir prophylaxis (480 mg/day orally or IV) according to the standard protocol until approximately 100 days post-transplantation, regardless of T-cell recovery status.
Standard Letermovir ProphylaxisDrug
Patients receive Letermovir prophylaxis (480 mg/day orally or IV) according to the standard protocol until approximately 100 days post-transplantation, regardless of T-cell recovery status.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (T-cell Guided Group) | Experimental | Not described Receives: Drug: CMV-Specific T-cell Guided Letermovir Discontinuation |
| Active Comparator (Standard Prophylaxis Group) | Active comparator | Not described Receives: Drug: Standard Letermovir Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Significant CMV Infection (CS-CMVi)
The percentage of participants who develop clinically significant CMV infection, defined as CMV DNAemia requiring preemptive antiviral therapy (PET) according to institutional guidelines (e.g., two consecutive positive results or a single viral load ≥ 500 copies/mL) or the occurrence of CMV disease (e.g., CMV pneumonia, enteritis, or retinitis).
Measured: Through 200 days post-transplantation
Secondary outcomes (1)
Duration of Letermovir Prophylaxis
The total number of days each participant received Letermovir prophylaxis from the start of treatment (between Day 0 and Day 28 post-HSCT) until the end of the intervention (up to 200 days). This measure will compare the median duration of medication between the experimental arm (T-cell guided) and the control arm (standard 200-day prophylaxis) to evaluate the reduction in drug exposure.
Measured: Through 200 days post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WeiShi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, WeiShi, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569653
- Sponsor's protocol ID
- [2025]num(0974)
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Letermovir Prophylaxis Duration Guided by Dynamic Monitoring of Specific T-cells for Preventing Cytomegalovirus Infection in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation in China.
- ClinicalTrials.gov ID
- NCT07569653
- Acronym / sponsor ID
- [2025]num(0974)
- Conditions
- Cytomegalovirus Infections, Cytomegalovirus Disease, Hematopoietic Stem Cell Transplantation, Graft vs Host Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- WeiShiUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2026 (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.
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 recovery. If the test shows that the patient's CMV-specific T-cells have recovered, Letermovir may be stopped earlier than the standard 100 days.
Control Group: Patients will receive the standard Letermovir prophylaxis for approximately 100 days, regardless of T-cell status.
The study aims to determine if this immune-guided strategy can effectively prevent CMV infection while potentially reducing the duration of medication and associated costs, without increasing the risk of CMV disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (T-cell Guided Group) | Experimental | Drug: CMV-Specific T-cell Guided Letermovir Discontinuation |
| Active Comparator (Standard Prophylaxis Group) | Active comparator | Drug: Standard Letermovir Prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- CMV serostatus of the recipient is positive (R+).
- Aged 18 years or older.
- Expected survival > 6 months.
- Provision of signed informed consent.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| CMV-Specific T-cell Guided Letermovir DiscontinuationPatients receive Letermovir prophylaxis (480 mg/day orally or IV) according to the standard protocol until approximately 100 days post-transplantation, regardless of T-cell recovery status. | Drug | Experimental (T-cell Guided Group) |
| Standard Letermovir ProphylaxisPatients receive Letermovir prophylaxis (480 mg/day orally or IV) according to the standard protocol until approximately 100 days post-transplantation, regardless of T-cell recovery status. | Drug | Active Comparator (Standard Prophylaxis Group) |
Primary outcome
Incidence of Clinically Significant CMV Infection (CS-CMVi)
Time frame: Through 200 days post-transplantation
The percentage of participants who develop clinically significant CMV infection, defined as CMV DNAemia requiring preemptive antiviral therapy (PET) according to institutional guidelines (e.g., two consecutive positive results or a single viral load ≥ 500 copies/mL) or the occurrence of CMV disease (e.g., CMV pneumonia, enteritis, or retinitis).
1 secondary outcome
Duration of Letermovir Prophylaxis
Time frame: Through 200 days post-transplantation
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 1 Jun 2026.
- Individual participant dataSharing planned: No
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CMV-Specific T-cell Guided Letermovir Discontinuation and Standard Letermovir Prophylaxis in people with Cytomegalovirus Infections and Cytomegalovirus Disease, run by WeiShi at 12 sites 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 5 inclusion and 4 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 wei MD, PhD (+86 027-85726003, shiwei076@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Significant CMV Infection (CS-CMVi) (time frame: Through 200 days post-transplantation). 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 1 Jun 2026.