Hematologic MalignancyPhase 3NCT06449586
CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT
A Phase 3 study testing Letermovir in people with Hematologic Malignancy, run by Ruijin Hospital at 5 sites in China.
Trial summary
To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Letermovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jul 2024to 1 Jun 2026
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first allogeneic hematopoietic stem cell transplantation;
- 18-70 years old;
- use cytomegalovirus prophylaxis with letemovir after allo-HSCT;
- CMV Ig G D+/R+;
Who cannot join
- Allergy, known hypersensitivity to letermovir tablet or injection components;
- CMV DNAemia within six months before transplantation or previous CMV disease;
- Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation;
- Second transplantation;
- Combination of immunodeficiency diseases;
- Those judged by the investigator to be unsuitable for participation in this trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The First Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Ruijin Hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai
Shanghai Liquan Hospital
Shanghai
Tongji Hospital of Huazhong University of Science and Technology, Wuhan
Wuhan, Hubei
About this study
Official title: CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After Allogeneic Hematopoietic Stem Cell Transplantation
To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT.
Read the detailed description
Reactivation of cytomegalovirus (CMV) leads to significant morbidity and mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Letermovir (LTV) has substantially reduced the risk of clinically significant CMV infection (csCMVi) in CMV seropositive recipients of allo-HSCT. LTV discontinuation after day 100 (d100) has been reported to increase the risk of late-onset csCMVi, causing by impaired reconstitution of CMV-specific T immunity. The investigator sought to decrease the probability of CS-CMVi after letermovir withdrawal. Restoration of CMV-specific T cells is imperative for effective control of CMV reactivation following allo-HSCT. Letermovir has been found impending recovery of CMV-specific T immunity. The investigators' retrospective study has proved that lower CMV-specific CD4+ T cells (<2.01 cells/µL) at week 8 increased the risk of late-onset CMV reactivation (50.0%) compared to the higher ones (7.69%, p=0.04) in letermovir prophylaxis. Thus, the guidance of CMV-specific cell immunity is recommended in letermovir prophylaxis.
Therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore and validate the efficacy of CMV-specific T cell immunity test guiding the prolonged usage of letermovir.
- Conditions
- Hematologic Malignancy
- Being tested
- Letermovir
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
letermovir stops when CMI>1.5
| Study group | Role | What they receive |
|---|---|---|
| CMI-F | Experimental | Letemovir prophylaxis stops when CMV-FlowSpot >1.5. Receives: Drug: Letermovir |
| CMI-N | Other | Letemovir prophylaxis stopos in the first 100 days after allo-HSCT. Receives: Drug: Letermovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of late-onset clinical significant CMV (cs-CMV) infection
Incidence of late-onset clinical significant CMV (cs-CMV) infection
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
cumulative incidence of cs-CMV infection
cumulative incidence of cs-CMV infection
Measured: through study completion, an average of 1 year
overall survival
overall survival
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Xiaoxia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449586
- Sponsor's protocol ID
- RJBMT-2024-02
- Status last verified
- Dec 2025
- First submitted
- 1 Jun 2024
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06449586
- Acronym / sponsor ID
- RJBMT-2024-02
- Conditions
- Hematologic Malignancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Jun 2024 (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.
To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT.
Detailed description
Reactivation of cytomegalovirus (CMV) leads to significant morbidity and mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Letermovir (LTV) has substantially reduced the risk of clinically significant CMV infection (csCMVi) in CMV seropositive recipients of allo-HSCT. LTV discontinuation after day 100 (d100) has been reported to increase the risk of late-onset csCMVi, causing by impaired reconstitution of CMV-specific T immunity. The investigator sought to decrease the probability of CS-CMVi after letermovir withdrawal. Restoration of CMV-specific T cells is imperative for effective control of CMV reactivation following allo-HSCT. Letermovir has been found impending recovery of CMV-specific T immunity. The investigators' retrospective study has proved that lower CMV-specific CD4+ T cells (<2.01 cells/µL) at week 8 increased the risk of late-onset CMV reactivation (50.0%) compared to the higher ones (7.69%, p=0.04) in letermovir prophylaxis. Thus, the guidance of CMV-specific cell immunity is recommended in letermovir prophylaxis.
Therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore and validate the efficacy of CMV-specific T cell immunity test guiding the prolonged usage of letermovir.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMI-F | Experimental | Drug: LetermovirLetemovir prophylaxis stops when CMV-FlowSpot >1.5. |
| CMI-N | Other | Drug: LetermovirLetemovir prophylaxis stopos in the first 100 days after allo-HSCT. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first allogeneic hematopoietic stem cell transplantation;
- 18-70 years old;
- use cytomegalovirus prophylaxis with letemovir after allo-HSCT;
- CMV Ig G D+/R+;
Key exclusion criteria (6 listed)
- Allergy, known hypersensitivity to letermovir tablet or injection components;
- CMV DNAemia within six months before transplantation or previous CMV disease;
- Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation;
- Second transplantation;
- Combination of immunodeficiency diseases;
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 |
|---|---|---|
| Letermovirletermovir stops when CMI>1.5 | Drug | CMI-F, CMI-N |
Primary outcome
Incidence of late-onset clinical significant CMV (cs-CMV) infection
Time frame: through study completion, an average of 1 year
Incidence of late-onset clinical significant CMV (cs-CMV) infection
2 secondary outcomes
cumulative incidence of cs-CMV infection
Time frame: through study completion, an average of 1 year
overall survival
Time frame: through study completion, an average of 1 year
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 15 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letermovir in people with Hematologic Malignancy, run by Ruijin Hospital at 5 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of late-onset clinical significant CMV (cs-CMV) infection (time frame: through study completion, an average of 1 year). 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 15 Dec 2025.