Cytomegalovirus Infection ReactivationNCT06441669
Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT
An observational study of Cytomegalovirus Infection Reactivation, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytomegalovirus Infection Reactivation
- What is being tested?
- Letermovir
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 20 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study consists 60 cases recipients of UCBT. All patients will receive letermovir prophylaxis within 0-28 days post UCBT.
Who may be able to join
- Patients are receiving a first unrelated cord blood transplantation (UCBT).
- Patients start letemovir prophylaxis within 0-28 days post UCBT.
Who cannot join
- Patients having active CMV DNAemia at the time of letermovir initiation.
- Patients recruited in a clinical study on an anti-CMV trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui
Xiaoyu Zhu, ph.D, 15255456091, xiaoyuz@ustc.edu.cn
Bingbing Yan, 15993691727, bing0415@mail.ustc.edu.cn
About this study
Official title: Effect of Letermovir Prophylaxis on Cytomegalovirus-specific Immune Reconstitution Post Unrelated Cord Blood Transplantation
To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation
Read the detailed description
To explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late CMV reactivation after letermovir discontinuation.
- Conditions
- Cytomegalovirus Infection Reactivation
- Being tested
- Letermovir
- Keywords
- Cytomegalovirus Infection, Umbilical Cord Blood Transplantation, CMV-Specific Immune Reconstitution, Letermovir
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT.
| Study group | Role | What they receive |
|---|---|---|
| letermovir group | Patients will be given Letermovir with a recommended dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine or according to clinical instructions) from +1 day to +100 days after UCBT. Receives: Drug: Letermovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of immune cells in peripheral blood
PBMCs from UCBT recipients were collected at 1 month, 2 month, 3 month, and 6 month and 12 month after HSCT, and tested for CMV-specific T cells, NK cells, T cells and other subsets.
Measured: one year
CMV DNAemia
CMV DNAemia is defined as the detection of CMV DNA in samples of plasma, whole blood or isolated peripheral blood leukocyte.
Measured: one year
Incidence of refractory CMV infection
Refractory CMV infection is defined as CMV viral load remaining at the same level or increasing despite appropriately doses of antiviral therapy for at least 2 weeks
Measured: one year
late CMV reactivation
Late CMV reactivation is defined as reactivation that occurs 100 days post UCBT, which means reactivation after discontinuing LET prophylaxis.
Measured: one year
Secondary outcomes (4)
Treatment-ralated mortality
Treatment-ralated mortality
Measured: one year
Incidence of other viral infection and viral-associated disease
Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV
Measured: one year
Overall survival
Overall survival
Measured: one year
serum immunoglobulin assay
The serum levels of IgG, IgM, and IgA were measured
Measured: 1,3,6,9 month post UCBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 May 2024
- Primary completion1 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus Infection ReactivationStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaoyu Zhu, ph.D, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provicial Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441669
- Sponsor's protocol ID
- CBCMV001
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Letermovir Prophylaxis on Cytomegalovirus-specific Immune Reconstitution Post Unrelated Cord Blood Transplantation
- ClinicalTrials.gov ID
- NCT06441669
- Acronym / sponsor ID
- CBCMV001
- Conditions
- Cytomegalovirus Infection Reactivation
- Keywords
- Cytomegalovirus Infection, Umbilical Cord Blood Transplantation, CMV-Specific Immune Reconstitution, Letermovir
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 4 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 explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation
Detailed description
To explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late CMV reactivation after letermovir discontinuation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| letermovir group | – | Drug: LetermovirPatients will be given Letermovir with a recommended dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine or according to clinical instructions) from +1 day to +100 days after UCBT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study consists 60 cases recipients of UCBT. All patients will receive letermovir prophylaxis within 0-28 days post UCBT.
Key inclusion criteria (2 listed)
- Patients are receiving a first unrelated cord blood transplantation (UCBT).
- Patients start letemovir prophylaxis within 0-28 days post UCBT.
Key exclusion criteria (2 listed)
- Patients having active CMV DNAemia at the time of letermovir initiation.
- Patients recruited in a clinical study on an anti-CMV trial.
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 |
|---|---|---|
| LetermovirPatients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT. | Drug | letermovir group |
Primary outcome
Numbers of immune cells in peripheral blood
Time frame: one year
PBMCs from UCBT recipients were collected at 1 month, 2 month, 3 month, and 6 month and 12 month after HSCT, and tested for CMV-specific T cells, NK cells, T cells and other subsets.
CMV DNAemia
Time frame: one year
CMV DNAemia is defined as the detection of CMV DNA in samples of plasma, whole blood or isolated peripheral blood leukocyte.
Incidence of refractory CMV infection
Time frame: one year
Refractory CMV infection is defined as CMV viral load remaining at the same level or increasing despite appropriately doses of antiviral therapy for at least 2 weeks
late CMV reactivation
Time frame: one year
Late CMV reactivation is defined as reactivation that occurs 100 days post UCBT, which means reactivation after discontinuing LET prophylaxis.
4 secondary outcomes
Treatment-ralated mortality
Time frame: one year
Incidence of other viral infection and viral-associated disease
Time frame: one year
Overall survival
Time frame: one year
serum immunoglobulin assay
Time frame: 1,3,6,9 month post UCBT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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RecruitingPhase 3
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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.
Xiaoyu Zhu, ph.D principal investigator
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provicial Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infection Reactivation, run by Anhui Provincial Hospital 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu, ph.D (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of immune cells in peripheral blood (time frame: one year). The study lists 4 primary outcomes in all. 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 4 Jun 2024.