Letemovir for the Prevention of CMV Infection After Allo-HSCTNCT06306989
Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT
An observational study of Letemovir for the Prevention of CMV Infection After Allo-HSCT, run by Cao Weijie at 1 site in China.
Trial summary
The goal of this observational study is to get a series of clinical data related to the prevention of CMV infection after allo-HSCT with letemovir. The main question it aims to answer are: Efficacy and safety of letemovir for the prevention of CMV infection after allo-HSCT. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Letemovir for the Prevention of CMV Infection After Allo-HSCT
- What is being tested?
- Letermovir
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Dec 2025
- How long will I take part?
- 1 Year
- 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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent hematopoietic stem cell transplantation at the Department of Hematology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Who may be able to join
- Biological age not less than 14 years.
- Positive CMV serology.
- No detectable CMV-DNA from plasma samples taken 5 days prior to randomization into groups.
Who cannot join
- severe hepatic impairment;
- estimated creatinine clearance of less than 10 ml/min;
- current or recent recipients of antiviral medications with anti-CMV activity; and
- any other factor that affects the impact of obtaining data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cao, Weijie
Zhengzhou, Henan, 450000
Weijie W Cao, doctor of medicine, +8618937390269, 2549509184@qq.com
Mengyang M Zhu, Postgraduate medical students, +8615093360671 ext. 0371-66913114, Caoweijie2003@126.com
About this study
The goal of this observational study is to get a series of clinical data related to the prevention of CMV infection after allo-HSCT with letemovir. The main question it aims to answer are:
- Efficacy and safety of letemovir for the prevention of CMV infection after allo-HSCT.
- Optimal initiation of letemovir to prevent CMV infection. Participants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days.Treatments they will be given and use bullets.
Read the detailed description
This observational study was conducted by collecting patients who underwent hematopoietic stem cell transplantation in the Department of Hematology of the First Affiliated Hospital of Zhengzhou University from September 2023 and had IgG-positive CMV serological status, according to whether they had combined risk factors for CMV infection: haploidentical transplantation; umbilical cord blood transplantation; pretreatment regimen of PT-Cy or regimen containing ATG; unrelated donor transplantation; and donor-recipient serological status of D-/R+; Age greater than or equal to 40 years; application of high-dose glucocorticoids (prednisone ≥ 1 mg/kg.d-1 for ≥ 5 days); comorbidities of degree II or greater aGVHD; and division into high-risk and standard-risk groups with different letermovir initiation regimens: letermovir prophylaxis was initiated on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients (patients with concomitant cyclosporine application, 240 mg. (240 mg, qd, for patients with concomitant cyclosporine; 480 mg, qd, for patients with concomitant tacrolimus) to +100 days, in order to compare the therapeutic benefits of a letemovir-initiated prophylaxis regimen in patients with different risks of infection. After transplantation, blood specimen RT-qPCR was applied once or twice a week for CMV viremia testing, which lasted until 100 days post-transplantation, and it was recommended to appropriately prolong the length of monitoring and shorten the testing interval for high-risk groups.CMV-DNA positivity, the combination of factors related to rejection, recurrence, and CMV, the dosage of immunosuppressant was adjusted, and the initiation of antiviral therapy (ganciclovir, phosphonoinositide, adenosine, etc.) was initiated, until two consecutive CMV-DNA positive days. until CMV-DNA turned negative twice consecutively; if the CMV-DNA copy number increased two weeks after initiating antiviral therapy, CMV drug resistance gene testing was performed. The data were processed statistically using SPSS 25.0 software, the chi-square test was used for categorical measures, and the Nsnn-Whitrey U test was used for continuous variables.OS, EFS, and PFS were analyzed by the log-rank test using the Kaplan-Meier method and survival curves were plotted.Primary study endpoints: incidence of +100-day CMVemia, CMV disease; secondary study endpoints:(1) +30-day CMVemia, CMV disease; +30-day overall survival, non-relapse mortality; +30-day relapse rate; +30-day aGVHD incidence; (2) +100-day overall survival, non-relapse mortality; +100-day relapse rate; +100-day aGVHD incidence;(3) +180 days CMVemia, CMV disease; +180 days overall survival, non-relapse mortality; +180 days relapse rate; +180 days cGVHD incidence.
- Being tested
- Letermovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Participants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days.
| Study group | Role | What they receive |
|---|---|---|
| High-risk groups | Not described Receives: Drug: Letermovir | |
| Low to medium risk group | Not described Receives: Drug: Letermovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CMV viremia and CMV disease within 100 days after allogeneic hematopoietic stem cell transplantation.
Prevalence of CMV viremia and CMV disease within 100 days after allogeneic hematopoietic stem cell transplantation.
[CMV viremia]: isolation of virus or detection of viral protein / nucleic acid in blood samples. Including: 1CMV-DNA blood: viral DNA;2CMV antigenemia was detected in blood samples; viral DNA;2CMV antigen was detected in peripheral blood leukocytes.
[CMV disease]: CMV infection with clinical symptoms and signs. Including: 1CMV syndrome: non-specific symptoms such as fever, fatigue, myelosuppression, elevated transaminase on the basis of CMV syndrome, and excluding fever caused by other causes and no CMV terminal organ disease; 2CMV terminal organ disease: CMV invades tissues and organs and leads to corresponding symptoms and signs (such as CMV pneumonia, CMV gastroenteritis).
Measured: within 100 days after allogeneic hematopoietic stem cell transplantation
Secondary outcomes (3)
+30-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +30-day relapse rate; +30-day aGVHD incidence.
+30-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +30-day relapse rate; +30-day aGVHD incidence;
Measured: within 30 days after allogeneic hematopoietic stem cell transplantation
+100-day overall survival, non-relapse mortality; + 100-day relapse rate; + 100-day aGVHD incidence.
+100-day overall survival, non-relapse mortality; + 100-day relapse rate; + 100-day aGVHD incidence.
Measured: within 100 days after allogeneic hematopoietic stem cell transplantation
+180-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +180-day relapse rate; +180-day aGVHD incidence.
+180-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +180-day relapse rate; +180-day aGVHD incidence.
Measured: within 180 days after allogeneic hematopoietic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jan 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Letemovir for the Prevention of CMV Infection After Allo-HSCTStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cao Weijie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cao Weijie, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306989
- Sponsor's protocol ID
- Zhengzhou University
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT
- ClinicalTrials.gov ID
- NCT06306989
- Acronym / sponsor ID
- Zhengzhou University
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cao WeijieUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Mar 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.
The goal of this observational study is to get a series of clinical data related to the prevention of CMV infection after allo-HSCT with letemovir. The main question it aims to answer are:
- Efficacy and safety of letemovir for the prevention of CMV infection after allo-HSCT.
- Optimal initiation of letemovir to prevent CMV infection. Participants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days.Treatments they will be given and use bullets.
Detailed description
This observational study was conducted by collecting patients who underwent hematopoietic stem cell transplantation in the Department of Hematology of the First Affiliated Hospital of Zhengzhou University from September 2023 and had IgG-positive CMV serological status, according to whether they had combined risk factors for CMV infection: haploidentical transplantation; umbilical cord blood transplantation; pretreatment regimen of PT-Cy or regimen containing ATG; unrelated donor transplantation; and donor-recipient serological status of D-/R+; Age greater than or equal to 40 years; application of high-dose glucocorticoids (prednisone ≥ 1 mg/kg.d-1 for ≥ 5 days); comorbidities of degree II or greater aGVHD; and division into high-risk and standard-risk groups with different letermovir initiation regimens: letermovir prophylaxis was initiated on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients (patients with concomitant cyclosporine application, 240 mg. (240 mg, qd, for patients with concomitant cyclosporine; 480 mg, qd, for patients with concomitant tacrolimus) to +100 days, in order to compare the therapeutic benefits of a letemovir-initiated prophylaxis regimen in patients with different risks of infection. After transplantation, blood specimen RT-qPCR was applied once or twice a week for CMV viremia testing, which lasted until 100 days post-transplantation, and it was recommended to appropriately prolong the length of monitoring and shorten the testing interval for high-risk groups.CMV-DNA positivity, the combination of factors related to rejection, recurrence, and CMV, the dosage of immunosuppressant was adjusted, and the initiation of antiviral therapy (ganciclovir, phosphonoinositide, adenosine, etc.) was initiated, until two consecutive CMV-DNA positive days. until CMV-DNA turned negative twice consecutively; if the CMV-DNA copy number increased two weeks after initiating antiviral therapy, CMV drug resistance gene testing was performed. The data were processed statistically using SPSS 25.0 software, the chi-square test was used for categorical measures, and the Nsnn-Whitrey U test was used for continuous variables.OS, EFS, and PFS were analyzed by the log-rank test using the Kaplan-Meier method and survival curves were plotted.Primary study endpoints: incidence of +100-day CMVemia, CMV disease; secondary study endpoints:(1) +30-day CMVemia, CMV disease; +30-day overall survival, non-relapse mortality; +30-day relapse rate; +30-day aGVHD incidence; (2) +100-day overall survival, non-relapse mortality; +100-day relapse rate; +100-day aGVHD incidence;(3) +180 days CMVemia, CMV disease; +180 days overall survival, non-relapse mortality; +180 days relapse rate; +180 days cGVHD incidence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk groups | – | Drug: Letermovir |
| Low to medium risk group | – | Drug: Letermovir |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent hematopoietic stem cell transplantation at the Department of Hematology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Key inclusion criteria (3 listed)
- Biological age not less than 14 years.
- Positive CMV serology.
- No detectable CMV-DNA from plasma samples taken 5 days prior to randomization into groups.
Key exclusion criteria (4 listed)
- severe hepatic impairment;
- estimated creatinine clearance of less than 10 ml/min;
- current or recent recipients of antiviral medications with anti-CMV activity; and
- any other factor that affects the impact of obtaining data.
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 |
|---|---|---|
| LetermovirParticipants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days. | Drug | High-risk groups, Low to medium risk group |
Primary outcome
Prevalence of CMV viremia and CMV disease within 100 days after allogeneic hematopoietic stem cell transplantation.
Time frame: within 100 days after allogeneic hematopoietic stem cell transplantation
Prevalence of CMV viremia and CMV disease within 100 days after allogeneic hematopoietic stem cell transplantation. [CMV viremia]: isolation of virus or detection of viral protein / nucleic acid in blood samples. Including: 1CMV-DNA blood: viral DNA;2CMV antigenemia was detected in blood samples; viral DNA;2CMV antigen was detected in peripheral blood leukocytes. [CMV disease]: CMV infection with clinical symptoms and signs. Including: 1CMV syndrome: non-specific symptoms such as fever, fatigue, myelosuppression, elevated transaminase on the basis of CMV syndrome, and excluding fever caused by other causes and no CMV terminal organ disease; 2CMV terminal organ disease: CMV invades tissues and organs and leads to corresponding symptoms and signs (such as CMV pneumonia, CMV gastroenteritis).
3 secondary outcomes
+30-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +30-day relapse rate; +30-day aGVHD incidence.
Time frame: within 30 days after allogeneic hematopoietic stem cell transplantation
+100-day overall survival, non-relapse mortality; + 100-day relapse rate; + 100-day aGVHD incidence.
Time frame: within 100 days after allogeneic hematopoietic stem cell transplantation
+180-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +180-day relapse rate; +180-day aGVHD incidence.
Time frame: within 180 days after allogeneic hematopoietic stem cell transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes
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.
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 Letemovir for the Prevention of CMV Infection After Allo-HSCT, run by Cao Weijie 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 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 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 Weijie Cao (+8618937390269, 2549509184@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CMV viremia and CMV disease within 100 days after allogeneic hematopoietic stem cell transplantation. (time frame: within 100 days after allogeneic hematopoietic stem cell 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 12 Mar 2024.