Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT

NCT06306989 | Recruiting FDA Drug

• 1 other identifier: Zhengzhou University
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.
• 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.

Conditions

Letemovir for the Prevention of CMV Infection After Allo-HSCT

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  within 30 days after allogeneic hematopoietic stem cell transplantation

• +100-day overall survival, non-relapse mortality; + 100-day relapse rate; + 100-day aGVHD incidence.

  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.

  within 180 days after allogeneic hematopoietic stem cell transplantation

Study Arms (2)

High-risk groups

Drug: Letermovir

Low to medium risk group

Drug: Letermovir

Interventions

Letermovir DRUG

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.

High-risk groups; Low to medium risk group

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent hematopoietic stem cell transplantation at the Department of Hematology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cao Weijie: lead

Study Sites (1)

Cao, Weijie

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Interventions

letermovir

Central Study Contacts

Weijie Cao

CONTACT

+8618937390269; 2549509184@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: January 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)