Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS

NCT06021210 | Unknown Phase 2

• 1 other identifier: mNGS+LMV
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS

Conditions

CMV Infection; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically significant CMV infection with letermovir prevention after HSCT Defined as CMV DNAemia leading to preemptive treatment or presence of CMV disease

  The diagnosis of CMV infection is based on CMV-DNA detection of qPCR.

  Time from registration to event, max 24 weeks

Secondary Outcomes (8)

• Cumulative incidences of CMV reactivation

  Time from registration to event, max 24 weeks

• Incidence of Acute and/or chronic graft versus host disease(a/cGVHD)

  Time from registration to event, max 24 weeks

• Incidence of transplantation Complications after transplantation

  Time from registration to event, max 24 weeks

• Incidence of CMV-related disease mortality

  Time from registration to event, max 24 weeks

• Incidence of all-cause mortality and non-relapse mortality

  Time from registration to event, max 24 weeks

Study Arms (1)

mNGS detection before stem cell transplantation

EXPERIMENTAL

Using letermovir to prevent CMV reactivation for high-risk patients with pre-existing CMV viremia based on the mNGS detection technology before HSCT

Drug: Letermovir Pill

Interventions

Letermovir Pill DRUG

Letermovir is the world's first and only new drug approved for the prevention of CMV infection. In 2017, it was approved by the U.S. Food and Drug Administration (FDA) for the prevention of CMV infection and disease in CMV-seropositive adult recipients (R+) of allogeneic hematopoietic stem cell transplantation (allo-HSCT). It was approved in China on December 31, 2021.

Also known as: Letermovir Tablets

mNGS detection before stem cell transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HSCT candidate who has decided to primary transplant and is willing to participate in the study.
• HSCT candidate undergo mNGS detection before transplantation.

You may not qualify if:

• Patients below 14 years ago or above 65 years ago.
• Patients having active infection at the time of letermovir initiation.
• Patient recruited in a clinical study on an anti-CMV trial, or took similar anti-CMV drugs previously.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

letermovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Xiaowen Tang, PhD

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Xiaowen Tang, PhD

CONTACT

67781525; xwtang1020@163.com

Depei Wu, PhD

CONTACT

67781525; drwudepei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Soochow University

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: July 7, 2022
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)