Using Letermovir to Prevent CMV Infection in Stem Cell Transplant Patients

Letermovir for the Prevention of Cytomegalovirus Infection in Hematopoietic Cell Transplant Recipients Based on the Outcome of Metagenomic Next-Generation Sequencing: a Phase 2, Open Label, Single-Arm Clinical Trial.

This study is testing if a new antiviral drug called Letermovir can help prevent CMV infections in patients getting stem cell transplants.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06021210 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Letermovir, a novel antiviral medication, to prevent cytomegalovirus (CMV) infections in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). CMV is a significant risk for these patients, particularly due to their compromised immune systems post-transplant. The study will assess the effectiveness of Letermovir based on the outcomes of metagenomic next-generation sequencing (mNGS) performed before transplantation. By focusing on CMV prevention, the trial aims to reduce the incidence of severe complications associated with CMV infections.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 14 to 65 who are preparing for an allogeneic stem cell transplant and are willing to undergo mNGS testing.

Not a fit: Patients with active infections at the time of treatment initiation or those who have previously participated in anti-CMV trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the risk of CMV infections and related complications in stem cell transplant recipients.

How similar studies have performed: Previous studies have shown promising results with Letermovir in preventing CMV infections, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Xiaowen Tang, PhD

Conditions: CMV Infection, Hematopoietic Stem Cell Transplantation