Reducing Post-Letermovir CMV Infection: Efficacy of an Immune-Reconstitution-Based Scoring System to Guide Prophylaxis Duration

NCT07443501 | Not Yet Recruiting DMC

• 1 other identifier: IIT2025141
• Study Type: observational
• Target: 1,114
• Locations: 0 countries
• Sites: N/A

Brief Summary

With the increasing use of letermovir and considering that haploidentical hematopoietic stem cell transplantation (haplo-HSCT) predominates in China alongside a high CMV seroprevalence in the population, multiple domestic centers have reported cases of CMV infection after letermovir discontinuation. Currently, there is no clear definition for the high-risk population who may benefit from extended letermovir prophylaxis. This study aims to utilize CMV-specific immune reconstitution to identify high-risk individuals for CMV infection after letermovir cessation post-transplant, thereby guiding the timing of letermovir discontinuation and balancing the risks and safety associated with prolonged prophylaxis.

Conditions

CMV Infection

Outcome Measures

Primary Outcomes (1)

• incidence of CMV reactivation and cs CMV infection

  one year after letermovir discontinuation

Secondary Outcomes (3)

• All-cause mortality

  one year

• treatment-related mortality

  one year

• Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  one year

Study Arms (1)

CMV high risk patients after transplantation

For enrolled subjects, at 3 months after transplantation, apply a predictive model incorporating CMV-specific immune reconstitution to evaluate the risk of CMV infection after discontinuation of letermovir. Based on the prediction results, define low-risk, intermediate-risk, and high-risk categories. For low-risk patients, direct discontinuation of letermovir is recommended; for intermediate-risk patients, discontinuation may be considered, but close monitoring of peripheral blood CMV-DNA is required after discontinuation; for high-risk patients, extending letermovir treatment until 200 days after transplantation is recommended.

Eligibility Criteria

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

Study Population

For enrolled subjects, at 3 months after transplantation, apply a predictive model incorporating CMV-specific immune reconstitution to evaluate the risk of CMV infection after discontinuation of letermovir. Based on the prediction results, define low-risk, intermediate-risk, and high-risk categories. For low-risk patients, direct discontinuation of letermovir is recommended; for intermediate-risk patients, discontinuation may be considered, but close monitoring of peripheral blood CMV-DNA is required after discontinuation; for high-risk patients, extending letermovir treatment until 200 days after transplantation is recommended.

You may qualify if:

• (1) Recipients who meet either of the following conditions:
• CMV IgG-positive recipients undergoing HLA-haploidentical hematopoietic stem cell transplantation (HSCT).
• CMV IgG-negative recipients receiving a graft from a CMV IgG-positive donor, and who have received letermovir as CMV prophylaxis post-transplant without prior discontinuation.
• (2) Plasma CMV-DNA level below the lower limit of detection (local threshold: 400 copies/mL) within 5 days before enrollment.
• (3) Age ≥ 18 years.
• (4) Ability to provide written informed consent independently.
• (5) Negative for HIV, HBV, and HCV.
• (6) Written informed consent must be provided before initiation of any study procedure. Consent may be provided by the patient or a legally authorized representative if, in the investigator's judgment, obtaining consent directly from the patient is not in the patient's best medical interest.

You may not qualify if:

• (1) Prior clinical diagnosis of CMV infection, CMV disease, or CMV viremia before enrollment;
• (2) Received ganciclovir, valganciclovir, foscarnet, acyclovir (oral dose \>3200 mg daily, or intravenous dose \>25 mg/kg daily), valacyclovir (oral dose \>3000 mg daily), or famciclovir (oral dose \>1500 mg daily) within 7 days before enrollment;
• (3) Received the following treatments within 30 days before enrollment: cidofovir, CMV hyperimmune globulin, any experimental anti-CMV therapy or biologics;
• (4) Presence of uncontrolled infection, requirement for mechanical ventilation, or hemodynamic instability at enrollment;
• (5) Suffering from mental illness or other conditions that prevent compliance with study treatment and monitoring requirements;
• (6) Inability or unwillingness to sign the informed consent form;
• (7) Other special circumstances deemed ineligible by the investigator.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 2, 2026
• Study Start: March 14, 2026
• Primary Completion (Estimated): December 14, 2027
• Study Completion (Estimated): December 14, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02