Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Recipients (INMUNOEND) (INMUNOEND)

November 21, 2025 updated by: Maimónides Biomedical Research Institute of Córdoba

Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in HSCT Recipients (INMUNOEND): a Protocol for a Prospective, Observational, Multicenter Study

Cytomegalovirus (CMV) infection is a common complication in patients undergoing hematopoietic stem cell transplantation (SCT). Fixed-duration letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, it is needed a study to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualization of CMV prophylaxis duration in these patients.

Methods and analysis: INMUNOEND is a multicenter, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post-SCT. Immunological and virological monitorization will be conducted until day +200 post-SCT. The primary outcome variable is the percentage of patients who develop clinically significant CMV infection up to day +200 post-SCT after completing LTV prophylaxis. Data collected will include: baseline characteristics of the hematological diseases and comorbidities, variables related to SCT (i.e. engrafment, graft-versus-host disease, use of letermovir and CMV replication) and variables related to CMV-specific immune reconstitution.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Córdoba
      • Córdoba, Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive CMV seropositive patients undergoing allogenic-SCT who receive LTV prophylaxis will be included. These patients will be prospectively evaluated during the first 200 days post-SCT.

Description

Inclusion Criteria:

  • Age >18 years.
  • CMV seropositivity (positive IgG) in the recipient at the time of SCT.
  • First allogeneic hematopoietic stem cell transplant recipient (bone marrow, peripheral blood, or cord blood).
  • Within the first 28 days post-SCT at the time of inclusion.
  • Indication for LTV prophylaxis within the first 28 days post-transplant up to 100 days post-SCT, according to the criteria established in each center.

Exclusion Criteria:

  • CMV seronegativity (negative IgG) in the recipient at the time of transplant.
  • Previous allogeneic stem cell transplant (patients with a prior autologous transplant are allowed to be included).
  • History of CMV disease in the 6 months prior to inclusion.
  • Need for preemptive therapy in the month prior to inclusion in the study.
  • Received any of the following in the 14 days prior to inclusion: Ganciclovir, valganciclovir, foscarnet, acyclovir (at doses >3200 mg orally per day or >25 mg/kg IV per day), valacyclovir (at doses >3000 mg orally per day), famciclovir (at doses >1500 mg orally per day).
  • Received any of the following in the 30 days prior to screening: Cidofovir, CMV hyperimmune immunoglobulin, any CMV antiviral in the investigational phase.
  • Suspected or confirmed hypersensitivity reaction to the LTV formulation or any of its components.
  • Severe hepatic insufficiency (defined as Child-Pugh class C).
  • History of primary immunodeficiency prior to transplant.
  • Participation in a clinical trial involving the administration of CMV vaccines, other investigational CMV drugs, or monoclonal antibodies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients undergoing allogenic-SCT who receive LTV prophylaxis with letermovir
Diagnostic test: Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV
A first determination will be made pre-HCT, followed by subsequent determinations at +30, +60, +90, +120, +150, +180, and +200 days post-HCT, as well as at the end of prophylaxis with Letermovir
Diagnostic test: Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV
A first determination will be made pre-HCT, followed by subsequent determinations at +30, +60, +90, +120, +150, +180, and +200 days post-HCT, as well as at the end of prophylaxis with LTV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of patients who develop clinically significant CMV infection (CMV-Cs) up to day +200 post-SCT after completing LTV prophylaxis
Time Frame: From enrollment to 200 days post-SCT
From enrollment to 200 days post-SCT

Secondary Outcome Measures

Outcome Measure
Time Frame
proportion of patients with CMV-specific immune reconstitution at each QTF-CMV measurement point
Time Frame: From enrollment to 200 days post-SCT
From enrollment to 200 days post-SCT
proportion of patients with CMV replication during the 30 days following QTF-CMV testing
Time Frame: From enrollment to 200 days post-SCT
From enrollment to 200 days post-SCT
percentage of patients without CMV-specific immune reconstitution at the end of LTV prophylaxis
Time Frame: From enrollment to 200 days post-SCT
From enrollment to 200 days post-SCT
detection of any CMV replication and maximum copy number (IU/mL) during follow-up
Time Frame: From enrollment to 200 days post-SCT
From enrollment to 200 days post-SCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCO-INM-2024-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available after the end of the study

IPD Sharing Time Frame

After publishing the results in a journal.

IPD Sharing Access Criteria

Upon request to uicec@imibic.org

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stem Cell Transplantation, Hematopoietic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe