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)

NCT06814301 | Not Yet Recruiting

• 1 other identifier: FCO-INM-2024-04
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cytomegalovirus Cell Mediated Immunity; Stem Cell Transplantation, Hematopoietic

Keywords

stem cell transplantation; cytomegalovirus; letermovir; prophylaxis; cytomegalovirus immunity

Outcome Measures

Primary Outcomes (1)

• percentage of patients who develop clinically significant CMV infection (CMV-Cs) up to day +200 post-SCT after completing LTV prophylaxis

  From enrollment to 200 days post-SCT

Secondary Outcomes (4)

• proportion of patients with CMV-specific immune reconstitution at each QTF-CMV measurement point

  From enrollment to 200 days post-SCT

• proportion of patients with CMV replication during the 30 days following QTF-CMV testing

  From enrollment to 200 days post-SCT

• detection of any CMV replication and maximum copy number (IU/mL) during follow-up

  From enrollment to 200 days post-SCT

• percentage of patients without CMV-specific immune reconstitution at the end of LTV prophylaxis

  From enrollment to 200 days post-SCT

Study Arms (1)

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

Interventions

Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV DIAGNOSTIC_TEST

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

patients undergoing allogenic-SCT who receive LTV prophylaxis with letermovir

Eligibility Criteria

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

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Related Publications (1)

• Caston JJ, Aparicio C, Paez-Vega A, Pozo Lopez L, Garcia E, Martin C, Ruiz-Arabi E, Cuesta-Casas MA, Bermudez-Rodriguez MA, Cerezo-Martin JM, Gonzalez-Sierra PA, Machuca I, Martin Dominguez FM, Saldana-Moreno R, Herrera C, Torre-Cisneros J. Impact of CMV-specific immune reconstitution at the end of letermovir prophylaxis on the development of late cytomegalovirus infection in haematopoietic stem cell transplant recipients (INMUNOEND): a protocol for a prospective, observational, multicentre study. BMJ Open. 2025 Oct 15;15(10):e101289. doi: 10.1136/bmjopen-2025-101289.

  PMID: 41093321 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 200 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publishing the results in a journal.
• Access Criteria: Upon request to uicec@imibic.org

Locations

ES (1)