NCT06814301

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)

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 123 (estimated)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2025-02-07
• Last updated: 2025-11-28

Locations

1 site across 1 country: Spain