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 Type
OBSERVATIONAL
Enrollment
123
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
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
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
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
proportion of patients with CMV-specific immune reconstitution at each QTF-CMV measurement point
Time frame: 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
detection of any CMV replication and maximum copy number (IU/mL) during follow-up
Time frame: 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
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