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.
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.
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.
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.
Cohort
Prospective
Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV
Diagnostic testA 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
Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV
Diagnostic testA 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
percentage of patients who develop clinically significant CMV infection (CMV-Cs) up to day +200 post-SCT after completing LTV prophylaxis
proportion of patients with CMV-specific immune reconstitution at each QTF-CMV measurement point
proportion of patients with CMV replication during the 30 days following QTF-CMV testing
detection of any CMV replication and maximum copy number (IU/mL) during follow-up
percentage of patients without CMV-specific immune reconstitution at the end of LTV prophylaxis
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