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)

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.