Immunoglobulin-specific Prophylaxis Against Cytomegalovirus Infections in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

What this Trial Is About

Researchers are studying the use of CMV-specific immunoglobulin prophylaxis to reduce the incidence and severity of cytomegalovirus (CMV) infections in children undergoing allogeneic hematopoietic stem cell transplantation (HSCT). CMV is a common virus that can reactivate in immunocompromised patients, especially HSCT recipients, leading to serious complications such as graft failure and increased risk of other infections. This study also aims to evaluate the impact of immunoglobulin prophylaxis on transplant outcomes and pharmacokinetics in pediatric patients. The study compares two groups of pediatric HSCT recipients: those who receive anti-CMV immunoglobulin prophylaxis called Megalotect and those who do not receive this prophylaxis. The immunoglobulin is given starting on day 3 of conditioning, then biweekly during hospitalization, and at each hospital admission post-discharge until immune recovery. If CMV DNA is detected, additional boost treatments are provided, and antiviral drugs are used according to the patient's risk and response. The study also monitors CMV viral loads frequently using blood tests. Participants will be followed for at least 12 months after transplantation. Researchers will regularly monitor CMV DNA levels, immune recovery by measuring CD4+ T-lymphocyte counts, overall survival, incidence of graft-versus-host disease (GVHD), and hospital stay duration. Pharmacokinetic analyses will assess how the immunoglobulin distributes and is cleared in the body. Safety and treatment outcomes will be tracked throughout the study period to better understand the role of immunoglobulin prophylaxis in preventing CMV complications.

Immunoglobiulin-specific Prophylaxis of Citomegalovirus Infections in Immunocompromised Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation