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

MI-összefoglaló

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The trial is looking for children who have had a stem cell transplant from a donor (allogeneic HSCT) for any condition. It studies anti-CMV immunoglobulin given to prevent CMV infection.

Életkor

1 Month to 18 Years

Nem

All sexes can join.

A betegség stádiuma

Children who had an allogeneic stem cell transplant (HSCT) for any condition.

Korábbi kezelés

Must have had an allogeneic HSCT. Children who had cell-based immune therapy (adoptive cellular immunotherapy) after the transplant cannot join.

A részvétel fő kizáró okai

• Past bad reactions to immunoglobulin
• CMV became active again before the immunoglobulin prevention started
• Cell-based immune therapy (adoptive cellular immunotherapy) after the transplant, for any reason

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Human cytomegalovirus (CMV) is a globally prevalent, human-specific herpesvirus characterised by a lifelong latency after primary infection, an often asymptomatic reactivation and affecting up to 100% of adults based on region and age. CMV reactivation has serious risks for immunocompromised patients, especially those undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In these patients, CMV can lead to graft failure, multiorgan disease, increased risk of other infections, GVHD, post-transplant lymphoproliferative disorders, and higher transplant-related mortality (TRM). Although antiviral prophylaxis, CMV infection occurs in 38-80% of HSCT recipients, but current antiviral drugs are insufficiently effective and they are associated with adverse effects. Furthermore, treatment failure is due to the high genetic variability of CMV. The protective role of virus-specific antibodies remains under debate. Some studies suggest that high neutralizing antibody titers protect transplant recipients from CMV, while others highlight the importance of T-cell responses. However, recent animal studies showed that humoral immunity alone can prevent CMV reactivation, even without T or NK cells. In solid-organ transplant patients, antibody titers ≥480 have been linked to reduced infection, shorter treatment, and full protection from CMV disease. Although the use of anti-CMV immunoglobulin remains controversial, the IRCCS Burlo Garofolo has used it as post-transplant prophylaxis and second-line treatment for over a decade.

A vizsgálat 2 csoportja

• Control Group

  Pediatric allo-HSCT recipients who have not received CMV-specific immunoglobulin prophylaxis after transplantation.

• Immunoprophylaxis Group

  Pediatric allo-HSCT recipients who received an anti-CMV prophylaxis with immunoglobulin (Megalotect)

  Kezelés: Anti-CMV immunoglobulins [Megalotect (R)]