CMV-specific immunoglobulin to prevent CMV problems in children getting allogeneic stem cell transplants
Immunoglobulin-specific Prophylaxis Against Citomegalovirus Infections in Immunocompromised Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
University of Pisa · NCT07013370
Doctors will try giving CMV-specific immunoglobulin to children having allogeneic stem cell transplants to prevent CMV reactivation and related transplant complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | University of Pisa (other) |
| Drugs / interventions | immunotherapy, cyclophosphamide |
| Locations | 1 site (Trieste) |
| Trial ID | NCT07013370 on ClinicalTrials.gov |
What this trial studies
Children who receive myeloablative allogeneic HSCT at IRCCS Burlo Garofolo are given biweekly CMV-specific immunoglobulin (Cytomegatect/Megalotect) starting on day 3 of conditioning and continuing during hospitalization and at admissions until CD4+ recovery. CMV DNAemia is monitored by real-time PCR twice weekly in hospital and weekly after discharge, with short 3–5 day "boost" doses if DNAemia appears based on risk. Key outcomes include overall survival, relapse-related mortality, graft-versus-host disease, immune reconstitution by CD4+ counts, and CMV reactivation rates, with follow-up for at least 12 months. The observational protocol enrolls children without prior CMV reactivation before prophylaxis and excludes those with immunoglobulin hypersensitivity or who receive adoptive cellular post-HSCT therapy.
Who should consider this trial
Good fit: Children who undergo myeloablative allogeneic HSCT, have not had CMV reactivation before prophylaxis starts, and have no history of immunoglobulin-related adverse reactions or post-HSCT adoptive cellular therapy.
Not a fit: Patients with CMV reactivation before prophylaxis, known immunoglobulin hypersensitivity, or who receive adoptive cellular immunotherapy after transplant are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this prophylaxis could lower CMV reactivation rates, reduce transplant-related complications, and improve survival after pediatric allo-HSCT.
How similar studies have performed: Some prior studies and observational reports suggest high CMV-neutralizing antibody levels may be protective, but evidence specifically in pediatric allo-HSCT is mixed and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children who underwent allogeneic HSCT due to any condition Exclusion Criteria: * Positive personal records of immunoglobulin-related adverse reactions * CMV reactivation before the CMV-specific immunoglobulin prophylaxis onset * adoptive cellular post-HSCT immunotherapy for any indication
Where this trial is running
Trieste
- IRCCS Burlo Garofolo — Trieste, Italy (RECRUITING)
Study contacts
- Principal investigator: Natalia Maximova, MD — IRCCS Burlo Garofolo - Trieste - ITALY
- Study coordinator: Natalia Maximova, MD
- Email: natalia.maximova@burlo.trieste.it
- Phone: +39-040.3785.111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immunoglobulin Prophylaxis, Cytomegalovirus Infections, Allogeneic Hematopoietic Stem Cell Transplantation, Transplant-Related Disorder, Cytomegalovirus, allo-HSCT, Transplant-Related mortality