CMV-specific immunoglobulin to prevent CMV problems in children getting allogeneic stem cell transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.