Clinical trial Recruiting at 4 sites Observational Ages 0 to 18

CMV reactivation after allogeneic stem cell transplant in children in Italy.

Official title: CMV PED Study - A Retrospective Observational Study To Understand The Clinical And Economic Burden Associated With Cytomegalovirus Reactivation and Related Health Outcomes In Pediatric Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation In Italy

Run by MSD Italia S.r.l. · NCT06916195 · Data updated 2026-11-12

This analysis looks at how often and how seriously cytomegalovirus (CMV) reactivates in children who had an allogeneic hematopoietic stem cell transplant in Italy between January 2018 and June 2020.

More Hematopoietic Stem Cell Transplantation trials

Quick facts

Study typeObservational
Ages0 Years to 18 Years
SexAll
Enrollment230 (estimated)
SponsorMSD Italia S.r.l.
Industry-sponsored
Locations5 sites (Genova and 4 other locations)
StatusRecruiting
StartedMay 9, 2025
Main results expectedApril 30, 2026
Study endsJuly 15, 2026
Registry record updatedApril 6, 2026
Trial IDNCT06916195 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children under 18 at the time of allogeneic HSCT performed in Italy between January 2018 and June 2020, with accessible medical records and consent for chart review, are eligible.

Probably not a fit

Patients transplanted after June 2020, adults, or children who received letermovir are unlikely to benefit from the study's findings.

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

What this trial studies

This is a retrospective observational chart review of pediatric patients who received allogeneic HSCT at about five major Italian centers, capturing consecutive transplants from January 2018 to June 2020 with up to 12 months of follow-up. Investigators will extract data from inpatient and outpatient electronic or paper medical records to describe patient characteristics, CMV risk factors, treatment patterns, clinical outcomes, and healthcare resource use. Patients who received letermovir at any time are excluded to avoid treatment-related bias. The goal is to quantify the clinical and economic burden of CMV reactivation to inform clinicians, guideline committees, and payers.

Why it matters

Potential benefit: Results could help clinicians and health systems reduce CMV complications and better allocate resources for pediatric transplant care.

How similar studies have gone: Retrospective analyses of CMV burden have informed adult transplant practice, but pediatric-specific data are more limited, so this established method addresses a gap in pediatric evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients from birth to less than 18 years of age (at the moment of the allogeneic HSCT);
* Patients who received allogeneic HSCT between January 2018 and June 2020;
* Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.

Exclusion Criteria:

* Letermovir use at any time

Where it's running

  • IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento di Onco-Ematologia Pediatrica
    Genova, Italy
    Recruiting
  • Ospedale San Gerardo, Clinica Pediatrica
    Monza, Italy
    Recruiting
  • IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia
    Roma, Italy
    Recruiting
  • Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino
    Torino, Italy
    Recruiting
  • Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica
    Padova, Italy
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.