Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients

Completed

• Conditions: Cytomegalovirus Infections
• Interventions: Drug: Ganciclovir

• Registration Number: NCT04478474
• Lead Sponsor: New York Medical College

Brief Summary

The primary objective is to determine the incidence of CMV viremia and disease in pediatric allogeneic stem cell transplantation recipients who received ganciclovir prophylaxis up until day +100 by retrospective analysis.

Detailed Description

This will be a single center, retrospective chart review of all pediatric patients who underwent allogeneic stem cell transplant between June 29, 2011 and December 31, 2019 at Westchester Medical Center (WMC). For this analysis, eligible patients will be identified through our transplantation database and clinical data collected through electronic medical record. This analysis will comprise of 100 pediatric allogeneic stem cell transplant recipients. CMV viremia will be defined as ≥2 CMV positive PCRs ≥500 copies and CMV disease will be defined as isolation of CMV in any body fluid or tissue specimen along with end-organ disease, as we have demonstrated.8 CMV viremia/disease will be evaluated through day +100 following allogeneic stem cell transplantation. Review of clinical records and collection of data with de-identified information will be performed. The study team will not access medical records (paper or electronic) directly. Medical records will be obtained through the Hospital's Health Information Management (HIM) department. HIM will query requested data / variables and provide a report / records of interest to Investigator.

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-20
• Study Start: 2020-09-15
• Primary Completion: 2021-12-15
• Study Completion: 2022-09-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Retrospective chart review of all pediatric patients who underwent allogeneic stem cell transplant between June 29, 2011 and December 31, 2019 at Westchester Medical Center (WMC).
• ages 0-≤26 years
• received an allogeneic stem cell transplantation on the pediatric bone marrow transplant service including matched unrelated donor, matched sibling donor, haploidentical donor, umbilical cord donor
• received ganciclovir prophylaxis for ≥14 days

Exclusion Criteria

• None listed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eligible	Ganciclovir	Retrospective chart review of all pediatric patients who underwent allogeneic stem cell transplant between June 29, 2011 and December 31, 2019 at Westchester Medical Center (WMC). Children, adolescent, and young adult patients, ages 0-≤26 years, who have received an allogeneic stem cell transplantation on the pediatric bone marrow transplant service including matched unrelated donor, matched sibling donor, haploidentical donor, umbilical cord donor, who received ganciclovir prophylaxis for ≥14 days.

Primary Outcome Measures

Name	Time	Method
Ganciclovir	June 29, 2011 through December 31, 2019	Ganciclovir will be safe, well tolerated, and effective to prevent CMV viremia and/or decrease in pediatric allogeneic stem cell transplant recipients.
CMV viremia and disease in pediatric allogenic SCT recipients	June 29, 2011 through December 31, 2019	The primary objective is to determine the incidence of CMV viremia and disease in pediatric allogeneic stem cell transplantation recipients who received ganciclovir prophylaxis up until day +100 by retrospective analysis.

Trial Locations

Locations (1)

New York Medical College; 🇺🇸 Valhalla, New York, United States