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OpenTrials
Completed

NCT Number: NCT04478474

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

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.

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Key information

Age range

Up to 26 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York Medical College

Valhalla, New York, 10595, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganciclovir

Drug

Type of allogeneic transplant, HLA match, graft manipulation, use of ATG and/or Campath, CMV status (donor and recipient), maximal acute GVHD stage and grade, CMV viremia/disease through day +100, days received ganciclovir prophylaxis, adverse events related directly or secondary to ganciclovir prophylaxis.

Other names: allogenic stem cell tranplatation

Primary outcomes

  1. Ganciclovir

    Time frame: 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.

  2. CMV viremia and disease in pediatric allogenic SCT recipients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New York Medical College

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients Following Ganciclovir Prophylaxis Until Day +100

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 20, 2020
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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