Clinical trial NCT04478474: Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients
Official title: Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients Following Ganciclovir Prophylaxis Until Day +100
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus Infections
Lead sponsor: New York Medical College
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-07-20
Enrollment: 100
Sex: ALL
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, adolescent, and young adult patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ganciclovir
timeFrame: June 29, 2011 through December 31, 2019
measure: CMV viremia and disease in pediatric allogenic SCT recipients
timeFrame: June 29, 2011 through December 31, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
References:
citation: Klejmont LM, Mo X, Milner J, Harrison L, Morris E, van de Ven C, Cairo MS. Risk Factors Associated with Survival Following Ganciclovir Prophylaxis through Day +100 in Cytomegalovirus At-Risk Pediatric Allogeneic Stem Cell Transplantation Recipients: Development of Cytomegalovirus Viremia Associated with Significantly Decreased 1-Year Survival. Transplant Cell Ther. 2024 Jan;30(1):103.e1-103.e8. doi: 10.1016/j.jtct.2023.09.025. Epub 2023 Oct 6.