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

Cytomegalovirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04478474
• Other study ID #: 14151
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: October 2023
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Viremia

Intervention

Drug:
• Ganciclovir
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.

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Medical College	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 CMV Viremia Associated with Significantly Decreased One-Year Survival. Transplant Cell Ther. 2023 Oct 6:S2666-6367(23)01578-6. doi: 10.1016/j.jtct.2023.09.025. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ganciclovir	Ganciclovir will be safe, well tolerated, and effective to prevent CMV viremia and/or decrease in pediatric allogeneic stem cell transplant recipients.	June 29, 2011 through December 31, 2019
Primary	CMV viremia and disease in pediatric allogenic SCT 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.	June 29, 2011 through December 31, 2019