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

NCT04478474 | Completed FDA Drug

• 1 other identifier: 14151
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Eligible

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.

Drug: Ganciclovir

Interventions

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.

Also known as: allogenic stem cell tranplatation

Eligible

Eligibility Criteria

• Age: Up to 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children, adolescent, and young adult patients

You may qualify if:

• 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

You may not qualify if:

• None listed

Sponsors & Collaborators

• New York Medical College: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

Related 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 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.

  PMID: 37806447 BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 20, 2020
• Study Start: September 15, 2020
• Primary Completion: December 15, 2021
• Study Completion: September 15, 2022
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

US (1)