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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-09-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cytomegalovirus Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Ganciclovir

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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allogenic stem cell tranplatation

Eligibility Criteria

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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