Cytomegalovirus InfectionsNCT04478474
Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients
An observational study of Cytomegalovirus Infections, run by New York Medical College at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 26 years
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Ganciclovir
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, adolescent, and young adult patients
Who may be able to join
- 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
Who cannot join
- None listed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients Following Ganciclovir Prophylaxis Until Day +100
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.
Read the 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.
- Conditions
- Cytomegalovirus Infections
- Being tested
- Ganciclovir
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanciclovirDrug
Also called allogenic stem cell tranplatation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ganciclovir
Ganciclovir will be safe, well tolerated, and effective to prevent CMV viremia and/or decrease in pediatric allogeneic stem cell transplant recipients.
Measured: 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.
Measured: June 29, 2011 through December 31, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Sep 2020
- Primary completion15 Dec 2021
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478474
- Sponsor's protocol ID
- 14151
- Status last verified
- Oct 2023
- First submitted
- 16 Jul 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37806447
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients Following Ganciclovir Prophylaxis Until Day +100
- ClinicalTrials.gov ID
- NCT04478474
- Acronym / sponsor ID
- 14151
- Conditions
- Cytomegalovirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible | – | Drug: GanciclovirRetrospective 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. |
Who may qualify
- Ages
- Up to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, adolescent, and young adult patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None listed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GanciclovirAlso: allogenic stem cell tranplatationType 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. | Drug | Eligible |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 37806447Klejmont 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ganciclovir (time frame: June 29, 2011 through December 31, 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.