RECRUITING

CMV CTLs in Neonates With CMV Infection

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Conditions

Congenital Cytomegaloviral (CMV) Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened. All patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if found to be safe, will proceed to cohort 2 for randomization to receive antiviral therapy with or without CMV CTLs. Funding source: FDA OOPD

Official Title

A Phase II Open-Label Randomized Study of Anti-Viral Antibiotic Therapy With and Without Familial (Maternal) Cytomegalovirus (CMV) Cytotoxic T Lymphocytes (CTLs) in Neonates With Moderate/Severe Maternal Acquired CMV Infection

Quick Facts

Study Start:2023-07-01
Study Completion:2028-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05564598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Days to 21 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age: ≤ 21 days of life
  2. * Birth Weight: ≥ 2500 gms
  3. * Gestational age: ≥ 34 weeks of age
  4. * Diagnosis of CMV viremia, viruria, and/or infection:Either one or more:
  5. * Thrombocytopenia (≤ 50,000 mm3)
  6. * Multiple petechiae
  7. * Hepatomegaly
  8. * Splenomegaly
  9. * Intrauterine growth retardation
  10. * Increased transaminases
  11. * Increased bilirubin
  12. * Microcephaly
  13. * Ventriculomegaly
  14. * Intracerebral calcifications
  15. * Periventricular echogenicity
  16. * Cortical or cerebral malformation
  17. * Chorioretinitis
  18. * Severe neonatal hearing loss
  19. * CMV DNA by PCR in CNS
  20. * Increased WBC for age in CNS
  21. * Minimal Organ Criteria Hematological: ANC ≥ 750/mm3, HgB ≥ 8gm/dl, Platelets ≥ 20,000/kmm3 Renal: Serum creatinine ≤ 1.0 mg/dl Hepatic: ALT/SGOT ≤3x upper normal limits
  22. * Donor Availability: Maternal donor available with a T-cell response CMV MACS® PepTivators. the donor is considered suitable if the percentage of IFN-gamma+ T cells is \> 0.01% after stimulation with PepTivators.
  23. * Patient receiving steroids (\> 0.5 mg/kg prednisone equivalent) on the same day of CMV CTL infusion. Antenatal steroids for lung maturation will have been cleared prior to CMV diagnosis.
  24. * Concomitant enrollment in another experimental clinical trial investigating the treatment of neonatal CMV viremia and/or infection.
  25. * Any medical condition that could compromise participation in the study according to the investigator's assessment.
  26. * Known history of HIV infection in the mother.
  27. * Patient's legally authorized representative unwilling or unable to comply with the protocol or unable to give informed consent.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mitchell Cairo, MD
CONTACT
914-594-2150
mitchell_cairo@nymc.edu
Edo Schaefer, MD
CONTACT
eshaefe@nymc.edu

Principal Investigator

Mitchell Cairo, MD
PRINCIPAL_INVESTIGATOR
New York Medical College

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Washington University
Saint Louis, Missouri, 63130
United States
New York Medical College
Valhalla, New York, 10595
United States
Nationwide Children's Hosptial
Columbus, Ohio, 43205
United States

Collaborators and Investigators

Sponsor: New York Medical College

  • Mitchell Cairo, MD, PRINCIPAL_INVESTIGATOR, New York Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01
Study Completion Date2028-10-31

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2028-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Congenital Cytomegaloviral (CMV) Disease