CMV CTLs in Neonates With CMV Infection

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

Conditions

Congenital Cytomegaloviral (CMV) Disease

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Study Overview

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Study Details

Study overview

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

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

CMV CTLs in Neonates With CMV Infection

Condition
Congenital Cytomegaloviral (CMV) Disease
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63130

Valhalla

New York Medical College, Valhalla, New York, United States, 10595

Columbus

Nationwide Children's Hosptial, Columbus, Ohio, United States, 43205

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age: ≤ 21 days of life
  • * Birth Weight: ≥ 2500 gms
  • * Gestational age: ≥ 34 weeks of age
  • * Diagnosis of CMV viremia, viruria, and/or infection:Either one or more:
  • * Thrombocytopenia (≤ 50,000 mm3)
  • * Multiple petechiae
  • * Hepatomegaly
  • * Splenomegaly
  • * Intrauterine growth retardation
  • * Increased transaminases
  • * Increased bilirubin
  • * Microcephaly
  • * Ventriculomegaly
  • * Intracerebral calcifications
  • * Periventricular echogenicity
  • * Cortical or cerebral malformation
  • * Chorioretinitis
  • * Severe neonatal hearing loss
  • * CMV DNA by PCR in CNS
  • * Increased WBC for age in CNS
  • * 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
  • * 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.
  • * 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.
  • * Concomitant enrollment in another experimental clinical trial investigating the treatment of neonatal CMV viremia and/or infection.
  • * Any medical condition that could compromise participation in the study according to the investigator's assessment.
  • * Known history of HIV infection in the mother.
  • * Patient's legally authorized representative unwilling or unable to comply with the protocol or unable to give informed consent.

Ages Eligible for Study

0 Days to 21 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

New York Medical College,

Mitchell Cairo, MD, PRINCIPAL_INVESTIGATOR, New York Medical College

Study Record Dates

2028-10-31