CMV CTLs in Neonates With CMV Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-21
SponsorNew York Medical College
About this trial
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
Eligibility criteria
Qualifiers
Age: ≤ 21 days of life
Birth Weight: ≥ 2500 gms
Gestational age: ≥ 34 weeks of age
Thrombocytopenia (≤ 50,000 mm3)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CMV Cytotoxic T-Lymphocytes
- Anti-viral Therapy
Treatment groups
23 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov