23
Participants
Start Date
July 1, 2023
Primary Completion Date
October 31, 2027
Study Completion Date
October 31, 2028
CMV Cytotoxic T-Lymphocytes
Patients will receive maternal CMV CTLs on day 0. Additional doses of CMV CTLs may be re-infused at a minimum of every two weeks for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg) only in patients not achieving a CR and no prior dose limiting toxicity of any prior dose.
Anti-viral Therapy
"All patients will receive anti-viral therapy with one of the following:~4.2.2 Valganciclovir Dosing: 16 mg/kg/dose PO q12h OR 4.2.3 Ganciclovir Dosing: 6 mg/kg/dose IV q12h~Dose adjustments:~* Reduce dose by 50% for ANC less than 500 cells/mm3~* Hold the dose if ≤ 200 cells/mm3 until recovery ≥ 500 cells/mm3~* Treatment will continue for 6 months"
RECRUITING
New York Medical College, Vallhala
RECRUITING
Nationwide Children's Hosptial, Columbus
RECRUITING
Washington University, St Louis
RECRUITING
Children's Hospital Los Angeles, Los Angeles
Lead Sponsor
New York Medical College
OTHER