Patients with refractory ADV or CMV infection post allogeneic stem cell transplant will be randomized to either Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) plus standard of care (SOC) vs SOC alone.
Consent: written informed consent given (by patient or legal representative) prior to any study related procedures
Performance Status >30% (Lansky < 16 yrs and Karnofsky > 16 years (BOTH COHORTS)
Age: 0.01 to 30.00 years (BOTH COHORTS)
Females of childbearing potential with a negative urine pregnancy test at study entry only (BOTH COHORTS)
Patient with acute GVHD > grade 2 or moderate or extensive chronic GVHD at the time of CTL infusion.
Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CTL infusion.
Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion.
Patient with poor performance status determined by Karnofksy (patients > 16 yrs) or Lansky (patients < 16 years) score < 30%.
Crossover
Standard of Care Antiviral medications
DrugStandard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2)
Viral CTLs
Biological/VaccineADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions
Viral PCR to determine resolution of disease
Patients will be monitored weekly by peripheral blood qtPCR values to monitor viral levels for resolution confirmation.
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