About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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%.
Trial design
Treatments tested in this trial
- Standard of Care Antiviral medications
- Viral CTLs