Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-30
SponsorNew York Medical College

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

Treatment groups

69 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators