Phase I/II clinical trial to assess the safety and biological efficacy of treatment with virus-specific, cytotoxic T-lymphocytes from partially matched third-party unrelated donors, in stem cell transplant patients with viral reactivation unresponsive to standard therapy (R3ACT trial)
In allogeneic stem cell transplant patients, with viral reactivation unresponsive to standard antiviral therapy, is therapeutic infusion of most closely HLA-matched, third party, donor-derived, virus-specific cytotoxic T-lymphocytes, safe and efficacious?
Western Sydney Local Health Districit
30 participants
Feb 11, 2013
Interventional
Conditions
Summary
To assess the safety and efficacy of providing partially HLA matched, third party donor-derived, EBV/CMV/adenovirus-specific cytotoxic t-cells, to allogeneic stem cell/marrow transplant patients who have developed post-transplant viral infections unresponsive to standard therapy. It is hypothesised that virus-specific t-cells infusions will improve or restore the virus-specific immunity of the transplant patient in a safe manner without precipitating graft versus host disease.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Treatment will consist of an initial infusion of 2 x 10^7/m^2 partially HLA-matched (minimum 1/6), third party, donor-derived, virus-specific (CMV, EBV, and/or adenovirus) cytotoxic T-lymphocytes. Up to 3 subsequent infusions (with an option of increased dose up to 5 x 10^7/m^2) may be repeated at fortnightly intervals, on the basis of persistent viral reactivation.
Locations(15)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12613000603718