A trial of donor-derived cytotoxic T lymphocytes stimulated with an adenoviral vector containing the pp65 gene to prevent reactivation of cytomegalovirus following allogeneic stem cell transplantation for haematological malignancy
Infusion of Ad5f35pp65 stimulated donor-derived cytotoxic T lymphocytes for the prevention of cytomegalovirus reactivation following allogeneic stem cell transplantation for haematological malignancy
Sydney West Area Health Service
60 participants
Oct 23, 2006
Interventional
Conditions
Summary
Stem cell transplant recipients will receive an infusion of donor cells at least one month post transplant. Cells will have been stimulated in the laboratory so that they specifically recognise and kill parts of the viruses known as cytomegalovirus and adenovirus.
Eligibility
Inclusion Criteria1
- myeloablative or non-myeloablative allogeneic stem cell transplant recipients receiving stem cells from an HLA identical or 1 antigen mismatched CMV seropositive donor. Adult patients judged eligible to undergo allogeneic stem cell transplant are eligible.
Exclusion Criteria1
- CMV seronegative donor, current grade II-IV graft versus host disease, receiving prednisone or equivalent >1mg/kg/day.
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Interventions
Infusion of a single dose of in vitro stimulated lymphocytes at a dose of 2 x10^7/m2 over 5 minutes at 28 days post allogeneic stem cell transplant or beyond 28 days post allogeneic stem cell transplant if exclusion criteria prevent infusion on day 28. Infusion can be given up to 12 months post-transplant according to trial inclusion and exclusion criteria.
Locations(1)
View Full Details on ANZCTR
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ACTRN12607000224426