Not Yet RecruitingPhase 2ACTRN12607000224426

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


Sponsor

Sydney West Area Health Service

Enrollment

60 participants

Start Date

Oct 23, 2006

Study Type

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

Sex: Both males and femalesMin Age: 16 Yearss

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 transpla

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)

Australia

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ACTRN12607000224426