Adoptive immunotherapy for the prevention of Human Cytomegalovirus (HCMV) reactivation and disease after Allogenic Stem Cell Transplantation
A phase I/II study to evaluate the effect of a single dose of human Cytomegalovirus (HCMV)-specific bulk cytotoxic T lymphocytes (CTL) to prevent complications associated with HCMV reactivation following allogeneic stem cell transplantation
Queensland Institute of Medical Research (QIMR)
15 participants
Jun 30, 2002
Interventional
Conditions
Summary
Since the inception of human organ transplantation, HCMV remains single most-important cause of infectious morbidity and mortality in immunocompromised transplant patients. This project is designed to develop immunotherapeutic strategies based on adoptve transfer of virus-specific killer T cells for the treatment of HCMV infection in transplant patients.
Eligibility
Inclusion Criteria1
- Consenting seropositive stem cell donors and recipients, Seropositive stem cell recipients; Without severe intercurrent illness/infection requiring inpatient care, <3x upper normal bilirubin, Creatinine clearance >35% normal for age, Availability of well-characterised HCMV-specific CTL with minimal detectable anti-host alloreactivity.
Exclusion Criteria1
- Active intercurrent infection requiring inpatient care, Laboratory evidence of active CMV infection prior to 1st CTL infusion, ECOG status >3, Positive serology for HIV, Hep B or Hep C.
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Interventions
Donor-expanded bulk HCMV-specific CTL at a single dose on four occasions at monthly intervals, then monthly for 1 year.
Locations(1)
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ACTRN12605000452695