A phase 1 clinical trial of peptide-pulsed monocyte-derived dendritic cell vaccination to expand adoptively transferred cytomegalovirus -specific cytotoxic T lymphocytes after allogeneic stem cell transplantatio
Phase 1
Recruiting
- Conditions
- Cytomegalovirus (CMV) reactivation and diseaseBlood - Haematological diseasesInfection - Other infectious diseases
- Registration Number
- ACTRN12608000458336
- Lead Sponsor
- Western Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Recipient and donor pairs with haemopoietic stem cell transplant
Human Leukocyte Antigen (HLA)-A2 positive
CMV seropositive donor
Fully HLA-matched or one antigen mismatched allogeneic transplant
Exclusion Criteria
HLA-A2 negative or CMV seronegative donor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety - acute toxicity. Measured by clinical history, physical examination and observation of vital signs before, during and for 4 hours after the infusion of lymphocytes or injection of dendritic cells.[4 hours post infusion/injection.];Safety - graft vs host disease. Measured by a standard clinical grading system as grade I-IV.[12 months post infusion/injection];Safety - progressive disease. Measured by the detection of recurrent malignancy on full blood examination or bone marrow biopsy.[12 months post infusion/injection]
- Secondary Outcome Measures
Name Time Method se of antiviral therapy[12 months];CMV specific immunological response. This is measured by in vitro assay of T cell response to CMV antigen (flow cytometry using tetramer/pentamer, ELISPOT and Cytokine Flow Cytometry).[12 months];CMV reactivation as measured by whole blood PCR or CMV disease diagnosed on standard clinical criteria.[12 months]