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Trial registered on ANZCTR


Registration number
ACTRN12608000458336
Ethics application status
Approved
Date submitted
23/07/2008
Date registered
15/09/2008
Date last updated
14/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
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 transplantation
Scientific title
A phase 1 clinical trial of peptide-pulsed monocyte-derived dendritic cell vaccination to expand adoptively transferred CMV-specific cytotoxic T lymphocytes after allogeneic stem cell transplantation
Secondary ID [1] 708 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus (CMV) reactivation and disease 3322 0
Condition category
Condition code
Blood 3481 3481 0 0
Haematological diseases
Infection 3483 3483 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Donor derived dendritic cells (DC) pulsed with cytomegalovirus (CMV) antigen and/or CMV antigen specific T cells will be injected into patients following haemopoietic stem cell transplantation. There will be 3 arms: Arm 1 - CMV cytotoxic T lymphocyte (CTL) infusion only; Arm 2 - DC vaccine with CMV cytotoxic T lymohocyte infusion; Arm 3 - DC vaccination only.
Doses are:
CMV cytotoxic T lymphocytes - 2x10^7 per square metre of body surface area once post transplant
DC vaccine - 2x10^6 per sqaure metre of body surface area twice at 7 day interval
Intervention code [1] 3060 0
Prevention
Intervention code [2] 3062 0
Prevention
Comparator / control treatment
The DC+CMV CTL arm will be compared with DC alone and CMV CTL alone. These will all be compared with historical controls.
Control group
Active

Outcomes
Primary outcome [1] 4387 0
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.
Timepoint [1] 4387 0
4 hours post infusion/injection.
Primary outcome [2] 4394 0
Safety - graft vs host disease. Measured by a standard clinical grading system as grade I-IV.
Timepoint [2] 4394 0
12 months post infusion/injection
Primary outcome [3] 4395 0
Safety - progressive disease. Measured by the detection of recurrent malignancy on full blood examination or bone marrow biopsy.
Timepoint [3] 4395 0
12 months post infusion/injection
Secondary outcome [1] 7402 0
Use of antiviral therapy
Timepoint [1] 7402 0
12 months
Secondary outcome [2] 7419 0
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).
Timepoint [2] 7419 0
12 months
Secondary outcome [3] 7420 0
CMV reactivation as measured by whole blood PCR or CMV disease diagnosed on standard clinical criteria.
Timepoint [3] 7420 0
12 months

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HLA-A2 negative or CMV seronegative donor

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of treatment is based on the time of recruitment-
Patients 1 to 6 - Arm 1
Patients 7-12 - Arm 2
Patients 13-18 - Arm 3
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Allocation of treatment is based on the time of recruitment-
Patients 1 to 6 - Arm 1
Patients 7-12 - Arm 2
Patients 13-18 - Arm 3
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
7/08/2012
Date of last participant enrolment
Anticipated
31/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1709 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 3528 0
Hospital
Name [1] 3528 0
Westmead Hospital
Country [1] 3528 0
Australia
Funding source category [2] 3529 0
Charities/Societies/Foundations
Name [2] 3529 0
The Cancer Council NSW
Country [2] 3529 0
Australia
Primary sponsor type
Hospital
Name
Western Sydney Local Health District
Address
Westmead Hospital
Hawkesbury Rd
Westmead
NSW 2145
Country
Australia
Secondary sponsor category [1] 3167 0
None
Name [1] 3167 0
Address [1] 3167 0
Country [1] 3167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5566 0
Sydney West Area Health Service HREC
Ethics committee address [1] 5566 0
Westmead Hospital
Hawkesbury Rd
Westmead
NSW 2145
Ethics committee country [1] 5566 0
Australia
Date submitted for ethics approval [1] 5566 0
Approval date [1] 5566 0
10/10/2005
Ethics approval number [1] 5566 0
HREC2005/8/4.22(2170)

Summary
Brief summary
A preliminary study of the use of immune cells from transplant donors to prevent cytomegalovirus infection in recipients of blood stem cell transplants. The study hypothesis is that stimulation of infused CMV specific lymphocytes by CMV peptide pulsed DC given as a vaccine will enhance immune reconstitution. The study will use two different sorts of immune cells (called T lymphocytes and dendritic cells). These cells will be prepared in the laboratory and given back to patients after transplant to try to prevent diseases caused by the CMV virus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28707 0
Prof David Gottlieb
Address 28707 0
University of Sydney, Western Clinical School Westmead Hospital Westmead NSW 2145
Country 28707 0
Australia
Phone 28707 0
+61298456033
Fax 28707 0
Email 28707 0
[email protected]
Contact person for public queries
Name 11864 0
David Gottlieb
Address 11864 0
University of Sydney, Western Clinical School
Westmead Hospital
Westmead
NSW 2145
Country 11864 0
Australia
Phone 11864 0
+61298456033
Fax 11864 0
Email 11864 0
[email protected]
Contact person for scientific queries
Name 2792 0
David Gottlieb
Address 2792 0
University of Sydney, Western Clinical School
Westmead Hospital
Westmead
NSW 2145
Country 2792 0
Australia
Phone 2792 0
+61298456033
Fax 2792 0
Email 2792 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.