Trial Review

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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
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
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.