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Trial registered on ANZCTR


Registration number
ACTRN12605000452695
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
21/09/2005
Date last updated
1/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adoptive immunotherapy for the prevention of Human Cytomegalovirus (HCMV) reactivation and disease after Allogenic Stem Cell Transplantation
Scientific title
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
Secondary ID [1] 171 0
Queensland Institute of Medical Research (QIMR): QIMR P395
Universal Trial Number (UTN)
Trial acronym
QR2002-CMV1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Cytomegalovirus (HCMV) reactivation and disease after Allogenic Stem Cell Transplantation 567 0
Condition category
Condition code
Cancer 643 643 0 0
Other cancer types
Infection 3192 3192 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Donor-expanded bulk HCMV-specific CTL at a single dose on four occasions at monthly intervals, then monthly for 1 year.
Intervention code [1] 471 0
Treatment: Other
Comparator / control treatment
None (single group, unrandomised study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 753 0
Safety
Timepoint [1] 753 0
Assessed at the time of vaccination for up to 1 year
Primary outcome [2] 754 0
Immunogenicity
Timepoint [2] 754 0
Assessed at the time of vaccination for up to 1 year
Secondary outcome [1] 1547 0
Assessment of viral load at weekly intervals
Timepoint [1] 1547 0
For the first 4 months, then every 2 weeks until day 180 and then at time intervals determined by the transplantation physician.

Eligibility
Key inclusion criteria
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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
30/06/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 703 0
Charities/Societies/Foundations
Name [1] 703 0
Leukaemia Foundation of Australia
Country [1] 703 0
Australia
Primary sponsor type
Government body
Name
Queensland Institute of Medical Research (QIMR)
Address
300 Herston Rd, Herston 4006
Country
Australia
Secondary sponsor category [1] 588 0
None
Name [1] 588 0
Not applicable
Address [1] 588 0
Country [1] 588 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1905 0
QIMR, Herston
Ethics committee address [1] 1905 0
Ethics committee country [1] 1905 0
Australia
Date submitted for ethics approval [1] 1905 0
Approval date [1] 1905 0
12/04/2002
Ethics approval number [1] 1905 0
EC00278
Ethics committee name [2] 1906 0
Royal Brisbane and Womens' Hospital
Ethics committee address [2] 1906 0
Ethics committee country [2] 1906 0
Australia
Date submitted for ethics approval [2] 1906 0
Approval date [2] 1906 0
27/03/2002
Ethics approval number [2] 1906 0
EC00172

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36219 0
Address 36219 0
Country 36219 0
Phone 36219 0
Fax 36219 0
Email 36219 0
Contact person for public queries
Name 9660 0
Dr Geoff Hill
Address 9660 0
Queensland Institute of Medical Research 300 Herston Road
Herston QLD 4006
Country 9660 0
Australia
Phone 9660 0
+61 7 38453763
Fax 9660 0
+61 7 33620107
Email 9660 0
[email protected]
Contact person for scientific queries
Name 588 0
Dr Rajiv Khanna
Address 588 0
Queensland Institute of Medical Research
300 Herston Road
Herston QLD 4006
Country 588 0
Australia
Phone 588 0
+61 7 33620385
Fax 588 0
+61 7 38453510
Email 588 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.