Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000224426
Ethics application status
Approved
Date submitted
19/10/2006
Date registered
27/04/2007
Date last updated
27/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of donor-derived cytotoxic T lymphocytes stimulated with an adenoviral vector containing the pp65 gene to prevent reactivation of cytomegalovirus following allogeneic stem cell transplantation for haematological malignancy
Scientific title
Infusion of Ad5f35pp65 stimulated donor-derived cytotoxic T lymphocytes for the prevention of cytomegalovirus reactivation following allogeneic stem cell transplantation for haematological malignancy
Universal Trial Number (UTN)
Trial acronym
WM-CMV Adpp65-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunosuppression post stem cell transplant for haematological malignancy 1755 0
Condition category
Condition code
Cancer 1846 1846 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infusion of a single dose of in vitro stimulated lymphocytes at a dose of 2 x10^7/m2 over 5 minutes at 28 days post allogeneic stem cell transplant or beyond 28 days post allogeneic stem cell transplant if exclusion criteria prevent infusion on day 28. Infusion can be given up to 12 months post-transplant according to trial inclusion and exclusion criteria.
Intervention code [1] 1411 0
Prevention
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 2586 0
Incidence of cytomegalovirus reactivation as measured by polymerase chain reaction positivity for the cytomegalovirus pp65 protein in peripheral blood
Timepoint [1] 2586 0
Assessed regularly (measured weekly for the first month, fortnightly from 1 to 3 months, monthly from 3 to 6 months, 3 monthly thereafter until 12 months) during the first 12 months post-transplant.
Primary outcome [2] 2587 0
Use of the anti-cytomegalovirus antibiotics ganciclovir, foscarnet or cidofivir in the first 12 months after allogeneic stem cell transplant performed for haematological malignancy. Pharmacological therapy will be given if a single blood sample reveals a CMV copy number over 3000 copies/ml or there is a doubling or greater of copy number over one week with the second and higher reading exceeding 2000 copies/ml.
Timepoint [2] 2587 0
Measured weekly for the first month, fortnightly from 1 to 3 months, monthly from 3 to 6 months, 3 monthly thereafter until 12 months.
Secondary outcome [1] 4445 0
Safety as determined by the incidence of adverse events occurring within 24 hours of cell infusion.
Timepoint [1] 4445 0
Secondary outcome [2] 4446 0
Effect on CMV specific immune reconstitution as measured by pp65 tetramer positivity, intracellular cytokine secretion and ELISPOT assay.
Timepoint [2] 4446 0
Measured weekly for the first month, fortnightly from 1 to 3 months, monthly from 3 to 6 months, 3 monthly thereafter until 12 months.

Eligibility
Key inclusion criteria
myeloablative or non-myeloablative allogeneic stem cell transplant recipients receiving stem cells from an HLA identical or 1 antigen mismatched CMV seropositive donor. Adult patients judged eligible to undergo allogeneic stem cell transplant are eligible.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
CMV seronegative donor, current grade II-IV graft versus host disease, receiving prednisone or equivalent >1mg/kg/day.

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)
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
Safety
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1994 0
Government body
Name [1] 1994 0
Sydney West Area Health Service
Country [1] 1994 0
Australia
Primary sponsor type
Government body
Name
Sydney West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 1805 0
None
Name [1] 1805 0
nil
Address [1] 1805 0
Country [1] 1805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3701 0
Westmead Hospital
Ethics committee address [1] 3701 0
Sydney
Ethics committee country [1] 3701 0
Australia
Date submitted for ethics approval [1] 3701 0
Approval date [1] 3701 0
30/07/2006
Ethics approval number [1] 3701 0
2006/5/3.5(1223)

Summary
Brief summary
Stem cell transplant recipients will receive an infusion of donor cells at least one month post transplant. Cells will have been stimulated in the laboratory so that they specifically recognise and kill parts of the viruses known as cytomegalovirus and adenovirus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27345 0
Address 27345 0
Country 27345 0
Phone 27345 0
Fax 27345 0
Email 27345 0
Contact person for public queries
Name 10600 0
Professor David Gottlieb
Address 10600 0
Department of Medicine
Westmead Hospital
Westmead NSW 2145
Country 10600 0
Australia
Phone 10600 0
+61 2 98456033
Fax 10600 0
+61 2 96872331
Email 10600 0
david_gottlieb@wmi.usyd.edu.au
Contact person for scientific queries
Name 1528 0
Mr. Leighton Clancy
Address 1528 0
Sydney Cellular Therapies Laboratory
Institute of Clinical Pathology and Medical Research
Westmead Hospital
Westmead NSW 2145
Country 1528 0
Australia
Phone 1528 0
+61 2 98456212
Fax 1528 0
Email 1528 0
leighton_clancy@wmi.usyd.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AICytomegalovirus-Specific Cytotoxic T Lymphocytes Can Be Efficiently Expanded from Granulocyte Colony-Stimulating Factor–Mobilized Hemopoietic Progenitor Cell Products Ex Vivo and Safely Transferred to Stem Cell Transplantation Recipients to Facilitate Immune Reconstitution2013https://doi.org/10.1016/j.bbmt.2013.01.021
N.B. These documents automatically identified may not have been verified by the study sponsor.